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TABLE OF CONTENTS - Quality MANUAL


CHANGE CONTROL 6
1.0 MISSION STATEMENTS 7
1.1 STRATEGIC INTENT – TERRITORY HEALTH SERVICES 7
1.2 STRATEGIC PLAN – ROYAL DARWIN HOSPITAL 7
1.3 MISSION STATEMENT - “OUR LAB” PATHOLOGY DEPARTMENT 7
2.0 QUALITY STATEMENTS 8
2.1 QUALITY POLICY 8
2.2 MANAGEMENTS’ COMMITMENT TO QUALITY 8
3.0 STANDARDS COMPLIANCE 8
4.0 PRINCIPLES, CODE OF CONDUCT & CONFIDENTIALITY 8
4.1 THE PUBLIC SECTOR EMPLOYMENT AND MANAGEMENT ACT 8
4.2 CONFIDENTIALITY 9
5.0 ORGANISATION 9
5.1 HOURS OF OPERATION 9
5.1.1 Biochemistry 9
5.1.2 Blood Transfusion/Haematology 10
5.1.3 Client Services - Specimen Reception 10
5.1.4 Client Services – Phlebotomy Inpatients 10
5.1.5 Client services – Phlebotomy Outpatients 10
5.1.6 Histology/Cytology 10
5.1.7 Microbiology 11
5.1.8 Serology 11
5.2 PATHOLOGY FLOOR PLANS 11
5.3 PATHOLOGY STAFF ORGANISATIONAL CHARTS 11
5.4 QUALITY ASSURANCE ORGANISATIONAL CHART 12
5.5 SAFETY ORGANISATIONAL CHART 12
5.6 CLINICAL REVIEW ORGANISATIONAL CHART 12
5.7 “OUR LAB” COMMITTEE STRUCTURE 13
5.7.1 Terms of Reference 13
6.0 JOB DESCRIPTIONS AND SPECIFICATIONS 13
6.1 JOB DESCRIPTIONS AND SELECTION CRITERIA 13
6.2 STAFF QUALIFICATIONS 13
6.3 RECRUITMENT 14
6.3.1 General 14
6.3.2 Redeployees 14
7.0 RESPONSIBILITIES AND CONTROLS 14
7.1 SPECIFIC RESPONSIBILITIES 14
7.1.1 Director of Pathology 14
7.1.2 Pathologists 15
7.1.3 Laboratory Manager 15
7.1.4 Deputy Laboratory Manager 15
7.1.5 Scientific Section Heads 16
7.1.6 Quality Management Scientist 16
7.1.7 Computer Support 16
7.2 NOMINATED OFFICERS 17
7.3 AUTHORISATION SIGNATORIES AND THEIR USE 17
7.3.1 NATA Authorised Representative 17
7.3.2 NATA Approved Signatories 18
7.3.3 Financal Administration - Authorised Signatures 18
7.3.4 Staff Signature Register 18
8.0 RANGE OF TESTING AND SCOPE OF NATA ACCREDITATION 19
8.1 GENERAL INFORMATION 19
8.1.1 Category GY (General) 19
8.1.2 Category B (Branch) 19
8.2 WHO IS NATA? 20
8.2.1 ISO/IEC 17025:1999 International Standard 20
8.3 LABORATORY COMPETENCE AND RESOURCES 21
8.4 USE OF NATA/RCPA ENDORSEMENT 21
8.5 WHO IS NPAAC? 21
9.0 QUALITY PLANNING 22
9.1 PATHOLOGY QUALITY ASSURANCE COMMITTEE - TERMS OF REFERENCE 22
9.2 QUALITY PLANS 22
9.3 QUALITY ASSURANCE ACTIVITIES 22
10.0 MANAGEMENT REVIEW 23
10.1 QA COMMITTEE ROLE 23
10.2 MANANGEMENT ROLE 23
10.3 OTHER REVIEWS 24
11.0 COMMUNICATION NETWORK 24
11.1 REQUEST AND REPORTING ROUTES 24
11.2 COMPUTER SYSTEM 24
12.0 ALLOCATION OF RESOURCES 25
12.1 FINANCIAL 25
12.2 HUMAN RESOURCES 25
13.0 STAFF TRAINING 25
13.1 GENERAL 25
13.2 PERFORMANCE MANAGEMENT 25
14.0 DEVELOPMENT & IMPLEMENTATION OF LABORATORY PROCEDURES 26
15.0 CONTROL DURING TESTING 26
15.1 GENERAL 26
15.2 CONTROL OF NON-CONFORMING WORK 26
16.0 METHOD MANUALS (WORK INSTRUCTIONS) 27
17.0 HANDLING OF REQUESTS AND SPECIMENS 27
17.1 SPECIMEN COLLECTION REQUIREMENTS FOR TESTING 27
17.2 REQUEST HANDLING 28
17.3 SPECIMEN REFERRAL (SUBCONTRACTING OF TESTING) 28
17.4 SPECIMEN TRANSPORT 28
17.5 HANDLING, STORAGE AND DISPOSAL OF SPECIMENS 28
18.0 EQUIPMENT 29
18.1 CALIBRATION 29
18.2 MAINTENANCE RECORDS 29
18.3 EQUIPMENT INVENTORY 29
18.3.1 “OUR LAB” Pathology Equipment Register 29
18.3.2 Asset Register 29
19.0 ACCOMMODATION AND TESTING ENVIRONMENT 29

20.0 RECORDS 30
20.1 GENERAL 30
20.2 CORRECTIONS 30
20.2.1 Hard-copy Corrections 30
20.2.2 Electronic Corrections 30
20.3 RECORD RETENTION TIMES 31
20.4 ARCHIVE STORAGE 31
20.5 RECORD DISPOSAL 31
20.6 COMPUTER RECORD SECURITY 31
21.0 HEALTH AND SAFETY 32
21.1 OCCUPATIONAL HEALTH AND SAFETY 32
21.2 SAFETY MANUALS 32
21.3 MATERIAL SAFETY DATA SHEETS (MSDS) 32
22.0 STATISTICS 33
23.0 DOCUMENT CONTROL 33
23.1 GENERAL 33
23.2 DOCUMENT CONTROL FLOW DIAGRAM 33
24.0 CORRECTIVE ACTION 34
25.0 PREVENTATIVE ACTION 34
26.0 AUSTRALIAN INCIDENT MONITORING SYSTEM (AIMS) 34
26.1 AIMS PART A 35
26.2 AIMS PART B 35
27.0 INTERNAL AUDITS 35
28.0 CUSTOMER COMPLAINTS 35
28.1 PATHOLOGY COMPLAINTS 35
28.2 COMPLAINTS RELATING TO THE TREATMENT OF A PATIENT 36
29.0 SERVICES & SUPPLIES (PURCHASING, RECEIPT & STORAGE) 36
29.1 PURCHASING 36
29.1.1 Internal Requisition 37
29.1.2 Qantel Orders 37
29.1.3 Internal Imprest Stock Items 37
29.2 RECEIPT OF SUPPLIES 37
29.2.1 Receipt in Pathology 37
29.2.2 Receipt in Departments 38
29.3 STORAGE 38
29.3.1 Perishable Storage 38
30.0 SERVICE TO THE CLIENT 38
30.1 LABORATORY ACCESS 38
30.2 CLIENT FEEDBACK 39
30.3 CLIENT SATISFACTION SURVEYS 39
31.0 SERVICE LEVEL AGREEMENTS 39

Note the Appendicies are empty - New Users will need to substitute their own files under these headings
APPENDIX A – ’STRATEGY TWENTY FIRST CENTURY – STRATEGIC INTENT XXXXX HEALTH SERVICES’ 40
APPENDIX B -STRATEGIC PLAN 41
APPENDIX C - PATHOLOGY FLOOR PLANS 42
APPENDIX D - STAFF ORGANISATIONAL CHARTS 43
APPENDIX E – “OUR LAB” COMMITTEE STRUCTURE 44
APPENDIX F - OCPE SELECTION PROCESS HANDBOOK (APPX 5) 45
APPENDIX G - STAFF SIGNATURE REGISTER 46
APPENDIX H – SCOPE OF NATA/RCPA ACCREDITATION (AS AT 1/10/99) 47
APPENDIX I – PATHOLOGY REQUEST FORMS 48
APPENDIX J – NATA ACCREDITED LABORATORIES FOR REFERRAL 49
APPENDIX K - CUSTOMER COMPLAINT FORM 50
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