primary sample collection manual (user guide)
Contents
1. of previous histopathology administration of drugs etc Patient s full home address A clear indication as to whether the tests requested are urgent or routine The signature of the requesting person completing the form 5 1 1 1 Minimum Requirements for Histology Request Forms 5 1 2 Include specimen type and anatomic site on both request form and specimen container Include all clinical details Include date specimen taken Prior to dispatch by service user each specimen is recorded on the relevant chain of custody form This form must be signed for by personnel involved in collection and dispatch of the specimen Upon receipt in the logistics company the chain of custody form is date and time stamped prior to dispatch This form is then signed for by a medical scientist laboratory aide upon receipt and verification that each specimen is present according to chain of custody form Cervical cytology not performed by MC Pathology but can be outsourced to an approved referral laboratory on request include last menstrual period LMP Cervical cytology specimen request form and or label requires the patient s address Labelling the Sample Container The following information must be documented in a legible manner on all sheets of the request form Items marked with an are minimum identifiers and failure to provide the minimum data required will delay processing of the sample Primary Sample Collection Manual User Guide Pa2. MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 PRIMARY SAMPLE COLLECTION MANUAL USER GUIDE Date of Issue 29 07 2015 Effective Date 29 07 2015 APPROVALS Name Date Written Reviewed By Grace Hanniffy 29 07 2015 Approved By Dr Susan Kennedy 29 07 2015 DOCUMENT REVIEW HISTORY Reviewed by Date Amendment Necessary Next Revision if yes state sections changed Date Grace Hanniffy 29 07 2015 1 4 5 6 7 8 29 07 2017 Applicable Change Control Number s 2015 40 Primary Sample Collection Manual User Guide Page of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 1 QUALITY POLICY AAA teser sesse sistis isoo orisosidest sise issos ioeie sesso ssi sieis 4 2 INTRODUCTION TT 6 3 GUIDE TO USING THIS MANUAL eesseeessseesscccesseceessccesccsecsscceesseceessecsssoecsscccecseceessecsscoeesseceessecesssseessoseessese 6 4 GENERAL INFORMATION eseesssseessesesssecesssecssoceesseceessecsssoeesscceesseceesssecssoecsseceessecesssecsssoeessseceessecsssseesssseessese 7 AL LABORATORY LOCATION Sit A a cataaeensesesesseesine T 4 2 LABORATORY OPENING HOURS into El 7 43 CONTACT INFORMATION ist A a a a 7 ASH KEY SMED da a 7 4A SERVICE DESCRIPTION sois coos ccgdacbecssbeed coils E E cake beak bes Bas ciate Boch See tt dela 7 ADs ACCREDITATI N veto Seki tect ees Boeke co
3. Royal College of Pathologists 3 GUIDE TO USING THIS MANUAL A controlled hardcopy of this manual is provided to each customer where requested at their principal offices and other relevant locations as authorised by the Laboratory Director A read only version of the manual is stored on the Laboratory website All tests and special requirements for testing in MC Pathology Group are documented in Section 8 of this manual Primary Sample Collection Manual User Guide Page 6 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 4 GENERAL INFORMATION 4 1 Laboratory Location The laboratory services are located at MC Pathology Group Northbrook Clinic 15A Northbrook Road Ranelagh Dublin 6 The laboratory is located on the first floor of this building The laboratory consists of the specimen reception and cut up area microtomy room immunohistochemistry room laboratory office consultant office reporting room and the store room The reporting office is located on the ground floor of the Northbrook Clinic 4 2 Laboratory Opening Hours Specimen Reception Monday Friday from 08 00 17 30hrs Routine Laboratory Diagnostic Service Monday to Friday 08 00 17 30hrs Emergency Out of Hours Service on call diagnostic service By arrangement 4 3 Contact Information The Histology Laboratory welcomes your queries The contact det
4. 10 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 Note Non Gynaecological specimens must be delivered to the laboratory in cytofix solution provided Please notify the laboratory if stocks are low 5 2 Computer Generated Specimen and Addressograph Labels Computer generated addressograph labels may be used on all samples and request forms Please check all details are correct on labels at patient s bedside before labelling specimens and forms Ensure all copies including back copy of request form are labelled 5 3 Histology Cytology Specimen Containers Type of Container Special Requirements Histology Biopsy Formalin Pots Adequate volume of formalin is essential for proper fixation pre filled The recommended volume of fixative formalin is ten times the volume of the tissue to be fixed Theatre Pots or Buckets Adequate volume of formalin is essential for proper fixation containing Formalin The recommended volume of fixative formalin is ten times the volume of the tissue to be fixed Sterile Dry Containers Fresh specimens requiring special analysis Any unfixed tissue should be transported to the laboratory urgently in refrigerated transport container and laboratory staff alerted immediately Saline Soaked Fine Gauze Use to gently wrap specimen inside a sterile dry specimen pot for skin specime
5. analysis Transport all specimens to the laboratory with minimal delay 6 2 Specimen Delivery e Place all specimens being sent to the laboratory in a plastic specimen transport bag attached to the request form or containing the request form in the outer sleeve ofthe bag The Gard specimen bag is slightly larger and should be used for larger histology specimens e Specimen containers that are contaminated externally or leaking in any way must not be sent to the laboratory The contamination or leak must be rectified prior to sending e High risk specimens i e specimens from a patient with a known infectious disease must be identified by attaching a RED STICKER to the request form and to the sample with an indication in the clinical details as to why the specimen is high risk However all specimens must be treated as high risk and appropriate health and safety precautions taken Primary Sample Collection Manual User Guide Page 12 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 6 3 Procedure for the Out of Hours Delivery and Storage of Specimens Store non urgent specimens as follows 1 Non gynaecologic cytology 1f fixative has not been added then refrigerate prior to transport and indicate on request form that specimen has been refrigerated 2 Routine Cellular Pathology specimens must be stored in appropriate contai
6. primary receptacle s shall be leak proof b The secondary packaging shall be leak proof c If multiple fragile primary receptacles are placed in a single secondary packaging they shall be either individually wrapped or separated to prevent contact between them d Absorbent material shall be placed between the primary receptacles s and the secondary packaging The absorbent material shall be in quantity sufficient to absorb the entire contents of the primary receptacle s so that any release of the liquid substance will not compromise the integrity of the cushioning material or of the outer packaging e The primary receptacle or the secondary packaging shall be capable of withstanding without leakage and internal pressure of 95 kPa 0 95 bar For solid substances a The primary receptacle s shall be sift proof b The secondary packaging shall be sift proof c If multiple fragile primary receptacles are placed in a single secondary packaging they shall be either individually wrapped or separated to prevent contact between them Refrigerated or frozen specimens Ice dry ice and liquid nitrogen a When dry ice or liquid nitrogen is used to keep specimens cold all applicable requirements of ADR shall be met When used ice or dry ice shall be placed outside the secondary packaging or in the outer packaging or an over pack Interior supports shall be provided to secure the secondary packaging in the original position after the ice or dry ice ha
7. uk regulations pdf To meet the requirements of P650 there are 3 levels of packaging for diagnostic liquid and solid samples 1 The primary receptacle containing the sample 2 This secondary containment receptacle containing the primary sample s and sufficient absorbent material to soak up any spillage that occurs 3 The outer packaging which is seen by delivery or postal staff At least one of the above packages must be pressure resistant to 56 kPa The outer packaging must be marked with UN 3373 and Biological substances Category B marked adjacent to the diamond shaped mark as overleaf Primary Sample Collection Manual User Guide Page 13 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 BIOLOGICAL SUBSTANCE CATEGORY B Jiffy bags do not meet the criteria in relation to the outer packaging All specimens referred for external testing are packaged using an UN approved packaging system The system used incorporates a triple packaging system and is fully P650 compliant It is based on the provision of a 95kPa leak proof bag and an outer study card board box offering physical protection during transport The outer boxes are labelled in compliance with ARD 2007 requirements 6 5 Disposal of Waste Material used in Specimen Collection Treat all materials used in specimen collection as potentially hazardous and discard us
8. Beaumont Road Gastric Laboratory before sending Dublin 9 Biopsies Immunostains Histopathology Laboratory 01 8093726 Tony O Grady Unstained Contact Cellular Pathology Molecular Testing RCSL Beaumont Road tissue Laboratory before sending Dublin 9 section Immunostains Immunohistochemistry 01 6373180 Mary Hunter Unstained Contact Cellular Pathology Laboratory National tissue Laboratory before sending Maternity Hospital Holles section Street Dublin 2 EGFR Mutation Histopathology Laboratory 01 8093726 Tony O Grady Unstained Contact Cellular Pathology Studies RCSI Beaumont Road tissue Laboratory before sending Dublin 9 section KRAS Mutation Histopathology Laboratory 01 8093726 Tony O Grady Unstained Contact Cellular Pathology Studies RCSL Beaumont Road tissue Laboratory before sending Dublin 9 section Primary Sample Collection Manual User Guide Page 21 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 1 Appendix No 3 Sample Packaging Instruction P650 This packing instruction applies to UN No 3373 Diagnostic Specimens 1 The packaging shall be of good quality strong enough to withstand the shocks and loadings normally encountered during carriage including transhipment between vehicles or containers and between vehicles or containers and warehouse as any removal from a pallet or over pack fo
9. Y GROUP Document No MP20 Version No 2 5 4 1 Sample Volume Adequate Fixative 10x formalin is required for optimised tissue preservation Refer to Section 8 for test specific sample volumes 5 5 Further Additional Testing If further additional testing is required on a specimen submitted to MC Pathology Group contact the senior medical scientist to investigate the feasibility of using the initial specimen for analysis since the age or remaining quantity of the specimen may impact on the validity of test results or preclude further testing Ideally a request form must accompany such a request but the lack of the request form will not impede the processing of an urgent request A record of the name and status of the person requesting the test will be entered on the original request form All requests for additional histology or cytology testing and or examination must be forwarded by FAX if necessary in writing and signed by the requestor All additional histology tests examinations are subject to authorisation by the Consultant Histopathologist at MC Pathology Group 6 DELIVERY PACKING TRANSPORT AND POSTAL REQUIREMENTS FOR SPECIMENS 6 1 General Information It is the policy of the laboratory to treat all specimens and samples as potentially infectious or high risk Therefore it is advised to take universal precautions in the collection packaging and the delivery of specimens being sent to the Laboratory for
10. ails for the Laboratory are as follows Tel 353 1 478 2274 Fax 353 1 478 2733 Email lab mcpathology ie Contact can also be made using the Contact tab on the MC Pathology Group website at www mcpathology ie 4 3 1 Key Staff Members Position Name Contact No Laboratory Director Professor Susan Kennedy 086 8387313 Consultant Histopathologist Dr Eoghan Mooney 01 4782274 Dr DS O Briain 01 4782274 Senior Medical Scientist Ms Lisa Jaynes 01 4782274 Quality Manager Ms Grace Hanniffy 087 2512391 Administration Enquiries Laboratory Office 01 4782274 4 4 Service Description MC Pathology Group provides a service in the discipline of Histopathology Where medical and scientific advice is required on medical indications and appropriate selection of available procedures please contact the laboratory For telephone queries use the list provided in Section 4 3 of this manual above The Laboratory has a complaints system to facilitate the reporting of any unsatisfactory product or service by users and or patients Refer to Section 10 of this document Primary Sample Collection Manual User Guide Page 7 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 The Laboratory located at Northbrook Clinic provides a comprehensive Histology Service across a wide range of specimens including gastr
11. aminated Any other goods and articles carried in the same vehicle or container shall be examined for possible contamination Primary Sample Collection Manual Page 23 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 1 Appendix No 4 Document Reading Record Primary Sample Collection Manual Document is NOT Controlled Unless Printed on Green Paper Page 24 of 25 MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 1 Appendix No 5 Amendment Proposal Record No Date Page No Amendment Authorised By l 2 3 4 5 6 7 8 9 10 NOTES e The amendment must be authorised by the author of the procedure e The amendment must be underlined and the corresponding number from this form written in the margin alongside the change with an asterisk correction fluid must not be used e Major changes must result in the immediate review of the procedure Primary Sample Collection Manual Page 25 of 25 Document is NOT Controlled Unless Printed on Green Paper
12. ests are Clinically Urgent please flag stamp as urgent on the request form If results are extremely urgent please contact the senior medical scientist to discuss your requirements e Cellular Pathology Histology and Cytology reports are usually available within 7 10 working days depending on the specimen size and complexity and unless extra tests are pending e Samples that need to be referred to outside institutions may take 10 14 days for a report to be available e Some specialised tests are not performed daily if such tests are required urgently please phone the appropriate laboratory to discuss the request e Please see relevant column in Appendix No 1 of this manual for specific Turnaround Times for individual tests Primary Sample Collection Manual User Guide Page 16 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 8 1 1 Tests Not Listed If a diagnostic test is required that is not listed below contact the laboratory for a list of approved Referral Laboratories and Referred Pathology Tests Refer Appendix No 2 Tests Referred to External Laboratories 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 laboratory in the event of an analytical failure to e Repeat the test usi
13. ge 9 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 1 Patients Full Surname 2 Patients Full Forename 3 Hospital number 4 Date of birth 5 Specimen Type Anatomic Site Containers must be individually labelled with specimen type description if more than one specimen is provided with a single request form 5 1 3 Key Points e Prior to sending specimen check the completion of the Request Form Always confirm the identity of the patient as per your establishments labelling and consent policy e Check the specimen pot is correctly labelled sealed and not leaking e Ensure that the specimen is in an adequately sized specimen pot and determine if specimen should be sent with or without fixative see Appendix No 1 e Minimise the risk of specimen interchange by not pre labelling pots and double checking request forms prior to sending 5 1 4 Specimen Rejection Specimens are rejected where they cannot be processed for histology although it is the policy of MC Pathology Group to make every effort to avoid rejection Specimens for histology are rejected where no tissue is present in the specimen container The source of the specimen is contacted as soon as possible and advised that no specimen is present in the container 5 1 5 Scope of Service and Specimen Requirements Routine Histology All specimens for routi
14. ing sharps containers and other appropriate colour coded bags Refer to your establishment waste disposal policy 6 6 Storage of Examined Specimens Minimum Retention Times 6 6 1 Clinical Specimens Clinical material is stored to facilitate repeat and further examination of material The retention times in this document refer to retention time for specimens post results being issued and are determined by the nature of the material and the type of analysis required Specimens are stored for a minimum of 4 weeks but may be stored for longer until the report is authorised Specimens are retained in accordance with the following guidelines e The Royal College of Pathologists The Retention and Storage of Pathological Records and Specimens current edition e ISO 15189 2012 Medical Laboratories Particular Requirements for Quality and Competence e Statutory Instruments S I 360 of 2005 and S I 547 of 2006 transposing the above directives into Irish Law e Irish National Accreditation Board Document INAB Terms and Conditions TC The minimum retention times for the most common specimens are detailed in the Table below Refer directly to the Cellular Pathology Laboratory for further details of minimum retention times for Cellular Pathology specimens Additional testing of specimens may be possible during this time Contact the laboratory for confirmation Primary Sample Collection Manual User Guide Page 14 of 25 Document is NOT Control
15. ke cc bec Reed coeliac bade Beebe aks dde CUE sence ak Beale id 8 BO SAFE Ge e ee tea dob ee Tes elo 8 5 LABORATORY REQUEST FORMS amp SPECIMEN CONTAINERS sscccsssssccssssccessssscccsssccsessscecees 8 DL GENERAL INFORMATION ao 8 S A Specimen Acceptance Criteria iia dida aia 9 5 1 2 Labelling the Sample Container TTT 9 KH Key Pontia hla 8 lanes ca E E RE E KE aida 10 DAA Specimen Rejection ennert a E E K A EER RER E i a ai iai 10 5 1 5 Scope of Service and Specimen Requirements Routine Histology 10 5 2 COMPUTER GENERATED SPECIMEN AND ADDRESSOGRAPH LABELS sse eee 11 5 3 HISTOLOGY CYTOLOGY SPECIMEN CONTAINERS sese 11 5 4 NON CONFORMING SPECIMEN CONTAINERS FORMS OR SPECIMEN QUALITY ISSUES ss se eee e eee 11 JA Sample Volume niod harei AA A AA AAA AANE A EE Aidaa 12 5 5 FURTHERADDILIONAL TESTING TTT 12 6 DELIVERY PACKING TRANSPORT AND POSTAL REQUIREMENTS FOR SPECIMENS 12 6 1 GENERAL INFORMATION 12 6 2 SPECIMEN DELIVERY ee 12 6 3 PROCEDURE FOR THE OUT OF HOURS DELIVERY AND STORAGE OF SPECIMENS ccsessscsscsscsssessssseseeeees 13 6 31 Urgent Specimens e a a E E E a aA A aa N O EEEa E TET 13 6 4 SPECIMEN DELIVERY WHEN REFERRING SPECIMENS ese e ee 13 6 5 DISPOSAL OF WASTE MATERIAL USED IN SPECIMEN COLLECTION eee 14 6 6 STORAGE OF EXAMINED SPECIMENS MINIMUM RETENTION TIMES sss se ee eee 14 6 6 1 Clinical SpeciM nS sitieni oaan AAA Ae Da aos AA aa Ai Aa 14 7 PATHOLOGY SERVICES AVAILABLE eesseeesssec
16. led Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 CELLULAR PATHOLOGY 1 Paraffin blocks slides and Cytology Held for a minimum of 30 years slides preparations 2 Cytology Specimens Processed blocked and kept for 30 years Non Gynae Gynae Sent to external location Slides kept for 10 years Thin prep vials kept for 4 weeks post report authorization 3 Frozen Sections Permanent tissue blocks held for a minimum of 30 years 4 Surgical Specimens Four Weeks following authorisation of final report 5 Stained Slides including controls Held for 30 years The laboratory participates in relevant available external third party assessment schemes This includes schemes operated by e NEQAS UK National External Quality Assurance Scheme e UK National Hospital Services National Liver Pathology Breast Pathology and National Ophthalmic Pathology EQA Scheme e Faculty of Pathology RCPI Irish General Histopathology EQA Scheme The laboratory is committed to participating in other schemes as they become available to ensure comprehensive assessment of the test repertoire Where EQA schemes are not available the laboratory participates in inter laboratory comparisons where possible 7 PATHOLOGY SERVICES AVAILABLE 7 1 Clinical and Scientific Advice Consultant Pathologists provide advice to customers on appropriate investigations in
17. ne histology must be fixed in 10x formalin Histology specimens need to be placed into a container at least 3 times the size of the specimen and fully covered with formalin All specimens must be accompanied by a fully completed MC Pathology request form or alternative as detailed in Section 5 1 of this document Relevant clinical details are essential Clinical details where relevant medical history symptoms and or possible diagnosis Samples without clinical details or with insufficient or incorrect patient and specimen details must be verified with the sample taker prior to processing This may result in a delay in reporting e Skin biopsies for direct immunofluorescence These specimens must not be placed in formalin and should be placed in saline dampened gauze Immediate delivery to the Cellular Pathology department is vital e Non Gynaecological Cytology Cervical cytology samples must be sent via the laboratory Slides spatulas brushes thin prep fixative and mailing containers are not available from the laboratory Reports are usually issued in 3 4 weeks of receipt Refer to Section 5 1 1 1 for specific requirements for request forms e Cytology please send to laboratory in universal container as soon after collection as possible with an appropriate request form detailing relevant clinical details If this is not possible the specimen must be refrigerated to prevent degradation Primary Sample Collection Manual User Guide Page
18. ners with fixative at room temperature until the next available delivery time to MC Pathology Group Keep these containers up right while being transported to the laboratory 3 Specimens for cytology or fresh tissue for histology must be stored in a refrigerated environment until the earliest available delivery to MC Pathology specimen reception If any fresh specimens including non gynaecological cytology samples for non urgent reporting for Cellular Pathology cannot be delivered during working hours they MUST be kept refrigerated then collected and delivered on the first following weekday Containers and request form must be labelled with full patient details and specimen details 6 3 1 Urgent Specimens Mark the request form Urgent Send all urgent specimens for delivery to Specimen Reception area The senior medical scientist will follow up where necessary In some cases Urgent specimens may be processed by prior arrangement after consultation with the laboratory director or senior medical scientist 6 4 Specimen Delivery when Referring Specimens All specimens transported by road must comply with the European Agreement concerning the International Carriage of Dangerous Goods by Road UNADR Package all specimens as per the ADR P650 Packaging Instruction It is the responsibility of the sender to ensure that specimens are transported in accordance with current regulations A copy of this regulation is available at www izvg co
19. ng a back up instrument or e Store the specimens in appropriate conditions until the cause of the analytical failure is identified and corrected and then repeat the test The urgency of the outstanding specimens is reviewed by the Consultant Pathologist or nominee e To refer out any urgent samples during this period to an approved referral laboratory 8 2 2 Further Examination of the Primary Specimen 1 Where further testing 1s 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 laboratory to pursue a diagnosis by performance of additional tests using the primary specimen 2 Users may request additional examinations on specimens already sent to the laboratory All requests for additional Cellular Pathology testing and or examination must be forwarded in writing FAX and signed by the requesting clinician All additional Cellular Pathology tests examination requests are subject to authorisation by the Consultant Histopathologist The analysis will be performed provided the specimen has been stored appropriately and there is sufficient specimen remaining to perform the additional tests There are time limits for additional tests please phone the laboratory to enquire 8 3 External Laboratory Testing Referral Laboratories Some specimen samples are referred to external laboratories for testing for specialised tests not performed in house at MC Pa
20. ns requiring direct immunofluorescence DO NOT add formalin ThinPrep Pap Test PreservCyt Use for cervical cytology smear specimens Referral service Solution only Any unfixed tissue should be transported to the White lid 20 ml laboratory urgently in refrigerated transport container and laboratory staff alerted immediately Sterile Universal Container Use for urine cyst synovial fluid bronchial washings or 20 ml other fluid specimens for cytology specimens If retaining Prefilled with cytofix solution overnight ensure specimen refrigerated If cytofix green or red solution added DO NOT refrigerate and indicate original volume of fluid DO NOT ADD formalin 5 4 Non Conforming Specimen Containers Forms or Specimen Quality Issues It is the policy of MC Pathology Group to accept specimens only if they meet the requirements set out in Section 5 1 Laboratory staff will inform the originator immediately on receipt if the sample is inadequately labelled and or otherwise unsuitable Given the invasive nature of histology specimens every effort will be made to ensure the specimen can be examined In some instances it may be necessary to hold the specimen prior to processing for clarification of patient identifiers etc resulting in a delay in examination diagnosis for the patient Primary Sample Collection Manual User Guide Page 11 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOG
21. ointestinal biopsies skin lesions surgical resections gynaecologic specimens and a wide range of other tissue types The department further provides a referral service for cytology samples including urine cyst fluid and fine needle aspirates and also a referral service for immunohistochemical techniques and molecular testing 4 5 Accreditation The Histology Laboratory is committed to achieving and maintaining accreditation under ISO 15189 for medical testing through the Irish National Accreditation Board INAB 4 6 Staffing The laboratory team consists of Management Team e Laboratory Director e Consultant Histopathologists e Quality Manager e Senior Medical Scientist s Technical Staff e Medical Scientist s e Laboratory Aide s e Support Services Secretarial Administration Staff 5 LABORATORY REQUEST FORMS amp SPECIMEN CONTAINERS 5 1 General Information This section details the information that must be documented on the laboratory request form and the specimen container prior to sending for analysis For accurate identification of specimens and patients it is essential that specimens are labelled properly and that request forms are completed fully and accurately The laboratory has a standard request form which is used to request histopathology examinations by customers These request forms are available on request from the Laboratory Customers may use their own request forms provided the necessary criteria for com
22. pleting the request form as listed below are adhered to Note Please ensure the request form is completed in a clear legible manner to ensure the prompt processing of specimens Note Where changes are made to the request form resulting in the issuing of a new version the customer is notified and the new request form is sent to service users A copy of the laboratory request form is also available on the MC Pathology website Primary Sample Collection Manual User Guide Page 8 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 5 1 1 Specimen Acceptance Criteria The information on the request form must be sufficient to identify the patient and the authorised requester The following essential information must be documented in a legible manner on the request form 1 DE tS T 8 9 10 Relevant clinical details appropriate to the test s requested must be supplied e g history 11 12 13 14 Patient s Surname Patient s Forename Patient s Date of Birth Patient s unique identification number Patient s gender Date of specimen collection see special requirements in Section 5 3 collection time is not critical to specimen processing Patient s location source and the postal address of the location The name and location of requestor Specimen type and anatomical site Examination s required
23. r subsequent manual or mechanical handling Packaging shall be constructed and closed to prevent any loss if contents that might be caused under normal conditions of carriage by vibration or by changes in temperature humidity or pressure The packaging shall consist of three components a a primary receptacle b a secondary packaging and c an outer packing Primary receptacles shall be packed in secondary packaging in such a way that under normal conditions of carriage they cannot break be punctured or leak their contents into the secondary packaging Secondary packaging shall be secured in outer packaging with suitable cushioning material Any leakage of the contents shall not compromise the integrity of the cushioning material or of the outer packaging For carriage the mark illustrated below shall be displayed on the external surface of the outer packaging on a background of a contrasting colour and shall be clearly visible and legible The width of the line shall be at least 2mm the letters and numbers shall be at least 6mm high UN 3373 The completed package shall be capable of successfully passing the drop test in 6 3 2 5 as specified in 6 3 2 3 and 6 3 2 4 except that the height of the drop shall not be less that 1 2m The smallest external dimension of outer packaging shall be not less than 100mm See note Note This condition has been removed in a corrigendum issued by the UN dated December 2004 For liquid substance a The
24. rmation system Hard copy reports are printed as reports are authorised Reports are dispatched by post to their destination daily if results are available before 15 30 hours otherwise they are dispatched on the first working day after authorisation 9 2 Telephoned Results e Itis the policy of the laboratory to telephone reports if the report is marked urgent or an unexpected result is obtained e Requests for verbal reports are not accepted except in urgent cases e Verbal unscheduled reports are recorded on the Laboratory Information System LIMS e The method by which results are phoned is clearly defined to ensure the results only reach an authorised receiver and that results are clear and unambiguous The security of the patient records is ensured and the risk of error reduced e Results provided verbally are followed by a written report 9 3 Faxed Reports Reports may be faxed following authorisation by the Consultant Pathologist In such instances the confidentiality of the patient results must be ensured Faxed reports are sent only to secure locations and when the reporting administration staff is satisfied that the report is to be received immediately 10 CUSTOMER COMPLAINTS MC Pathology Group operates a complaint system The objectives of the complaints handling system are as follows e That all complaints are rapidly and effectively handled e Customer patient difficulties are alleviated as soon as possible e The same p
25. roblem will not occur again as following identification of the cause appropriate corrective actions will be put in place e That customer confidence is restored in the service e That the relevant information is formally recorded and reported to the Laboratory Director as soon as possible If the service provided by the laboratory is not satisfactory contact the Laboratory Director Quality Manger to process the complaint Refer to Section 4 3 of contact details Primary Sample Collection Manual User Guide Page 18 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 11 DATA PROTECTION POLICY MC Pathology Group complies with all legislation pertaining to the rights of the patient and staff and to act in an ethical and responsible manner in maintaining the security and integrity of all personal information 12 APPENDICES Appendix No 1 Repertoire of Tests Provided by The laboratory Appendix No 2 Tests Referred to External Laboratories Appendix No 3 Sample Packaging Instruction P650 Appendix No 4 Document Reading Record Appendix No 5 Amendment Proposal Record Primary Sample Collection Manual User Guide Page 19 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No Appendix No 1 Repertoire of Tests Provided by
26. s dissipated If ice is used the outside packaging or over Primary Sample Collection Manual Page 22 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 1 pack shall be leak proof If carbon dioxide solid dry ice is used the packaging shall be designed and constructed to permit the release of carbon dioxide gas to prevent a build up of pressure that could rupture the packaging and the package the outer packaging or the over pack shall be marked Carbon dioxide solid or Dry ice b The primary receptacle and the secondary packaging shall maintain their integrity at the temperature of the refrigerant used as well as the temperatures and the pressures which could result if refrigeration were lost 9 Infectious substances assigned to UN No 3373 which are packed and packages which are marked in accordance with this packing instruction are not subject to any other requirement in ADR 10 Clear instructions on filling and closing such packages shall be provided by packaging manufacturers and subsequent distribution to the consignor or to the person who prepares the package e g patient to enable the package to be correctly prepared for carriage 11 If any substance has leaked and has been spilled in a vehicle or container it may not be reused until after it has been thoroughly cleaned and if necessary disinfected or decont
27. sescscscusucesssssesessssssveveveseseveveveveveveseseess 18 9 37 AXED REPORTS Gaeta Sets De Eo ten ae eine EE EOE EEA 18 11 DATA PROTECTION POLICY ccscssscssrserssssrsereessrsessessrsessessssessesscsessessssssesessessesessesscssessssessesesseseeee LO APPENDIX NO 1 REPERTOIRE OF TESTS PROVIDED BY THE LABORATORY ee 20 APPENDIX NO 2 TESTS REFERRED TO EXTERNAL LABORATORIES cssscsssceeseseseeeseseeecececececececececececececeeececeseceeecs 21 Primary Sample Collection Manual User Guide Page 3 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 1 QUALITY POLICY The Laboratory is committed to providing a histopathology service of the highest quality where the needs and requirements of its users are always considered In order to ensure that the needs and requirements of users are met The The department will comply with the requirements of ISO 15189 2012 Medical laboratories Particular Requirements for Quality and Competence INAB Terms Conditions and Regulations Current Editions ILAC and EA Documents Guidelines for the Implementation of a National Quality Assurance programme in Histopathology scope of tests with respect to accreditation with INAB is detailed in Appendix No 1 of this document The department will commit to No Quality Objecti
28. sscseessoceesseceesoccssoseesscoceesseceessecssssoecssoceesseceessecesssessssseessese 15 Primary Sample Collection Manual User Guide Page 2 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 7 1 CLINICAL AND SCIENTIFIC ADVICE sse ee eee 15 D2 SERVICE DESCRIPTION da 15 8 LABORATORY TESTS PROFILES AVAILABLE scssssssssssesssssssersesessersesessersesessersesessessersesesserssvees LO 8 1 LIST OF LABORATORY TESTS PROFILES cocococcnononononononononononononononononononononononononononnnnononono nono etere no nono no nonanononono 16 8 1 1 Tests Nortel a td la te iE e Muda dra bles rea o e ace 17 8 2 REPEAT EXAMINATION DUE TO ANALYTICAL FAILURE OR FURTHER EXAMINATION OF THE PRIMARY SPECIMEN skapanina ote Diana cis E A 5 ZK HES E A EE 22 17 8 2 1 Repeat Examination due to Analytical Failure sss esse sese 17 8 2 2 Further Examination of the Primary Specimen sse ee sese eee eee 17 8 3 EXTERNAL LABORATORY TESTING REFERRAL LABORATORIES sese eee ee 17 8 4 FACTORS KNOWN TO AFFECT EXAMINATION PERFORMANCE OR RESULT INTERPRETATION sse eee eee 17 9 REPORTING OF TEST RESULTS ccssssssssssssssesssssssessssessessssessersesessersessesersesessersesesessssessesseseesessersevees LO OT REPORTING OF RESULTS ori eco au aa 18 9 2 TELEPHONED RESULLTG c cscscssssssssssvsssscscvsecssssvcscscscssecscscscecscesscscsc
29. sult notification 11 Providing clinically useful information through the laboratory examination of samples from atients and reporting of reliable results in a timely fashion 12 The assessment of user satisfaction in addition to internal audit and external quality assessment in order to produce continual improvement 13 The use of examination procedures that will ensure the highest achievable quality of all tests performed Primary Sample Collection Manual User Guide Page 4 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 14 Compliance with relevant environmental legislation and all relevant national and international guidelines and legislation Signed Primary Sample Collection Manual User Guide Document is NOT Controlled Unless Printed on Green Paper Laboratory Director Page 5 of 25 MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 2 INTRODUCTION This manual is designed to give an overall view of the histology services available to customers of MC Pathology Group It is intended as a quick reference guide for all our users The purpose of this manual is to provide the user with sufficient information to enable them to ensure the delivery of the highest quality pathological samples This will in turn facilitate the laboratory in i
30. terpretation of laboratory results and patient management Medical Scientists are responsible for carrying out the cellular pathology techniques The Consultant Pathologists are responsible for providing interpretative comments and advice MC Pathology Group consultant histopathologists are involved in continuous medical education If clinical or scientific advice is required contact the laboratory and you will be directed to the appropriate staff member 7 2 Service Description SERVICE DESCRIPTION Consultant Service There are Medical Consultants available in Cellular Pathology The Laboratory Director deputy will consult a Consultant on clinician request Refer to section 4 3 of this document for contact details Cellular Pathology AI Histology specimens and Body Fluids for Cytology received in MC Pathology are processed Cervical Cytology specimens are referred to external location Primary Sample Collection Manual User Guide Page 15 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 8 LABORATORY TESTS PROFILES AVAILABLE 8 1 List of Laboratory Tests Profiles A list of all tests available from the Laboratory is available in Appendix No 1 of this document Each laboratory test will be described under the following headings Test Name Specimen type site Specimen requirements required specimen vol
31. the Laboratory Temperature formalin for at least 24 hours appropriate to size of specimen form Do not store in fridge as formalin is inactivated below room temperature Test Profile Product Sample Type Sample Requirements Special Requirements Turnaround Additive Fixative Volume Test Time Required mL Frequency Routine Urgent Cytology FNA Body Fluids Fine Fresh Equal volume N A Daily N A 7 10 working days Non cervical Needle Aspirates of Cytofix fluid Routine Histology Any Formalin at Room 10x volume Daily Cellular Pathology request 7 10 days varies with nature of tissue and extent of investigations 24 48 hrs if urgent discuss with Cellular Pathology laboratory staff Primary Sample Collection Manual User Guide Page 20 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 Appendix No 2 Tests Referred to External Laboratories Investigation Address Telephone No Contact Sample Specimen Handling Comments FISH Analysis Histopathology Laboratory 01 8093726 Tony O Grady Breast amp Contact Cellular Pathology RCSL Beaumont Road Gastric Laboratory before sending Test Dublin 9 Biopsies is requested by Pathologists HER2 Histopathology Laboratory 01 8093726 Tony O Grady Breast amp Contact Cellular Pathology RCSL
32. thology Group A detailed list of tests referred and referral laboratories used is available in Appendix No 2 of this document Specimen handling and sample type necessary for each test is detailed here along with any special requirements Please refer to this before contacting the laboratory as they may answer any queries you may have in relation to the required test Ref Appendix No 2 Tests Referred to External Laboratories 8 4 Factors known to Affect Examination Performance or Result Interpretation Inadequate formalin fixation can affect examination performance Please ensure the specimen fully immersed for all histology specimens Ensure pot is large enough to hold the specimen in 10x formalin Timely transportation of specimens is also recommended Primary Sample Collection Manual User Guide Page 17 of 25 Document is NOT Controlled Unless Printed on Green Paper MEDICAL CONSULTANTS PATHOLOGY GROUP Document No MP20 Version No 2 9 REPORTING OF TEST RESULTS The main method of reporting results is by the production of a printed report and MC Pathology Group issues its own distinctive report The laboratory ensures that tests are performed to the highest possible standard and reported in the time specified within this User Manual It is the responsibility of the requesting clinician to follow up on the test results 9 1 Reporting of Results All results once released are available on the laboratory info
33. ts efforts to deliver the most effective service to support good clinical decision making The manual lists the histology tests available within MC Pathology Group details the request forms and specimen containers required the information necessary in the labelling of forms and containers the procedure for taking packing delivering storing and transporting specimens and the reporting of test results This manual is intended for all staff involved in the collection packaging and transportation of patient samples e g clinicians nurses etc MC Pathology Group is a privately owned histology laboratory that provides a high quality histopathology service to external customers All Histopathology services undergo continuous review through quality assurance and audit activities The Laboratory is committed to performing its activities in accordance with the requirements of the following regulations bodies and standards e The International Standard ISO 15189 current version Medical Laboratories Particular Requirements for Quality and Competence e Irish National Accreditation Board Regulations INAB R1 Regulations current version and all INAB mandatory documents e Relevant ILAC EA Guidelines e Guidelines for the Implementation of a National Quality Assurance Programme in Histopathology Faculty of Pathologists Royal College of Physicians of Ireland e The Retention and Storage of Pathological Records and Archives current edition
34. ume and container type Special requirements The special requirements column defines for each diagnostic test if applicable the following Patient preparation Consent form Special timing for collection of samples Any special handling needs between time of collection and time received by the laboratory transport requirements refrigeration warming immediate delivery etc Test Frequency A test frequency which is stated as daily means that the test is available on each working day i e Monday to Friday A Turnaround Time TAT described as same day means that the result is available on the day that the sample was processed provided that it was received in time for a process run that day If not the sample is held over until the next process run unless it is considered urgent Referral of samples for diagnostic tests to external referral laboratories may also extend the turn around time Please take the time to read any special instructions included under the test you are looking for Turnaround time e Turnaround time is given as the maximum number of working hours days between specimen receipt in the laboratory and issuing a report under normal operating conditions Working days denotes Monday to Friday and does not include out of hours including weekends and bank holidays e n addition to the routine service the laboratory operates an URGENT system whereby the target turnaround time is shorter If t
35. ve 1 Provide an environment to ensure consideration of health safety and welfare of its entire staff Visitors to the laboratory will be treated with respect and due consideration will be given to their safety while on site 2 Operate a quality management system to integrate the organisation procedures processes and resources 3 Set and review quality indicators quality objectives and plans in order to implement and maintain this quality policy 4 Ensure that all personnel are familiar with the quality manual and all procedures relevant to their work to ensure user satisfaction 5 Uphold professional values and is committed to good professional practice and conduct quality of examinations and compliance with the quality management system The department is committed to 6 Comprehensive orientation and induction programme for all new members of staff 7 Staff recruitment training development and retention at all levels to provide a full and effective service to its users 8 The proper procurement and maintenance of such equipment and other resources as are needed for the provision of the service 9 The collection fixation transport sample preparation identification and handling of all specimens in such a way as to ensure the correct performance of laboratory examinations and ensure that all stages in the sequence are embedded in the QMS 10 Providing turnaround times within specified limits and ensuring critical and abnormal re
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