TITLE: PRIMARY SAMPLE COLLECTION MANUAL BST/PATH/GDE/001 Ver. 6
BST/PATH/GDE/001 TITLE: Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 1 of 47 PRIMARY SAMPLE COLLECTION MANUAL Written/Revised by: _______________________________________ Mary B Murphy, Laboratory QA Officer Date: ____/____/____ Reviewed by: _______________________________________ Gene Ferris, Senior Medical Scientist Haematology Date: ____/____/____ Reviewed by: _______________________________________ Sheila Rahilly, Senior Medical Scientist Blood Bank Date: ____/____/____ _______________________________________ Linda O’Reilly, Senior Medical Scientist Histology Date: ____/____/____ _______________________________________ Michelle Dowling, Medical Scientist Microbiology Date: ____/____/____ _______________________________________ Dr. William Dibb, Consultant Microbiologist Date: ____/____/____ _______________________________________ Dr. Cleona Duggan, Consultant Haematologist Date: ____/____/____ _______________________________________ Luke O’Sullivan, Laboratory Services Manager Date: ____/____/____ Reviewed/ Revised by: Reviewed by: Reviewed/ Authorised by: Reviewed/ Authorised by: Reviewed/ Authorised by: Reviewed/ Authorised by: _______________________________________ Date: ____/____/____ Dr. Des Farrell, Consultant Histopathologist/Clinical Director Effective Date: 05/06/2014 Supersedes: Ver.5 Copy No.: ______________ Assigned to: ____________________ Change Control No.: CCR164/244/252/266/267/270/280/294/295/296/341/364/367/382/386/387 DOCUMENT REVIEW HISTORY First Review Date: 21/08/2008 Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Date Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE 21/08/08 QA Officer Document Amended YES/NO Yes 27/08/09 QA Officer Yes 28/09/10 QA Officer Yes 28/06/12 QA Officer Yes 18/06/13 Reviewed by: QA Officer Gene Ferris Sheila Rahilly Linda O Reilly Michelle Dowling Chris O Shea Dr Bill Dibb Dr C Duggan Dr D Farrell Luke O Sullivan Yes Page 2 of 47 Page(s) Amended Next Review Date 8,14,16,24,25 6, 9, 12, 16, 20, 21, 24, 25, 26 10,11, 7, 11-13, 1620, 23, 25-28, 30, 31, 36-38 21/10/2010 Entire Document 15/06/2011 23/08/2014 05/06/2016 Change Description: V5 to V6 i. Section 1.0: Introduction now includes Microbiology in the scope of accreditation and include INAB registration number. ii. Section 2.0: Revised to state that the version of the manual is available on Q Pulse as a controlled document but copies printed from Q Pulse are uncontrolled. A controlled hard copy of this manual will no longer be issued to each ward or clinical area. iii. Section 3.0: Revised to include location of the Pathology Department. iv. Section 3.1, 3.2: Revised to reflect the current opening times of the Pathology Department and the procedure for contacting the on-call Medical Scientist. v. Section 3.2.2: Medical Scientists do not contact the Clinical area to confirm the status of group and hold specimens received after 15:30 or cross match specimens 13:00. vi. Section 3.3.1: Revised to include new phone number for Blood Transfusion. vii. Section 3.3.2: Revised to remove telephone numbers for IBTS and include instructions for contact of Laboratory Consultants. viii. Section 3.8: Microbiology included in scope of accreditation. Revised to state The Laboratory is accredited by JCI (Joint Commission International) as part of the overall Hospital accreditation process. ix. Section 3.9, 3.10: New sections to detail the protection of personal information and the procedure for obtaining patient consent. x. Section 4.1: Revised to correct and update Laboratory request form identification numbers. xi. Section 4.2: Revised to state that where the time of collection is not provided, the laboratory may issue comments on the interpretation of results. Clinical information should rather than must be supplied. Reason for MRSA requests must be provided. xii. Section 4.4: Revised to include reference to inspection of specimen quality in relation to age/storage conditions of specimen prior to receipt in the laboratory. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 3 of 47 xiii. Section 4.5, Table 4: Revised to remove reference to specimen returns data base. Revised to state what action to be carried out if demographics are not provided on request form. xiv. Section 5.1, 5.2.1: Revised to state that samples should be delivered to the laboratory as soon as possible and instructions are provided for storage requirements outside routine hours. xv. Section 5.5, Table 6: Revised to reflect the minimum retention period and storage location of examined specimens. xvi. Section 6.0: Updated to reflect the external third party assessment programmes that the Pathology Department participates in. xvii. Section 7.0, Table 7: Updated to reflect the products provided by the Blood Transfusion Department. xviii. Section 8.0: Revised to include reference to the BST/PHLE/SOP/001 for instructions for sample collection tubes. xix. Section 8.2.1: Updated to include procedure for notifying clinician/clinical area in the event of analytical failure. xx. Section 8.4: Updated to include reference to Histology and Microbiology Departments. xxi. Section 9.0: Sample collection tube descriptions expanded. White bottles removed as no longer used. xxii. Section 9.1 Table 8, Section 11.0: Updated to include revised sample requirements (white bottle removed). Revised to update the improved turnaround times. New tests added to repertoire. xxiii. Section 10.0 Table 9: Updated to remove red tubes, these are now replaced by RBT tubes. Brown tube now used for Cold Agglutinins. xxiv. Section 10.2: Revised to state that only one sample required for Antibody Identification. White tubes replaced by brown tubes for platelet and white cell antibodies. xxv. Section 10.3 Table 11: Updated to state that Uniplas is an unlicensed product. xxvi. Section 10.3: Note in relation to products marked with Δ removed. xxvii. Section 10.4: Revised to state that requests for Platelet/Plasma Products will be issued against the most recent EDTA-BT sample up to a maximum of 28 days. xxviii. Section 12.0, Table 13: Revised to update TAT and minimum requirements for Microbiology specimens. CLO tests TAT changed from 1 day to 2 days. Blood Cultures changed from 7 days to <8days. Updated to include tissue specimens. xxix. Section 12.1: Updated to include instructions for samples collected directly by the patient. xxx. Section 12.1.1: Revised to state that the sensor at the bottom of a blood culture bottle is grey. Revised to include updated instructions for taking blood culture samples. xxxi. Section 12.1.1.4: New section to detail procedure for loading Blood Culture bottles onto the BacT/ALERT 3D. xxxii. Section 12.1.2.3: Updated to include more detailed Normal CSF values. xxxiii. Section 12.2: New section to detail referred tests from Microbiology. xxxiv. Section 13.2: Bronchial Brushings now sent in Cytospin Collection fluid. Bile Duct Brushings added to specimen type. xxxv. Section 13.3: Revised to change TAT for Bone Marrow Biopsies and Molecular testing to 4 weeks. Revised to change sample requirements for Muscle biopsies, these are now wrapped in clingfilm. Slides for external testing now sent to UCLAD and Bon Secours Hospital, Cork. xxxvi. Section 14.1, 14.2: Updated to detail procedure for printing and delivery of Pathology reports including delivery to Kerry Clinic. xxxvii. Section 14.5: Updated to include details of Biological reference intervals and Critical Values and reference to BST/PATH/SOP/007 and relevant attachments. xxxviii. Section 15.0: Updated to refer to BST/QA/SOP/016 for customer complaints. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 4 of 47 V4 to V5 i. Section 1.0: Introduction now includes Histology in the scope of accreditation. ii. Section 3.8: Histology included in the scope of accreditation. iii. Section 4.2: Clinician’s signature and MCRN must be on all BT requests. iv. Section 4.3.1: New section on positive patient identification when taking all samples. Subsequent sections renumbered accordingly. v. Section 5.2: Blood cultures now placed in BacT/Alert in Microbiology. CSFs and Frozen sections included in urgent delivery to the lab. Deliveries from Theatre and Endoscopy also included. vi. Section 5.2.1: CSF samples for neurological investigations to be stored in the fridge in Microbiology. vii. Section 5.5: Storage of archived histology specimens grouped together. Specimens are held for a minimum of 6 weeks, not 12 weeks as previously stated. Paraffin blocks are held for at least 30years, not permanently. viii. Section 6.0: Now includes IEQAS Labquality Scheme for ABG and participation in National QA Programme for Histopathology. ix. Section 7.0: Related Diagnostic Services now includes POCT for ABG, Troponin-I and Blood Glucose. x. Section 9.1: BNP included. xi. Section 9.2: Sections relating to Aminoglycoside toxicity, dosing and recommended therapeutic levels removed. xii. Section 10.1: Routine TAT for ABIN states that the TAT will depend on the complexity of the Antibody. xiii. Section 10.3: Comments on special requirements and seeking advice from Consultant Haematologist included in the table of products available from BT. xiv. Section 10.5: Retention of samples for BT. Previously included as a minor document amendment. xv. Section 12.0: Corrections to the colours of the Blood culture bottles in use. xvi. Section 12.1: Reference to INF/PPG/31 for Guidelines on Specimen Collection included. Procedure for taking blood cultures updated to reflect collection system in place. xvii. Section 13.1: TAT for Histology specimens reduced to 3 days and Frozen sections to 20 mins. xviii. Section 13.2: Bronchial Brushings collected into Cytospin collection fluid. Consultant Pathologist to be contacted for advice on the collection of FNA slides if required. xix. Section 13.3: New section added for External Tests for Histology. V3 to V4 i. 4.1 & 4.2: Request Forms must be handwritten. ii. 4.3.1.1: Removal of application of Typenex label. iii. 10.4: Removal of reference to Typenex details. iv. 12.1: Materials and procedure for taking blood cultures revised. v. 13.1: TAT for histology specimens may be extended if additional/special stains deemed necessary. vi. Attachment 16.1: Removed V2 to V3 i. 3.2.2: Clarification of the cut-off times for Blood Transfusion specimens. ii. 3.8: Blood Transfusion Laboratory accreditation status updated. iii. 4.5: Where no request form is received with a sample the sample must be rejected. iv. 6.0: Inclusion of IEQAS for DCT and NEQAS for Histopathology v. 9.1: Digoxin removed from available tests list. vi. 9.1: Glucose ward requirements revised to state that B/W/O bottle acceptable when taken during routine hours only. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 5 of 47 vii. 10.1: Routine TAT for GH extended to 3 days. viii. 10.2: Number of bottles required for ABID increased from RBT x 2 to x 3. ix. 10.3: Albumin 5% now routinely available. Removal of Cryoprecipitate. Inclusion of Fibrinogen Concentrate. x. 10.4: Clarification of special timing of transfusion specimens. xi. 12.0: Inclusion of Norovirus test for Microbiology and reduction in routine TAT for CDiff. V1 to V2 i. 4.1 Reference is made to BST/PHLE/SOP/001. ii. 4.2 Gender must be ticked on the request form when using addressograph label. iii. 5.4 Document number INF013 replaced with INF/PPG/32 iv. 7.0 Consultant Service section amended as Consultant Haematology Services are available for all Blood Transfusion incorporating Haemovigilance and Traceability activities. v. 7.0 Haemovigilance Service amended to include BST/HV/SOP/006 rather than Transfusion Handbook vi. 10.3 Patients must give their consent prior to administration of the blood and/or blood component/product. Consent is filed in the patient chart and documented on the Patient Consent Form. vii. 10.4 New section detailing Special Timing of specimens for Blood Transfusion Requests Reason for Change: V5 to V6 i. Extension of scope of accreditation to include Microbiology and to include the INAB Registration number. (CCR/266/280) ii. Recommendations from INAB.(CCR/280) Improved document control.(CCR/387) iii. To comply with changes in external guidelines. CCR/341) iv. Change of opening times of Pathology Department to provide improved service.(CCR/386) v. Procedure not reflective of current practice.(CCR/386) vi. Introduction of a new dedicated phone for Blood Transfusion.(CCR/386) vii. Clarity of instruction for clinical users for contacting Laboratory Consultants. (CCR/386) viii. Extension of scope of accreditation to include Microbiology. (CCR/266) Reference to JCI omitted from previous version. (CCR/386) ix. To comply with changes in external guidelines. (CCR/341) x. Previously not included or incorrect in manual. (CCR/386) xi. To comply with changes in external guidelines. (CCR/341) xii. To comply with changes in external guidelines.(CCR/341) xiii. Specimen returns procedure revised. (CCR/226). Recommendation by INAB. (CCR/269) xiv. To comply with changes in external guidelines. (CCR/341) xv. BST/QA/SOP/005 updated to reflect the correct retention periods and location of stored samples. (CCR/244/267/295) xvi. EQA schemes updated for Microbiology and Histology. (CCR/266) xvii. Complete list of licensed manufactured Blood Transfusion products not included in last version. (CCR/386) xviii. To comply with changes in external guidelines. (CCR/341) xix. Recommendations from INAB.(CCR/296) xx. Extension of scope of accreditation to include Microbiology and Histology. (CCR/164/266) xxi. Recommendations from INAB. (CCR/296). Removal of white sample collection tubes. (CCR/382) xxii. Removal of white sample collection tubes. (CCR/382). Update of Turnaround times. (CCR/294). New tests added to repertoire. (CCR/386) xxiii. Replacement of Red tubes with RBT tubes and removal of white sample collection tubes. (CCR/382) xxiv. Removal of white sample collection tubes. One RBT only required for ABID. (CCR/382). Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 6 of 47 xxv. xxvi. xxvii. xxviii. xxix. xxx. xxxi. xxxii. xxxiii. xxxiv. xxxv. Recommendation by INAB.(CCR/270) Incorrect in last version.(CCR/386) Uniformity in sample requirements.(CCR/354) Update of Turnaround times. (CCR/294). Omitted from last version. (CCR/386) To comply with changes in external guidelines. (CCR/341) Updated procedure for taking Blood Culture samples. (CCR/252) Updated procedure for loading Blood Culture samples onto BacT/ALERT. (CCR/252) Omitted from previous version. (CCR/367) Extension of scope of accreditation to include Microbiology. (CCR/266) New test added. (CCR/283) Update of Turnaround times. (CCR/294). Request by CUH. (CCR/364). Change in procedure for external Immunohistochemistry. (CCR/364) xxxvi. Following VSM and recommendation from INAB. (CCR/385) xxxvii. To comply with changes in external guidelines. (CCR/341) xxxviii. To comply with changes in external guidelines. (CCR/341) V4 to V5 i. Extension of scope of accreditation to include Histology. (CCR/164) ii. Extension of scope of accreditation to include Histology. (CCR/164) iii. Introduction of revised BT Request forms. (CCR/120) iv. Clarity of instruction for staff when taking specimens. (CCR/165) v. Procedure not reflective of current practice. (CCR/166) vi. Procedure not reflective of current practice. (CCR/166) vii. Procedure not reflective of current practice. (CCR/164) viii. New EQA scheme subscribed to for ABG analysis and participation in National EQA programme by the Histology Department. (CCR/168) ix. Procedure not reflective of current practice. (CCR/168) x. Request from Clinical users to provide BNP in-house. (CCR/168) xi. Aminoglycoside guidelines beyond the scope of the laboratory. (CCR/80) xii. Procedure not reflective of current practice. (CCR/168) xiii. Clarity of instruction for staff when ordering products. (CCR/168) xiv. Recommendations from INAB. (CCR/115) xv. Clarity of instruction for staff when taking specimens. (CCR/167) xvi. Clarity of instruction for staff when taking specimens. (CCR/167) xvii. Commencement of participation in National EQA programme by the Histology Department. (CCR/139) xviii. Recommendations from DSS in Histology as procedure not reflective of current practice. (CCR/168) xix. Previously not included in manual. (CCR/139) V3 to V4 i. Removal of Typenex Band from use throughout the hospital. (CCR/14). ii. As above in (i). CCR/14. iii. As above in (i). CCR/14. iv. Introduction of new BacT/Alert Blood Culture System. v. CCR following IA 05/10. CCR/47. vi. Inclusion of Order of Draw in Phlebotomy Guidelines. CCR/45. V2 to V3 i. Guide not reflective of current practice. ii. Following INAB recommendations June 2009. iii. Following INAB recommendations June 2009. iv. Omitted from previous version. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 7 of 47 v. Digoxin now a referred test. vi. Samples >2hrs old taken into B/W/O for glucose measurements are not suitable for analysis. vii. Recommendations from Consultant Haematologist following review of workflow in Blood Transfusion. viii. Guide not reflective of current practice. ix. Following request from clinical users for same. Cryoprecipitate no longer available as instructed by the IBTS. x. Clarity of instruction for clinical users. xi. New test kit acquired and guide not reflective of actual TAT for CDiff. V1 to V2 i. Following INAB Recommendations in July 2008. ii. Following INAB Recommendations in July 2008. (CCR 46/08) iii. Infection Control document revision update iv. New consultant Haematologist contracted for the provision of services. v. Clarity of instruction vi. Procedure not reflective of current practice as highlighted by INAB assessment in July 2008. vii. Following INAB Recommendations in July 2008. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 8 of 47 Table of Contents 1.0 Introduction..........................................................................................................................10 2.0 Guide to Using this Manual ................................................................................................10 3.0 General Information............................................................................................................11 3.1 Pathology Department Opening Times .............................................................................11 3.2 Cut-off Times for Processing of Requests in the Pathology Department..........................11 3.2.1. Cut-off Times for Receipt of Biochemistry/Haematology Specimens......................11 3.2.2. Cut-off Times for Receipt of Blood Transfusion Specimens ....................................11 3.2.3. Cut-off Times for Receipt of Microbiology Specimens ............................................12 3.2.4. Cut-off Times for Receipt of Histopathology Specimens .........................................12 3.3 Pathology Department Telephone Numbers......................................................................12 3.3.1. Routine Enquiries ......................................................................................................12 3.3.2. List of Contacts for Out of Hours Service .................................................................13 3.3.3. Urgent Request for Testing Out of Hours..................................................................13 3.3.4. Urgent Request for Blood Components/Products Out of Hours ...............................13 3.4 Pathology Department Fax Number ..................................................................................13 3.5 Bon Secours Hospital Website and Telephone Number....................................................13 3.6 Laboratory Staffing............................................................................................................14 3.7 Laboratory Fees .................................................................................................................14 3.8 Laboratory Accreditation...................................................................................................14 3.9 Protection of Personal Information....................................................................................14 3.10 Patient Consent ..................................................................................................................14 4.0 Laboratory Request Forms, Specimen Bottles and Containers ......................................15 4.1 General Information...........................................................................................................15 4.2 Completing the Request Form ...........................................................................................15 4.3 Labelling the Specimen Container.....................................................................................16 4.3.1. Positive Patient Identification....................................................................................16 4.3.2. Specimen/Container Essential Information ...............................................................17 4.3.3. Use of Addressograph Labels ....................................................................................17 4.4 Specimen Quality...............................................................................................................18 4.5 Non-Conforming Specimen Bottles, Forms or Specimen Quality Issues .........................19 4.6 Further Additional Testing ................................................................................................20 4.7 Non-Conforming Issues and Credit ...................................................................................21 5.0 Delivery, Packaging, Transport and Postal Requirements for Diagnostic and Infectious (or Suspected Infectious) Specimens..............................................................................................21 5.1 General Information...........................................................................................................21 5.2 Specimen Delivery from Within the Hospital ...................................................................21 5.2.1. Procedure for the Out of Hours Delivery and Storage of Specimens to Pathology ..21 5.3 Specimen Delivery from Outside of the Hospital..............................................................22 5.3.1. Packaging Procedure for the Transport of Diagnostic Specimens (Non-Infectious) 22 5.3.2. Procedure for the Transport of Infectious or Suspected Infectious Specimens.........22 5.4 Disposal of Waste Material Used in Specimen Collection................................................23 5.5 Storage of Examined Specimens for Archive and Look Back Purposes...........................24 6.0 External Third Party Assessment Programme.................................................................25 7.0 Provision of Services............................................................................................................26 8.0 Laboratory Tests/Profiles Available ..................................................................................27 8.1 Laboratory Test/Profile Description ..................................................................................27 Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 9 of 47 8.2 Repeat Examination due to Analytical Failure or Further Examination of the Primary Specimen........................................................................................................................................28 8.2.1. Repeat Examination due to Analytical Failure..........................................................28 8.2.2. Further Examination of the Primary Specimen .........................................................28 8.3 Tests Not Listed.................................................................................................................28 8.4 External Laboratory Testing ..............................................................................................28 8.5 Emergency Out of Hours Service ......................................................................................28 9.0 Biochemistry Tests...............................................................................................................29 9.1 Routine Biochemistry ........................................................................................................29 9.2 Aminoglycoside (Gentamicin) Assay Guidelines .............................................................31 10.0 Blood Transfusion................................................................................................................32 10.1 Blood Transfusion Tests ....................................................................................................32 10.2 Referred Tests from Blood Transfusion ............................................................................32 10.3 Products Available through the Blood Transfusion Laboratory........................................33 10.4 Special Timing of Specimens for Transfusion Requests...................................................34 10.5 Retention of Crossmatched Blood for Patients..................................................................34 11.0 Haematology Tests...............................................................................................................35 12.0 Microbiology Tests...............................................................................................................36 12.1 Special Requirements for Microbiology Sampling and Testing........................................37 12.1.1. Blood Cultures ...........................................................................................................37 12.1.2. Cerebrospinal Fluid (CSF).........................................................................................40 12.1.3. Fluids from Sites Normally Sterile ............................................................................41 12.1.4. Urine ..........................................................................................................................41 12.2 Referred Tests from Microbiology ....................................................................................42 13.0 Histopathology .....................................................................................................................42 13.1 Routine Histopathology .....................................................................................................43 13.2 Cytopathology....................................................................................................................44 13.3 Referred Tests from Histology ..........................................................................................45 14.0 Reporting of Test Results....................................................................................................46 14.1 Reporting of Results within the Hospital...........................................................................46 14.2 Reports for External Locations..........................................................................................46 14.3 Telephoned Results............................................................................................................46 14.4 Faxed Reports ....................................................................................................................46 14.5 Reference Ranges (Biological Reference Intervals)..........................................................47 15.0 Customer Complaints and Feedback.................................................................................47 16.0 Attachments..........................................................................................................................47 Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 1.0 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 10 of 47 Introduction This manual is designed to give an overview of the services available in the Pathology Department. It is intended as a quick reference guide for all Pathology Service users. All Pathology services undergo continuous review through quality assurance and audit activities. The laboratory is committed to performing its activities, including Microbiology, Histology and Blood Transfusion incorporating Haemovigilance and Traceability, in accordance with the requirements of the International Standard 1SO 15189, Registration number 206MT and Joint Commission International. This manual is intended for users of the Pathology Services both within the Hospital and those from outside agencies. Laboratory management are committed to: Staff recruitment, training, development and retention at all levels to provide a full and effective service to its users. The proper procurement and maintenance of such equipment and other resources as are needed for the provision of the service. The collection, transport and handling of all specimens in such a way as to ensure the correct performance of laboratory examinations. The use of accredited examination procedures and methods that will ensure the highest achievable quality of all tests performed. Reporting results of examinations in ways which are timely, confidential, accurate and clinically useful. The assessment of user satisfaction, in addition to internal audit and external quality assessment, in order to produce continual quality improvement. 2.0 Guide to Using this Manual For internal users an electronic version of the manual is available on Q-Pulse, which allows all computer users to read the document while preventing modification. Please note copies printed from Q-Pulse are uncontrolled. To enable the user to perform a search for a particular item in the manual, press the keys CTRL+ F which opens a “Find” window. Enter a key word for the text to be located in the “Find what” field and select “Find Next”. The first instance of the text containing the selected word is located. Press “Find Next” until the required section is located. Information on the Laboratory Tests/Profiles provided are located in this manual under sections 9 to 13 and are traceable to the department where the tests are performed. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 3.0 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 11 of 47 General Information The Pathology Department is located in the main hospital. Hospital Reception staff can guide patients to the Pathology Department and provide assistance if required. 3.1 Pathology Department Opening Times Table 1: Ref.3.1 Department/activity Pathology Reception Opening Hours Monday to Friday 08:00 – 17:00 for hand delivery of specimens. 24hrs via Pneumatic chute system. Phlebotomy Out-patient Service Monday to Friday 09:30 – 13:00 and 14:00 – 16:00 Routine Laboratory Diagnostic Service* Biochemistry Haematology Blood Transfusion Emergency out of hours service (on call diagnostic service) * Monday to Friday 08:00–20:00 Monday to Friday 09:00–17:00 Microbiology Monday to Friday 08:00–17:00 Histology Biochemistry, Haematology, Blood Transfusion Monday to Friday 20:00–08:00 next routine working Saturday/Sunday/Bank Holiday 08:00–08:00 next routine working day Microbiology Monday to Friday 17:00–9:00 next routine working day Saturday/Sunday/Bank Holiday 9:00–09:00 next routine working day For individual department cut-off times for processing of requests refer to Section 3.2 below. 3.2 Cut-off Times for Processing of Requests in the Pathology Department 3.2.1. Cut-off Times for Receipt of Biochemistry/Haematology Specimens Specimens received in Specimen Reception by 19:30h are processed within the routine working day. Specimens received after 19:30h require Clinical area to contact the Medical Scientist on call via Hospital switch. The Medical Scientists will subsequently contact the Clinical Area to confirm the status of the specimen as urgent or non-urgent. Urgent Specimen: Must be registered and tested as soon as possible by the On-Call Medical Scientist and charged as a call. Non-urgent: Specimen Reception/Scientific personnel must follow the relevant departmental procedure for labelling and separation of samples. 3.2.2. Cut-off Times for Receipt of Blood Transfusion Specimens Group and Hold specimens for processing during the routine working day must be received by 19:15h in the Laboratory. Specimens requested for crossmatching in advance of elective surgery, must be received by 13:00 on the day prior to theatre to guarantee availability of crossmatched blood. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 12 of 47 3.2.3. Cut-off Times for Receipt of Microbiology Specimens Specimens received in Microbiology by 16:45h are processed within the routine working day. All specimens received after this time will be placed in the overnight storage facility and processed on the next routine working day unless the form has been identified as being an urgent specimen. Urgent specimens received after this time are analysed during the On-Call emergency service. 3.2.4. Cut-off Times for Receipt of Histopathology Specimens All adequately fixed specimens received by 15:30h will be processed the same day. Specimens received after 15:30h and before 16:50h will be checked to ensure the specimen/form are adequately documented and that no parts are missing. Physical processing of these samples will not commence until the following working day. All specimens received after this time will be processed on the next routine working day. 3.3 Pathology Department Telephone Numbers 3.3.1. Routine Enquiries The Pathology Department welcomes any queries on medical indications and/or available scientific procedures provided/facilitated by the laboratory. For telephone queries use the listing provided. For enquiries from an external source contact the main hospital switch on 066 7149800 and ask for the relevant extension as listed below. Table 2: Ref.3.2.1 Section Histopathology Office Specimen Reception/General Enquiries Microbiology Biochemistry Histopathology Haematology Blood Transfusion Outpatient Phlebotomy Laboratory Services Manager Laboratory QA Officer Haemovigilance Officer Dr. Des Farrell Consultant Pathologist/Clinical Director Dr. Cleona Duggan Consultant Haematologist Dr. William Dibb Consultant Microbiologist Phone extension inside the Hospital 578/605 604 253 255 406 286 323 228 582 407 584 285 323 589 Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 3.3.2. Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 13 of 47 List of Contacts for Out of Hours Service Table 3: Ref.3.2.2 CONTACT TELEPHONE NUMBER Laboratory Consultant Histoathologist/ Clinical Director Laboratory Consultant Microbiologist Laboratory Consultant Haematologist Laboratory Services Manager Medical Scientist On-Call Number available at Hospital Reception Switch 066 7149800 Number available at Hospital Reception Switch 066 7149800 Number available at Hospital Reception Switch 066 7149800 3.3.3. Urgent Request for Testing Out of Hours Contact main reception and inform them that you require to speak with the On-Call Scientist in the laboratory. You must state that this request is urgent. The following details must be given to the On-Call Scientist: Ward/Location making the request The urgency of the request Details of the testing required 3.3.4. Urgent Request for Blood Components/Products Out of Hours Contact main reception and inform them that you require to speak with the On-Call Scientist in the laboratory. You must state that this request is urgent. The following details must be given to the On-Call Scientist: Ward/Location making the request The urgency of the request The patients details i.e. patient’s name Proposed movement of the patient i.e. if the patient is to be relocated to perhaps Theatre or ICU The blood components/tests requested State, if known, whether a blood sample for Group and Screen has already been reserved. If so a Blood Transfusion Request Form (PRF03) must be completed requesting the additional units required. Note: “Emergency Stock” of group O Rh D Negative Blood is always available in the Blood Bank Issue fridge. It is the responsible clinician’s decision to use the emergency stock or decide if it is safe to wait for the arrival of the On-Call Scientist and have the samples processed. 3.4 Pathology Department Fax Number 066-7149824 3.5 Bon Secours Hospital Website and Telephone Number Website: Phone No.: http://www.bonsecours.org/ie 066-7149800 (General Hospital Number) Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 3.6 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 14 of 47 Laboratory Staffing The Pathology department team consists of: Laboratory Services Manager Consultant Histopathologist/Clinical Director Consultant Microbiologist Consultant Haematologist Laboratory/Quality Assurance Officer Departmental Senior Scientists Medical Scientists Support Services Household Phlebotomy Secretarial Specimen Reception 3.7 Laboratory Fees A list of Pathology charges is available from the Laboratory Services Manager at 0667149800, ext 582 or on email at ldosullivan@bonsecours.ie. 3.8 Laboratory Accreditation 3.9 The Laboratory was awarded accreditation as a medical testing Laboratory to the International Standard ISO 15189 for the Blood Transfusion Department including Haemovigilance and Traceability, in December 2008 and extended to include Histology in June 2012 and Microbiology in October 2013 by the Irish National Accreditation Board (Registration number 206MT). The Laboratory is accredited by JCI (Joint Commission International) as part of the overall Hospital accreditation process. Protection of Personal Information All staff in the course of their duties may be in possession of confidential information/materials. Staff must not disclose such information to unauthorised personnel. A breach of confidentiality is classed as gross misconduct and is subject to the invocation of the hospital disciplinary procedure. The Bon Secours Healthcare System is registered with the Data Protection Commissioner in Ireland. It is the policy of the Bon Secours Tralee Pathology Department to manage all data and information with integrity and to ensure patient confidentiality is maintained at all times. In certain circumstances, such as sample/report referral, data extracts to the National Cancer Registry, etc., patient details/results may be disclosed to outside agencies or external bodies. 3.10 Patient Consent When obtaining any samples from patients verbal or written consent should be obtained. The procedure to be carried out must be fully explained to the patient. Written consent is required for invasive procedures, e.g. surgery, and for transfusion of blood components Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 15 of 47 and/or products. The risks and benefits must be explained to the patient and documented either within the medical notes, the consent form or the Record of Transfusion Support, where appropriate. Note: Venepuncture is not considered invasive but verbal consent should be obtained. In an emergency and in the best interests of the patient it might be necessary to carry out a procedure without obtaining consent. 4.0 Laboratory Request Forms, Specimen Bottles and Containers 4.1 General Information This section deals with the information that is required to be documented on the laboratory request form and the specimen bottle or container, prior to the analysis of samples. For phlebotomy techniques and the completion of the request form by the person taking the sample refer to BST/PHLE/SOP/001 titled “Guidelines for Phlebotomy”. The laboratory has a number of request forms. These are used for different pathology analyses as outlined below. It is important that the correct form is supplied for a particular test. 1) General Laboratory Request Form (PR001) is used for Biochemistry, Haematology/Coagulation, TDM, Hormone Assay, and In-House Immunology. 2) Histopathology Request Form (PRF002) is used for Histopathology/Cytology specimens 3) Microbiology Form (PR005) is used for Urines, Swabs, Sputum, Blood Cultures, Faeces and Cerebrospinal Fluid (CSF) specimens. 4) Blood Transfusion Request Form (PRF03) is used for Blood Transfusion Grouping/Crossmatch requests and must be hand-written. 5) External Request Form (PRF004) is used for tests to be referred from the laboratory to external laboratories for testing. 4.2 Completing the Request Form The following essential information must be documented in a legible manner on both the front and back copy of the request form: 1) 2) 3) 4) 5) Patient’s Hospital Number (For all in-patients) Patient’s Full Name (Surname, Forename) Patient’s Full Home Address Patient’s Date of Birth Patient’s Location (Hospital Ward, room number or OPD). Where the requesting Physician is at an external location to that of the Bon Secours Hospital, Tralee the postal address of the location should be included. Note: The Kerry Clinic is not considered an external location. 6) Patient’s Gender. 7) The name of the requesting Clinician 8) Specimen type and anatomical site where appropriate (specifically Histopathology/Microbiology specimens) 9) Examination(s) required 10) Date and time of specimen collection (Time of specimen collection is not a requirement for Histopathology or Cytology specimens). Please note that where the time of collection is not provided, the integrity of the sample may be brought into question and the laboratory may issue cautionary comments on the interpretation of results. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 16 of 47 11) Relevant clinical information appropriate to the test(s) requested should be supplied to aid in result interpretation, e.g. Antibiotic therapy, blood transfusion history, fasting status, special timing relating to drug therapy, etc. The minimum clinical information supplied relevant to the patient must include gender and date of birth for interpretative purposes. 12) Specific requirements of individual laboratories: Blood Transfusion Must be hand-written All requests must be signed by the requesting Clinician and MCRN provided Date and Time by which the Blood Components/Products are required If specific blood products are required i.e. CMV negative, irradiated, this should be requested. The specific surgery or reason for a transfusion request must be documented on the transfusion form. Previous Blood group if known Previous Transfusion History (where appropriate) Obstetrical History (Females ≥10yrs) Microbiology Reason for MRSA Screen should be provided in line with Infection Control Guidelines. 13) A clear indication as to whether the tests requested are urgent or routine 14) Signature of the person collecting the sample Note: Some of the laboratory request forms have carbon copies. If using Addressograph Labels, these must be placed on every page of the request form. The gender must be ticked on the request form. 4.3 Labelling the Specimen Container 4.3.1. Positive Patient Identification Positive patient identification of patients for all samples must be carried out as outlined in the sections below. Refer also to BST/PHLE/SOP/001 titled “Phlebotomy Guidelines” for the taking and labelling of blood samples. 4.3.1.1. In-patients: All in-patients must be wearing an appropriate Patient Identification Band/Bracelet. Patient Identification Band/Bracelet for elective/acute adult and paediatric admissions are applied by the nursing staff admitting the patient. Positive patient identification of the: Conscious Patient is carried out by: Asking the patient to state their Name and DOB. Read the information on the armband and confirm that the details are correct. Confirm that the details on the Request Form correspond also. Unconscious Patient or Children or Patients whose first language isn’t English is carried out by: Confirming with a nurse in the clinical area the details on the Patient’s Identification Band, which contains the patient’s name, DOB and Hospital Number/Medical Record Number (MRN). Confirm that the details on the Request Form correspond also. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 17 of 47 4.3.1.2. Out-patients Identification of outpatients is achieved by verbal confirmation of Name, Address and Date of Birth. Special care should be taken with patients who are unable to identify themselves including patients who are confused, young children or patients whose first language is not English. 4.3.1.3. Emergency Situations or Samples Taken in Theatre In emergency situations or when samples are taken in theatre, it may not be practicable for the individual taking the sample to gain access to the patient’s armband and or label the sample that has just been taken. In such instances attending nursing and/or medical staff are authorised to positively identify and/or label the sample on behalf of the person obtaining the sample. 4.3.2. Specimen/Container Essential Information The following essential information should be documented in a legible manner on the specimen container: 1) Patient’s full name 2) Hospital number and/or Date of birth (both required for BT specimens) Note: All patient samples must be labelled at the bedside (This is to prevent misidentification and labelling errors). 4.3.2.1. 4.3.3. Specific Requirements of Individual Laboratories Blood Transfusion Specimens in addition to 4.3.2 above must have: Initials of person taking the sample Microbiology/Histology Specimens in addition to 4.3.2 above must have: Specimen type Qualifier i.e. Left, Right, Upper, etc. Anatomical site Cytopathology/Bone-Marrow Slides must be: Labelled with Patient’s Name and MRN using a pencil Specimens for TDM or Dynamic Function Tests must have: Collection Date and Time on each sample sent with the request Pre or Post clearly identified where relevant to analysis Use of Addressograph Labels Not Permitted on blood specimens except: Arterial Blood Gas syringes which do not have an existing label facility. The addressograph label applied must be signed by the person taking the sample. Microbiology samples for Blood Culture analysis Are permitted on: Histology/Cytology specimens Microbiology Samples Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 4.4 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 18 of 47 Specimen Quality Laboratory personnel must inspect prior to testing each blood specimen received for: Evidence of Haemolysis Gross Lipaemia Presence of clots in all specimens requesting full blood count and coagulation tests Under or Over-filling of specimens where the ratio of liquid anti-coagulant may affect the results obtained, e.g. ESR, samples for Coagulation testing Age/Storage conditions of specimen prior to receipt in the laboratory, where the results may be compromised. For other specimens, the integrity of the specimen is inspected, e.g. leaking urine containers etc. In such instances, the primary sample may be rejected and a second specimen may be requested or where the sample is processed the issued report will have a comment noting the concern raised re the quality of the specimen received, as appropriate. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 4.5 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 19 of 47 Non-Conforming Specimen Bottles, Forms or Specimen Quality Issues Where the requirements with respect to labelling the request form and specimen container or specimen quality issues are not met the following will apply. Table 4: Ref.4.5 SPECIMEN ISSUES ACTION No Specimen Received Reject request and request specimen and form. Rejected request report is issued. Specimen site not identified for Histology or Microbiology specimens. Specimen site on form/specimen do not correspond. Clinical area identifies the correct site on the specimen or corrects the site. Specimen collected at incorrect time e.g Cortisols, Urine for Cytology. Reject request and request second specimen and form. Rejected request report is issued. Specimens unlabelled. Two of the three mandatory unique identifiers are not correct or absent from the specimen (Full name, DOB, hospital no). Reject request and request second specimen and form and rejected request report is issued or the originator accepts responsibility for same in emergency cases or where the specimen cannot be replaced. Addressograph label on Blood Bank tubes(s) or unlabelled Blood Bank tube(s) Reject request and request second specimen and form. Rejected request report is issued. Addressograph label on blood specimen other than Blood Transfusion. Request second specimen and form or the originator accepts responsibility and removes the label and hand writes the patient details on the specimen. Incorrect container used. Reject request and request second specimen and form. Rejected request report is issued. Specimen received in incorrect storage conditions. Reject request and request second specimen and form and rejected request report is issued. In cases where the specimen cannot be replaced e.g: Out patients the specimen will be processed. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE FORM ISSUES Page 20 of 47 ACTION No request form provided with specimen. No demographics provided on Request form. Addressograph label on Blood Transfusion form. Request another specimen and form or the originator accepts responsibility for same in emergency cases or where the specimen cannot be replaced. Details on the form/historical record do not match (for blood specimen other than Blood Transfusion.) Clinical area corrects details. Blood transfusion specimens: Reject request and request second specimen and form or the originator accepts responsibility for same in emergency cases or where the specimen cannot be replaced. Clinical area corrects details depending on the issue. Collection Details incomplete e.g. no date or time of collection/signature of person taking sample No Clinical Details provided. Some details on the form are absent e.g. Reason for Transfusion. Request details incomplete e.g no test requested Clinical area contacted. Any sample that fails the minimum acceptance criteria but where the originator accepts responsibility for same in emergency cases or where the specimen cannot be replaced will have the appropriate nature of the quality issue indicated on the final report following correction. The laboratory staff will record all quality issues electronically. Table 5: Ref.4.5 4.6 SPECIMEN APPEARANCE/ QUALITY ISSUES Evidence of Haemolysis Gross Lipaemia Presence of clots in specimens requesting FBC and coagulation tests For coagulation tests, specimens that are under filled or over filled cannot be analysed. Age of specimen Integrity of specimen compromised Insufficient sample volume Miscellaneous quality issues ACTION DOCUMENTATION The Pathology department will make a decision on whether or not the specimen is suitable for testing and a second specimen is requested as appropriate. The Pathology department may report results within a multi test profile on analytes unaffected by the specimen quality, while not reporting affected analytes in the profile. If tested, the appropriate nature of the quality issue will be recorded on the LIS and the final report will show the relevant details. If rejected a rejected request report is issued. Further Additional Testing If on sending a specimen for testing, further additional testing is required, please contact the Pathology department to investigate the feasibility of using the initial specimen for analysis, as sample age/volume required may impact on the validity of test results. Where sufficient sample is available a new request form must be sent detailing the extra additional testing required. In the case of a medical emergency the lack of a request form should not impede the processing of an urgent request. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 4.7 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 21 of 47 Non-Conforming Issues and Credit It is the policy of the Pathology department to credit the patient’s account where nonconforming issues lead to the non-testing of specimens. 5.0 Delivery, Packaging, Transport and Postal Requirements for Diagnostic and Infectious (or Suspected Infectious) Specimens 5.1 General Information It is the policy of the Pathology Department to treat all specimens and samples as potentially infectious or high risk. Therefore, we advise universal precautions are taken in the collection, packaging and the delivery of specimens sent to the Pathology Department for analysis. All samples should be delivered to the laboratory as soon as possible after being collected to minimise sample deterioration. Refer to section 5.2.1 below for specific storage requirements for samples collected outside routine hours. Note: Routine specimens collected and delivered to the Laboratory during the out of hours period will result in an increase in the turnaround time for the test, as testing will not be performed until the next routine working day. 5.2 Specimen Delivery from Within the Hospital 5.2.1. During the routine Pathology opening times samples will be delivered to the laboratory by either the Phlebotomist(s), through the Pneumatic Chute System or hand-delivered by staff from the clinical area. Outside routine Pathology opening times blood specimens will be delivered to the laboratory by either the medical doctors/ward staff or through the Pneumatic Chute System. All specimens being sent to the laboratory should be placed in a plastic sample bag. The sample bag may or may not be attached to the form. This depends on the form type. Blood culture bottles are to be hand-delivered to the laboratory within one hour of being taken. Blood Culture bottles are to be loaded directly onto the analyser and the form placed in the basket beside the BacT/Alert labelled “Blood Culture Request Forms”. The analyser is located in Microbiology. This is the procedure to be carried out throughout the day regardless of whether it is during routine or non-routine hours. Arterial Blood Gases, CSFs and Frozen sections are to be hand-delivered ASAP to the laboratory and the person delivering the sample must ensure that a laboratory staff member is present to take responsibility for the sample. Histology specimens are collected by portering staff from Theatre and Endoscopy at approximately 9am and 1pm and delivered to the laboratory. Procedure for the Out of Hours Delivery and Storage of Specimens to Pathology Urgent out of hours specimens delivered by designated Hospital staff are to be sent to the laboratory via the Pneumatic Chute System or hand-delivered to the Specimen Reception area, once contact has been made with the On-Call Scientist. Non-urgent specimens (excluding blood specimens) are to be stored as follows: 24 hour urines are stored in the fridge labelled “Non-Urgent Specimens Over Night Storage”, located in Microbiology. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 5.3 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 22 of 47 Microbiology Specimens for refrigeration are stored in the fridge labelled Microbiology Specimens Out of Hours”, located in Microbiology. These specimens include: Urines (universal specimen) Faeces specimens Occult blood specimens Swab specimens Sputum specimens CSF samples for neurological investigations which do not require a cell count. There is a separate box for CSF specimens. Pus specimens Miscellaneous Histopathology specimens are stored at room temperature in appropriate containers with fixative, for subsequent delivery to the laboratory. Routine Blood Samples for Haematology/Biochemistry/Immunology Testing are to be sent to the laboratory via the Pneumatic Chute System or hand-delivered to the Specimen Reception area, unless specified storage conditions/treatment is required on receipt by the laboratory. In such cases the scientist on-call should be contacted. Specimen Delivery from Outside of the Hospital The requirements stated below apply to all specimens or samples directed to the Pathology Department. These specimens should be packaged and transported in accordance with the European Agreement concerning the International Carriage of Dangerous Goods by Road (UNADR). It is the policy of the Pathology department to provide our customers with specimen transport packaging materials where appropriate. Please do not hesitate to ask us for a supply of same. 5.3.1. Packaging Procedure for the Transport of Diagnostic Specimens (Non-Infectious) Take the sample into the appropriate primary container, e.g. Blood Tube Wrap the container in tissue or cotton wool which will act as absorbent material in event of any spillages. Specimen to be sent should be stored in a secure (preferably plastic) secondary container. Place in a biohazard bag. Place the biohazard bag with the sample in a padded (Jiffy bag) envelope. Label the envelope with a hazard warning label, “Diagnostic Specimen, Category B, UN 3373”. Place the name, address and contact number of the destination laboratory on the outside of the envelope. The specimen can be transported or posted as appropriate. There is no requirement for a licensed courier to transport non-infectious diagnostic samples. 5.3.2. Procedure for the Transport of Infectious or Suspected Infectious Specimens When sending specimens or samples suspected or known to contain infectious or suspected infectious substances, the Microbiology department should be contacted for advice regarding transport. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 5.4 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 23 of 47 Disposal of Waste Material Used in Specimen Collection All materials used in specimen collection should be treated as potentially hazardous and discarded in sharps containers and other appropriate colour coded bags. Please refer to the current hospital guidelines for “Waste Management” available on Q-Pulse) prepared by the Infection Control Committee. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 5.5 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 24 of 47 Storage of Examined Specimens for Archive and Look Back Purposes Table 6: Ref.5.5 Storage Requirement Storage Location Minimum Retention Period 28 days ID Specimen Description 1. Serum/ plasma for group/ antibody screen and crossmatch Serum/ plasma (all other tests) -30oC Haematology freezer 4oC 3. Body fluids/ aspirates/ swabs excluding urine 18oC - 25oC Fridges in scientific departments Microbiology 48 hours after Departmental Senior release of Scientists (DSS) reports 48 hours after DSS Microbiology release of reports 4. Urine Specimens for: Microbiology 18oC - 25oC Microbiology Biochemistry 48 hours after DSS Microbiology release of reports DSS Biochemistry 2. Biochemistry 4oC Responsibility DSS Blood Transfusion 5. Whole Blood 4oC Fridges in scientific departments 24 hours after DSS release of reports 6. Histopathology Samples 18oC - 25oC 4 weeks after final report. DSS Histopathology 7. Cytology Specimens 4oC Paraffin blocks 18oC - 25oC 2 weeks after reporting At least 30 years DSS Histopathology 8. Ventilated cabinet in Histopathology Microbiology Fridge Pathology Department 9. Stained Slides - Microbiological Microbiology 7 days post report DSS Microbiology Haematology 7 days post report DSS Haematology Pathology Department Pathology Department Pathology Department 20 years DSS Histopathology Senior Scientist - Blood films (routine) 18oC - Bone marrow smears - Cytology - Histopathology 25oC all stained slides for DSS Histopathology 10 years 10 years Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 6.0 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 25 of 47 External Third Party Assessment Programme The Pathology Department participates in relevant available external third party assessment schemes. These include schemes operated by: NEQAS (UK, National External Quality Assurance Scheme) for Blood Transfusion, Haematology, Microbiology for General Bacteriology, Antimicrobial Susceptibility Testing, MRSA Screening, CDiff Toxin Screening, Cellular Pathology, Cytology, Immunohistochemistry and Cardiac Markers (Biochemistry) Troponin for POCT IEQAS (Irish External Quality Assurance Scheme) for DCT (Direct Coombs test) in Blood Transfusion and Occult Blood, Adenovirus and Rotavirus in Microbiology. Wessex and SW England General Histopathology External Quality Assurance Scheme Bio-Rad External Quality Assurance Scheme for Clinical Chemistry and Immunoassay (Biochemistry). WEQAS (Wales External Quality Assurance Scheme) for Glucose Point of Care Testing and urine Pregnancy Testing in Microbiology. Irish Histopathologists General External Quality Assurance Scheme IEQAS Labquality Acid Base Scheme for Blood Gas Analysis. National Slide Based Uropathology Scheme (UK) The Pathology Department also participates in the National Quality Assurance Programme in Histopathology run by the Royal College of Physicians in Ireland (RCPI). As stated by the RCPI “The fundamental aim of this QA Programme is to assure enhancement of patient care with timely, accurate and complete pathology diagnoses and reports.” The Pathology Department is committed to participating in other schemes as they become available and are required to ensure comprehensive assessment of the test repertoire. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 7.0 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 26 of 47 Provision of Services Table 7: Ref.7.0 SERVICE DESCRIPTION Diagnostic Service There is a wide range of pathology tests available. These will be outlined, in this handbook under the different laboratory disciplines detailing the sample requirements and advice pertaining to individual tests. Biochemistry The automated chemistry section provides analysis of samples for renal, liver, cardiac, lipid, iron studies and specific protein assays. The Immunoassay section performs endocrine, tumour marker, troponin and therapeutic drug monitoring (TDM) assays. Haematology A diagnostic haematology service is provided which includes Full Blood Counts and blood film examination, ESR and Infectious Mononucleosis (IM) testing. Routine Coagulation Screening includes PT-INR and APTT. Ddimers are also available. Blood Transfusion The Hospital Blood Bank provides routine and emergency compatibility testing for both surgical and medical patients. The Blood Bank laboratory along with red cells provides a stock of manufactured blood products including solvent detergent plasma, Fibrinogen Concentrate and Prothrombin Complex Concentrate (PCC) and albumin. Histopathology The Histopathology department provides a varied range of services including Tissue Pathology (including frozen sections for rapid diagnosis), NonGynaecological Cytology and Immunohistochemistry. Microbiology The Microbiology Laboratory examines a diverse range of specimens for bacterial, fungal, and viral and determines the sensitivity of bacteria to antibiotics. The department provides a clinical service which ensures that patients are treated in a timely and effective manner. The department works closely with the Hospital Infection Prevention and Control Department. Sweat Test. Glucose Tolerance Test. Point of Care Testing (POCT) for ABG, Troponin-I and Blood Glucose. (Refer to Q-Pulse for POCT procedures and sample requirements) Related Diagnostic Services Phlebotomy Service Outpatient Phlebotomy is provided by the Pathology Department. Phlebotomists from 09:30h to13:00h and 14:00h to 16:00h. Consultant Service Interpretative Consultant Pathology Services are available in the following specialities, Histopathology, Cytopathology, Clinical Microbiology and Blood Transfusion incorporating Haemovigilance and Traceability activities. In disciplines in which there is not a lead Consultant Pathologist the Clinical Director will endeavour to provide advice or liaise with external organizations where appropriate in the provision of advice. All haemovigilance events are documented and reported to the National Haemovigilance Office as per the requirements of BST/HV/SOP/006 titled “Procedure for the Management of Serious Adverse Reactions/Events by Haemovigilance Staff”. The Bon Secours Pathology Department is committed in conjunction with the Haemovigilance Officer to providing a reporting mechanism that assists the Quality Management Review Process. A Hospital Transfusion Committee exists that includes Medical, Scientific and Nursing staff, Consultant Haematologist and also includes the Director of the Irish Blood Transfusion Service or nominee. The committee meets approximately 4 times a year and discusses and advises on transfusion policies, inventory management, quality issues, haemovigilance and traceability. Haemovigilance Service Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 8.0 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 27 of 47 Laboratory Tests/Profiles Available This section outlines the tests that are available in the different Pathology laboratories. These tests will be described under the following disciplines/sections: Biochemistry Blood Transfusion Haematology Histopathology/Cytopathology Microbiology Refer to Attachment 6.3 of BST/PHLE/SOP/001 titled “Phlebotomy Order of Draw” for a colour coded guide to the sample collection tubes used for blood testing. A Key to samples/sample collection tubes required is also provided at the beginning of each laboratory section. 8.1 Laboratory Test/Profile Description Each laboratory test will be described under the following headings: Apex code (Code used for requesting test on LIS) Description Turnaround Time (TAT) for Urgent (U) and Routine (R) specimens Turnaround time is defined as, the time from specimen receipt in the Pathology department to the time results are available. H – Hours D – Days Where testing is initiated outside routine hours the turnaround time may be affected: For urgent samples as the On-Call Scientist may have to travel to carry out the work. (Allowed travel time is 45mins.) For routine samples as testing will not be carried out until the next routine working day. Specimen type Container including any necessary additives for Microbiology/Histology samples Special requirements The special requirements column defines for each diagnostic test, if applicable, the following: Patient preparation, e.g. fasting Consent form, e.g. Genetic Screening Special timing for collection of samples e.g. pre and post drug administration Any special handling needs between time of collection and time received by the laboratory (transport requirements, refrigeration, warming, immediate delivery etc.). Minimum Requirements refers to the minimum volume to be sent to the laboratory for examination. Note: Where multiple tests are required the minimum volume will increase but will not necessarily be the total volume of the individual tests. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 28 of 47 8.2 Repeat Examination due to Analytical Failure or Further Examination of the Primary Specimen 8.2.1. Repeat Examination due to Analytical Failure It is the policy of the Pathology department in the event of an analytical failure to: Repeat the test. Store the specimens in appropriate conditions until the cause of the analytical failure is identified and corrected and then repeat the test. The relevant senior scientist or nominee reviews the urgency of the outstanding specimens and will inform the Clinician/Clinical Area if a prolonged delay is anticipated. The Clinician will be given the option of requesting that the tests be referred to another laboratory for testing, if required prior to the expected availability of the test result. Send urgent samples to Kerry General Hospital for analysis if required. 8.2.2. Further Examination of the Primary Specimen Where further testing is relevant to the investigation or diagnosis of the condition or symptoms, which gave rise to the original test request, then it is the policy of the Pathology department to pursue a diagnosis by performance of additional tests using the primary specimen, subject to approval by the requesting clinician. 8.3 Tests Not Listed If you require a diagnostic test that is not listed, please contact the Pathology department who will endeavour to outsource, as appropriate, your test requirement. 8.4 External Laboratory Testing Samples referred specifically by the Blood Transfusion, Histology and Microbiology Departments are listed in the relevant departmental sections. All other referred tests including specimen requirements are available on the Hospital Intranet. If you require a diagnostic test that is not listed on the Hospital Intranet, please contact the Pathology department who will endeavour to outsource as appropriate your test requirement. 8.5 Emergency Out of Hours Service Tests provided out of hours in this service will be recognised by the presence of this symbol † in the description column. Other tests which may be processed on call subject to confirmation by the responsible consultant with the On-Call Scientist are indicated by ‡. If any other test is required the person requesting the test should contact the Laboratory Services Manager to request the test. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 9.0 Page 29 of 47 Biochemistry Tests Key 9.1 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE R B CSF O Y U 24HU Red – EDTA Brown – Gel/clot activator Cerebrospinal Fluid – Yellow lidded Universal Container Orange – Lithium Heparin Yellow – Fluoride Oxalate Spot Urine – Universal Container 24 Hr Urine – 5L Plain Container Routine Biochemistry Table 8: Ref.9.1 Apex Code Description TAT-U TAT-R Sample Container/Ward Requirements Min Requirement A1C Haemoglobin A1C N/A 2D R N/A 1ml AMY †Amylase 2H 4H B/O N/A 1.1mls ASO †Anti-Streptolysin O (ASO) 2H 1D B N/A 1.1mls B12 Vitamin B12 4H 1D B 1.1mls B12FOL B12 & Folate 4H 1D B BGA †Blood Gas (Arterial) 0.5 H 1H Blood Gas BNP Brain Natriuretic Peptide 2H 3D R BP CA CA125 CEA Cl CORT †Bone Profile †Calcium Ca 125 Carcinembryonic Antigen †Chloride ‡Cortisol 2H 2H 4H 4H 2H 4H 4H 4H 3D 3D 4H 3D B/O B/O B/O B/O B/O B/O CORTDC ‡Cortisol Dynamic Function 4H 3D B/O CP CR CRP †Cardiac Enzymes †Creatinine †C-Reactive Protein 2H 1H 2H 4H 4H 4H B/O B/O B/O CRTCL Urinary Creatinine Clearance N/A 3D 24HU CRY Cryoglobulins N/A 7D B N/A Patient fasting preferably Addressograph label to be applied to 3ml Blood Gas syringe and signed. Send ASAP Send to Lab ASAP. N/A N/A N/A N/A N/A N/A AM - Patient must be resting. PM - 12 hrs after AM sample N/A N/A N/A 24hr Urine Cont. Serum Creatinine must also be sent within a 24hr period of the collection Contact lab prior to taking sample. Sample must be taken at 37C using heated needle and kept at 37C. Special transport flask available in lab. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. 1.1mls 1.1 mls 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls N/A 3mls ® BST/PATH/GDE/001 Apex Code CSFG CSFP Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Description †CSF Glucose (Part Of CSF/CS) †CSF Protein (Part Of CSF/CS) Page 30 of 47 TAT-U TAT-R Sample Container/Ward Requirements Min Requirement 2H 8H CSF UC 0.5ml 2H 8H CSF UC 0.5ml FE †Iron 2H 4H B/O FER Ferritin 4H 1D B/O FOL Folate 4H 1D B/O FSH Follicle Stimulating Hormone 4H 3D B/O G †Glucose 1H 4H Y GEN †Gentamycin DFT (Patients On Multi-Dose Regimen) 2H 8H B/O GENT †Gentamicin Random For Once Daily Dose Regimen 2H 8H B/O HDL HDL Cholesterol 2H 4H B/O LDH †Lactate Dehydrogenase 2H 4H LFT †Liver Function Tests 2H LH Lutenizing Hormone LIP Patient fasting preferably N/A Patient fasting preferably N/A B/ O acceptable when taken during routine hours. Pre -Take immed before dose. Post (After dose) 30 mins (IV) 60 mins (IM) 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls B/O Refer to section 9.2 of this manual for specific requirements Patient fasting preferably N/A 1.1mls 4H B/O N/A 1.1mls 4H 3D B/O 1.1mls †Lipids 2H 4H B/O LIPPRO †Lipid Profile 2H 4H B/O N/A Patient fasting preferably Patient fasting MG †Magnesium 2H 4H B/O N/A 1.1mls OEL Oestradiol 4H 3D B/O N/A 1.1mls P †Phosphate 2H 4H B/O N/A 1.1mls 1.1mls 1.1mls 1.1mls 1.1mls PA †Protein/Albumin/Globulin 2H 4H B/O N/A 1.1mls PRO Prolactin 4H 3D B/O N/A 1.1mls PSA Prostate Specific Antigen 2H 4H B N/A 1.1mls RF ‡Rheumatoid Factor 2H 4H B 1.1mls SGTT Glucose Tolerance Test 2H 4H Y and U SWNA Sweat Test For CF 2H 4H Sweat SYN ‡Synacthen Test 4H 3D B/O N/A 3-4 Samples at timed intervals. Sample must have the time of collection clearly written on them. Contact the Lab to discuss Pre - Taken immed before dose given. Patient must be resting. Post - 30 - 60 mins after dose 2H 1D B/O N/A 1.1mls 2H 1D B/O Patient fasting 1.1mls TFT TRFPRO Thyroid Function Tests (T4 And TSH) Transferrin Controlled copies printed on Lilac paper only. All other copies are uncontrolled. 1.1mls N/A 1.1mls ® BST/PATH/GDE/001 Apex Code and FE TROPI Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Description TAT-U TAT-R Sample Page 31 of 47 Container/Ward Requirements Min Requirement preferably N/A 1.1mls 2H 4H B/O 2H 4H B/O Patient fasting preferably 1.1mls U †Troponin I Transferrin Saturation (Iron Saturation) Refer To Transferrin †Urea 1H 4H B/O N/A 1.1mls UA †Urate (Uric Acid) 2H 4H B/O N/A 1.1mls UCA 4H 1D U UC 0.5mls 1H 4H B/O N/A 1.1mls UK UMG UNA Urinary Calcium †Renal Function Tests (U&E – Sodium, Potassium, Urea And Creatinine) Urinary Potassium Urinary Magnesium ‡Urinary Sodium 4H 4H 4H 1D 1D 1D U U U 0.5mls 0.5mls 0.5mls UP Urinary Phosphate 4H 1D U URK URNA URPR URUA UU UUA URCA URUU Urinary Potassium 24 Hour Urinary Sodium 24 Hour Urinary Protein 24 Hour Urinary Urate 24 Hour Urinary Urea Urinary Urate Urinary Calcium 24 Hour Urinary Urea 24 Hour 4H 4H 4H 4H 4H N/A N/A N/A 1D 1D 1D 1D 1D 1D 1D 1D 24HU 24HU 24HU 24HU U U 24HU 24HU UC UC UC Sample collected must not be the first sample of the day. Send to Lab <2hrs. 24hr Urine Cont 24hr Urine Cont 24hr Urine Cont 24hr Urine Cont UC UC 24hr Urine Cont 24hr Urine Cont Refer to TRFPRO UE 9.2 0.5mls N/A N/A N/A N/A 0.5mls 0.5mls N/A N/A Aminoglycoside (Gentamicin) Assay Guidelines For patients on once daily Gentamicin regimens: Sample should be taken 18hrs post infusion of the first dose. For patients on divided dose (usually 3 doses/day) aminoglycoside regimens: Pre-dose samples should be taken immediately before the 4th dose is given. Post-dose samples should be taken 30mins after IV dose or 1hr after IM dose is given. Once stabilised assays should be performed twice weekly on patients with normal renal function. More frequent assays will be required in patients with impaired renal function. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE 10.0 Blood Transfusion 10.1 Blood Transfusion Tests Key: B Brown – Gel/clot activator Page 32 of 47 RBT Red EDTA Table 9: Ref.10.1 Apex Code Description ABIN CAT DCT GH X Sample Container/Ward Requirements Min Requirement 1 D* RBT N/A 7mls 1D 3D B Contact lab prior to taking the sample. 1.5mls 2H 4H RBT N/A 1ml 1H 3D RBT N/A 3mls 1H 1D RBT N/A 3mls TAT-U TAT-R Antibody Investigation 6 H* Cold Agglutinins †Direct Coombs Test (Part of Haemolytic screen) †Blood Group and Antibody Screen †Crossmatch *Urgent/Routine TAT for samples for Antibody Investigation will depend on the complexity of the antibody detected. The sample may also have to be referred to the IBTS, Cork for identification and/or confirmation TAT will also depend on whether a blood transfusion sample has already been grouped and is suitable for use in the laboratory. Refer to section 10.3 for list of products available from the Blood Transfusion Laboratory 10.2 Referred Tests from Blood Transfusion Antibody Identification is sent out by the Blood Transfusion department when it is unable to identify or confirm the antibody detected. This test request is initiated by the Blood Transfusion department. Should the patient require blood for transfusion then the IBTS may also be required to antigen-type compatible red cell units and crossmatch them against the patient sample, for the Bon Secours Hospital, Tralee. On investigation of Suspected Transfusion Reactions (Refer to BST/BB/SOP/013) samples may also be referred by the Blood Transfusion Department to the IBTS, Dublin for White Cell and/or Platelet Antibody investigation. Table 10: Ref.10.2 Apex Code Description TAT-U TAT-R Sample Container/Ward Requirements Min Requirement 9mls ABID Antibody Identification 1 D* 1W RBT The laboratory initiates this request. The request form must be hand written. PLTAB Platelet Antibodies 1W 2W B N/A 5mls WCABS White Cell Antibodies 1W 2W B N/A 5mls *Urgent TAT for samples for Antibody Identification will depend on the complexity of the antibody detected. Results may also be issued by telephone where required and this Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 33 of 47 may reduce the TAT to <1 day. 10.3 Products Available through the Blood Transfusion Laboratory It is the responsibility of the requesting clinician to ensure that all patients who may receive Blood and/or Blood Components/Products: Must have the risks and benefits of the transfusion explained and documented in the patient notes. Give their consent prior to administration of the blood and/or blood component/product. Consent is filed in the patient chart and documented on the Patient Consent Form: BST_CFBT_AD for adults BST_CFBT_CH for children. Table 11: Ref.10.3 Description Comments Albumin 20% 100mls Albumin 5% 250mls Paediatric Use Factor concentrates* Contact Haematologist for advice Rho (D) Immune Globulin To be administered within 72hrs of sensitising event. Fibrinogen Concentrate* Used now instead of Cryoprecipitate Octaplas Prothrombin Complex* Rapid reversal of warfarin Platelet Concentrate* Special Requirements may be needed$ Pooled Platelets* Special Requirements may be needed$ Red Cells in SAGM LD Special Requirements may be needed$ Uniplas Uniplas is currently unlicensed in Ireland/EU. Varitect 500IU 20mls* Whole Blood* Sample requirements and TAT for the listed products is as per Crossmatch request above (Section 10.1). Note: * Products marked with * must be ordered on a patient by patient basis from the IBTS. Products will be delivered by the IBTS van at the next available delivery date/time for routine orders. In an emergency a taxi will be ordered for the delivery of the product(s) to the Blood Transfusion Laboratory. $ Contact Consultant Haematologist if advice required. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 10.4 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 34 of 47 Special Timing of Specimens for Transfusion Requests Previously grouped specimens are stored in the Blood Bank. The following is a guide to the suitability of specimens as per 2004 BCSH “Guidelines for Compatibility Procedures in Blood Transfusion Laboratories”: Patient transfused within the last 3 - 14 days Sample to be taken not more than 24hrs before transfusion Patient transfused within the last 15 - 28 days Sample to be taken not more than 72hrs before transfusion Patient transfused within the last 29days - 3months Sample to be taken not more than 7 days before transfusion Patient transfused >3months ago or never Sample to be taken not more than 28days before transfusion New samples must be retaken if the above criteria are not met. In situations where patients are being repeatedly transfused, a daily sample is not a requirement. These patients will be screened for the development of irregular antibodies every 72 h. This interval has been selected as both practical and safe. Requests for Platelet/Plasma Products will be issued against the most recent EDTA-BT sample received by the Blood Transfusion Department up to a maximum sample age of 28 days. Any requests received beyond this time must be accompanied by a new sample. 10.5 Retention of Crossmatched Blood for Patients Requests for Blood/Blood Components are valid up to the “Date and Time required”, as indicated on the request form (PRF03). The Blood Transfusion Department will return crossmatched blood to stock the day after this date, providing the haemoglobin for the patient is at a level that would indicate the blood is no longer required (see below). If any doubt arises as to the requirement for the blood, e.g. borderline haemoglobin, the Blood Transfusion Department will contact the Clinician/clinical area to ascertain if the blood will be required. The following criteria are used as a guideline when returning issued units to stock: Day after the Date Required has passed, on checking the post-op haemoglobin: Hb ≥10g/dl the blood may be returned to stock. Hb ≤10g/dl the clinical area should be contacted to confirm that units are not needed at present. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 11.0 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 35 of 47 Haematology Tests Key: B G P R Brown – Gel/clot activator Green – Tri-sodium Citrate Purple – Tri-sodium Citrate/Citric acid Red – EDTA Table 12: Ref.11.0 Apex Code APTT COAG Description †Activated Partial Thromboplastin Time †Coagulation Screen (INR & APTT) Sample Container/Ward Requirements Min Requirement 4H G N/A Fill to line 1H 4H G N/A Fill to line TAT-U TAT-R 1H DDP †D-dimer 1H 4H G Send to Lab ASAP Fill to line ESR †Erythrocyte Sedimentation Rate 3H 1D P N/A Fill to line FBC †Full Blood Count 1H 4H R N/A 1ml INR †INR (Includes PT Prothrombin Time) 1H 4H G N/A Fill to line MON †Monospot 2H 1D R/B N/A 1.5mls RETIC Retic Count 4H 1D R Send to Lab ASAP 1ml Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 12.0 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 36 of 47 Microbiology Tests Key Sample: Bl F U Container: Blood Faeces Urine CSF FL SNS Cerebro-Spinal Fluid Fluid Specific Named Site UC RCTS DAVOL UC BC Bottle Universal Container Routine Charcoal Transport Swab DAVOL Universal Container Blood Culture Bottle Table 13: Ref.12.0 Apex Code Description AV BAL BC Sample Container/Ward Requirements Min Requirement F UC Pea sized quantity Bronchial Washings DAVOL UC N/A <8 D Yellow Capped BC Bottle Inject 1-3mls of whole blood into Pink Capped BC Bottle 1-4mls Inject 8-10mls of whole blood into each BC bottle <10mls per bottle UC Pea sized quantity TAT-U TAT-R Adenovirus (Faeces) 2H 1D Bronchial Washings C&S N/A 2-4D Blood Culture Children N/A BC Blood Culture Adult N/A <8 D Blue & Burgundy Capped BC Bottle CDIFF Clostridium Difficile 2H 1D F Gastric Biopsy CLO CLO test N/A 2D CSFM N/A 1-4 D CSF N/A 1-3 D U UC 0.5ml FB †CSF - C&S †Catheter Specimen Urine C&S Body Fluid C&S CLO test Must be handdelivered to the Laboratory UC N/A 2-4D FL UC FC Faeces C&S N/A 2-4 D F UC FSY Synovial Fluid C&S N/A 2 - 4D FL UC 0.5ml Pea sized quantity 1ml HVS High Vaginal Swab C&S N/A 2-4D SNS MRSA MRSA N/A 1–3D SNS MSU †Mid-Stream Urine C&S N/A 1-3 D U OB †Faeces Occult Blood 2H 1D F POD Pouch of Douglas Fluid C&S N/A 2-4D FL PR †Pregnancy Test 0.5 H 3H U RCTS - Black RCTS - Black For Screens Nasal & Perineum/Groin Swabs required UC UC 3 Consecutive Samples ideally. Sample must have the date/time of collection clearly written on them. UC UC Early Morning Specimen CSU Controlled copies printed on Lilac paper only. All other copies are uncontrolled. N/A 0.2-0.5ml N/A N/A 0.5mls Pea sized quantity 0.5mls 0.5mls ® BST/PATH/GDE/001 Apex Code Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Description TAT-U TAT-R Sample Page 37 of 47 Container/Ward Requirements Min Requirement recommended SNS UC containing pus recommended. RCTS - Black also accepted. F UC 2-4D SNS RCTS - Black Pea sized quantity N/A N/A 2-4D SNS RCTS - Orange N/A Swab – Eye C&S N/A 2-4D SNS RCTS - Black N/A SMOU Mouth Swab C&S N/A 2-4D SNS RCTS - Black N/A SNAS Nasal Swab C&S N/A 2-4D SNS RCTS - Black N/A SPU Sputum C&S N/A 2- 4 D SP UC N/A SSK Swab - Skin C&S N/A 2-4D SNS RCTS - Black N/A ST Swab from Tip site C&S N/A 2-4D SNS RCTS - Black N/A STH Throat Swab C&S N/A 2-4D SNS RCTS - Black N/A SULC Ulcer Swab C&S N/A 2-4D SNS RCTS - Black N/A SV Vaginal Swab C&S N/A 2-4D SNS RCTS - Black N/A SW Swab – Wound C&S TIPS (Central or Arterial) C&S Vulval Swab C&S Tissue N/A 2-4D SNS RCTS - Black N/A N/A 2-4 D Tip UC N/A N/A 2-4D SNS RCTS - Black N/A N/A N/A 2-4D 7D SNS SNS UC UC N/A N/A PUS Pus C&S N/A 2-4D ROT Rotavirus (Faeces) 2H 1D SAB Abscess Swab C&S N/A SEAR Swab – Ear C&S SEYE TPCL VS TIS TIS 12.1 Tissue ( Antral/Gastric biopsies) 0.5mls Special Requirements for Microbiology Sampling and Testing Refer to hospital policy INF/PPG/31 titled “Guidelines on specimen collection” for the taking of swabs and collection of urine, faeces and sputum samples. Urine, faeces and sputa samples may on occasion be collected by the patient directly. These samples should be collected into a sterile universal container available from the Pathology Department. Many local pharmacies also stock universal containers and may be purchased from them, if the patient is an outpatient. 12.1.1. Blood Cultures The blood culture bottles and system in use are the BacT/ALERT system. When selecting the relevant bottles for blood culture analysis, ensure the sensor at the base of the bottle is grey. Discard any bottles where the sensor is yellow prior to inoculation. There is an expiry date on each bottle and they should not be used after this date. All bottles must be kept at room temperature on the wards prior to use. Relevant Bottles: Adults: One aerobic: Blue top (8-10mls of Blood) One anaerobic: Burgundy top (8-10mls of Blood) Paediatrics: One biphasic: Yellow top (1-3 mls blood) 12.1.1.1. Materials Blood culture collection pack which includes: Microbiology Request form PR005 Safety-Multifly needle (23 gauge safety Butterfly with adaptor attached) Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 38 of 47 Blood culture-adaptor cap Blood culture-adaptor Chloraprep 2% w/v 70% v/v cutaneous solution 2 Clinell Wipes, Alcohol 2% Chlorhexidine Disposable tourniquet Sterile drape Additional materials required: Relevant blood culture bottle(s) see 12.1.1 above Completed request forms Sharps Container Cotton wool/adhesive tape Disposable Gloves 12.1.1.2. Procedure for Taking Blood Cultures Positively Identify patient as per BST/PHLE/SOP/001 “Guidelines for Phlebotomy” Explain procedure and gain verbal consent from the patient. Adhere to Hand-hygiene guidelines for taking blood samples. Choose venepuncture site and clean vein with Chloraprep 2%w/v/70%v/v cutaneous solution for 30 seconds and allow to air dry for an additional 30 seconds as per Infection Control guidelines. Remove coloured caps from blood culture bottles and clean each bottle with fresh Clinell alcohol wipe and allow to air dry. Open packaging of the Safety-Multifly needle and the packaging of the adaptor. Remove the protective sleeve and hold adaptor just behind the threading and screw into adaptor cap. Attach Safety-Multifly needle to the assembled unit Perform venepuncture as per BST/PHLE/SOP/001 “Guidelines for Phlebotomy” Insert the upright blood culture bottle to the adaptor cap and allow to fill. Remove the blood culture bottle and attach the second blood culture bottle to be filled. Please Note: The blood culture bottles must remain upright during collection process to prevent cross contamination from fluid in bottles to adaptor. If further bloods required, detach the collection unit from the Multifly needle and collect blood as per. BST/PHLE/SOP/001. When the last bottle is taken release the tourniquet. Do not leave in situ >60 seconds. Withdraw needle and engage the safety device. Dispose of needle, Chloraprep and adaptor in sharps container. All other waste can be disposed of as per INF/PPG/032 “Guidelines on Waste Management” Secure cotton wool over venepuncture site using adhesive tape. Label bottles with patient details, Name and MRN and the date/time of collection. If using an addressograph label, place the label either vertically to the right of the barcode or horizontally under the barcode. Do not place the addressograph over barcode on bottle or on the bottom of the bottle. Remove barcode tear off labels from blood culture bottles and place on request form. If taking blood cultures/bloods on insertion of cannula a Multi adapter is attached to cannula and process above can be followed. 12.1.1.3. Transport to the laboratory Blood Culture Bottle s must be brought to the Laboratory promptly and placed directly into the BacT/ALERT (Blood Culture analyser) located in the Microbiology department. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 39 of 47 12.1.1.4. Procedure for Loading Blood Culture Bottles onto the BacT/ALERT 3D Health and Safety Precautions Staff must wear gloves at all times during the loading of bottles onto the BacT/Alert. Disposable gloves are available beside the instrument and should be put on prior to removing bottles from the speci-bag attached to the request form. In the event of a bottle breaking or leaking please attend to the spillage in accordance with the Hospital policy INF/PPG/3 titled “Policy for the Management of Blood and Body Fluid Spillages” using the spill kit kept at the First Aid Station outside Specimen Reception. Record the details of the event on the “BacT/ALERT Blood Culture Loading Register”. Contact a member of the Pathology Department for advice in all cases. Procedure Put on gloves. Remove the BC bottles from the speci-bag and discard the bag in the bin provided. Complete the “BacT/ALERT Blood Culture Loading Register”. Place the Microbiology Request Form in the labelled box beside the instrument. Open either drawer 1A BC or 1B BC of the instrument by gently pulling handle toward you. Gently push the bottles – ONE AT A TIME – into an empty slot with the coloured neck pointing outward (see how other bottles are loaded). Look to right hand side to see the empty slots to place bottle/bottles. Close the drawer once the bottles are loaded. Ensure the drawer is closed fully. The yellow light at the front of the instrument will go out when the drawer is closed correctly. Important Notes If the drawer is left open for too long, the instrument will begin to alarm. Simply close the drawer and the alarm should stop. You may resume loading bottles as outlined above, once the alarm has stopped. Please contact Laboratory staff if you encounter any problems which you cannot resolve during this procedure. Outside routine laboratory hours contact the medical scientist on call via the front desk. Use the “BacT/ALERT Blood Culture Loading Register” to document any error codes or problems encountered during the loading process. 12.1.1.5. Reporting Blood cultures are incubated for up to 7 days but this time may be extended to 21 days in some cases e.g. Sub-acute Bacterial Endocarditis (SBE) provided this is indicated in the clinical details on the request form. Most organisms will be detected within 24-48 hrs. Positive cultures are notified to the ward involved immediately on detection by the microbiology/on call staff therefore there is no need for ward staff to contact the microbiology laboratory to determine if a blood culture is positive. Full identification including antibiotic susceptibility patterns may take a further 2448hrs to time of completion. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 12.1.2. Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 40 of 47 Cerebrospinal Fluid (CSF) Bacteraemia is sometimes seen associated with meningitis, and a blood culture should be taken when meningitis is suspected. If in doubt, the Consultant Microbiologist should be contacted for advice. 12.1.2.1. Specimen Requirements: CSF sample divided into 3 sterile universal container bottles sequentially marked I, II and III in order of collection. Note: For Oligoclonal banding a Yellow-CAPPED Universal container is used. Oligoclonal banding profile requires a minimum of 1.5ml in at least one Yellowcapped Universal container Send all specimens to the laboratory as soon as possible. Send a blood glucose sample (to compare with CSF glucose value) Send blood culture as outlined in section 12.1.1 above Send R x1 - Standard Full Blood Count EDTA (Ethylenediaminetetraacetic Acid) blood sample for PCR for meningococcus if this is suspected. Send a throat swab for meningococcus if this is suspected. 12.1.2.2. Results Microscopies are available for ward access once resulted on the laboratory system. Positive Culture results are phoned as soon as detected. Biochemistry results are available once authorised. 12.1.2.3. Normal CSF values Table 14: Ref 12.1.2.3 Test Patient Normal Values Leucocytes Neonates 1-4yr old 5yr-puberty Adults Newborn Adults 0-30 cells/cmm 0-20 cells/cmm 0-10 cells/cmm 0-5 cells /cmm 0-675 cells/cmm 0-10 cells /cmm 10-50mg/dl (<1% of serum protein concentration) 2/3 of simultaneously determined plasma concentration <2.2 mmol/L is reduced- (if no blood glucose available) No Growth after 48hrs Erythrocytes Protein Glucose Culture: Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 41 of 47 12.1.3. Fluids from Sites Normally Sterile 12.1.3.1. Samples Required A sample for culture in a sterile universal container. An R x1 (EDTA) filled with the fluid sample for white cell count is also recommended. Note: If a delay in processing is anticipated, i.e. sample is taken outside routine hours, refrigeration is preferable to storage at ambient temperature. Delays of over 48 hours are undesirable. 12.1.3.2. Normal Findings Peritoneal/Ascitic Fluid Synovial/Joint Fluid 12.1.4. White Cell Count: White Cell Count: 0 - 200 /cmm 0 - 200 /cmm Urine In Urinary Tract Infection (UTI) the bacterial count exceeds 100,000 organisms/ml in the majority of cases. Two samples should ideally be taken to make a diagnosis. A clean mid-stream specimen is the recommended specimen for analysis. Urine acts as a culture medium. After collection of the patient sample, specimens should be stored at 4oC to prevent subsequent multiplication of bacteria which would invalidate the bacterial count. Any sample which may be subject to delay of more than 2 hrs before being sent to the laboratory should be refrigerated. 12.1.4.1. Samples Required MSU – Mid-stream Urine Midstream urine is the recommended sample and requires careful collection. CSU – Catheter Specimen Urine Samples may be from patients who have had a catheter passed for a one-off urine sample or who have in-dwelling catheters. In patients with a long term indwelling catheter samples should only be sent if clinically indicated Patient symptomatic Systemically unwell Catheter change BSU – Bag Specimen of Urine. A sterile collection bag is applied to the cleansed perineum to catch urine, which must then be drained into a sterile universal container. This is commonly used in infants. Culture results are difficult to interpret as contamination is common with this method of specimen collection. 12.1.4.2. Normal Findings White Cell Count Colony Count ≤10/cmm <103/ml Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 12.2 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 42 of 47 Referred Tests from Microbiology Microbiology samples are referred to external laboratories as detailed in Table 15 below. Some of the referred tests are initiated within the Microbiology Department of BSHT. Need details here of Primary Requests and Confirmatory Tests referred to other labs. Table 15: Ref 12.2 Description TAT-U TAT-R Sample Container/Ward Requirements Referral Lab Noravirus N/A <2W Faeces Universal NVRL Mycology N/A <8W Skin/Nail Universal BSHC Samonella/shigella/ listeria N/A <15 days Organism Slope UCHG AFB N/A <8W Urine/Spt/BAL Universal BCHC Carbapenenase Prouducing Enterobacteriaceae CPE N/A <15 days Organism Slope UCHG E.coli 0157 N/A <5 days Organism Slope Cherry Orchard Hosp 13.0 Histopathology The “Nature of Specimen” as documented on the Histopathology request form by the Clinician is required for the appropriate examination and relevant laboratory procedures relating to the sample. This description also forms part of the final diagnostic report and consequently historical medical record of a patient. The accuracy of this description is an essential requirement for all requests. The Histopathology department may require clarification from the source of the specimen in cases where the description is absent, ambiguous or incomplete. For non-conforming specimens/forms BST/PATH/SOP/009 Note that the “Nature of Specimen” description should not include the procedure, previous diagnosis or clinical history. There is a separate area on the request form for this information. The time required to receive clarification may result in a delay of the final report. This can be avoided by the initial accurate completion of the specimen description on the request form. For all urgent or unusual cases please contact the Consultant Histopathologist to discuss the case. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 13.1 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 43 of 47 Routine Histopathology Table 16: Ref.13.1 Specimen Type Specimen Requirements Additive Required Volume Required Container /Type Small Biopsy Sample or GI Endoscopic Biopsy 10% Buffered Formalin Sufficient to fully immerse the specimen Pre-filled container with lid firmly closed Non-Biopsy – Cancer Resection / Other 10% Buffered Formalin Sufficient to fully immerse the specimen Pre-filled container and ensure that the lid is firmly closed Frozen Section (Fresh Tissue) None N/A Empty Histopathology Container * Special Requirements Completed request form indicating the Clinical History outlining the suspected nature of the lesion and any relevant history or treatment As Above. A description of the surgical procedure carried out to allow proper interpretation of the specimen with a description of any sutures or inking used for orientation or to mark relevant margins/structures. Consultant surgeon must give the laboratory 24hrs advance notice of the planned procedure. On the day Theatre must contact the histopathology department 30 mins prior to commencement of the procedure to ensure required personnel are present to process the sample. TAT* 3D 4 -7 D 20mins Occasionally samples may exceed the stated TAT for reasons including but not limited to: Immunohistochemical or Special Stains Special procedures such as decalcification or prolonged fixation Examination of additional tissue Referral for external technical services Consultation with Clinical or Pathology Colleagues Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 13.2 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 44 of 47 Cytopathology Unfixed specimens for cytology should be sent during routine working hours, as these require the immediate attention of laboratory staff. The integrity of unfixed samples taken outside routine working hours may be compromised. If a delay is anticipated please refridgerate the sample. Do not take a urine sample for cytology if a delay is anticipated out of routine hours as cytology must be performed on a fresh random sample. Table 17: Ref.13.2 Specimen Type Specimen Requirements Additive Required Volume Required Container Type Special Requirements TAT Body Fluid (Various, e.g. Pleural, Joint, Ascitic etc.) None >0.5ml Universal None 3D Bronchial Brushings Cytospin Collection Fluid 10ml Universal Cytospin Collection fluid. Brush to be broken off into the container. 3D Bronchial Lavage None N/A DAVOL Universal None 3D CSF None >0.5ml Universal None 3D 3D FNA – Slides (Fine Needle Aspirate) None N/A Slide Holder Alcohol Spray Fix and/or Air-dried according to the nature of the specimen. Advice available from the Consultant Histopathologist if required. All slides must be labelled using a pencil with patient’s name and MRN FNA – Fluids (Fine Needle Aspirate) Unfixed or Cytospin Collection Fluid N/A Universal None 3D Sputum None N/A Universal None 3D Urine None 1ml Universal Bile Duct Brushings None N/A Universal Random fresh sample. First void of morning is to be avoided Brush to be broken off into the dry container Controlled copies printed on Lilac paper only. All other copies are uncontrolled. 3D 3D ® BST/PATH/GDE/001 13.3 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 45 of 47 Referred Tests from Histology Histology Samples are referred to external laboratories as detailed in Table 18 below. Some of the referred tests are initiated within the Histology Department of BSHT at the request of the Consultant Pathologist and are indicated with * below. Table 18: Ref.13.3 Description TAT-U TAT-R Sample Minimum 8 aspirate slides. Bone Marrow Biopsy and Aspirate Slides 1W 4W Biopsy specimen in 10% Buffered Formalin Skin Biopsy in Michel’s medium. Container/Ward Requirements Slides must be labelled with a pencil. Histology request form. Histology Department, Bon Secours Hospital Cork Histology Department St. John’s Institute of Dermatology, St. Thomas’ Hospital, London Bon Secours Hospital, Cork Skin Biopsies for Skin Immunofluorescence N/A 5W Slides for External Testing (Immuno histochemistry)* 2W 4W N/A N//A Molecular Testing (e.g KRAS & EGFR)* N/A 4W N/A N/A RCSI, Beaumont, Dublin 5W Fresh Specimen wrapped in Saline moistened gauze. External Request Form. Neuropathology Department, Cork University Hospital, Cork 5W Fresh Specimen wrapped in Cling Film External Request Form. Neuropathology Department, Cork University Hospital, Cork Sural Nerve Biopsy Muscle Nerve Biopsy 2W 2W St John’s Institute request form Referral Lab UCL Advanced Diagnostics, London Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 14.0 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 46 of 47 Reporting of Test Results Refer to BST/PATH/SOP/007 titled “Procedure for the Review and Release of Reports to Users” for full details of the Pathology Department’s policy on the reporting of results. Listed below is a concise guide to elements of this procedure. 14.1 Reporting of Results within the Hospital All results, once released, are available on the Hospital computer system. Hard copy reports are printed in real time and delivered to the clinical area via the pneumatic chute system. Reports for Outpatients and requests originating from Consultants from the Kerry Clinic are placed in relevant consultant internal post boxes in Specimen Reception. Postal delivery of reports may be facilitated by prior arrangement with the Pathology Department. They are placed in envelopes and delivered to the relevant consultant’s post box in the Hospital Post Room daily at 15:30h. 14.2 Reports for External Locations Reports for External Locations, e.g. Outpatient requests from General Practitioners, will be posted on the day of testing if results are available and printed before 15:30h. These reports are addressed to the relevant Medical Practitioner/Health Care Office and delivered to the main Hospital Reception for postage at 15:30h. 14.3 Telephoned Results 14.4 It is the policy of the Pathology Department to avoid issuing results on the telephone. All telephone conversations relating to such results are documented on the i.Lab/Apex LIS (Laboratory Information System) as per procedure BST/PATH/SOP/007. Parameters that have reached critical levels will be notified to the relevant clinical area by telephone. The nurse clinician receiving the call will be advised of the parameter that has reached a critical level and directed to review the result for clinical impact. The overall policy of the Laboratory is to limit the need for verbal reports. Where the issuing of such reports may be necessary to ensure the optimum care of a patient, trained staff may issue such reports. At ward level, where information is received concerning reports, a record should be maintained on the ward of the nature of the verbal communication. Faxed Reports The overall policy of the Laboratory is to limit the need for such reports whilst at all times recognising that the issuing of such reports may be necessary to ensure the optimum care of patients. Faxed reports are only issued on receipt of a request for the results to be faxed to the relevant healthcare professional. Refer to BST/PATH/SOP/007. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ® BST/PATH/GDE/001 14.5 Effective Date: 05/06/2014 Ver. 6 BON SECOURS HOSPITAL, TRALEE Page 47 of 47 Reference Ranges (Biological Reference Intervals) Reference ranges for test attributes are documented on all reports where appropriate. Biological reference Intervals are provided where clinically indicated on all tests performed by the Pathology Department as defined by BST/PATH/SOP/007 titled “Procedure for the review and release of reports to users” Attachment 6.1, 6.2 and 6.3. In addition a list of Critical Values has been prepared in consultation with our clinical users. These ranges are available in all clinical areas, on Q Pulse and are also available on the intranet. Warning: Many diaries and handbooks provide lists of reference intervals for common analytes. You are asked not to refer to these in the interpretation of results generated by the Pathology laboratory. We have prepared our own reference intervals, which are dependent on the method of analysis, used and are also specific to the population, which we serve. The use of inappropriate reference intervals can be at best confusing and at worst dangerous. If you are in any doubt about the validity of any reference interval provided to you, please contact the Pathology laboratory for clarification. 15.0 Customer Complaints and Feedback The Pathology department operates a complaints system. Complaints to the Pathology Department are managed in accordance with BST/QA/SOP/016 titled “Complaints and Feedback Handling System”. The objectives of our complaints handling system are: That all complaints are rapidly and effectively handled. The customer and/or patient difficulties are alleviated promptly. That the same problem will not occur again because the cause has been identified and corrected. That customer confidence is restored in our service. That relevant information is recorded and reported to Clinical Director & Laboratory Services Manager. If the service provided is not satisfactory, please contact the Pathology Department/ Laboratory Services Manager/ Laboratory Quality Assurance Officer to process the complaint. 16.0 Attachments There are no attachments relevant to this procedure. Controlled copies printed on Lilac paper only. All other copies are uncontrolled. ®
© Copyright 2024