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QUALITY AND STAFF ORIENTATION MANUAL

1. ation and lining Attendance Database Internal Staff Meetings Internal Staff Education and Traini Pathology Continuing Education Seminars Last updated 8 2 2011 http rhhlas26 health local pathology nata documentation toms code default_genuser201 1 A register of attendance at these meetings is taken All scientific and technical staff are required to attend a minimum of three sessions per year All the relevant professional societies have branches in Tasmania and staff are encouraged to be active participants in the professional and educational activities organized by these Branches It is recognized that given the complexity of much of our work it requires a specialist to design and document technical training programmes and then to assess competency It is expected that the components of on site training will include e Initial Staff Orientation on their appointment to the position in the Department e Reading and discussion of the relevant Policy and Procedure Manuals e Demonstration of procedures to new staff e Observation by the trainer of new staff performing those procedures e Sign off of new staff as competent to perform those procedures within prescribed limits eg only when senior staff are available can work unsupervised etc Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 23 of 89 RHH PATHOLOGY SERVICES Incorpo
2. results lookup system CIS users only OWNED BY TASMANIANS If you are not authorised 5 the Royal Hobart Hospital to view patient information please notify the Pathology I T coordinator immediately via 6222 8410 and return any printed pages to Royal Hobart Hospital Pathology Services Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 52 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Royal Hobart Hospital Integration Enter Patient CIS LINKS BOOKMARKS HISTORY User HELP LOGOUT Welcome to the RHH Pathology Results System Users can now search by Statewide THCI patient number directly from the Enter Patient field Royal Hobart Hospital medical staff are reminded that pathology result sign off must be carried out on the Digital Medical Record DMR system at http dmr dhhs tas gov au Pathology Patient Search Pathology Test Information Search tH General Pathology Information Clinical Guidelines Pathology tests This database contains the details of tests available through Royal Hobart Hospital Pathology Services To search type the name of the test eg fbc or full blood count For best results please make your search as specific as possible New or Updated tests from the last 30 days Pathology Specimen Tubes Quick Reference Guide Type the Name or Acronym of the Test y
3. Describe the follow up taken to verify the corrective action has been a success Names of participants in this corrective action activity Signed off by participants on Signed off by Senior Management on Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 88 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH APPENDIX 4 INCIDENT REPORT FORM QS Form 3 RHH PATHOLOGY SERVICES INCIDENT REPORT FORM QPulse No This form and its attachments will be scanned and filed inside QPulse Date of Incident Time Reported by Location of Incident Sample Numbers and or UR Numbers Involved Do you need this Customer or Customer Contact added into QPulse Do you need this Supplier or Supplier Contact added into QPulse Objective account of what happened and what has been done to correct it so far Give the names of staff who you think need to follow this Incident up Who knows about this Incident Attach copies of request forms invoices letters etc that are relevant to this Incident Make a photocopy of this completed form for your records and put the originals into the Quality Manager s mail box Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 89 of 89
4. Internal 9 Customer Against 2 Department Family Planning Tasmania _ Contact M Roberts Clare Family Planning Tasmania Process Fault Category Product Service 8 Decide if the Incident is being raised against another Department in Pathology or against a Supplier 9 Ifraised against another Department pick the Department off the drop down list Against Department O Supplier Seve Keywc Anatomical Pathology E Bone Marrow Transplant Document Central Processing Unit Resolution Ca CentrePath Closed By Core Laboratory dD Endocrinology Information Technology 10 If raised against a Supplier then pick the Supplier and the appropriate contact off the drop down lists If the Supplier or Supplier Contact that you want are not on these lists then let Tom Hartley or Graham Banks know and they will add them onto the lists You can continue filling in the form WITHOUT these details in the meantime Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 39 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Against Department 9 Supplier Radiometer Pacific Keyworc Contact E Resolution Closed 11 Select the Severity Code off the drop down list Be aware that SAC Codes 1 and 2 are actioned with high p
5. 2013 10 30 B11A 30 2013 25 2013 12 30 B14B iC 23 Jan 2013 30 Jan 2013 10 00 B12A ew 2 28 Jan 2013 30 Jan 2013 10 20 B17 George 27 Jan 2013 30 Jan 2013 5 15 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 73 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Clinical Information Portal RHHW2D Wednesday Patient Lists gt Unit gt CARDIOTHORACIC gt CLEM 129101 amp Demographics HCL Jan 1946 67y Female Alerts 1 Pathology Pathology gt Last 7 Days Last 8 Hours Last 24 Hours Last 7 Days Full History ALL Radiology Observation Request Status Ordered By Date Collected Full Details Biochemistry Routine Final New Doctor Code Reqd 13 50 Tuesday 29 January 2013 View Detail Full Blood Exam Final New Doctor Code Reqd 13 50 Tuesday 29 January 2013 View Detail Full Blood Exam Final Dr Xiaoping Jiang 11 30 Friday 25 January 2013 View Detail Biochemistry Routine Final Dr Xiaoping Jiang 11 30 Friday 25 January 2013 View Detail Dr Geetha Kottakad Pharmacy Blood Cultures Final 06 26 Friday 25 January 2013 View Detail B Remarks Audit Gopalakrish Microbiology Urine Final Dr Golsa Adabi 07 46 Thursday 24 January 2013 View Detail Microbiology Swab Final Dr Golsa Adabi 19 30 Wednesday 23 January 2013 View Detail Microbiology Swab Final Dr Golsa Adabi 19
6. 57 Hot Keys EEEa VEEE 58 OVEFvViIeEW T H 65 REPORTING OF RESULTS Clause 55 70 TRE DMR Results System m 71 The CLIP Results System 72 Results Policy 74 Telephoned Results Procedure Checklist eee 74 REMEDIAL ACTIONS AND HANDLING OF COMPLAINTS Clause 4 8 eese 75 COMMUNICATIONS AND OTHER INTERACTIONS WITH PATIENTS HEALTH PROFESSIONALS REFERRAL LABORATORIES AND SUPPLIERS Clauses 4 4 4 5 4 6 and 4 7 04 40 24 0 0000 20 0000000000000 75 TELE PHONE DIRECT ORY a 78 Pathol ISIS 78 AY MAI 78 INTERNAL AUDITS Clause 4 14 80 ETHICS ANNEX ET 80 STAFF ORIENTATION AND ORIENTATION 187 224 2 24 00 0000000000001000000000000000002042000000000000 00000 82 APPENDIX 1 ISO 15189 Contents Page eise eene onn enr eo e soasecesesesdesdavecsscaasasecsassassseseecs 64 APPENDIX 2 RHH QI Activity FOM veccscssnnssocsses
7. 1 Adds further detail to the Record Details if required 2 Reviews who has been nominated as the Corrective Action owner 3 Decides if additional people need to be nominated for additional Corrective Action steps Quality Manager QM 1 Reviews the CA PA Record 2 Scans the supporting documentation and attaches it to the Properties 3 Decides if additional people need to be nominated for additional Corrective Action stages 4 Discusses the CA PA with Dr Marsden and Dr Vervaart at the next weekly QM meeting Tuesdays 5 Regularly revisits the CA PA Record to see what progress has been recorded If there seems to be no action and it is getting close to the Target Date then QM will meet with SIC and discuss Once the Target Date has been reached QM will re table CA PA at Tuesday meeting and seek approval to close the record or extend the Target Date because actions are incomplete Uf ihe latices then OM vill meet with SIC and discuss Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 41 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH RECORDS MAINTENANCE AND ARCHIVING Clause 4 13 Request Forms We use only request forms that have been approved by the Health Insurance Commission Canberra We use this as our method of document control for these forms All Request Forms are scanned at time of Data Entry by the CPU staff and this
8. Reproduced here Quality Control Result Entry Word Processing Types of Notifications Report Group Scripts Worklists Entry Turnaround Time Utility Hot Keys PLS Purpose Throughout PLS there are a number of shortcuts available to the user to speed up the navigation to more frequently used tables or menu options These are available in the form of HOT Keys Hot Keys Alt 1 Table 1 Alt 1 Alt 2 gt Table 2 Alt 2 Alt 3 gt Comments Table Alt 4 Table 4 Alt 4 Alt 5 Urno Request Table Alt 6 Notifications Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 58 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Alt 7 Sample Sequences Alt 8 Print Definitions Alt 8 Alt 9 Test Information Table Alt B Edit Samples for Bactec Alt D View Scanned Images Refresh Alt E EMail Facilities Alt F Alt P gt Report Redirection Options Alt Q Quick Test Entry Alt S View Scanned Images Prompt Alt V View Doctor Table Alt W gt Histology Worklists Ctrl 9 Quick Entry Menu List Ctrl B gt Ctrl D gt View Scanned Images Refresh lt L gt Logout Ctrl Change Password Ctrl Q gt Produce Quote Ctrl R gt View Continuous Reports Ctrl S View Scanned Images Hot keys may be acti
9. 4 709 O ZI 02 11 10025 Jetuip 100 puno15 209 Lt uoniqiqx3 pue 45209 jenuuy GOVW 61 97 RAE MOM ERUNT epp JOOYIS Je2iui 200 4 punosg 709 1 O ZI OEIL 0 510322 02 10220485 UJ S puejeaz May 330H 5 j enuuy YSOH ETOZ IEEE EET I erui 109 4 209 2105 OE ZT OE TT 0 2ynuars jenuuy 10 1205 5 P EE suone3nss u ereds pue qeq gt gt 10224285 u T JOOYIS 2 10014 Wooy eurwas ASojoy3eg OE ZT O TT Tdv 00425 e3iui 200 5 punosy pO Tara lt
10. 5 2 10 All Staff must familiarise themselves with the Safety Manual Document ID QS Proc 4 viewable and printable from the Pathology Intranet Hardcopies have been issued to all Scientists in Charge for display in their areas If you have any difficulties in obtaining access to a Safety Manual then contact the Principal Scientist who will issue you with a copy All staff should complete the Staff Laboratory Safety Induction Form in the Appendix of the Safety Manual All specimens must be regarded as potentially infectious and handled accordingly Gloves aprons face shields masks and laboratory glasses are available for all staff If you require particular non stock sizes or types eg hypoallergenic gloves then you should contact your supervisor to arrange for these to be supplied There are adequate fume hoods laminar flow hoods Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 49 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH and designated containment areas around the laboratories for you to handle all specimen types and chemical hazards It is essential that when leaving a laboratory area you remove your laboratory apron and gloves and wash your hands It is not acceptable practice for staff to be seen walking into office and other non laboratory areas while still wearing laboratory aprons and or gloves The laboratories have adequate hand wash basins
11. Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 54 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH In addition we have the RHH PATHOLOGY SERVICES USER MANUAL see QS Proc 5 VALIDATION OF RESULTS Clause 5 7 Staff responsible for validating patient results will take into consideration o The adequacy of the Internal Quality Controls run at the same time as the patient specimen o The appropriateness of the specimen submitted for examination o The degree of agreement between the patient result and the Clinical Notes provided on the Request Form comparison between this result and the same patient s previous results delta checks On the basis of their assessment they will do one or more of the following Release the result for reporting Authorise Interim the result for review by a second person Withold the result and place it on the Pathologist Verify List in Kestral PLS Institute repeat testing to confirm the result before releasing any information about the result o Notify appropriate laboratory staff Pathologists and Clinical Staff Requestor according to triggers specified in the procedure for that examination Normal results and some abnormal results obtained from our highly automated online instrumentation are autoauthorised within the Kestral system without operator intervention Staff who are operating these instruments are ex
12. The RHH QI Unit provide forms for this purpose and they take on the responsibility for collection and follow up as part of the RHH ACHS Accreditation activities A copy of the Form is in Appendix 2 Instrument Maintenance Records and Calibration Records These are held in the relevant laboratory areas in close proximity to the relevant instrumentation Maintenance records are held for the duration of the lifetime of the instrument In the case of highly automated instruments calibration records are kept electronically within the instrument and on backup media In the case of less sophisticated analyzers calibration records are kept as defined within the relevant procedure manuals usually as a calibration worksheet Lot Documentation Certificates of Supplies and Package Inserts The original documents that come with calibrators QCs and reagents which contain specific data as to assigned values handling preparation or storage are kept within the relevant laboratory areas In the majority of cases these documents are scanned in whole or in part and these scanned images stored within the Document Control system as Word or Adobe PDF files for example see FISH Ref 13 and CHEM Proc 46 Incident Records and Action Taken Incidents are managed via the CA PA module in QPulse Staff Training and Competency Records Refer back to Section 6 for background information on this topic Bench level training records are kept in the laboratories and ret
13. amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 84 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH um ROYAL HOBART HOSPITAL QUALITY IMPROVEMENT ACTIVITY REGISTRATION Part A Unit Department 0 Division 0 Cross Divisional Organisation Wide Date 2008 Expected Completion Date 2008 UNIT DEPARTMENT DIVISION QUALITY IMPROVEMENT ACTIVITY TITLE EXECUTIVE SPONSOR CONTACT RESPONSIBLE PERSON NUMBER SUPPORT CORPORATE 0 CLINICAL QUALITY IMRPOVEMENT ACTIVITY INITIATED IN RESPONSE OsiP LICLINICAL INDICATOR LIRECOMMENDATION LCIEIMS LISERVICE IMPROVEMENT Comments SAC RATING ACTION TAKEN TO ACHIEVE PREDICTED OUTCOME 1 AIM OF THIS QUALITY IMPROVEMENT ACTIVITY Define the Activity in clear concise statement 2 DESIRED OUTCOME purpose or desired outcome of the activity The reasons why it is necessary to change 3 METHOD gathering the information Pamphlet Patient Staff Interview In patient Staff Phone O Staff Consultation 0 Staff Education Workshop 0 Consumer Involvement O Criteria Audit 0 Documentation Audit Patient Questionnaire O Patient Focus Group 0 Staff Questionnaire 4 PLAN OF ACTION Break down activity in key tasks The key tasks will form the major goals or milestones that will need to be achieved in
14. e Discipline based Unit Trust Funds Requests for accessing these funds should be directed in the first instance to your Scientist in Charge who will then discuss your application with the Staff Specialist s in charge of those funds e Pathology Department s Staff Development amp Equipment Allocation Requests for accessing these funds should be directed in the first instance to your Scientist in Charge who will then forward your application for consideration by PMC e Continuing Professional Fund Staff Specialists wishing to access this source of funds under the Salaried Medical Practitioner s Award should contact the Business Manager There is an annual internal programme of regular meetings coordinated by the Quality Manager and presented by staff drawn from each area of pathology The timetable for the year is available as a link from the Quality Systems Intranet webpage Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 21 of 89 un E Q p gt 2 E un 5 5 x gt T z Incorporating PATHOLOGY SOUTH 1002 jezu 100 4 709 suone3nsaAu er22ds OE ZT 06 11 edt E diera E D RN 2 241u2 uoniqiux3 25207 Suse HISY 8 LISZNY ZNYSH amp 0 0 100425
15. isolating identifying and characterising micro organisms causing disease A variety of methods are used including e direct microscopy e culture Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 7 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH serology and molecular techniques 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 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 Tasmanian 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 Ce
16. order for the activity to be completed What Who When How are you going to ensure staff know about this activity How will you know if this activity is a success Is this Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 85 of 89 Administration Only RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH activity designed to prevent incidents etc 6 EVALUATION When will this QIA be evaluated TIMEFRAME 3 6 9 12 months DATE REGISTERED AS ACHS EQuIP NUMBER GIA FILE NUMBER RECEIVED BY DATE APPROVED BY DATE EXEC HOD Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 86 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH APPENDIX 3 Corrective Action Form QS Form 6 RHH PATHOLOGY CORRECTIVE ACTION REQUEST AND REPORT FORM Brief title of the problem requiring corrective action Date Issued Issued by Issued to Full description of the problem requiring corrective action Define and verify the root cause of the problem Describe any interim corrective action taken Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 87 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Describe the permanent corrective action taken
17. Alt S View Scanned Images Prompt and Ctrl D View Scanned Images Refresh hot keys Further Hot Keys Alt A gt Alt C lt gt Alt T Alt U Ctrl A gt Ctrl Arrow Left Right gt Ctrl End gt Ctrl 12 gt ctr W gt Esc F4 lt Tab gt There are a number of keys available that act like Hot Keys Unlike the Hot Keys described above the following keys vary in where they may be activated from Some may be activated anywhere in the application others require the user to be in specific fields lt Alt A gt Return to Further Hot Keys Menu With the cursor positioned on a test field the individual test will be marked as an Add on and will appear in magenta In browsers the test will be flagged with a amp to indicate it is an add on test Add on tests are tests which are request usually verbally after the specimen has been received in the laboratory For more information on using this hot key please refer to the document Flagging Test Codes PLS lt Alt C gt Return to Further Hot Keys Menu If a specific field within an RDL Report Script is set up to take comment codes from the Comment Table follow this LINK to see how this is done and the user is in a report in edit mode with the cursor resting in that field then by pressing the Alt C hot key the user is displayed the list of codes in the specified category for the specified comment letter lt Alt H gt Return to Furt
18. Consultant oAnatornical Pathology amp Mortuary RAHAC e Core Laboratory Preanalytical e Cytogenetics Manager e Endocrinology e Microbiology State wide Sexual Molecular Medicine Health Centrepath RHH Phlebotomy CPU Pathology Infectious Registrars Diseases Admin and Clerical X 2 Physicians Send Aways Clinical Chemistry o Path Support Special Haematology Coagulation Special Chemisty Haematology Flow Cytometry Transfusion Medicine Stern Cell Laboratory Near Patient Testing Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 10 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH ROLES OF RESPONSIBILITIES OF MANAGEMENT Clause 4 1 5 LINES OF MANAGEMENT DIAGRAM PATHOLOGY SERVICES MANAGEMENT COMMITTEE PMC PATHOLOGY ADVISORY PATHOLOGY OPERATIONS COMMITTEE COMMITTEE PAC POC SUPPORT SERVICES Quality Management Purchasing Officer ANCILLARY UNITS Information Technology Centrepath Pathology Tasmania Statewide Sexual Health Service TERMS OF REFERENCE AND MEMBERSHIP OF MANAGEMENT COMMITTEES a PATHOLOGY MANAGEMENT COMMITTEE Membership Director of Pathology Principal Scientist Business Manager Terms of Reference e Undertake strategic planning for Pathology Services and Pathology South e Develop policies and guidelines to ensure the efficient use of the physical human and financial resources of Pathology Services and Patho
19. List RHH Coagulation Profle 30 Jan 13 0400 J woe 96 59 31 n Unit List RHH Full Blood Exam 30 Jan 13 0400 Diagnostic Cup 134 130 427 418 Doctor List Blood Gases Elecs 30 Jan 13 01 18 Blood Gases Elecs 29 Jan 13 22 54 e ree 438 4 24 412 3 84 My Detail RHH Blood Gases Elecs 29 Jan 13 18 35 C pondence mee RHH Blood Bank 29 Jan 13 1830 T Het 25 ES ES 255 Blood Gases Elecs 29 Jan 13 16 19 p mcv 92 91 92 92 Support RHH Blood Gases Elecs 29 Jan 13 14 13 Admission RHH Blood Gases Elecs 29 Jan 13 11 59 31 31 31 31 Blood Gases Elecs 29 Jan 13 10 03 RHH Chest X Ray 29 Jan 13 07 13 Archive 331 339 336 333 giL RHH Blood Gases Elecs 29 Jan 13 06 05 Blood Gases Elecs 29 Jan 13 04 01 Aes xS e Biochemistry Routine 29 Jan 13 0350 Platelets 277 258 223 220 RHH Full Blood Exam 29 Jan 13 0350 92 92 97 94 t 1 2 pow 10 2 10 3 10 7 10 5 ems 1 20 of 22 Neutrophils 47 34 29 20 4 Hos Pi immature Gran 01 04 01 04 Lymphocytes 34 27 34 23 Monocytes 1 3 0 9 0 6 0 6 m Eosinophils 0 48 H 0 29 0 29 0 20 Basophils 0 03 0 03 0 03 0 03 address bar Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 72 of 89 RHH PATHOLOGY SERVICES Inc
20. analyst will attempt to ascertain any causes in the first instance but failing to find solutions to the problem then he or she will alert the Senior Scientist for the area and then work with the Senior Scientist to try and effect a solution Monthly review of Internal QC is the responsibility of the Senior Scientist for the particular area of the lab Once testing has been halted because of Quality Control failures then it can only recommence when the Senior Scientist Scientist in Charge or Pathologist has issued a clear directive to this effect Unity Real Time QC In 2009 we began be rolling out BioRad s Unity Real Time QC package to most areas involved with quantitative QC You should check with your Section Supervisor as to the current situation in your area Unity Real Time File Select View Review Analysis Ady x4 ti Lab Panel Lab Panel 352334 Archi 1 352346 Immulite2500 a 352979 Veronica a 352429 Bio Rad 010 352432 CA1500 a 352444 STA Compact 371114 ELISA 3 6 6 6 E Refer also to CHEM Proc 79 for further details on the Unity Real Time QC system and its use LABORATORY INFORMATION SYSTEM Annex B Pathology Services uses Kestral PLS as its Pathology Laboratory Information system This system then feeds results data into the web based Clinical Information System and the Digital Medical Record system From the hardware point of view the system is maintain
21. company a solicitor the police etc then you must decline to assist and refer them to your Supervisor your Director the Principal Scientist or the Director of Pathology RESPECT FOR HUMAN SAMPLES AND REMAINS Staff are reminded that all Pathology Specimens particularly those sent for Histopathological examination are body parts and should be treated with respect Staff involved with the handling of post mortem and products of conception specimens are under particular obligation to handle these items ethically You should consult with your Supervisor in those areas as to the correct procedures GENETIC MATERIAL AND INFORMATION All samples that are examined for genetic information must be processed as confidentially as is practical Electronic and Hardcopy Records of genetic information must be stored in secure locations Genetic information must only be released to persons entitled to view it AUTOPSY INFORMATION A national code of Ethical Autopsy Practice was released in 2002 and staff are requested to follow these guidelines Staff of RHH Pathology carry out work on both clinical and coroner s cases Those involved must observe the highest levels of confidentiality practical AIDS HIV INFORMATION Staff involved with this testing and information must observe the highest levels of confidentiality practical There is National and State Legislation that applies to AIDS testing Electronic access to these results has been strictly re
22. eply key when positioning the highlight bar on a received email in the browser As you can see below some details are automatically filled in for you Users who do not have the authority to Send EMail are not allowed to change the recipient PLS32 Bl pls00200 htm Reading EMail Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 69 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH EMail can be viewed by any user of PLS and RMS by pressing the lt Enter gt Read EMail key if they have received any mail 5 Compile PLS A background task may also be set up to alert users to any Email which has come in Refer to Check For New Email for further information Deleting EMail Deleting EMail will remove it permanently from the browser REPORTING OF RESULTS Clause 5 8 Reporting of results is all handled in the first instance by Kestral PLS This system then feeds results data into the web based Clinical Information System CIS and the Digital Medical Record system Hard copy reports related to Medical Testing are only issued on colour coded stationery with a watermark showing the approved RCPA NATA Logo and Accreditation wording Reports that are not related to Medical Testing are issued on plain stationery Kestral PLS also has the functionality to fax reports For details on how to access Pathology Results on the CIS system st
23. image is viewable by pressing ALT and S keys simultaneously whilst in the Patient Details screen of Kestral PLS This means that we have electronic records of all Request Forms received since this procedure was commenced in March 2006 Original Request Forms have to be stored for 3 years Those that are not stored on site are stored with the company Recall Results and Reports All results are stored within Kestral PLS These records go back to 1994 Reprints of these results as patient reports can be produced at anytime Since November 2007 all reports on RHH Patients have been sent electronically via HL7 messages into the RHH Digital Medical Record system Results and Reports from Referral Laboratories The relevant information from these reports have been transcribed into the Kestral PLS system and hence are just as retrievable as our internally generated reports In 2013 we commenced scanning these reports into the Kestral PLS Request Form scanners system to make them electronically searchable Instrument Printouts These are usually stapled to the associated worklist and retained for three years Examination Procedures Documentation of Procedures are retained indefinitely as electronic records within the Document Control system Users of the Document Control system have the option of including obsolete document within their search criteria and in this way can retrieve any document that has been document controlled but since
24. information that relates to the current session of PLS or RMS and the workstation it is run on To learn more about the information that this screen provides follow the link Ctrl A world of information at your fingertips Ctrl Arrow Left Right Return to Further Hot Keys Menu Alter the date forward or backward a day at a time when used in any date field within the application Ctrl End Return to Further Hot Keys Menu Will return user to the main data entry Ctrl Fi2 gt Return to Further Hot Keys Menu Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 64 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH End session without saving This is a hot key that may be used from anywhere within the application It is a shortcut to the Utilities Menu Option Exit lt W gt Return to Further Hot Keys Menu Where multi worksite functionality is activated it is possible to allow users to change their worksite using the Ctrl W hot key The user must have the Worksite privilege to allow this By pressing Ctrl W the list of worksites will appear If the user does not choose a worksite then it will not be changed lt Esc gt Return to Further Hot Keys Menu To quit without saving and return to the previous screen lt F4 gt Return to Further Hot Keys Menu Lookup of tables from specific fields within the application Any fie
25. instructions and or the procedure put in place by Pathology Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 42 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH IT Support staff These data will be retained for up to three years the criteria for earlier deletion will vary but normally will be related to the fact that the patient s data have been passed to the patient s database in Kestral PLS which is also the repository of the relevant Quality Control data obtained at the same time of testing of that patient s sample s Complaints and Action Taken The centralized computerized Incident Reporting system is the repository of all such records The Incident Reporting system is also the repository of the Corrective Action records Records of Internal Audits All audit reports are lodged within the Document Control system The Audit Report is also the repository of the record of corrective actions taken Records of External Audits The NATA Assessment Reports have all been filed since 1999 in individual folders These folders include the paper records of the pre assessment questionnaires the assessment reports and the responses to the assessment findings External Quality Assurance Records The RCPA EQAP records are kept for a minimum of three years They are located in the laboratory areas responsible for the actual data returns Quality Improvement Records
26. of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 2 Document Module e Acknowledging Receipt of a New Updated Document e Searching for and Viewing Documents e Adding a Change Request on a Document 3 CA PA Module Corrective Action Preventative Action where we will lodge our Incident Reports e Read CA PA s that involve your Department e Lodge new CA PA s either by filling in the QPulse data entry screen or the via the Wizard If you do not wish to use either and would prefer to use a handwritten form then you should call up QS Form 3 for Incidents or QS Form 6 for Corrective Actions print a copy out fill it in and then forward it to the Quality Manager who will enter the details into QPulse on your behalf HOW TO ACCESS Q PULSE AND CHANGE YOUR PASSWORD 1 From the desktop double click on the Q Pulse 5 icon Q 5 2 The screen below should appear Welcome to Q Pulse Please Log on press F1 for help User Name Password 3 Enter your user name this will be the same as your computer login user name 4 The first time a staff member logs into Q Pulse the default password will be nata Click on the Log On button Once logged in the Reset Password screen will appear Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 29 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Reset Passwor
27. reply to a specific EMail lt Del gt ete Mail Allows you to delete mail from your list Sending EMail You are able to send EMail by selecting lt W gt rite Email You will be presented with the screen below PLS32 Iof Fields To This field can be filled in 3 ways Either by entering another user s PLS Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 68 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH or RMS user code by entering an EMail Group code or by selecting F4 to view all Subject This field allows you to specify the subject of your EMail up to 20 characters Urgent You are able to specify if the EMail is urgent or not by using either Y Yes or N No Include File This field allows you to attach a file to your EMail Here you specify the path to access that file For example H WORKPLS EXEC UPGRADE CUSTOMER LST The Word Processing field where you type the contents of your EMail is the last section to complete and can be accessed by pressing lt F10 gt Once you are happy with the contents of your EMail select F9 to Accept Send or if you no longer want to send the EMail press Esc and all input is abandoned After selecting either of these options you are presented with the Main EMail screen as described earlier Replying to EMail EMail can be replied to by any user by pressing the lt R gt
28. the anniversary of each document Externally produced documentation can often be obtained as PDF files These can be processed by the staff responsible using the Typewriter tool in the public domain program Foxit Reader so that a Pathology Document Control Number becomes an integral part of that document before it is distributed electronically All Controlled Documentation should only be printed out on the special paper with the red stripe along the right hand edge This paper is locatable from within Word from the available printers list viz RHH 1D Document Control Printer Colour HP LJ CP2025 Scientists in Charge are responsible for ensuring that out of date hard copy documentation is physically removed from the work areas The use of sticky notes and other handwritten instructions is not permitted There is an electronic sticky notes system available on the Pathology Intranet This records dates times and authorship of short term communications about Medical Testing related matters It is searchable by Test Instrument and Lab Requests for changes to controlled documents must be lodged via the QPulse Change Request module Q PULSE QUALITY MANAGEMENT SYSTEM SOFTWARE LEVEL 4 USERS GUIDE Users of Q Pulse with Level 4 will have access to the following functions 1 Launch Pad e Logging in e Changing Password Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 28
29. to the development evaluation and use of technologies that will increase the speed sensitivity and specificity of DNA testing in the future Endocrinology The Endocrinology Laboratory functions as a tertiary referral centre for the investigation of most endocrine disorders The service includes Acomprehensive range of basic and specialised hormone assays that are indicated in the areas of Diabetes Thyroid Adrenal Pituitary Fertility Growth and Parathyroid disorders e Tests carried out in the dynamic assessments of patients to investigate abnormalities in trophic to target hormone relationships e Biochemical and genetic screening of patients who have Multiple Endocrine Neoplasia Type 1 MEN1 e The Department has strong research commitments in the areas of Thyroid Autoimmunity and metabolism Diabetes management 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 Microbiology This includes Viral Serology Infectious Diseases and Sexual Health Services The Microbiology Laboratory supports clinicians managing patients with infections by
30. 0 2 104 821485 St pT 00 71 00 zepdn 3ojoyzed l l 00425 e tui 100 4 puno15 209 2 OE ZT OE TT 67 087890 Knsumqooig saves ul SpYI OOvI _ ens 2102 31 SLN3 3 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Issued February 2012 Page 22 of 89 Document ID QS Proc 1 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH RHH PATHOLOGY SERVICES INTRANET QUALITY SYSTEMS WEB PAGES Most of our Quality Systems Activities are now recorded in the Q Pulse Program There should be a quick link to that program on your Desktop or on your Start menu If not please contact Graham Banks Pathology IT Support Useful External Quality System Links NATA Homepage NPAAC Homepage Westgard s QC Website Standards Australia Website CLSI Clinical Laboratory Standards Institute Click here to return to go to Old Pathology Document Control Pages QUALITY SYSTEMS ONLINE DATABASES Haemoglobin Aic Analyzer Comparisons 000000000 Glucometer vs Architect Comparisons Fridges and Freezers Inventory System Pipette Calibrations Menu THERMOMETER CALIBRATION CHECKING TIMERS CALIBRATION CHECKING Conference External Education and Training Attendance Database
31. 00 Wednesday 23 January 2013 View Detail Blood Bank Final Dr Madeleine Beaumont 11 25 Wednesday 23 January 2013 View Detail Coagulation Profile Final Dr Madeleine Beaumont 10 55 Wednesday 23 January 2013 View Detail Full Blood Exam Final Dr Madeleine Beaumont 10 55 Wednesday 23 January 2013 View Detail Biochemistry Routine Final Dr Madeleine Beaumont 10 55 Wednesday 23 January 2013 View Detail A star denotes that the collection time has been estimated due to the omission of a written time on the sample Telephoned Results Policy Pathology results are only to be given to the Requesting Doctor or to medical staff involved in the care of the patient the Ward and Clinic environment pathology results can be given to Senior Nursing Staff and Senior Clerical Staff You should always make sure that telephone enquirers identify themselves to you first If in doubt take the patient details and the caller details and then arrange to call them back You can then check with your Supervisor that they are entitled to be given the results in question and that they are calling from a phone number in a known RHH Specialist Clinic or GP location Unauthorised incomplete interim or results awaiting verification by a pathologist may be communicated verbally to a Requesting Doctor or medical staff involved in the care of the patient by qualified scientists and experienced technical staff if circumstances warrant The staff member MUST ma
32. 9 CGen RC 5 Temperature Chart 7 07 2008 CGen RC 6 Test approval process 7 07 2009 CGen RC 7 CYTOGENETICS TUBE FOR BONE MARROW SPECIMENS 9 07 2009 CGen RC 8 ANALYSIS BY MICROSCOPY 3 08 2009 CGen RC 9 ANALYSIS BY MICROSCOPY 3 08 2009 CGen RC 10 ANALYSIS 9 07 2009 CGen RC 11 C Banding 3 08 2009 CGen RC 12 Silver Staining NOR 3 08 2009 CGen RC 13 Temperature Chart 28 07 2009 CGen RC 14 Temperature Record 29 07 2009 CGen RC 15 Temperature Record 3 08 2009 CGen RC 16 Solid Staining 3 08 2009 CGen RC 17 Selecting the best cell culture method 3 07 2009 Default CGen RC 18 twest 14 08 2009 27 Documents Awaiting CGen RC 20 Change request doc 1 19 08 2009 Documents Held 3 CGen RC 21 change request doc 2 19 08 2009 gt Draft Workflow Stopped CGen RC 22 change request doc 3 19 08 2009 My Draft Documents Doci Test2 5 08 2003 ICTC Pol 1 How to Restart CIS 3 08 2009 ICTC Pol 2 Testing Draft 23 06 2009 ICTC Pol 3 23 06 2009 ICTC Pol 5 Test 200908034 3 08 2009 Pee a go d Details Supportinginformation Confirm raise information Raised by Account1 Test Raised Date 20 08 2009 Severity Normal 4 Supply information about the change request in the details field 5 If there is any supporting information to be added to the change request this can be done by clicking on the supporting information
33. February 2012 Page 65 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH EMail facilities can be accessed using the AIt E hot key EMail Options The options available within the EMail browser are to Send Reply to Read and Delete EMail EMail can only be sent by users who have the Send EMail flag set to Y in the Authority Group Table PLS and Can Send Email in Privileges RMS You are able to send EMail to individuals or groups where the latter needs to be set up via the EMail Group Table To access the EMail facility use Alt E If you don t have any EMail in your browser you will be presented with a box as seen below with the option to either lt W gt rite Mail This option is described later in Sending EMail You must have the authority to send mail to have this option via the Authority Group Table PLS and Privileges RMS lt Esc gt ape No Mail To View You have not received any mail You do not have the authority to send mail PLS32 PLS EMail Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 66 of 89 RHH PATHOLOGY SERVICES E Incorporating PATHOLOGY SOUTH 1 al xl 12 19 13 11 Jan 2001 77777777 PLS EMail lt Esc gt ape No Mail To View However if you have EMail that you have either sent or received in your browser then the first screen you will be presented wi
34. 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 e a surgical biopsy service e autopsy service e gynaecological and non gynaecological cytology services including fine needle aspirate cytology e statewide renal biopsy service State Reference Service for specialist techniques such as electron microscopy and immunohistochemistry 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 Core Laboratory This includes Clinical Biochemistry Coagulation Haematology Transfusion Medicine It is also the location of the Central Specimen Receipt and Processing Unit CPU This laboratory provides the critical care and automated services to the RHH the Hobart Private Hospital Clinics and General Practitioners These services include the routine investigations associated with Full Blood Examination Haematomorphology Routine Coagulation tests Coagulation Factor assays Hypercoagulability testing Platelet Function studies Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 5 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Routine Biochemi
35. PATHOLOGY SOUTH INSTRUMENTS REAGENTS AND CONSUMABLES MANAGEMENT Clause 5 3 Analytical work on reportable pathology specimens ie Medical Testing must only be carried out using equipment owned or leased and maintained by this Laboratory Specimens may be processed on equipment outside of this Laboratory provide it is formally included of our Laboratory s Quality Systems or is maintained at a level equal to or better than our Quality Systems e Staff must only use laboratory equipment that is appropriate to the tests being performed well maintained and in good working order Defective equipment must be reported to your Scientist in Charge immediately who should withdraw it from service until it is repaired Defective equipment must be clearly labeled as defective and if possible disabled from use eg remove power cord remove all sample trays remove keyboard etc Redundant or backup equipment that has not been checked recently to be in good working order should be removed from the routine work area and or clearly labeled as Not To Be Used for Medical Testing Staff are expected to check critical operating characteristics of all equipment that they are required to use and to do this at the specified intervals mentioned in the procedure manuals and as appropriate to the equipment and its workload e Staff are expected to complete the relevant Equipment Records in the QPulse Assets Module The Assets Module of QPulse currently has
36. Proc 1 Issued February 2012 Page 34 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH File Edit View Actions Window Help i Register Active 5 08 2009 3 08 2009 3 08 2009 7 07 2009 7 07 2009 9 07 2009 3 08 2009 3 08 2009 9 07 2009 3 08 2009 3 08 2009 28 07 2009 29 07 2009 3 08 2009 3 08 2009 3 07 2009 14 08 2008 19 08 2009 19 08 2009 19 08 2009 5 08 2009 3 08 2009 23 06 2009 23 06 2009 3 08 2009 ysis FISH Certificate of Analysis Temperature Chart Test approval process CYTOGENETICS TUBE FOR BONE MARROW ANALYSIS BY MICROSCOPY ANALYSIS BY MICROSCOPY ANALYSIS C Banding Keywords Silver Staining NOR Temperature Chart Temperature Record Advanced Temperature Record Solid Staining CGen RC 17 Selecting the best cell culture method My Searches A S Default l CGen RC 18 twest 27 Documents Awaiting CGen RC 20 Change request doc 1 27 Documents Held CGen RC 21 change request doc 2 27 Draft Workflow Stopped 8 CSET C change request doc 3 My Draft Documents Doci Test2 ICTC Pol 1 How to Restart CIS ICTC Pol 2 Testing Draft ICTC Pol 3 ICTC Pol 5 Test 20090803A mom NI rS IN pew Document s Found 31 4 Ensure that the Register field at the top of the screen is set to Active 5 Click on the Search button 6 A list of all the relevant documents stored in Q Pulse will be presente
37. RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Document ID QS Proc 1 EXPIRES FEBRUARY 2014 4 4 DESCRIPTION OF PATHOLOGY SERVICES 4 5 EUUInislliqguiil 5 LADO Alor RE 5 CytogenelitS 6 Molecular Medicine 7 Endotriholo ty anarian PP 7 Microbiology 7 Special INVES SALONS 8 Phlebotomy Service 9 ox cusvosssseseiectceveneshersrensesevenesecestench 9 Information Technology Support 9 DIAGRAM OF ORGANISATIONAL STRUCTURE SHOWING INTERNAL AND EXTERNAL INUP VELAT cg 10 ROLES OF RESPONSIBILITIES OF MANAGEMENT Clause 4 1 5 eese tnnt tnn 11 TERMS OF REFERENCE AND MEMBERSHIP OF MANAGEMENT COMMITTEES 11 QUALITY STATEMENT POLICY and SCOPE OF ACCREDITATION Clause 4 2 3 14 QUALIT
38. S system provides patient billing facilities and management statistics The installation is now quite extensive and operates the Hospital s SITE2 compliant computers This infrastructure of hardware and software requires a dedicated team of support staff comprising a Senior Scientist from the Laboratory with special responsibilities for the ongoing development and upgrades to the Kestral PLS software and an Information Technology Support Technician with special responsibilities for the installation and maintenance of fileservers desktop PCs and printers These staff work in close association with PEC and POC and interface extensively with Kestral DHHS IT Services and hardware vendors in order to maintain a 24 hour a day 7 days a week 365 days a year service Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 9 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH DIAGRAM OF ORGANISATIONAL STRUCTURE SHOWING INTERNAL AND EXTERNAL RELATIONSHIPS RHH PATHOLOGY ORGANISATIONAL CHART Group Manager Clinical Support Feb 2042 ii lecuuenwandabweaaen i Director RHH Pathology PATHOLOGY Business Development Oficer DIRECTORS Anatomical Pathology Principal Scientist Clinical Chemisty Quality Manager Endocrinology Haematology Business Support Oficer Microbiology Purchasing Oficer Transfusion SCIENTISTS IN CHARGE Clinical Nurse
39. Y STATEMENT sonesssasepsdeensdnessensenessendoresbansonsdsondosestorseressonsdte 14 OBJECTIVES PEE A 14 SCOPE SERVICES 15 STAFF EDUCATION AND TRAINING Clause 5 1 19 QUALITY ASSURANCE Clause 4 2 eese eee eee sene tata 24 DOCUMENT CONTROL Clause 4 3 26 DOCUMENTATION THAT IS INCLUDED IN THE DOCUMENT CONTROL SYSTEM 27 Q PULSE QUALITY MANAGEMENT SYSTEM SOFTWARE eese eee entente tnn 28 LEVEL 4 USERS GUIDE 28 HOW TO ACCESS Q PULSE AND CHANGE YOUR PASSWORD scsssssssssssesssssssesscssssessessssesssssssssssessseasoes 29 ACKNOWLEDGING RECEIPT OF A NEW UPDATED DOCUMENT eese 31 SEARCH FOR AND VIEWING 34 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 1 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH ADDING A CHANGE REQUEST ccsisecsccscsccssusuventsuscsccocsveventeatesedscesuveutsstonscaeasesasheessesessocessranesusactensecgedactsteneestenesics 35 HOW TO RAISE A NON CONFORMANCE IN QPULSE scssssssssssssssossncssssecss
40. ade our staff s professional and technical skills via support for continuing education and for attendance at meetings of relevant professional societies To promote collaborate with and conduct research and development in all areas of diagnostic pathology To collaborate with the other units of the Department of Health and Human Services the University of Tasmania and the Menzies Institute for Medical Research in areas of mutual responsibility and interest To continuously review our activities and procedures to ensure that they remain consistent with the contemporary best practices expected of diagnostic pathology laboratories To continuously upgrade our instrumentation and information technology infrastructure to keep the laboratories in line with the best possible practices SCOPE OF SERVICES This laboratory was last accredited by NATA Medical Testing Accreditation following their inspection in March 2009 and is next due for their inspection in March 2012 NATA Accreditation No 3036 Medicare Accreditation No 38273 Facilities Category GX General Last Modified 20 June 2012 This facility complies with the requirements of AS 4633 2004 ISO 15189 2003 Detailed Scope 10 10 Microbiology 10 11 Bacteriology 01 Preparation of films for microscopic examination 02 Inoculation of cultures 03 Microscopic examination of clinical specimens 04 Identification of organisms including antibiotic susceptibility testing Au
41. aff should consult Document QS Proc 52 Within the RHH the Digital Medical Record DMR and the Clinical Information Portal CLIP are the two access points to online results Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 70 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH The DMR Results System Y INFO Username Password Copyright 2001 2013lnfoMedix Pty Ltd By logging onto the Clinical Patient Folder system you are agreeing to strictly abide by the patient confidentiality policy You can read the policy for confidentiality on patient information here Logout Advanced Search thartley Patient Search Episode Search Enter UR Advanced Search Patient details Patient List URNO D in All Search Family Name Advanced Given Name s Ward List DOB dd mm yyyy Clinic List Unit List Sex All Doctor List Treating doctor inpatients My Details Family Name Given Name s Support Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 71 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Patient Summary thartley URNO 104943809 Sex F DOB 13 Feb 1949 List Patient Cover URNO s Add to My Patient List Enter UR Advanced Search Patient List Date of Death Emergency Ad
42. ained until the person concerned resigns but if there is a prospect that the staff member may return in the foreseeable future then the records are retained eg staff member goes on maternity leave secondment to another Department etc The Departments are being encouraged to migrate some aspects of their Training Records system into Qpulse Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 43 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH ACCOMMODATION AND ENVIRONMENT Clause 5 2 We are expected to provide adequate space and facilities for the Handling of Specimens e Handling of Hazardous Substances e Laboratory Testing e Instruments and Equipment Reagent storage e Specimen Storage Records Storage This requires that all staff follow tidy work practices and good housekeeping Staff who work in common work areas such as the Core Laboratory or use common instrumentation such as the balances fume cupboards etc are under a particular obligation to conform with safe and tidy work practices Bench space results sheets and instruments must be left in a tidy and operational condition before you leave the area either having completed your analyses there or having come to the end of your shift there Staff should advise their Supervisor if they find that their work area has been left in an unacceptable condition by another staff member When new meth
43. al QC failure are e Is the QC Material still in date f Has there been a batch change g Has there been recent equipment maintenance repairs engineering h Has there been a change of calibration material eg new calibrator lot numbers new batch numbers or new sources 1 Does the QC Material appear homogeneous ie Was it reconstituted properly and stored properly after reconstitution j Are the appropriate method specific QC Values on the package insert being used If one of these is the cause then the error should be corrected and the Internal QC Material re run before proceeding to analyze any patient samples If none of these are the source of the Internal QC failure then consider k Use of different batches or lot numbers of the Internal QC Material Use of an equivalent Internal QC Material from a different manufacturer m Use of an equivalent Internal QC Material sourced from another laboratory In cases of equipment failure decisions will need to be made about repairs in house with or without the assistance of engineering staff either on site or off site Where the analytical system has been checked as much as possible the system has appropriate calibration and the QC materials are good then the problem must be referred to a Senior Scientist Scientist in Charge or Pathologist The Senior Scientist Scientist in Charge or Pathologist for the particular area may waive the QC rejection using their judgement after c
44. and you must wash your hands after all bench work involving specimens or chemicals and before leaving a laboratory area You should be careful not to contaminate telephone keypads or handsets and computer mice and keyboards by carelessly moving from your bench work to handling the phone or PC whilst still wearing gloves or before you have washed your hands Some areas have designated dirty telephones these should always be used with gloves on Some PC keyboards have keyboard protectors on these should be regarded as potentially contaminated infectious You must familiarise yourself with the contamination containment practices within your work area There are Spill Clean Up kits for the containment and clean up of chemical and biological material spills You must familiarise yourself with their location in your area and how to use them Your outdoor clothing personal bags shopping etc should be stored away from possible contact with lab coats or specimens so as to minimise the risk of contamination being carried outside of the laboratory areas Staff lockers are available in various areas of the laboratories and in Room D1 65 adjacent to the Pathology Administration area Consumption of food or drink in laboratory areas is strictly forbidden These activities must be restricted to the Common Room adjacent to the Core Laboratory the Conference Room D1 05 and staff offices Personal food items that require refrigeration must be placed in t
45. aramesh Parameswaran Sci in Charge 6222 7991 Pager 3640 Infection Control Mrs Rachel Thomson Clinical Nurse Consultant 6222 7882 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 Fax 6222 8047 Quality Systems Dr Tom Hartley Quality Manager 6222 8780 Specialised Investigations Mr Andrew Hudspeth Sci in Charge 6222 8396 Dr Scott Ragg Flow Cytometry and Stem Cell Transplantation 6222 8431 Pager 5812 Ms Janet Bartle Special Chemistry 6222 8742 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 79 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH INTERNAL AUDITS Clause 4 14 Internal audits are conducted on a regular basis with the objective of covering all clauses of the ISO 15189 standard within a twelve month period Emphasis however is usually given to the Technical Clauses of the standard as deficiencies in those areas will directly affect the quality of Medical Testing results The policy for internal auditing is covered in Document ID QS Pol 7 the procedure in Document ID QS Proc 9 and the schedule of audits in Doc
46. atomical Pathology Core Laboratory Cytogenetics Molecular Medicine Endocrinology Microbiology 00000 0 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 12 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH o Special Haematology Business Manager Quality Manager Information Systems Technician Pathology South Business Development Officer Preanalytical Manager Terms of Reference The role and function of the committee are to Assist in the implementation of strategies and resolutions received from the Pathology Management Committee PMC and the Pathology Advisory Committee PAC Assist in the implementation of the Division of Pathology Services business model Assist and report on the recruitment of staff and coordinate the duties responsibilities and leave of staff in the division Provide details of staff development and workplace requirements and assist in the implementation of staff professional review and development Assist in the resolution of problems associated with equipment quality of reagents and related consumables and in the coordination of equipment maintenance repair and service and on the acquisition of new equipment reagents and consumables Assist in the use of information management systems Provide advice and assist in resolution of problems associated with all of those components associated with the production of a patie
47. ble Hospital Ward Tables Service Team Table Fax Table Collection Centres HIC Doctor Table HIC Speciality Reference Alt 2 Table 2 Alt 2 Return to Hot Keys Menu Department Table Cost Centres Item Table Group Item Table Single Test Table Combination Test Table Report Group Table RDLs Aliquots Table Sample RDLs Sample Ranges Test Information Ward Report Table Alt 3 gt Comments Table Return to Hot Keys Menu Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 60 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH This option takes the user straight to the comments table listing each comment and its code category and date added Select from the options at the bottom of the screen as usual lt INS gt Add lt Cr gt Modify lt F2 gt Find lt F3 gt Report lt F4 gt List Alt 4 Table 4 Alt 4 Return to Hot Keys Menu Authority Department Table Authority Group Table Authority User Table EMail Groups Alt 5 Urno Request Table Return to Hot Keys Menu This Hot Key is in use at Royal Hobart Hospital It links to a table where Urno may be associated to an episode number Follow the Urno Request link for more information Alt 6 Notifications Return to Hot Keys Menu This hot key takes the user to the Notifications Menu Alt 7 Sample Sequences Return to Hot Keys Menu Shortcut to printin
48. boratory performs constitutional cytogenetics on peripheral blood from patients suspected of having a congenital chromosome abnormality Such patients may include dysmorphic infants young children with growth retardation adolescents with late onset of puberty or adult couples experiencing infertility 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 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 6 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Molecular Medicine 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 e Infectious Diseases e Markers of neoplastic diseases e 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 This laboratory has active externally funded research programmes and the staff are dedicated
49. ces External Documentation Instruction Manuals supplied with equipment Manuals and Electronic Media supplied with computers and computerised instrumentation Package Inserts supplied with Test Kits See Note 1 Package Inserts supplied with Quality Control materials See Note 1 Calibration Specification Certificates for Balances Thermometers Centrifuges Fume Cupboards Biological Safety Cabinets Timers Standard Weights spectrophotometric standards radiometric standards reference standards calibration materials Textbooks specifically referred to in Medical Testing Policies or Procedures and which must be referred to in order to perform the testing Journals specifically referred to in Medical Testing Policies or Procedures and which must be referred to in order to perform the testing Relevant ISO and AS Standards All relevant NATA documentation See Note 2 All relevant NPAAC documentation See Note 2 All relevant TGA documentation See Note 2 All posters flow charts and wall charts that have information directly referred to a Laboratory Policy or Procedure NOTE 1 Laboratories should retain a complete set of package inserts so that it is possible to follow the audit trail of all critical materials used in testing Every worklist should indicate the unique identity ie Version Number Lot Number Pathology Document Control ID Number of the relevant package insert NOTE 2 These or
50. cision was made to remove all Protocols and Guideines with a Medicine review date older than March 2010 as at 9 May 2011 Committee s Clinical Corporate Spreadsheet all current expired documents THO South Home Page List s of Removed Documents as at 9 May 2011 search Clinical Corporate Within C whole Intranet C RHH Ol PPG Intranet Page Editor lidija kalimnios dhhs tas gov au Managers Service Centre Employees Service Centre INTRODUCTION The purpose of this document is to provide all staff with an outline of the Department s overall e objectives e functions management e organisation e policies Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 4 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH e procedures and define how these are aligned with the specifications given in ISO 15189 Medical Laboratories Particular Requirements for Quality and Competence DESCRIPTION OF RHH PATHOLOGY SERVICES Clause 4 1 The Department is located in the Royal Hobart Hospital on Level 1 D Block The Specimen Collection Service that operates under the name of Pathology South is located on the 274 Floor of the Wellington Centre Argyle Street Royal Hobart Hospital Pathology Services is composed of the following discipline specific functional units Anatomical Pathology This includes Routine
51. commended for determining when separate reference intervals for subclasses are necessary 8 In those cases where a laboratory implementing a new analytical method wants to adapt a reference interval determined previously on its own patient population the process of transference can be used Several specific caveats are described In addition the working group strongly encourages laboratories to verify the new reference interval with a small group of reference individuals 9 The working group recognizes that establishing reference intervals is beyond the capability of most individual laboratories However the working group believes that verifying reference intervals established elsewhere eg manufacturers product inserts is feasible for most individual laboratories One can with as few as 20 samples from reference individuals use a relatively simple test to verify the applicability of a reference interval to one s own population The performance characteristics of this test and several other tests are described 10 In increasing numbers of cases eg cholesterol glycatedhemoglobin establishing and verifying traditional reference intervals as described in this document is not appropriate For such analytes where national or international consensus on decision limits exists it is critical that manufacturers and laboratories ensure their methods provide accurate results on patient samples SAFETY Clause 5 1 4 m 5 1 19 5 2 2
52. corded automatically Account1 Test Pathology Informat 19 08 2009 5 24PM 10 Click on the Save icon at the top of the screen Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 33 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 111 Recd Save 5 ee very Save the record 11 Close down the Document Details screen and Exit out of Q Pulse SEARCH FOR AND VIEWING DOCUMENTS 1 Login into Q Pulse using appropriate credentials 2 Click Documents on the Q Pulse Launch Pad Q LaunchPad lt Cole 3 The Custom Filter screen will appear Using the search engine the left hand side of the screen boxed in red select from the following parameters a Type a drop down menu will appear highlight and select the department the document originated from if known b Owner a drop down menu will appear highlight and select the name of the document owner if known c Keywords this is a free text field Type in any of the words that are in the title of the document or any words that may relate to the document e g After hours Out of hours Spills etc Using any one of these parameters will be useful in searching for a document searching using combinations of 2 or all 3 parameters will result in lists with fewer documents Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS
53. d Your password has expired or been reset by an administrator Please specify anew password Enter New Password Confirm New Password a registered traad Gaei Ltd Copyright 2007 Cancel Build 5 20 14 333 5 You must change this to something you will remember The new password will be case sensitive 6 The Q Pulse program will continue to login The Launch Pad screen will appear Le LaunchPad lt Cole___ fC 1 me ulse 7 To change your password in future click on the down arrow next to the second icon at the top of the launch pad head icon arrowed 9 LaunchPad lt Ej Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 30 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 9 To log out of Q Pulse click on the pad icon at the top right hand corner of the launch 10 If you are unable to log in or have forgotten your password contact the Pathology Quality Manager Tom Hartley or the Pathology I T Manager Graham Banks ACKNOWLEDGING RECEIPT OF A NEW UPDATED DOCUMENT Users of Q Pulse will be notified via email when relevant documents are updated or added to the Q Pulse quality management system The email will be sent to the users Microsoft Outlook account details of the document will appear in the email as in the example below New doc
54. d in the Customer Filter screen NOTE Pressing the Search button without filling in any of the details will produce a list of all documents on the system 7 To view the document click on the document title underlined and highlighted in blue 8 Documents stored in the Q Pulse quality management system are Read Only 9 If searching for the document could be improved by the addition of certain keywords contact the document owner with suggestions ADDING A CHANGE REQUEST Adding a change request to a document is a way of logging improvement ideas correction of errors or ensuring updates are made to that document The document owner will be notified of the change request raised against the document if the document owner chooses to reject the change request they must record reasons for the rejection 1 While the Custom Filter screen is displayed highlight the document that you wish to raise a change request for 2 Click on the Add Change Request Icon at the top right hand side of the screen Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 35 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH DER Active Date la APCyt Rec 2 very testing Add Change Request 1 Analysis Banding Quali 4 Add a change request to the selected documents CGen RC 3 Kestral Test Codes For FISH 11 06 2009 CGen RC 4 Vysis FISH Certificate of Analysis 3 08 200
55. dress Filter Search Select action View blank alert update form 7 episodes Be Outpatient sc Search Post Code Medicare No Home Phone Mobile Phone ATSI Status Advanced Ward List Clinic List Unit List Doctor List 60 62 nil Neither Aboriginal nor Torres Strait Islander origin Anglican English igned K Patient Bookmarks Diagnostic Number of documents Sr C pondence Cover 0 Religion Language My Details Emergency o p Admission Outpatient Support Community SS Archive Diagnostic Pathology Radiology Documents Description Correspondence Admission Archive Total The CLIP Results System When logged into Internet Explorer as a valid DHHS user of the intranet type clip into the Logout Cumulative Test Summary thartley List Patient Diagnostic Cover Enter UR LS RHH Full Blood Exam Filter ALL Emergency Patient List 5 Test Date Time Search s RHH Blood Gases Elecs 30 Jan 13 12 12 5 RHH BloodGasesiElecs 30 Jan 13 0958 f Test Type 30 13 04 00 29 13 03 50 28 13 04 00 27 13 04 00 Units Advanced RHH Blood Gases Elecs 30 Jan 13 06 54 RHH BloodGases Elecs 30 Jan 13 04 13 Community Film Made ae RHH Biochemistry Routine 30 Jan 13 04 00 r Clinic
56. e Document details record will open The document can be viewed by clicking on one of three icons a Click on the View Document icon located at the top of the screen APCyt Rec 2 1 Documents Details Q Pulse c A the top of the screen click on File View Document Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 32 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Ctrl 5 4 Review the document NOTE For documents that have been updated if it is not clear what changes have been made consult with the document owner 5 Once the document has been reviewed and understood the document can be closed 6 To acknowledge that the document has been read open the Distribution tab by clicking on the located next to the symbol on the right hand side of the screen 7 Locate and highlight your name in the distribution list Coles Helena Pathology Anatomical Pathology Account1 Test Pathology information Technology Townsend Alistair Pathology Anatomical Pathology Coles Helena Pathology Anatomi 19 08 2009 3 33 PM Accounti Test Patholoay Unformat Ve 19 08 2009 5 24 PM Townsend Alistair Pathology Anatomi 5 08 2009 4 31PM 5 08 2009 4 31PM Acknowledge the receipt of this document for the selected copyholder 9 The date and time the document was acknowledged will be re
57. earch staff can be reassured that the documentation they are referring to at the time is in date and is relevant to the task they are performing Documentation throughout Pathology is classified as being A Policy A Procedure A Record Form A Reference A Technical Report DEFINITIONS Document text or pictorial items that are used in either paper or electronic form Procedure this is synonymous with Method Record Form a template for hand entering or electronic entering of information by clients and or staff eg Pathology Request Forms Worksheets Temperature Charts Excel spreadsheets Registers of Essential Information Lists of information that staff are required to refer to as part of a procedure Examples could include Names and Address Lists Test Codes SNOMED codes lists of Accepted Abbreviations lists of Synonyms website addresses Normal Ranges Panic Values Delta Limits etc Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 26 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH DOCUMENTATION THAT IS INCLUDED IN THE DOCUMENT CONTROL SYSTEM Internal Documentation Policies Procedures Records Forms Technical Reports Minutes or Minute Books of Meetings Technical and Operational Memoranda Letters and or Memoranda issued to clients that relate directly to the provision of Pathology Servi
58. ed unbalanced chromosomal abnormalities by FISH 10 75 Molecular genetics Endocrinology Laboratory 99 Miscellaneous tests Genetic testing for Multiple Endocrine Neoplasia Type 1 STAFF EDUCATION AND TRAINING Clause 5 1 Staff can access their Position Description and Statement of Duties via online access to the DHHS Human Resources site Generic SODs are located on ftp Antra dhhs tas gov au pub agency_sod THO 20Sth Clinical 20Support Older SODs are located on ftp intra dhhs tas gov au pub agency_sod UNDER 20PREVIOUS 20STRUCTURE Southern 20Tasmania 20Area 20Health 20Service Royal 20Hobart 20Hospital You may be asked for your DHHS username and password before the page will open for you and you will need to know your Position Number The Department is committed to providing and supporting all relevant educational and training activities Whenever new complex items of equipment are purchased then the Department will ensure that relevant staff receive appropriate training If it is warranted then certain staff will be given advanced training usually by the supplier of the equipment and they will then be expected to be part of a train the trainer scheme for other staff in their area Staff are expected to share the responsibility with their supervisor for ensuring that their training and continuing education records are kept up to date Supervisors must ensure that records on external training and education are kept up
59. ed by our IT Support Technician From the functionality point of view this is maintained under contractural arrangements with Kestral Pty Ltd Staff who have issues with functionality should direct these to the Pathology IT Coordinator Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 57 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Access to the DHHS Network is administered by DHHS IT Services who can be contacted on 1300655564 They should be contacted in relation to problems with the programs included in the Microsoft Office suite Access to Kestral PLS is administered by the Pathology IT Coordinator who may consult with your Scientist in Charge or Departmental Director to determine the finer details of the level of access you require to perform your work Access to the Pathology Intranet site is administered by the Pathology IT Support Technician Up to date documentation on Kestral PLS is retained on the Kestral PLS website which can be accessed at any time http kms kestral com au products pls help index001 htm 11 You will need to be a registered user to access this online information IT Support can assist you with this if necessary The key functionalities of Kestral PLS documented there in alphabetical order include Aliquotting Anatomical Pathology Blood Bank Central Specimen Reception Daybook Faxing Hot Keys Reproduced here KMail
60. ed either by the enquirer or by the supplier of the goods or services in question If in doubt you should refer the enquiry to a more senior member of staff Although we are a public laboratory we do compete in the private arena via Pathology South Consequently you should not discuss or reveal aspects of our operations that give us various competitive advantages over other providers of pathology services LABORATORY CONFIDENTIALITY Virtually all laboratory tasks are privileged and confidential In addition to this a large amount of privileged information is available to staff in laboratory reports requests and records It is mandatory for every staff member to observe the utmost discretion with regard to their duties On no account are patients affairs of any kind to be discussed or any laboratory records or reports improperly or without authority disclosed to any unauthorised person whether within the Department or outside Staff must familarise themselves with the Department s full Confidentiality Policy and procedures see QS Pol 4 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 80 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH PUBLICATION OF PATIENT DATA IN PROFESSIONAL JOURNALS LECTURES AND ELECTRONIC MEDIA Professional publications and educational material prepared by you for publication or display at forums such as Grand Rounds Conferences Works
61. entsosesexssssocseidesssvoctessadssieeiesandseseessisesnescesdsesondesteescteesssendseteess ceteesedea 85 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 2 of 89 Document ID QS Proc 1 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Issued February 2012 Page 3 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH SCOPE This document complies with the ISO 15189 Clause 4 2 4 o It applies to all areas of Pathology Services at the o It must be read in association with the documents listed in the Quality Systems section of QPulse o Departments within Pathology Services may have Departmental Quality Manuals which contain additional material and those must be read in association with this document o In addition the Royal Hobart Hospital has Policy and Procedure Manuals which are now only available online on the RHH Intranet http intra dhhs tas gov au dhhs online page php id 16956 M D A DHHS Intranet THO South Policy Protocol Guidelines Clinical Policy Protocol Guideline ce Clinical Policy Protocol Guideline Corporate amp Corporate amp Support ABCDEFGHIJKLMNOPOQRSIUVWXYZ Support Policies Policy Protocol Guidelines amp Guidelines i Procedures Submitting a Protocol Emergency or Guideline An Executive Committee de
62. estigation of transfusion reactions 06 Red cell phenotyping 07 Antibody elution 10 Storage and distribution of blood and blood components 10 30 Haematology Special Haematology incl Flow amp Stem Cell 08 Blood film examinations involving special staining procedures 09 Examination for malarial parasites Thick and thin film examination ICT kit Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 16 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 25 Progenitor cell transplantation procedures Products received from Oncology Outpatient Unit Royal Hobart Hospital WP Holman Clinic Launceston General Hospital 35 Tests to investigate haemolysis 36 Screening tests for G6PD deficiency 41 General haemostasis related tests 70 Immunophenotyping Cytogenetics and Molecular Medicine incl virol 80 Molecular genetic studies Core Laboratory 01 Blood counts 02 Visual examination of blood films 03 Erythrocyte sedimentation rate 05 Automated differential leucocyte counts 06 Automated reticulocyte counts 20 Bone marrow examination 31 Tests for foetal Hb 41 General haemostasis related tests 45 Tests of platelet function 57 Screening test for infectious mononucleosis 58 Vitamin and folate serum and red cell Including intrinsic factor antibodies 59 Cryoglobulins 61 f microglobulin 10 40 Immunology Special Haematol
63. eters temperature loggers and glucometers in the Pathology Department Collect and collate data from all temperature monitors and temperature loggers in the Pathology Department Collate calibration and performance check certificates provided by external providers of services for pathology equipment Perform regular maintenance of all Pathology maintained point of care instruments POCT held outside the Pathology Department and maintain adequate supplies of consumables for these instruments Enter all data collected during the above activities into the appropriate databases Report any detected departures from specifications to the responsible Scientist in Charge and to the Quality Manager DOCUMENT CONTROL Clause 4 3 All documentation that relates directly to Medical Testing or our Quality Systems must be 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 The objective of the Document Control System is to ensure that only approved documentation is used at the bench for Medical Testing Purposes The system is designed to be as user friendly as possible so that by making a quick online s
64. ficient numbers of reference individuals the working group has introduced the concepts of multicenter trials and robust statistical methods a Well organized multicenter trials should allow for pooling of data from multiple sites By ensuring comparability in analytical methods as well as adhering to strict selection criteria the only remaining reasons precluding pooling of data might relate to population differences such as race and region Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 48 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH b Even in the absence of multicenter trials individual laboratories may be able to establish reference intervals with smaller numbers of reference individuals by employing modern statistical methods Examples of one of those techniques are provided 6 The working group has placed new emphasis on the concept of confidence limits of reference intervals With too few points confidence limits can be so wide as to make the reference intervals virtually meaningless As noted even though one can theoretically establish 95 reference intervals with the nonparametric method using just 39 values one actually needs 120 values to obtain 90 confidence limits for such intervals For any method of data analysis the use of more points translates into tighter and more useful confidence limits 7 A rigorous and systematic approach is re
65. field and selecting the appropriate file Ensure that the Embed in Q Pulse option is selected to attach the file 6 If required choose the severity of the change request from the drop down menu If the change request does not require immediate attention the severity level should be kept at Normal Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 36 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 7 Click on the OK button The document owner will receive an email informing them that a change request has been received on this document It will also appear on their Actions folder If the change request is not dealt with the change request will appear on the next draft review HOW TO RAISE A NON CONFORMANCE IN QPULSE 1 Login to QPulse and click on CA PA and then New then New Non conformance Recently Viewed From Wizard From Template E Q Pulse 2 Complete Source from the drop down list 3 Complete Owner as the Scientist in Charge of your area 4 Complete two to four lines of details be brief 5 Decide if the Incident is being raised by your Department Internal or raised on behalf of a Customer e g a doctor or clinic has phoned and pointed out a mistake we have made 6 If internal select your name off the drop down list Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Pr
66. g 6222 8770 Dr Shaun Donovan 6222 8770 Dr John McArdle 6222 8770 Clinical Chemistry Dr Udayan Ray Director 6222 8234 Endocrinology Dr John Burgess Director 6222 8732 Dr Tim Greenaway 6222 8732 Haematology Dr Katherine Marsden Director 6222 8337 Dr Liz Tegg 6222 8410 Dr Anna Johnston 6222 6637 Microbiology Dr Alistair McGregor 6222 8022 Pager 2414 Dr Louise Cooley 6222 8255 Dr Tara Anderson 6222 7449 Infection Control Dr Alison Ratcliffe 6222 8255 Sexual Health Service Dr Louise Owen Statewide Director 6233 3557 Senior Staff Anatomical Pathology Mr Alistair Townsend Sci in Charge 6222 8771 Deanne Lamb Cytology 6222 8235 Nino Mele Mortuary 6222 8333 Core Laboratory Mr Rob White Sci in Charge 6222 8199 Ms Terri Kidd Haematology 6222 8776 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 78 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 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 Fax 6234 7463 Pathology South Located in the Wellington Centre Reception Desk 6214 3058 or 6222 7121 Jane Stevenson Business Development Officer 6166 0152 Fax 6222 7097 Cytogenetics Ms Karen Dun Sci in Charge 6222 8297 Endocrinology Dr V P
67. g labels for Anatomical Pathology Cytology Alt 8 Print Definitions Alt 8 Return to Hot Keys Menu Print Definition Functions Normal Print Definitions Extended Report Definition Additional Report Definitions Request Letter Print Definitions Print Properties Alt 9 Test Information Table Return to Hot Keys Menu Shortcut to Test Information Table in Preparation Menu under Charges RDL Reports amp Tests This table is accessed also via the Alt 2 hot key Alt B Edit Samples for Bactec Return to Hot Keys Menu Shortcut to Bactec Interface For more information follow the link to Sample and Bottle Recording Alt B Alt D View Scanned Images Refresh Return to Hot Keys Menu For sites with scanning of request functionality set up this hot key allows the user to refresh the view of scanned images See also Alt S View Scanned Images Prompt and Ctrl S View Scanned Images hot keys Alt E EMail Facilities Return to Hot Keys Menu This hot key takes the user to the PLS EMail screen to quickly write and send a new Email Alt F Return to Hot Keys Menu Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 61 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Shortcut to activate the Manual Faxing option Alt P Report Redirection Options Return to Hot Keys Menu Shortcut to the Printer Report Redirectio
68. ganisations all have websites from which the most up to date documentation must be sourced as required The relevant URLs are NATA To get full access to all their documentation you need to register as a Member RHH Pathology staff qualify as Members see the Quality Manager if you encounter problems http www w nata asn au publications NPAAC http www health gov au internet main publishing nsf Content health npaac publication htm Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 27 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH TGA http www tga gov au industry devices htm All Pathology Policies Procedures and Records documentation must have a Title or Header that shows identity of the area to which the documentation applies ie RHH Pathology Services Name of Area involved All Pathology Policies Procedures and Records documentation must have a footer that shows unique Document ID Number as issued by the QPulse Document Control System program name of the person s Authorising the document Date Effective Page Number if greater than One Total Number of Pages A template for our documentation is available as Doc ID QS Form 1 All documentation must be reviewed by the author on a regular basis The QPulse Document Control Program will automatically email authors on
69. he Food Only designated refrigerators ENVIRONMENTAL ASPECTS Clause 5 4 6 All specimens should be transported as soon as possible to the laboratory Specimen Reception Area The RHH Wards all have access to Vacuum Tube Stations which makes it easy to send the majority of their specimens Bulky specimens have to hand delivered The online database of Pathology Tests and Specimen Requirements located on the RHH Intranet provides details on specimen transport and storage requirements Specimens that we refer to other laboratories have to be specially packed in accordance with the referring laboratories requirements and statutory authorities such as IATA This activity is co ordinated on a Pathology Department wide basis You should not dispatch specimens yourself without first discussing it with your Scientist in Charge All staff are responsible for checking that specimens have been handled correctly before they proceed to analyze them Incorrectly handled specimens will probably give erroneous results and they should not be processed Some specimens such as biopsies cannot usually be repeated so any mishandling is a disaster Some disasters can be fully or partially compensated for but this decision must be given to your supervisor or Scientist in Charge to make Results obtained from specimens that may have been mishandled prior to analysis must be clearly annotated as having Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley D
70. her Hot Keys Menu Host Lookup facility For sites with a PMI interface the user has the facility to access data stored in the PMI Host database by hitting the Alt H hot key This is typically done while in the Patient Episode screen or in Bag Tracking The user may search by Name URNO or Episode Nbr Lookup lt Alt T gt Return to Further Hot Keys Menu With the cursor positioned on a test field the individual test will be marked as to be telephoned and will appear in green In browsers the test will be flagged with a to indicate it is to be phoned For more information on using this hot key please refer to the document Flagging Test Codes PLS Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 63 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH In request entry Alt T will display the Telephone browser and allows details to be viewed or entered for telephoned results Alt U Return to Further Hot Keys Menu For larger sites making comprehensive use of the notifications system it has become necessary to implement a method of not only marking an entire request urgent using the U Special Condition but also to allow central specimen reception to flag only some test s on a request as urgent For example on a request containing multiple tests such as full blood count coagulation screen and liver function tests only the coagula
71. her number Hang up Enables you to redial the last number Redial TH called RECALL Establishing a telephone Dial conference call between you and two RECALL other parties 3 Way Conference RHH PATHOLOGY SERVICES PATHOLOGY SOUTH Callback Tone Pick up the receiver To Activate listen for dial tone Dial 70 and hear special dial tone Dial the number to which calls are to be forwarded Wait for confirmation tone To Cancel Listen for dial tone Dial 70 Wait for Confirmation Tone Hang up To Activate Dial 80 and the extension number to which calls are to be forwarded To Cancel Dial 80 To Activate 90 and the extension number to which calls are to be forwarded To Cancel 90 To Activate Press the recall button hear Special Dial Tone dial 74 Wait for confirmation Tone Hang up Call is now on hold Your phone will ring every 60 seconds as a reminder that you have a held call To Retrieve Held Call Pick up the receiver or press the switch hooks if receiver not hung up To Activate Press the recall button Original call is now on hold You hear Special dial Tone Dial the third party Consult with third party Press the recall button twice To Activate Press the recall button to place the call on hold dial 75 Wait for Confirmation Tone Hang up The call is now parked against the number of that extension To Retrieve Dial 75 followed by the extension number against which the call is par
72. hone extension can have voice mail activated on their phone This Code Will Let You How Feature Call back a busy extension To Activate On hearing a busy tone When your line and the called line are press the recall button hear Special dial Automatic Pe aL free automatic Callback rings you and Dial 88 hear confirmation Tone Callback 88 the call is automatically connected Hang Up when you lift the receiver To Answer You hear an automatic Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 75 of 89 Incorporating Forward all incoming calls to Call Forward 70 another extension All calls Some extensions may be able to call forward to a mobile phone Call Forward 80 Divert calls to another extension if if no answer not answered in the prescribed time Call Forward 90 Calls will divert if the extension is if busy busy Call Hold Place a call on hold Talk privately with a third party Consultation before returning to held call Hold transferring the call or establishing Three way Conference Park a call against the extension on which the call is answered or placed and retrieve the parked call from any other extension in the TASINET system RECALL Call Park 75 Answer incoming calls to other Call Pick Up 77 extensions within your defined Call Pick up Group RECALL Call Transfer Dial Transfer Calls to anot
73. hops etc must be rendered as anonymous as possible You should remove anything that identifies the patient s from photographs data tables pathology reports slides etc that you intend to use outside of the RHH Pathology Dept Electronic transmission of information on patients eg as email attachments to colleagues outside the RHH Department should be rendered anonymous before transmission Encryption of such electronic information should also be considered the Pathology IT Group should be consulted on your options in this area Faxes of patient information must only be sent to fax machines that are known to be in secure professional environments Before a computer leaves the Department for disposal or relocation elsewhere outside of the RHH Pathology Dept you must delete all confidential patient related information The Pathology IT Group should be consulted on your options in this area If you remove electronic media eg floppy disks or CDs with confidential patient information on it to do further work on it using eg your home computer then you must not store that information in an unencrypted form on that computer s hard drive Ideally the data components should remain on the portable electronic media at all times and returned to the RHH Department or destroyed If in doubt then the Pathology IT Group should be consulted on other options in this area If you are approached by an external agency for patient related information eg an insurance
74. ke it clear that the result being given is a preliminary or provisional report only Where applicable the laboratory should have documentation detailing the circumstances when release of such results is warranted Transcription errors are not uncommon when results are given over the telephone If you are giving out numeric results such as biochemistry or haematology then you should ask the caller to repeat each result as you read it out or ask the caller to read back all the results before they hang up Staff are required to use the ALT T function in Kestral PLS to record the date time and ID of the person to whom telephoned results have been issued Telephoned Results Procedure Checklist Identify yourself to the caller Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 74 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Y Identify the caller Y Ask for the Name and UR number of the patient V Ask for the Dates and Times of the specimens Y Read back the results v Ask the caller to read back all numeric results Y Record the ID of the caller using the ALT T Function in Kestral or by recording more extensive detail in the silent field of the relevant Kestral report Patients are not normally given their results over the telephone You should acquaint yourself with Policy and Procedure for the Release of Pathology Results to Patients Document ID QS P
75. ked To Activate Pick up receiver Dial 77 To Transfer Press the recall button Caller is now on hold Hear dial tone dial the number to which the call is being transferred Announce call To Return to Original Caller If the called extension is busy or there is no answer press recall twice to return to original party To Activate Pick up receiver Dial To Activate Call the first party explain you will be adding another party Press the recall button dial the other party Explain you are establishing a conference call press the recall button to connect all parties Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 76 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH The RHH Hospital switchboard can provide Voice Paging when required dial 9 to speak to the operator Most RHH clinical senior RHH clinical support staff and some Pathology staff carry NEC Pagers These can be used to alert those staff to call you back on a nearby telephone extension To do this dial 50 and follow the voice prompts In response to the request Enter message type in the 4 digit extension number you wish to be called back on followed by two asterisks Mobile phones are used by some staff however there is a risk that these can interfere with the electronics of computers and instrument electronics You should check with your supervisor before using a pe
76. ld that has a table associated will give the user access to the table via the F4 key In the Episode Entry screen at the Referring Doctor field for example one may gain access to the entire Doctor Table by pressing the F4 lookup key If the user types a few letters of the Doctor s surname as a prefixed search F4 will display all entries that start with the typed letters Further to this in a Date or Time field F4 will insert the current date or time The F4 key is the only way to gain access to the Isolate and Sensitivity Module ISM Access to the ISM is achieved by pressing the F4 key from the Sample Number field Internal Number 253 within a report in edit mode lt Tab gt Return to Further Hot Keys Menu Move to the next mandatory field in the episode registration screen KMail Overview Purpose The purpose of this overview is to outline the use Kmail within PLS and RMS Overview Kmail provides the facility for internal Kestral email Kmail to be sent to users of PLS or RMS Only certain users will have the ability to send but everyone will be able to receive and view mail How to Send and Receive KMail internal Kestral Email Purpose It is now possible for internal email to be sent to users of PLS or RMS Only certain users will have the ability to send but everyone will be able to receive and view mail The Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued
77. ll 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 e Quantitative CD34 assays to evaluate the transplantation of potential stem cell harvests The Special Haematology Laboratory performs specialist testing including e Haem pigment investigations e Lysozyme assays Red Blood Cell haemolysis investigations e Identification of Malarial Parasites e ELISA based assays including Anticardiolipin 32 glycoprotein Intrinsic Factor antibodies e ENA The Specialised Chemistry Laboratory performs a range of specialised complex and largely non automated tests for clients throughout Tasmania including organizations requiring occupational monitoring Specialist testing includes Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 8 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH e Trace element analyses Lead and cadmium usually for occupational monitoring and copper zinc and selenium usually for nutritional studies and parenteral nutrition patients e Urinary free catecholamines e A large number of qualitative and quantitative protein assays by Automated immunoassays Electrophoresis i
78. logy South Actas a conduit for input from Pathologists via the Pathologists Advisory Committee and other staff via the Pathology Operations Committee e Ensure processes and procedures are in place for the ongoing development of high quality customer focused services Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 11 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH e Enhance management reporting systems to facilitate optimum operational and financial control e Ensure that operational and financial systems are regularly reviewed for adequacy and compliance e Ensure compliance with legislative and regulatory requirements Facilitate integration where appropriate and liaison with external agencies b PATHOLOGY ADVISORY COMMITTEE Membership Director of Pathology Principal Scientist Director of Haematology Director of Anatomical Pathology Director of Endocrine Services Laboratory Director of Microbiology Director of Clinical Chemistry All Full Time and Sessional Pathologists Business Manager Quality Manager Terms of Reference e Staffing Education and Training Operational Issues Pathology South Equipment issues Quality issues Finance Business arising from other committee meetings Risk and safety Research c PATHOLOGY OPERATIONS COMMITTEE Membership Director of Pathology Principal Scientist Scientists in Charge An
79. lytical instrument to another o Changeover from one published method to another o Changeover from one sample type to another The evaluation will also include the effects upon Diagnostic Reference Intervals for the test s Pathologists are required to formally evaluate the clinical significance of any patient results observed in the comparison studies that fall into the zones with red dots in on the graph shown below Comparison of Patient Data vs Old amp New Ranges New Method Evaluation of non quantitative tests will be evaluated by appropriate Non Parametric Statistical Tests usually a Chi Squared Test and a rank test such as the Mann Whitney U Test sensitivity and specificity calculations and expert evaluation by a pathologist of the clinical performance of the old test versus the new test Areas performing microscopy based testing will use peer review as their method of method validation BIOLOGICAL REFERENCE INTERVALS Reference Intervals Clause 5 5 5 All laboratories producing numeric results must also provide the user with an appropriate biological reference interval or clinical decision limit against which the reported result can be interpreted It is our policy to follow the CLSI guidelines described in Defining Establishing and Verifying Reference Intervals in the Clinical Laboratory C28 A3 Third Edition 2008 This is available from the document control system as QS Ref 1 In the interest of brevity only the Summary p
80. n and corrective action taken Identify opportunities for improvement of the technical and quality systems Ensure that all technical and quality records are retained according to acceptable policies and procedures Acceptable policies and procedures are ones that comply with the stated requirements of NPAAC and NATA Establish and maintain procedures for identification collection indexing access filing storage maintenance and disposal of quality and technical records including reports from internal audits and management reviews Gather and distribute relevant information and directives from NATA and other accreditation bodies and relevant hospital committees and ensure that they are distributed to the relevant areas of the Department Organise an ongoing programme of education and training as needed for the staff of the laboratory about general quality matters Oversee the internal audit process including the training of internal auditors as necessary and the ongoing scheduling performance reporting and follow up of audits Organise and report on Management Review of the system The Quality Manager is assisted by a Quality Technician The Quality Technician s duties are Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 25 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Perform calibrations and performance checks for pipettes timers thermom
81. n facility Enables the user to temporarily redirect the printing of reports from the current workstation to a print queue other than the default print queue Alt Q Quick Test Entry Return to Hot Keys Menu For sites where the Quick Test Entry functionality has been specified Follow the link Quick Test Entry for more information Alt S View Scanned Images Prompt Return to Hot Keys Menu For sites with scanning of request functionality set up this hot key allows the user to view a scanned image See also Alt D View Scanned Images Refresh and Ctrl S View Scanned Images hot keys Alt V View Doctor Table Return to Hot Keys Menu This hot key allows for a user to view the doctor table without the ability to edit any of the enteries and add a new entry To activate this hot key the user must also have the authority Access View Doc Table enabled It would also advisable to deactivate the authority Setup Doctors Alt W gt Histology Worklists Return to Hot Keys Menu This hot key takes the user to the Histology worklists available for a specified sample letter Ctrl gt Quick Entry Menu List Return to Hot Keys Menu This hot key takes the user to Q Menu Only available for some sites Q Menus are generally run from Services Ctrl B Return to Hot Keys Menu Shortcut key to Blood Bank Information Table where specified for site Ctrl D View Scanned Images Refresh Return to Hot Keys Menu Fo
82. ndards as set by their professional societies the provision of the highest standard of service and support commensurate with their human physical resources abiding by all their published Objectives of the Department maintaining their familiarity with all documented policies and procedures relevant to the performance of their work and the provision of service to their clients the standards and sentiment of Total Quality Improvement as embodied in ISO 15189 and all relevant interpretative documents of that Standard as published by NPAAC NATA and the TGA OBJECTIVES To provide a comprehensive Pathology Service to the Wards and Departments of the Royal Hobart Hospital and the wider community To deliver Pathology Results that have been subjected to strict Quality Control Procedures prior to their release Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 14 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH To deliver Pathology Results with the shortest possible Turnaround Times To provide advice and consultation about interpretation of results and diagnostic procedures To provide educational and general advice on pathological matters to the medical practitioners and people of Tasmania To provide teaching and educational support to the hospitals and to the University of Tasmania Faculty of Health Sciences continuously upgr
83. nsibility 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 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 24 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH The position of Quality Manager will normally be held by a person with a senior laboratory scientist background Quality Manager s Responsibilities Establish and maintain procedures to control all documents that form part of the quality system Establish and maintain procedures for the review of requests tenders and contracts Ensure that work which is subcontracted by the laboratory is referred to a competent subcontractor who complies with ISO 15189 standards Ensure policies and procedures are in place for the selection and purchase of services and supplies which affect the quality of test results Ensure procedures exist for the purchase reception and storage of reagents and consumables Develop and implement mechanisms to obtain feedback from clients and monitor the laboratory s performance Establish and maintain policies and procedures for the resolution of complaints and non conforming testing Ensure that records are maintained of all complaints their resolutio
84. nt diagnostic result and on operational enhancements of processes and procedures associated with service delivery cost quality and value to our clients Assist in the resolution of any complaint received Assist in the implementation of research programs The Committee is an ongoing Committee and has Statutory Immunity from FOI requests For full details refer to Document QS Pol 16 old number 7605 d INFORMATION TECHNOLOGY SUPPORT Membership A Senior Laboratory Scientist An Information Technology Technician Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 13 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Terms of Reference To ensure the adequate resources for the operation of Pathology Laboratory Information System To maintain the computing resources of the Department To provide user support with computer programs To ensure the regular and secure backup of all Departmental Computer Files and Datafiles To safeguard the Departmental Computer Systems from unauthorized use and unauthorized access To ensure that the Pathology IT activities are compatible with the DHHS computer network QUALITY STATEMENT POLICY and SCOPE OF ACCREDITATION Clause 4 2 3 QUALITY STATEMENT The staff of the Department are committed to the provision of a professional pathology service that abides by all legislative requirements by all sta
85. oc 1 Issued February 2012 Page 37 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Raised Internal Customer Against 2 Departmer es eee Diano Joe Diggle Lisa Marie Process Donahue Patricia Donovan Shaun D Silva Tetyana Product Dun Karen Service Durack Juliana Fault Category CAMMYCytogenetics Endocrinology Special InvestigationsYSp Anatomical Pathology Core Laboratory CAMM Cytogenetics Microbiology v E Corrective Acton 7 If raised on behalf of a Customer search for the customer and select them off the list You can then select a contact from the list of contacts for that customer If the customer or customer contact that you want are not on these lists then let Tom Hartley or Graham Banks know and they will add them onto the list You can continue filling in the form WITHOUT these details in the meantime Raised By Internal 9 Customer Against Department Supplier Severity Search for Customer Contact Process Keyword Fault Category 2 search Description Family Planning Tasmania Corrective Acton Follow Up Properties Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 38 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Raised
86. ocument ID QS Proc 1 Issued February 2012 Page 50 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH been obtained under non ideal conditions and that the results may therefore be of inferior quality and or accuracy All staff are expected to record notes on specimen conditions that may affect results eg blood staining of CSF haemolysis lipaemia or icterus in serum samples etc Specimens collected for referral to other laboratories must be collected and transported under the conditions specified by the Referral Laboratory Any errors or deviations from their procedures must be documented on the Pathology Request Form we send to them with the specimens so that they are fully informed of the circumstances LIST OF EXAMINATION PROCEDURES Clause 5 1 4 Consult the online Specimen Requirements Database http rhhlas26 health local path tests dhhs default asp REQUEST PROTOCOLS PRIMARY SAMPLE COLLECTION AND HANDLING OF LABORATORY SAMPLES Clause 5 4 We are obliged to give to our requesting doctors and their patients adequate information and equipment to enable them to understand e what patient preparation is required what equipment is required for appropriate specimen collection Because this information changes on a regular basis the Department has opted to distribute this information via the RHH Intranet You should familiarise yourself with this facility so that you can guide people making telephone enquirie
87. ods and procedures are introduced this will affect how bench space and instrumentation are used in the future Staff are expected to be flexible contribute to the redesign of their facilities and adapt to the changed requirements If you regard that any work area is being compromised on any of the above criteria then your must discuss this with your Supervisor The laboratories are all centrally air conditioned If the ventilation appears to be inadequate inform your supervisor who should then follow the matter up with RHH Facilities Management Some areas have additional air conditioning eg Core Lab where there is a an extra thermal or other load These can be adjusted by staff in those areas by using the unit s infra red controls Lighting must be adequate for your work and defective light globes fluorescent tubes etc must be reported to your supervisor who should then call in RHH Facilities Management to replace the defective item s Colour Coded Emergency Power Outlets are provided throughout the laboratories and you should ensure that all mission critical instruments and computers are connected to these outlets The Emergency Power generators are tested once a month by RHH Facilities Management and you should report any power fluctuations during these tests to your supervisor Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 44 of 89 RHH PATHOLOGY SERVICES Incorporating
88. ogy incl Flow amp Stem Cell 12 Detection of autoantibodies in body fluids and biopsy material Special Chemistry 02 Qualitative investigation of immunoglobulins G A M and D in body fluids including paraprotein typing CSF oligoclonal bands and Bence Jones Proteins 12 Detection of autoantibodies in body fluids and biopsy material Endocrinology Laboratory 12 Detection of autoantibodies in body fluids and biopsy material Core Laboratory 01 Quantitative investigation of immunoglobulins A M and D in body fluids 10 Rheumatoid factor quantitative assays 10 50 Anatomical pathology 10 51 Histopathology 01 Histopathology of biopsy material 02 Immediate frozen section diagnosis Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 17 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 03 Immunohistochemical investigation 10 52 Cytopathology 01 Gynaecological cervical 02 Non gynaecological 03 Fine needle aspiration of biopsy specimens 10 54 Examination by electron microscopy 10 60 Chemical pathology 10 61 General chemistry Special Chemistry 03 Proteins qualitative and semiquantitative analysis including by electrophoresis and immunoelectrophoresis 09 Trace elements 30 Sweat electrolytes 56 Biogenic amines 60 Glycohaemoglobins 62 pH of urine and fluids by electrode 63 Breath tests 74 Reducing substances and or other sugar
89. oints have been reproduced here Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 47 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH The basic principles that follow are uniformly important and must underlie any reference value study 1 The selection of reference individuals must be thoughtful with advance consideration given to exclusion and partitioning criteria The reference population must be appropriate and useful to the process of determining disease or abnormalities in the patient population The evaluation of the health status of the reference individuals must be documented and described as part of the reference value study or reference intervals defined The better the reference individuals are defined and described the greater the value of the reference interval studies a The working group again rejected the concept of a gold standard reference population of absolutely healthy young adults as a prerequisite for the determination of a health associated reference interval b As a general rule the use of hospital or clinic patients as a source for reference individuals was also rejected Patient data should only be used for deriving a reference interval when nonpatient reference individuals cannot be obtained and only with careful selection and attention to exclusion and partitioning criteria 2 All of the preanalytical and analytical processe
90. onditions specified by the manufacturer Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 45 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Only supplies that are in date will be used in Medical Testing procedures Only supplies that are received intact will be used in Medical Testing Supplies used for Medical Testing will be purchased with the longest Lot Runs and Use By Dates possible Supplies which deviate from these requirements will be the subject of Incident Reports There will not normally be periodic review of supplier performance but instead supplier performance will be monitored continuously on a by exception model ie If there are no Incident Reports that cite a particular supplier then that supplier is classified as compliant with our requirements VALIDATION OF EXAMINATION PROCEDURES Clause 5 5 2 All medical testing procedures have to be validated before use and revalidated after any substantial change in the procedure In our Department the usual situation is that we change from an old kit to a new kit or an old instrument to a new instrument In these scenarios we must determine that if there are differences in the analytical and diagnostic performance associated with the change A recent background article on the relevant issues and statistical data handling appeared in the Clinical Biochemist Review A
91. onsidering factors such as n Is the rejected QC at a similar concentration to the test samples The clinical impact of releasing the test results p The possibility of matrix effects in the QC material creating different responses in the analytical system to test samples etc REVIEW OF INTERNAL QC Initial review of internal QC is the responsibility of the analyst performing the testing and at the time of testing All numeric QC Data will be recorded on either paper or electronic forms of the Levy Jennings Plot All areas involved in quantitative testing will document monthly Means SDs and Coefficients of Variation on all of those assays Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 56 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH All areas involved in quantitative testing will document monthly assessments of fixed or relative bias in the monthly Internal QC Data Where batch frequencies are low this will be extended to a more relevant frequency eg once every 10 15 batches All areas involved in quantitative testing will periodically compare their Internal QC Statistics with their External QC Statistics and with the statistics reported by External Quality Assurance Programmes for the same methodologies as their own Periodically means at least at the end of each External QAP Cycle of testing In the event of an Internal QC failure then the
92. orporating PATHOLOGY SOUTH e 7 https clip health local Public Home aspx 117 Favorites 13 Abbott Diagnostics Tests L suggested sites v Connecting th bj em Safety Tools e Anonymous Login Clinical Information Portal Wednesday 30 Jan 2013 14 42 0 Actions Help Select your facility Royal Hobart Hospital Patient Lists Prescription Tracking Drug Location Search Customisable practice Dispensing status of Availability of drugs in centric lists of patient current and recent imprest lockers as sourced mm E from iPharmacy stock levels centric data combined into prescriptions at your a single access point hospital Pharmacy 9 1 4 EDIS View Summary emergency department patient lists for non emergency department staff 77 s Digital Medical e Medical Images PharmCare Citrix Kestral CIS Nursing Referrals DMR Emergency Honeywell Work Patient Flow Manager DHHS Intranet DHHS Internet Backup Link Requests RHH Clinical Intranet Pathology Test Information CLIP CARDIO Clinical Information Portal Royal Hobart Hospital Patient Lists gt Cardiology gt CARDIO gt Please Select a Patient gt Cardiology Ward Bed Alert Admitted Pathology Result Ward RHHW2D B16 BA d iC 28 Jan 2013 30 Jan 2013 4 30 B12C iC 18 Jan 2013 30 Jan 2013 10 15 B11C i 27 0 2012 30
93. ou wish to search for Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 53 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Synonyms Lanoxin Digoxin Levels Dig Levels Result Daily as required at RHH Biochemistry Tel 6222 8775 Collect sample immediately prior to next dose or alternatively 6 8 hours post dose Digoxin assays will not be reliable during treatment with digibind as the drug interferes with the assay Reliable results will only be achieved after digibind is cleared through the kidneys The half life of digibind is some 15 20 hours in Comments patients with normal renal function Click for appropriate sampling times and intervals Sample type Venous Blood Vol required Tube type Tube details 2 mL SST 4mL Red top with gel y This test is rebatable through Medicare MBS Item No 66800 Fee 18 45 Benefit 75 13 84 Benefit 85 15 68 NOTE Approximate cost e Medicare coning rules may apply e A Patient Episode Initiation PEI fee may be charged General Advice e Patients are asked to bring their Medicare card for bulk billing e Public Inpatients and Emergency Department admissions will not receive an invoice RCPA Pathology Test Information A version of this database suitable for viewing on web enabled mobile phones can be accessed at www centrepath dhhs tas gov au testinfo Authorised by
94. owers and Eye Wash Station Location of Spill Cleanup Kits Introduced to the local Safety Representative and Fire Warden Location of printed MSDS and shown how to access online What to do in case of Accident at work Attend staff health clinic and reminded of recommended immunisations for work area Read Pathology Laboratory Safety Manual NOTE In addition to the Pathology Safety Manual some laboratories have developed their own Safety Manual The new staff member must also read their departments safety manual if available Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 83 of 89 ISO Int 1Sc N OO 1 OY O1 CO O1 O1 O1 O1 O1 S US uu RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH APPENDIX 1 ISO 15189 Contents Page 15189 CONTENTS PAGE ONG ormative references Terms and definitions Management requirements Organization and management SVSECM x DOCUMENT 19 4 2 Review of contracts Examination by referral laboratories External services and supplies Quality management Advisory services Resolution of Complaints seste ee ans con
95. pected to be familiar with the autoauthorisation rules that are being applied QUALITY CONTROL Clauses 4 9 and 5 6 Test results from patient samples shall not be released if the analytical system is demonstrably not working within acceptable Quality Control Limits This decision will be made during Normal Working Hours by the Senior Scientist or Pathologist responsible for the area Out of Normal Working Hours this decision can be made by the Scientist performing the testing with or without consultation with the On Call Senior Scientist or Pathologist for the area provided this is in accordance with the local Departmental Policy under these circumstances Troubleshooting In general terms failures in Internal QC will reflect failures in the post patient sampling components of the test ie failures in one or more of the following areas a The equipment or analytical methodology b The analytical skills of the operator or adherence to the analytical protocols specified for the test c The integrity of the calibration material d The integrity of the Internal QC material itself Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 55 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH It may be necessary to visit each of these areas in detail to solve a problem in the event of the internal QC appearing out of control Commoner areas to check in the event of Intern
96. r sites with scanning of request functionality set up this hot key allows the user to refresh the view of scanned images See also Alt S View Scanned Images Prompt and Ctrl S View Scanned Images hot keys Ctrl L gt Logout Return to Hot Keys Menu Logs the user out back to Login Screen Shortcut to the Utilities Menu Option Log Off Ctrl P Change Password Return to Hot Keys Menu From anywhere in the application the Ctrl P hot key allows the user to change their password As a security measure before any modification is permitted the user is prompted to enter their old password If the user forgets their password they should contact their key user to have a new password issued Ctrl Q Produce Quote Return to Hot Keys Menu From anywhere within the application the Ctrl Q key combination allows the user to produce a quote for the test codes and bill category entered Ctrl R View Continuous Reports Return to Hot Keys Menu Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 62 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH For sites where Continuous Reporting is set up Ctrl R displays Page Number Series Number of the specified report lt S gt View Scanned Images Return to Hot Keys Menu For sites with scanning of request functionality set up this hot key allows the user to view scanned images See also
97. rating PATHOLOGY SOUTH On site training will be repeated for staff who e have been involved in the production of sub standard work e have been absent from a work area for more than a prescribed period of time and are returning to perform that work again e have not been familiarised with recent technical modifications to the procedure s Wherever possible Scientist in Charge will nominate specific trainers for the activities in their areas and periodically review the competency of those staff as trainers Reference Work based assessment ABC of learning and teaching in medicine John J Norcini BMJ 2003 326 753 755 In 1990 psychologist George Miller proposed a framework for assessing clinical competence At the lowest level of the pyramid is knowledge knows followed by competence knows how performance shows how and action does In this framework Miller distinguished between action and the lower levels Action focuses on what occurs in practice rather than what happens in an artificial testing situation Training records will be developed in all areas and at each stage of the training the record will show that both the trainee and trainer have signed off and dated each stage or logical block as defined by the Scientist in Charge or Pathologist in their Training Policy and Procedures QUALITY ASSURANCE Clause 4 2 The overall coordination and management of the quality systems in this Department are the respo
98. records on Centrifuges Incubators Laminar Flow Hoods Biological Safety Cabinets Microscopes Thermocyclers and Weighing Balances This list will be extended over the coming months as Scientists in Charge add more of their items to this list e Regular service checks preventive maintenance and calibration checks must be made on all equipment and appropriate records kept Repairs to equipment must be documented as part of the service record e Cleaning and decontamination of equipment and instruments must be performed on a regular basis and occasional spillages must be cleaned up immediately e Water baths and heating blocks must be checked regularly for growth of microorganisms and an appropriate decontamination program implemented on both a preventive and corrective basis Where electrical power fluctuations are liable to occur and adversely affect equipment performance voltage stabilisers must be fitted Blood Bank refrigerators must be provided with continuous temperature monitoring and include an appropriate alarm system to alert staff if the temperature exceeds pre set limits These refrigerators must be commissioned and maintained according to Australian Standard AS 3864 2 Medical Refrigeration Equipment for the storage of Blood and Blood Products QS Ref 21 All temperature sensitive supplies used in Medical Testing will be checked on receipt with regard to the temperature they were transported at and then stored under the c
99. riority 12 Complete the Process Fault Category and Product Service from the drop down lists These are not compulsory and may be altered by the Scientist in Charge or Quality Manager later on 13 Fields Document Resolution Closed by Standard Root Cause Closed Date Target Date should not be completed by you 14 Open up the Corrective Action tab and only put your suggestions in the Details box 15 Do not complete anything in the Follow Up tab 16 Click on the Floppy disk icon to save your CA PA record When you do this the Number on the very top row will be completed by QPulse Write this number onto your handwritten copy of the Incident Form 17 Put a copy of your handwritten Incident Form into the Quality Manager mail box This will be scanned for you and attached to the Properties tab of the QPulse CA PA form This way the full details of the original incident and larger documents associated with follow up and correction will be lodged here 18 You can log back into QPulse to view the progress of your Incident Report at any time Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 40 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH LIFE CYCLE OF A CA PA Staff Member Raises the CA PA Scientist In Charge SIC reviews the entries made by the staff member and the supporting documentation
100. roc 51 REMEDIAL ACTIONS AND HANDLING OF COMPLAINTS Clause 4 8 All complaints that are considered to be of sufficient importance are to be lodged into the Incident Reporting System refer back to relevant section in this document The full policy and procedure for Incident Reporting is covered in Document ID QS Pol 8 The Incident Reporting System now referred to as the CA PA module in QPulse is also the repository of all Corrective Actions taken as a result of an incident A copy of the Incident Report Form is available online as Document ID QS Form 3 and also in Appendix 4 A copy of the Corrective Action Request and Report Form is available online as Document ID QS Form 6 and also in Appendix 3 COMMUNICATIONS AND OTHER INTERACTIONS WITH PATIENTS HEALTH PROFESSIONALS REFERRAL LABORATORIES AND SUPPLIERS Clauses 4 4 4 5 4 6 and 4 7 All staff are expected to conduct their communications in a professional and ethical manner regardless of the medium being used phone email memorandum letter etc Any communication directly related to Medical Testing and which has the potential to affect testing operations testing equipment testing controls testing results or testing interpretations must be formally recorded and retained as per the guidelines in Records Maintenance and Archiving of this document The internal telephone system is maintained by Tasinet and has a number of user features In addition staff who have a dedicated p
101. rsonal mobile phone in your laboratory area Some laboratory areas issue Departmentally owned mobile phones to on call staff Official Pathology business calls to mobile phones should be kept to a minimum because of the extra costs associated with these A recent directive recommends that if possible you should use SMS messaging to mobile phones To use the GDS SMS messaging service e Goto DHHS Online http intra dhhs tas gov au dhhs online dhhsonline php e Click on the GDS item at top right of the Home Page e Enter Family Name e g Carey e Click on Family Name Displayed e Scroll to bottom of page e Click on Mobile Number Hyperlinked and will open field for short specific SMS Message To Change Details eg to have your mobile number listed o Click on GDS Change Form o Click on Submit Should you require further information please contact RHH Communications on telephone Ext 7999 Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 77 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH TELEPHONE DIRECTORY GENERAL ENQUIRIES Ext 8416 Senior Management Director of Pathology Dr Katherine Marsden 6222 8410 Principal Scientist Dr Peter Vervaart 6222 8240 Business Manager Mr Mike Jones 6222 8948 Fax 6222 8996 Pathologists Anatomical Pathology Dr David Challis Director 6222 8770 Dr Peter Jessup 6222 8770 Dr Vince Murdolo 6222 8770 Dr Eileen Lon
102. s in urine and faeces including laxative screen 77 Calculi 78 Intermediary metabolites Endocrinology Laboratory 02 Proteins quantitative analysis 20 Hormones 47 Vitamin assays Vitamin D 78 Intermediary metabolites Homocystine 99 Miscellaneous tests Chromogranin A Core Laboratory 01 Analytes in general use in cardiac liver function lipid renal and other profiles and metabolic studies 02 Proteins quantitative analysis 04 Point of care testing for blood gases glucose and other profiles Analysers located in the Intensive Care Unit Neonatal Intensive Care Unit Operating Theatres and Emergency Department of the Royal Hobart Hospital 06 Blood pH and gas tensions 07 Other analytes performed on a blood gas analyser 10 Drugs for therapeutic monitoring 14 Alcohol for non legal purposes 15 Drugs for toxicological purposes 20 Hormones Quantitative B hCG 40 Iron studies Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 18 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 50 Protein peptide tumour markers 61 Point of care testing for Two analysers located with the Diabetes Educators in the Telstra Building and another in the Paediatric Diabetic Clinic 10 70 Genetic Testing 10 71 Cytogenetics 01 Blood 02 Bone marrow 20 Other tissues malignant Cytogenetics and Molecular Medicine incl virol 25 Detection of defin
103. s related to the measurement of reference values must be thoughtfully considered and controlled where appropriate It is essential that these factors be treated in the same manner for the reference individuals as for the patient population tested 3 Once the data are collected a frequency histogram should be prepared and examined visually in order to facilitate analysis A process for detecting and discarding outlier values is recommended In addition to the Dixon Reed rule See QS Ref 1 pages 18 and 31 recommended in the previous edition of C28 an alternative rule based on Tukey See QS Ref 1 pages 18 and 19 was added to this document 4 The nonparametric method of estimation of the reference interval is again strongly recommended as the preferred method for analysis because of its simplicity and reliability More importantly this method requires no specific assumption about the mathematical form of the probability distribution of reference values For the nonparametric method a minimum sample of 120 reference values is recommended for each reference population or subclass This is the smallest number of samples that allows the determination of a 90 CI around the reference limits eg the 2 5th and 97 5th percentiles Greater confidence or improved precision in an estimated 95 reference interval can be accomplished using a larger sample of reference individuals 5 Recognizing the difficulty for individual laboratories to obtain suf
104. s to this resource Login to the new THO South Website http www dhhs tas gov au intranet stho and go down to the Shortcuts and click on Pathology Test Search Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 51 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Shortcuts Select shortcut 4 New Employee Orientation PageUp recruitment management system PAS DHHS Pathology Results CIS Pathology Test Search qm Policies Protocols Guidelines THO South Research THO South RHH Clinical Intranet Right Job Right Person Smartfleet vehicle booking system SoDS Statements of Duties from Monday 14 January More news Alternatively staff can access the same database via Pathology Results CIS login using your Kestral User Name and Password 4 g 4 lij 2 gen v Safety Toos B osa Royal Hobart Hospital Pathology Results You need to log in USERNAME th 00 PASSWORD The System Administrator may be contacted via 6222 8410 Royal Hobart Hospital users may also use their personal network log in as supplied by I T Services to access pathology results for RHH patients via the DMR system on http dmr dhhs tas gov au PATHOLOGY S U T DISCLAIMER The information on these pages is confidential and is intended for authorised Pathology
105. scscsscsscesecssssccssceacesacsesssseassesesees 37 LIFE CYCLE OF A CAPA 41 RECORDS MAINTENANCE AND ARCHIVING Clause 4 13 eese eee 42 ACCOMMODATION AND ENVIRONMENT Clause 5 2 sten se then seen ete 44 INSTRUMENTS REAGENTS AND CONSUMABLES MANAGEMENT eeeeeeeeeen eee tenent teintes 45 VALIDATION OF EXAMINATION PROCEDURES Clause 5 5 2 eee eee 46 BIOLOGICAL REFERENCE INTERVALS Reference Intervals Clause 5 5 5 47 SAFETY Clase 5 1 4 m 5 1 19 5 2 2 5240 esee 49 ENVIRONMENTAL ASPECTS Clause 5 4 6 eere eee esee ee 50 LIST OF EXAMINATION PROCEDURES Clause 51 51 REQUEST PROTOCOLS PRIMARY SAMPLE COLLECTION 51 HANDLING OF LABORATORY SAMPLES Clause 5 4 51 VALIDATION OF RESULTS Clause 5 7 ccisssesscadcstscssiesesssetsnsvesecusastssdenteesetasanesesenssnsesecudcestensetcelesededeceneshdetenacssssese 55 QUALITY CONTROL Clauses 4 9 and 5 6 ssccscoscssetncsisvsicncceccecererenssisisestsosseotsttenevacectsncventeteudeod sabiensisnsisocesecaseiceesten 55 REVIEW OF INTERNAL QC tonic RR tena e OUI Eas aD 56 LABORATORY INFORMATION SYSTEM Annex ene teen noinen tne tn sete
106. soelectric focussing e Faecal occult blood e Antinuclear antibodies e urinary free catecholamine analyses using high performance liquid chromatography HPLC for the diagnosis of phaeochromocytoma as well as neuroblastoma and similar diseases in children 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 Pathology South is our specimen collection centre for patients referred by private medical practitioners and the RHH Specialist Clinics It is located in the Wellington Centre on Argyle Street Further details on this service is provided in Document ID CPATH Proc 2 and via their website www pathologysouth com au Information Technology Support Group The provision of a modern diagnostic pathology service is heavily reliant upon Information Technology for the speedy analysis and reporting of results RHH Pathology uses the Kestral PLS system within the laboratories to register track and report all pathology results In line with modern trends the system has been extended out to the Wards and Clinics via a web browser interface known as Kestral CIS and by directly feeding Pathology Results into the Digital Medical Record DMR In addition the PL
107. stricted within Kestral PLS DMR and CIS A copy of the Tasmanian HIV AIDS Preventive Measures Act 1993 No 25 of 1993 and associated Guidelines can be viewed on the internet at http www thelaw tas gov au index w3p Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 81 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH You should type in HIV in the quick search box and that will take you to the document It is anticipated that during 2009 this Act will be repealed or modified to bring it into line with the more relaxed legislation operating in the mainland States of Australia STAFF ORIENTATION AND ORIENTATION CHECKLIST Refer to ADMIN Proc 02 for latest version When the new employee begins their manager will need to ensure the following information is conveyed Pathology Tour L1 00 Introduction to all relevant staff a Pathology Administration b Central Processing c Stores d Pathologist and Scientists in Charge of departments e Staff working with the new staff member Location of Staff Tea Room and cafeteria Locations of Staff Toilets and Change Rooms Location of Mail Boxes Arrangements for sending and receiving Faxes Locations of Meeting Rooms Location of resources for continuing education Orientation of relevant areas of the hospital outside Pathology Systems L1 Familiarisa
108. stry electrolytes liver function tests amylase calcium and magnesium Lipids Cardiac Markers Therapeutic Drug Monitoring Drugs of Abuse Screening tests Arterial Blood Gases and Electrolytes Near Patient Testing Instrumentation support 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 Cytogenetics Cytogenetics is the study of chromosome structure function and pathology Cytogenetic studies are used for diagnostic purposes in three main areas of medicine e Congenital Disorders Indications include dysmorphic infants growth retardation late onset of puberty or infertility Leukaemia diagnosis and prognosis e Other Cancers The Cytogenetics La
109. th is the Main EMail Screen which is described This is the screen that displays all the information regarding your own personal EMail From here you are able to perform all functions associated with EMail ol x 11 51 56 11 Jan 2661 MANAGER PLS EMail Urgent Sent Date amp Time Subject Zzzzzzzz 11 61 2661 11 51 Patient Details Manager 11 61 2661 11 56 Patient Details Manager 11 61 2661 11 14 This Is A Test lt Enter gt Read Mail lt W gt rite Mail lt R gt eply lt Del gt ete Mail Fields Urgent A tick will be displayed indicating that this is an urgent EMail Sent A tick will be displayed if this is an EMail that you sent Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 67 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Who Depending on whether or not the EMail is received or sent by you this field will display your code if you sent the EMail or the senders code if you are receiving the EMail Also notice that EMails sent by you are coloured white and those received by you are coloured yellow Date and Time Displays the date and time the EMail was sent Subject Displays the subject of the EMail Browser Options lt Enter gt Read Mail Allows you to enter into a screen where the entire contents of the EMail are viewable lt W gt rite Mail Allows you to write send a new EMail lt R gt eply Allows you to
110. thorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 15 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH 06 Detection of bacterial antigens by non cultural non molecular techniques 99 Miscellaneous tests Clostridium difficile toxin 10 12 Parasitology 01 Preparation and examination of films 02 Definitive identification of parasites 10 13 Virology Cytogenetics and Molecular Medicine incl virol 05 Detection of viral antigens by non cultural non molecular techniques 10 14 Mycology 01 Microscopic examination of clinical specimens 02 Culture of specimens 03 Limited identification of fungi 10 15 Mycobacteriology 01 Microscopic examination of clinical specimens 02 Culture for isolation of mycobacteria 10 16 Serology of infection 02 General serological testing 03 Specialised or uncommon serological testing procedures 10 17 Detection and characterisation of microbial DNA RNA Cytogenetics and Molecular Medicine incl virol 01 Detection and characterisation of bacterial DNA RNA 03 Detection and characterisation of viral DNA RNA 10 19 Miscellaneous 01 Semen analysis Screening Test Post vasectomy specimens only 10 20 Immunohaematology 01 Blood grouping including ABO Rh D 03 Blood group antibody screen 04 Identification of blood group antibodies 05 Determination of compatibility of donor units using appropriate techniques including the inv
111. tion may be required urgently Hence it is now possible to flag just the coagulation as urgent From the List of Patient Request screen Alt U is used to remove an episode from archive and back into the main file The user must have privileges View Archive and Maintain Archive In PLS a user is able to nominate that only specific tests are urgent In the case of fully automated laboratories then PLS will only generate URGENT notifications for those departments tests that is an URGENT notification would only be generated for the coagulation sample but not for the FBE or the biochemistry samples To mark an individual test URGENT use the new Alt U facility Place the cursor on the relevant test code and press Alt U You will see that PLS will change that test code to be displayed in RED on the request entry screen Any number of individual tests may be marked as urgent When viewing results for requests that have individual tests marked as urgent that PLS will display the list of test codes with an asterisk in front of any urgent tests as they are not shown in RED Note that Alt U has a toggle action That is pressing Alt U repeatedly will add and remove the urgent status assigned to the test in question For more information on using this hot key please refer to the document Flagging Test Codes PLS Ctrl A Return to Further Hot Keys Menu This shortcut opens a sub screen that displays
112. tion with DHHS Intranet site Familiarisation with Pathology Intranet site Familiarisation with the Kestral LIS Familiarisation with the Q Pulse Management System DHHS Pathology Policies and Procedures L1 Organisational Structure Pathology Quality System NATA Standard and accreditation Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 82 of 89 Safety 00 dep 0 0 0 0 0 O0 O0 O L1 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Specimen workflow Logging Incidents EIMS Human Resources who to contact in situations Continuing Education Expectation of staff Staff Entitlements Policies concerning working hours meal allowances sickness whilst on duty what to do in the event of sick leave applying for annual leave T O LL and other internal arrangements Outline the probation procedure Discuss Performance Review and Development Location of EXITS Emergency Evacuation Routes and assembly points Location of Fire Extinguishers and Fire Blankets Location of Emergency Power cut outs Location of Duress Alarms Location of protective clothing and procedure for replacement if applicable Location of Hot and Cold Room Duress Alarms and Escape technique if applicable Organise appropriate eye protection equipment if applicable Location of First Aid Kits Emergency Sh
113. tions must be on approved forms and will have to be countersigned by the Director of the Pathology Department and the CEO of the RHH e Applications for overseas travel will have to be countersigned by the Minister for Health e In view of the above two points you are well advised to follow the advice given by our Business Support Officer and Business Manager who have had considerable experience in meeting the expectations of these important counter signatories e Under current rules staff should not book and pay for flights themselves with a view to seeking retrospective reimbursement The Business Support Officer will book all flights through our Corporate Account with the Travel Studio in consultation with you Again there are acceptable and unacceptable ways of traveling in advance of the meeting or delaying departure after a meeting and you should follow the advice given e To ensure your attendance at the conference of your choice please initiate applications well in advance of your travel dates Allow a minimum of 6 weeks for overseas travel applications to get through the system FUNDING SOURCES AVAILABLE TO STAFF e Pathology South profit allocation to your Department Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 20 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Requests for accessing these funds should be directed to your Scientist in Charge
114. to date in the online database Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 19 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH rhhlas26 quality_databases admin moddata asp Microsoft Internet Explorer File Edit View Favorites Tools Help gt A A Asearch SdFavortes C 55 2 2 3j Address http frhhlas26 quality_databases adminjmoddata asp Links RHH PATHOLOGY STAFF LEAVE DATABASE Including Conference and External Education Leave SQL statement SELECT FROM leavedates ORDER BY surname dept startyear startmonth startday ADD A NEW ENTRY DISPLAY BY DEPARTMENT No Selection z CLICK HERE to search for Entries for a SURNAME There are strict RHH guidelines for financial support of staff attending Conferences and Continuing Educational Activities that require payment of your registration fees travel and accomodation costs You should consult the DHHS Travel Policy online at http intra dhhs tas gov au dhhs online page php id 279 You should first discuss your intentions with your Scientist in Charge and obtain the necessary forms from our Business Support Officer You application will be reviewed by our Business Manager before it is sent to the RHH CEO for final approval The following notes are for your further information e All applica
115. trol of nonconformities Identification and OO Oy 4S uS BREE lI0 Corrective ACTION esee radiada Bale ll Breventive ACTLON whe So diene stad da 12 Continual zmptovemernt 215 eee ee wae SUR RU 13 Quality and technical records nee 14 Internal a udltsS wed erg aie ere des ae 15 Management OSS P REOR wr Technical requirements sesa sa scia sa sa sog OK e a d 12 1 Personnel ch Pace ata deca we 12 2 Accommodation and environmental conditions 14 3 Laboratory equipment eae EE e 15 4 Pre examination Procedures ewe vows we 17 5 Examination Procedures 2 29 ww Uy 19 6 Assuring quality of examination procedures 21 7T Post examination procedures 22 8 Reporting of Xes lts sss sodhad ewe e neg RUE a ok Ee RUN RUD XO 22 Annex A Correlation with ISO 9001 2000 ang ISO IEC 170251999 2912929429399 2 93 29 53 25 Annex B Recommendations for protection of laboratory information systems LIS 29 Annex C Ethics in laboratory medicine 33 Authorised by Dr Marsden Dr Vervaart
116. ugust 2008 and a complete copy is on the document control system as Doc ID QS Ref 19 Staff should also refer to NATA Technical Note 17 Guidelines for the Validation and Verification of Quantitative and Qualitative Test Methods available on their website Currently our method evaluations for quantitative tests will follow as a minimum the Procedure described in o INSTRUCTIONS FOR BLAND AND ALTMAN PLOTS USING EXCEL Document ID QS Proc 36 along with any additional practical investigations and statistics as suggested in Doc ID QS Ref 19 The raw and processed results will be recorded a New Record document with a unique Document ID number A good example can be viewed in Document ID QS Rep 5 EVALUATION OF THE EXISTING CELLDYNE CD4000 VERSUS THE NEW CELLDYNE CD3200 IN THE CORE LABORATORY In addition the Uncertainty of Measurement Budget will be completed as per Document ID QS Proc 37 UNCERTAINTY OF MEASUREMENT BUDGETS POLICY AND PROCEDURE and the associated Excel Template Document ID QS Form 8 UNCERTAINTY OF Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 46 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH MEASUREMENT BUDGET TEMPLATE Method evaluations will be performed whenever there is about to be a significant change in the testing procedure eg o Changeover from one Diagnostic Kit to another o Changeover from one ana
117. ument ID QS Form26 The list of qualified auditors in covered in Document ID QS Ref 17 There are currently two principal audit questionnaires in use Document ID QS Proc 66 is a questionnaire directed at the Management of Laboratory Activities Document ID QS Proc 50 is a technical clauses questionnaire designed for use with staff while they are performing a procedure There is a Staff Training audit questionnaire in Document ID QS Proc 69 ETHICS ANNEX C PROFESSIONAL INTEGRITY AND IMPARTIALITY It is important that in your dealings with both clients of and suppliers to RHH Pathology you say or do nothing that could compromise the Laboratory s impartiality and independence This is particularly important for those staff involved with the choice of suppliers of laboratory goods and services Major items of equipment have to be purchased via a formal tendering process and there are strict State Government Guidelines for the conduct of evaluations tendering short listing etc All staff must be careful that their actions could be construed as an acceptance of an inducement or that their comments are a Departmental endorsement or censure of a particular product or service It is not unusual for colleagues at other Laboratories who are considering a new purchase contacting you because you use the equipment they are considering Verbal and written replies to such enquiries should be very carefully worded so that they are not misconstru
118. ument created Message HTML File Edit Insert Format Tools Actions Reply S Reply to Forward 5 23 X19 gt From QPulse dhhs tas gov au To Banks Graham R Hartley Tom Gc Subject New document created Attachments Record qpulse 295 B Details The following active document has been created Type QualManagement Procedure Number DOC1 Title Test2 Revision 1 Status Active Author Hartley Tom Owner Banks Graham When an email like this is received the user must read the document and acknowledge that they have read and understood the new or updated document This is performed by following the procedure below 1 Click on the Locate Record in Q Pulse icon Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 31 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH E New document created Message HTML t File Edit View Insert Format Tools Actions Help Reply to All t Forward 3 5 amp From QPulse amp dhhs tas gov au To Banks Graham R Hartley Tom Subject New document created Attachments Record qpulse 295 B d Details The following active document has been created Type QualManagement Procedure Number DOC1 Title Test2 Revision 1 Status Active Author Hartley Tom Owner Banks Graham 2 Log into Q pulse 3 Th
119. vated from any part of the application Lookup additions modifications are permitted in the accessed table then by pressing the ESC key the user is returned to wherever they were when they selected the hot key Following is a list of the HOT KEYS displayed when using the Alt 02 hot key 15 59 66 27 Dec 2666 MANAGER PLS Hot Keys Description PLS Hot Key Table Doc Units Hosp Ward Dpt Itms Grp Tst RDL Comments User Accounts URNO Request Number Notifications Sample Sequence Numbers Printer Definitions Test Information Blood Cultures View Scanned Images Prompt Refresh EMail Facilities Faxing Printer Redirection Authorised by Dr Marsden Dr Vervaart amp Dr Tom Hartley Document ID QS Proc 1 Issued February 2012 Page 59 of 89 RHH PATHOLOGY SERVICES Incorporating PATHOLOGY SOUTH Description Quick Entry View Scanned Images Prompt Histology Worklists Quick Entry Menu List Blood Bank Information View Scanned Images Refresh Logout Change Password View Continuous Reports lt 1 5 gt View Scanned Images Each of the above Hot Keys are described below listing the options each HOT key will provide access to To choose the desired option within the menu option or table press the corresponding letter Alt 1 Table 1 Alt 1 gt Return to Hot Keys Menu Doctor Table Unit Table Surgery Table Surgery Packages Table Institution Ta
120. withdrawn from use Laboratory Workbooks and Worksheets These are retained for three years Calibration Functions and Factors These are usually only applicable to computerized automated equipment and are stored in the instrument and on backup electronic media if applicable Factors associated with manual instrumental procedures such as HPLC where there are retention times specific to the instrument setup calibration factors etc are usually recorded on the worksheet However if these factors are likely to be sufficiently persistent then the values are recorded within the versions of the procedures Factors which are reagent batch specific eg in INR testing are similarly recorded on worksheets or within procedures Quality Control Records Wherever possible Internal Quality Control Records have been computerized either within Kestral PLS or within the instrumentation External Quality Control Records are still predominantly paper report based These paper reports are filed in the relevant areas of the laboratories and are retained for three years More recently we have been submitting a large proportion of our internal QC data into commercial system such as Bio Rad s Unity Realtime system and Radiometer s WDC programme Electronic Records All Medical Testing related data held on computerized systems will be backed up to remote systems or removable media The procedure for each particular item will vary according to the manufacturer s

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