aspen healthcare limited subject: pathology user hand book ......16 document format and control...

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Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30 TH-PATH30 Pathology User Manual Rev 21 Signature: This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use Page 1 of 50 ASPEN HEALTHCARE LTD Document Title: Pathology User Hand Book Category Pathology Policy Number LP-TH-PATH30 Group/Local Policy Local Hospital Policy -The Holly- Pathology Policy Author Shameem Dukandar-Patel Responsible Person: Pathology Manager Barry Hearn Approved for issue by (and signature) Director of Nursing and Clinical Services Lorraine Kelly Date Issued: March 2007 Last review date October 2018 Next review date: October 2020 (2 years or in line with changes in practice, legislation or guidance) Number of Copies Pathology Department, Electronic copy Netconsent,

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Page 1: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 1 of 50

ASPEN HEALTHCARE LTD

Document Title:

Pathology User Hand Book

Category

Pathology

Policy Number

LP-TH-PATH30

Group/Local Policy

Local Hospital Policy -The Holly- Pathology

Policy Author

Shameem Dukandar-Patel

Responsible Person:

Pathology Manager

Barry Hearn

Approved for issue by (and signature)

Director of Nursing and Clinical Services

Lorraine Kelly

Date Issued:

March 2007

Last review date

October 2018

Next review date:

October 2020 (2 years or in line with changes in practice, legislation or guidance)

Number of Copies Pathology Department, Electronic copy –Netconsent,

Page 2: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 2 of 50

Version History

Version No

Date Details of Changes included in Update Amendments by name and job title

15 June 2015

Updated to comply with Aspen DOCUMENT FORMAT AND CONTROL Policy GP-CORP-1

Insertion of contents page

Highlighted amendments:

– Insertion of definitions – Change of CPA to ISO 15189 – Change to management review items

Shameem Dukandar-patel Quality Manager/Senior BMS)

16

November 2016

Updated to comply with Aspen DOCUMENT FORMAT AND CONTROL Policy GP-CORP-1

Update of name change from Holly house hospital to The Holly Private Hospital

Update to consultants list: removal of Dr Akhtar and Suki addition of Rosa, update to Dr Al-Refaie information

Highlighted amendments: Updates to the following:

- 5 Insertion of Responsibilities section - 6.3 Malaria parasite added as an out of

hours test - 6.3 Data protection GP-IT32 - 6.4 High risk specimens - Pathology consultants - Measurement of Uncertainty for in house

tests are available on request. - 6.8.1 Information leaflets and addition of

links to information regarding specialised conditions/requirements for testing (e.g. gastrin)

- 6.8.6 Phlebotomy order of draw - 6.14 Viral investigations - 6.16 Referral laboratory work - 10 References updated - Appendix 2, added reference ranges and

updated tests - Appendix 4, reporting critical levels - Reference units added

Shameem Dukandar-Patel Pathology Manager

17 Jan 2017 Update to blood culture bottle section in line with new practise Update to Semen analysis procedure

Shameem Dukandar-Patel Pathology Manager

Page 3: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 3 of 50

Amendment to high risk sample referred to GP-INF24 Consultant biochemist now permanent no longer locum in NHS

18 May 2017 Highlighted changes: - Amendment to ’typo’ in history table

version 16 incorrectly stated 2017 should have read 2016.

- Update to section 5 responsibilities - Update to specimen TAT section - Addition of ‘reports state reference

ranges of tests requested’ (p10) - Update to section 6.8 - Update to section 6.9 – addition of brown

gel tubes - Update of reference range for APTT in

index (Appendix 2, p31) - Tests included in coagulation screen re-

highlighted (p18). - Blood film examination TAT updated now

5-7 working days (p34) - Removal of ‘protect from light’ for lead

testing in index (Appendix 2, p38) - CSF Culture updated to R to indicate not

performed in house but sent to a referral lab (Appendix 2, p35)

- Update to Appendix 4 critical; reporting for Microbiology.

- Ferritin reference range updated in line with Manufacturers range and confirmation with pathology Biochemistry and Haematology consultant and Updated to reflect comment on reports (Page 36)

Shameem Dukandar-patel Quality Manager/Senior BMS)

19 November 2017

Update 6.14. Added antibiotic reporting

Carol Law Senior BMS

20

September 2018

Minor Highlighted changes Barry Hearn Pathology manager

21

October 2018 Removed mention of CFT’s. Referral of CSF to Whipps Cross removed. Updated TDL reference page hyperlink. Updated specimen requirements to 2 bottles.

Martin Mensik Senior BMS

Page 4: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 4 of 50

Consultation and Ratification of Policy

Version No.

Date Person/Group Consulted on Policy During Development/Amendment:

Committee Ratified by:

15 June 2015 Pathology daily meeting Pathology team meeting 2015

16 December 2016

Pathology consultants, Director of Nursing, and Head of Departments : OPD and Ward

Pathology Consultants and internal Users

17 February 2017

Senior Microbiology lead and Pathology manager

Pathology team meeting 2017

18 May 2017 Pathology consultants, Senior BMS staff Pathology team meeting 2017

19 November 2017

Microbiology consultant Pathology team meeting 2017

20

September 2018

Senior pathology team Pathology team meeting Sept 2018

21

October 2018

Senior pathology team Pathology team meeting Oct 2018

Page 5: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 5 of 50

Table of Contents

1. INTRODUCTION ............................................................................................................... 7

2. SCOPE.............................................................................................................................. 7

3. EXCLUSIONS ................................................................................................................... 7

4. DEFINITIONS.................................................................................................................... 7

5. RESPONSIBILITIES.......................................................................................................... 7

6. IMPLEMENTATION........................................................................................................... 7

6.1 Services offered ........................................................................................................... 7

6.2 QUALITY ASSURANCE .............................................................................................. 8

6.3 GENERAL LABORATORY INFORMATION ................................................................. 8

6.4 PHLEBOTOMY SERVICE ..........................................................................................11

6.5 Pathology Consultants ................................................................................................13

6.6 Laboratory Staff ..........................................................................................................14

6.7 Quality assurance .......................................................................................................14

6.8 Specimen collection ....................................................................................................15

6.9 BIOCHEMISTRY.........................................................................................................17

6.10 ENDOCRINOLOGY, TUMOUR MARKERS AND METABOLIC ASSAYS .................18

6.11 HAEMATOLOGY ......................................................................................................19

6.12 COAGULATION ........................................................................................................20

6.13 BLOOD TRANSFUSION ...........................................................................................20

6.14 MICROBIOLOGY ......................................................................................................23

6.15 SEROLOGY ..............................................................................................................26

6.16 REFERRAL WORK ...................................................................................................27

6.17 HISTOLOGY/CYTOLOGY ........................................................................................28

7. TRAINING ........................................................................................................................29

8. MONITORING AND REVIEW ...........................................................................................30

9. EQUALITY IMPACT ASSESSMENT ................................................................................31

10. REFERENCES/BIBLIOGRAPHY ....................................................................................32

11 APPENDIX ......................................................................................................................33

Appendix 1 ........................................................................................................................33

Appendix 2 ........................................................................................................................34

Appendix 3 ........................................................................................................................47

Appendix 4 ........................................................................................................................48

12 FLOWCHARTS ...............................................................................................................50

Page 6: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 6 of 50

13 FORMS ...........................................................................................................................50

Page 7: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 7 of 50

1. INTRODUCTION The Pathology Laboratory is located in the Theatre suite at The Holly Private Hospital. It is equipped with modern equipment on-line to a laboratory information management system (LIMS) from which the reports are generated.

2. SCOPE

This is a guide to the services available from the pathology department

3. EXCLUSIONS

4. DEFINITIONS BMS – HCPC Registered Biomedical Scientist MLA – Medical Laboratory Assistant UKAS – United Kingdom Accreditation Services Winpath – Laboratory Information Management System (LIMs)

5. RESPONSIBILITIES

The Laboratory provides a service to the consultants and general practitioners at The Holly Private Hospital. As such, this User Manual does not seek to provide clinical advice on the indications for collection of particular investigations. Any such queries are likely to be complex in nature and the Laboratory's consultants should be pleased to discuss relevant investigations or result interpretation with consultants and general practitioners as necessary on request.

It is the responsibility of the user of this manual to use in accordance with any relevant guidelines that may be available. If there are any queries the laboratory should be contacted for clarity and the specialist Consultants are available for advice on requesting specialist tests.

It is the responsibility of the ‘User’ of the Service and/or ‘Requestor’ of tests to check the results of each test. However specialist consultants are available for interpretation advice if required.

6. IMPLEMENTATION

6.1 Services offered The department provides a comprehensive service over a broad spectrum of pathology tests and investigations

Haematology

Page 8: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 8 of 50

Blood transfusion

Chemical Pathology

Endocrinology

Microbiology

Serology

Virology The following disciplines are referred to accredited laboratories:

Virology – specialised tests

Endocrine - specialised tests

Chemical Pathology - specialised tests

Immunology

Histopathology

Cytology

Microbiology – TB, CSF, faeces and other Specialised tests

Haematology – Specialised tests

Blood Transfusion – Antibody screening The department’s results are independently monitored by Regional, National and European quality assurance organisations.

6.2 QUALITY ASSURANCE The laboratory is regulated by a quality system that aims to conform to the UKAS ISO 15189 standards.

6.3 GENERAL LABORATORY INFORMATION Pathology Laboratory The Holly Private Hospital High Road Buckhurst Hill Essex IG9 5HX Tel: 0208 936 1204 Fax: 0208 559 2161

Routine Laboratory Service (excludes public bank holidays) Samples will be accepted by the laboratory between the following times: Monday 09:00 – 17:00 Tuesday 09:00 – 19:00 Wednesday 09:00 – 17:00

Page 9: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 9 of 50

Thursday 09.00 – 17:00 Friday 09.00 – 17.00 Saturdays 09:00 – 13.00 For enquiries, sample requirements and results telephone extension 4321. The direct line to Pathology is 020 8936 1204 and the fax number is 020 8559-2161

Access to Laboratory Access to the department is restricted to laboratory personnel only. Staff delivering specimens should go to the specimen reception area. Please ring the bell in the event that staff are unavailable in the specimen area.

Data Protection The pathology department follows the hospital data protection policy GP-IT32 which ensures the safekeeping of patients’ records and information.

Patient Request Form To comply with good clinical practice it is important that there is one request form for each patient request, and forms are correctly and fully labelled, to include a minimum of three unique patient identifiers:

First name, Surname, Date of Birth, Hospital number

Time and Date of collection of Samples

Type of Sample and anatomical site where appropriate (e.g. swabs)

Name of person requesting tests (Consultant, GP)

Relevant clinical information

Relevant details of medication/antibiotic therapy

Patient address and GP for all Histology and Cytology samples.

High risk samples should be identified.

If addressograph labels are used, they must not cover up essential information.

Samples should be labelled with a minimum of full name and either date of birth or hospital number in accordance with laboratory policy and national guidelines. Addressograph labels are not to be used on blood samples. They must be hand written.

Page 10: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 10 of 50

Out of Hours Service (includes public bank holidays) A Biomedical Scientist (BMS) is always available to carry out URGENT emergency pathology work. They can be contacted via the Hospital Switchboard or Senior Nurse on duty. The RMO should take all necessary blood samples in the event of any such emergency. The out of hours BMS is not on site, but all staff are within 30 minutes of the Hospital at all times. The urgent emergency test repertoire includes:

Full Blood Count

Sickle cell screen

Coagulation Studies, Prothrombin Time, Activated Partial Thromboplastin Time

Group and Crossmatch of blood and the issue of blood products

Urea, Creatinine & Electrolytes (Na, K, Urea, Creatinine)

Liver Function Tests (Total Bilirubin, Alkaline Phosphatase, Alanine Transaminase, Aspartate Transaminase, Gamma Glutamyl Transferase, Total Protein, Albumin, Globulin)

Cardiac Enzymes (Creatine Phosphokinase, Aspartate Transaminase, Lactate Dehydrogenase)

Amylase

Blood Glucose

CRP

Calcium

CSF protein, cells, glucose and culture are sent directly to The Dr’s Laboratory (TDL)

Blood Cultures. (To be placed in the 350C incubator in the laboratory by the senior nurse on duty or the RMO.)

MRSA Screening swab (is only offered as an emergency service for surgery scheduled within 24 hrs).

Urine for culture and microscopy

Troponin T (referral)

Malarial parasites (referral)

Request for other tests to be carried out in an emergency should be discussed with the on-call BMS. All results will be telephoned or taken to the appropriate ward. The on call BMS should be contacted via the hospital switchboard/reception to discuss the urgency of results. The on-call BMS will not be available to report results of normal routine work that is processed during the day.

Page 11: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 11 of 50

6.4 PHLEBOTOMY SERVICE The Out Patient Department provides a phlebotomy service. Any requests for blood tests on the wards are dealt with by the duty RMO. All routine Saturday morning in-patient samples should be taken and made ready for laboratory analysis by 11:00 am.

Sending Specimens Specimens should be correctly labelled in accordance with this policy and must be accompanied by a fully completed request form. The specimen and request form must be placed in a mini-grip bag with the specimen and request form in their separate compartments. The laboratory is able to assay the majority of analytes on site. Any assays requiring referral are sent to approved reference centres.

‘High Risk’ Specimens Refer to the Aspen policy GP-INF24

Specimen Turn-around Times Specimens received in the department before 16:00 Monday to Friday will generally be processed and Haematology and Biochemistry reports issued by 17:00. Dependent on workload and commitment to processing “urgent specimens” first, the technical staff will use their discretion as to which specimens can be refrigerated overnight. Haematology: Full blood counts including ESR, Coagulation and Anticoagulation screens, Sickle Cell screens, Glandular Fever screens – 4 hours from receipt of sample. Biochemistry: Renal, Liver, Lipids, Bone, Cardiac profiles, 4 hours from receipt of sample Blood Transfusion: Blood grouping and antibody screens –are performed daily. Routine requests for group and save and/or cross matches should be taken 2 working days before they are required. Plasma shall be saved for 3-5 days dependent on the previous transfusions status of the patient. A sample can only be used for crossmatching purposes and blood products reserved for 3 days for patients transfused within the last 3 months and & for up to 5 days for patients not transfused in the past 3 months.

Page 12: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 12 of 50

Endocrinology: Thyroid function, Hormone assays, Tumour markers – Within 48 working hrs. Pregnancy tests: 15 – 30 minutes from receipt of sample Microbiology: Urine specimens – 24 hours (for a negative result) Swabs, Aspirates - 48 hours (for a negative result) Blood Cultures – up to 7 days Fungal Cultures – up to 28 days TB Cultures – up to 2 months. Referred specimens: Histopathology: 3 – 4 working days, special processes including second opinions 10 – 14 days. Other specimens: 1 day to 6 weeks dependent on type of tests. Please contact lab for specific times.

Reports Many routine investigations are reported the same day or within 24 hours .The hospital porters deliver reports to the Wards as soon as possible. These results may also be viewed on terminals using ward enquiry at various locations around the hospital e.g. Cedar ward, Oak ward, Out Patients, Diagnostics, Theatres and in the Cosmetic/GP Suite. Outpatient reports are placed in labelled envelopes for the consultants and placed in their appropriate pigeonhole in the main building, unless the Consultant has made other arrangements with the laboratory. Grossly abnormal results and urgent investigations will be reported back to source by telephone facsimile or via an nhs.net account. All reports are issued with reference ranges applied to the tests requested. Please note: Reports from referral laboratories shall be sent out as hard copies and scanned onto APAS. Measurement of Uncertainty for in house tests (Biochemistry, Coagulation and Haematology) are available on request.

Page 13: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 13 of 50

6.5 Pathology Consultants

All the Pathology Consultants are available as required for clinical advice and the interpretation of results. They may be contacted via the Pathology Department at The Holly Private Hospital on 02089361204 during working hours or out of hours via the hospital switchboard on 0208 505 3311

Haematology Dr Faris N Al-Refaie MBChB, MD, FRCP, FRCPath

Consultant Haematologist who is based at The Princess Alexandra Hospital in Harlow. He has many interests in haematology, particularly lymphomas, myeloma, chronic leukaemia and anti-coagulation therapy Clinical Biochemistry Dr Rosa Saldana Chaparro MC, MSc FRCPath Consultant Chemical Pathologist at Princess Alexandra Hospital NHS Trust, Harlow Special interest – Lipid Disorders Microbiology Dr Albert J. Mifsud MSc, MBA, FRCP(Ed), FRCPath, MD (Lond).

Consultant microbiologist with Public Health England where he is responsible for providing advice and support to consultant microbiologists and consultants in communicable disease control within his sector of responsibility in London. He is Honorary Consultant Microbiologist at Barts Health NHS Trust, where he delivers clinical sessions. Prior to the Trust merger, he was Director of Infection Prevention & Control at Whipps Cross University Hospital and head of its department of microbiology. He has a particular interest in infection in surgical specialties, as well as in infection control and public health microbiology. He is a member of various professional committees including Council of the British Infection Association, on the Royal College of Pathologists Specialty Advisory Committee on Microbiology and is a UK representative to the Microbiology Section of the European Union of Medical Specialists. He is the Infection Prevention and Control representative on The Holly Private Hospital Medical Advisory Committee (MAC).

Page 14: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 14 of 50

All Pathology Consultants can be contacted via the Pathology Department on 020 8936 1204 at The Holly Private Hospital, or via the switchboard out of hours. Arrangements are made for locum cover when they are unavailable

6.6 Laboratory Staff

Laboratory Personnel are a combination of MLA and Biomedical scientist (BMS) staff. The technical BMS are experienced, fully qualified and professionally registered with the Health and Care Professions Council (HCPC). They are dedicated to the service and, in conjunction with the Consultant Pathologists, are constantly striving to expand and further improve the service provided. There is an on-going internal training and competency programme as well as attendance at external courses to ensure that an up-to-date service is available in all aspects of pathology. These external courses are either provided by professionally accredited meetings or instrument manufacturers. Telephone: 020 8936 1204 Fax: 020 8559 2161

6.7 Quality assurance

To ensure compliance with UKAS ISO 15189 standards, the department adopts a Quality Assurance Programme defined in the department’s quality manual. The programme encompasses standard operating procedures, regular training and updates for our fully qualified staff, as well as internal and external quality control and preventative maintenance schedules. Regular audits and reviews by quality assurance staff ensure continued compliance with ISO 15189 standards and the principles of Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) and Health & Safety Regulations. The department participates in all relevant National Quality Assurance Schemes and performance in these schemes is available for inspection upon request. Internal Quality Assurance is also run on a daily basis and performance monitored. Each discipline has direct input from a Consultant, who also monitors the Quality Control for the relevant department. There are regular reviews of the performance by the Pathology Team. All equipment is subject to extensive preventative maintenance schedules and servicing. The department continually updates its equipment and embraces new technology that will be beneficial to the service it provides, either by decreasing turn-around time or offering a wider range of in-house testing subject to demand and technical expertise.

Page 15: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 15 of 50

The quality system in place in the laboratory is constantly under review. The laboratory should always be notified quickly of any complaints/anomalies or if the Clinician has reason to believe that incorrect results have been reported, such results should not be simply ignored. Such observations are dealt with and used to further improve the service provided. The ultimate objective is to attain a zero error rate.

6.8 Specimen collection The quality of results obtained from samples is directly related to the condition in which the specimen is collected/taken. Good practice points are: 1. Observe any dietary requirements and any other appropriate preparatory instructions before performing investigations (information leaflets are available from the Outpatient department or available at http://www.theholly.com/services/general-

medicine/pathology or contact the laboratory if you require further information for specialised tests. 2. Do not shake the container with samples of blood as haemolysis may result, which can prevent the analysis of, or invalidate the results of, several measurements (for example bilirubin, potassium, and urate). 3. Do not overfill or under fill tubes, which contain liquid anti-coagulant. e.g.: ESR samples and Coagulation (green) tubes. 4. Always use the correct tube as specified in the Test Index. If in doubt about the requirements, please contact the laboratory. 5. Never transfer a specimen taken mistakenly into the wrong type of tube into the correct one. 6. Please follow the recommended order of draw when taking samples. If using Sarstedt S-Monovette tubes the manufacturers recommended order of draw is as follows White (serum -B), or Brown (Serum Gel Tube), green (Citrate-C) , purple (Citrate-D), Red (EDTA-A), yellow (Fluoride G). Further information can be obtained at: https://www.sarstedt.com 7. After samples have been taken please bleep the hospital porter and ensure that the samples are collected. If the porter is unavailable, then it is the responsibility of the phlebotomist to take the samples to the laboratory. All specimen and request forms must be fully labelled with name, date of birth, hospital number and container signed by the person taking the specimen. Conditions under which specimens are not acceptable: 1. Specimens and forms, which are incompletely labelled so that the patient cannot be uniquely identified with the request form, will not be accepted. 2. Unlabelled samples will be discarded. 3. Samples, which have leaked on receipt, will also be rejected. 4. Any sample not meeting the above requirements will not be analysed.

Page 16: Aspen Healthcare Limited Subject: Pathology User Hand Book ......16 DOCUMENT FORMAT AND CONTROL Policy November 2016 Updated to comply with Aspen GP -CORP 1 Update of name change from

Aspen Healthcare Limited Subject: Pathology User Hand Book Version: 21 Reference; LP-TH-PATH30

TH-PATH30 Pathology User Manual Rev 21 Signature:

This document is electronically controlled. The master copy is maintained by the author within the document library on Netconsent. Once printed, this document becomes uncontrolled. For assurance that the most up to date

guidance is being used, staff should refer to the version held on Netconsent. This document is confidential to Aspen Healthcare Limited and is only for internal use

Page 16 of 50

5. Completely unidentified samples will not be processed. Minor amendments (to non-blood transfusion specimens maybe completed by the person initially responsible for taking the blood sample. This will be at the discretion of senior laboratory staff and will be reviewed on an individual basis dependent on the nature of the omission. If the person responsible is not available, it will be discarded and a repeat sample requested. 6. If the laboratory has any concerns regarding the labelling of a blood sample, it will be discarded and a repeat sample requested. Note: The laboratory operates a zero tolerance sample labelling policy on all blood transfusion requests. This means that if samples do not meet the specified sampling labelling criteria they shall not be accepted. This is in accordance with ‘Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories’ BCSH Guidelines November 2012. 7. The date and time of operation and details of the procedure should also be given. It should be remembered that if the details given to the Laboratory differ from the admission details, blood or blood products may not be available. 8. A hospital incident (using the Datix system) will be reported for each event. Key Factors which are known to affect the performance of tests

Storage Haemolysis Lipaemia Icteric samples

Blood tubes must be filled in the correct order e.g. plain tubes/gel tubes before those containing anticoagulant. Samples (especially those containing liquid anticoagulant) should be filled to the line. Samples should reach the laboratory within 1 hour of being taken and must be tested or centrifuged on day of taking. Urines for culture and sensitivity need to be a midstream sample, not an early morning sample and refrigerated as soon as possible if outside the laboratory opening hours. Time limits for requesting additional examinations Time limits for requesting extra tests are test specific. If additional tests are required, Please contact the laboratory on 020 8936 1204 for advice. Samples are stored within timeframes according to their discipline. Additional tests from Thin Prep Vials (after LBC) may be requested up to 21 days after the sample has been taken. E.g. HPV, 7 STD profile. Chlamydia, Gonorrhoea.

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Blood Transfusion samples are viable for 5 days if the patient has not been transfused in the past 3 months. If the patient has had a transfusion in the past 3 months the viability is reduced to 3 days (72 hours). Full Blood count samples viable on day of taking only. Chemistry testing will depend on the test required. Microbiology: Additional sensitivities may be requested up to 5 days following issue of the report.

6.9 BIOCHEMISTRY

BLOOD SAMPLES All specimens for biochemical analysis must be fully labelled with the patient’s name, date of birth, hospital number (if available), ward or source and date. A fully completed request form giving appropriate clinical information should also accompany them. Types of Blood Tubes used:

Plain tube white cap, which contains beads or brown cap, which contain Gel. These tubes are used for the majority of biochemical, endocrine and tumour marker investigations, e.g. Biochemistry profile, U&E, LFT, TFT etc. and allows the blood to clot, yielding serum which is used for analysis.

SST gel tubes can also be used (gold top)

Tube with yellow cap. This tube contains an anticoagulant - fluoride oxalate and is used for blood glucose estimation.

For type of sample required for a particular test please refer to the test list. PLEASE NOTE: Haemolysis and ageing of samples adversely affects the accurate analysis of certain components. Therefore, if old or haemolysed samples are received, this will be noted on the report and a repeat sample advised. Biochemical Profiles: Biochemistry Profile (P003) Sodium, Potassium, Chloride, Urea, Creatinine, eGFR, Total Bilirubin, Alkaline Phosphatase, ALT, AST, GGT, Total Protein, Albumin, Globulin, Uric Acid, Calcium, Phosphate, Cholesterol, Triglyceride, Glucose. Liver Function Tests (LFT) (P012) Total Bilirubin, Alkaline Phosphatase, ALT, AST, GGT, Total Protein, Albumin, Globulin.

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Lipid Profile (P013) Total Cholesterol, Triglyceride, HDL Cholesterol, LDL Cholesterol. Cardiac Enzymes (P005) AST, Creatine Kinase, Lactate dehydrogenase Renal Profile (Urea and Electrolytes (U&E) (P018) Sodium, Potassium, Chloride, Urea, Creatinine, eGFR and Glucose. Bone Profile (P004) Alkaline Phosphatase, Calcium, Phosphate, Albumin, Uric Acid Biochemistry Tests: Amylase, C Reactive Protein (CRP), CK, LDH, Glucose Tolerance Test. (by arrangement) All the profiles and miscellaneous assays listed above are performed daily. Urgent requests are dealt with accordingly. Instruments are programmed to continuously analyse samples. URINE SAMPLES Random urine samples should be received in a 20ml universal container (please do not overfill). 24-hour urine containers are available from outpatients, as well as any special instructions such as dietary requirements. Early morning samples may be collected in the 24hr urine containers. For full details of tests available and containers required, see Appendix 1 & 2. Patient information sheets are available on the Holly House website. For more details of specimen requirements and tests available refer to the Pathology Tests List (Appendix 2).

6.10 ENDOCRINOLOGY, TUMOUR MARKERS AND METABOLIC ASSAYS

Thyroid Function Profile Thyroid stimulating hormone (TSH) Free Thyroxine (FT4) Free Triiodothyronine (FT3) Reproductive Hormones Luteinising hormone (LH) Follicle stimulating hormone (FSH)

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Tumour Markers Total Prostatic antigen (PSA) Ca-125 Metabolic Ferritin B12 All the above assays are routinely performed on Monday, Wednesday and Friday. Urgent samples are processed as required. For more details of specimen requirements and tests available refer to the Pathology Tests List. Appendix 2

6.11 HAEMATOLOGY All specimens for haematological analysis must be fully labelled with patient’s name, date of birth, hospital number, ward or source, date and accompanied by a fully completed request form giving appropriate clinical information. Types of Blood Tube used: 1. For Vitamin B12, Serum Folate, Ferritin or Paul Bunnell, a 7ml clotted sample (white/brown gel) is required. 2. For full blood count, haemoglobin, haemoglobin electrophoresis, reticulocyte count, red cell folate, malarial parasites etc. an E.D.T.A. sample is required. This is a pink-topped tube. A sample is required for each test. 3. For Erythrocyte Sedimentation Rate (ESR) a Sodium Citrate sample is required. This is a mauve topped thin tube. Full Blood Count Haemoglobin, Haematocrit, Mean cell volume, Mean cell haemoglobin, Mean cell haemoglobin concentration, Platelet count, Total white cell count, Machine 5 part differential. A film may be performed on request. Miscellaneous Reticulocyte count pink-topped tube Sickle cell screen pink- topped tube Malarial parasites pink- topped tube Cold agglutinins contact laboratory for details of collection Paul Bunnell (GFST) white/brown gel or pink-topped tube Direct Antiglobulin test pink-topped tube All the above tests are performed on receipt. Urgent samples are given priority.

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Requests for Bone Marrow examination should be made directly with the Consultant Haematologist for the department or with the relevant Consultant Haematologist with admitting privileges at the hospital. For further advice on patient investigation/management contact the Consultant Haematologist via the hospital switchboard. For more details of specimen requirements and tests available refer to the Pathology Tests List (Appendix 2).

6.12 COAGULATION For coagulation studies, such as coagulation screen, prothrombin time (PTT), I.N.R., activated partial thromboplastin time (APTT), etc., a green citrate tube should be used. PLEASE NOTE: This tube should be filled exactly to the line and care must be taken not to under fill or overfill. Incorrectly filled tubes will not be assayed as the results will be inaccurate. Samples must not be taken as a vacuum but should be pulled back as a syringe. Specimens should not be taken from lines or from arms with drips in situ as even small quantities of heparin can give erroneous results. If the patient is being treated with anticoagulants, this must be stated on the accompanying request form. Coagulation Profile PTT, INR, APTT and FBC. Requires 1 green tube + 1 pink tube. Thrombophilia Profile PTT, APTT, Thrombin Time, Fibrinogen, Antithrombin III, Protein C, Protein S, Activated Protein C resistance (APC), Factor V Leiden, Factor II Prothrombin Gene mutation, Lupus Inhibitor studies, Anticardiolipin and CRP. Requires 4 green, 1 white and 1 pink tubes. PLEASE NOTE: Specimens must be dealt with immediately and therefore should not be taken after 16:00 or left overnight in the fridge. For more details of specimen requirements and tests available refer to the Pathology Tests List. Appendix2. The consultant haematologist can be contacted via the laboratory if required for clinical advice on all Haematology/Blood transfusion issues.

6.13 BLOOD TRANSFUSION

Blood Components Whipps Cross Blood Transfusion Department supplies blood and blood components. The department orders and receives blood directly from Whipps Cross. Availability of blood products depends upon national blood stocks and, whilst most blood groups are usually available, occasional shortages of a

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particular group do occur. It is therefore preferable that requests for blood are generated well in advance of elective surgery, 3-7 days prior to the patient’s admission date (dependent on the patient’s previous transfusion status. A group and antibody screen sample sent in advance will allow compatible blood to be provided at short notice. However, if more than 5 days have passed since the collection of the transfusion sample, a fresh specimen will be required for crossmatching purposes. A blood transfusion request form must accompany all requests for transfusion signed by the requesting Consultant or, in his/her absence, the Resident Medical Officer. The details on the sample and the request form must agree. Failure to comply with these requirements may result in a delay in issuing compatible blood for the patient. Sample Requirements [TH-PATH 31] A 7.5ml-EDTA (large pink topped sample in a transfusion bottle is required. These bottles are distinguished by the label. The following information must be provided on the request form:

Forename and Surname of patient (initials are not sufficient)

Date of birth

Gender/Sex of patient

Hospital number

Source/of location originating department (e.g. OPD, TCI, Ward)

Type of operation

Previous transfusion and obstetric history (including known blood group, atypical antibodies and previous transfusions)

Date and time of operation

Date of and time of specimen collection

Number of units required

Signature of person taking the specimen

The form must be signed by a Doctor

Special requirements (e.g. irradiated products)

Address (If applicable) The following information must be provided on the specimen:

Forename and surname of patient (initials are not sufficient)

Date of Birth

Hospital Number

Source

Date and time of collection

Signature of person taking the specimen Note: The laboratory operates a zero tolerance sample labelling policy on all blood transfusion requests. This means that if samples do not meet the specified

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sampling labelling criteria they shall not be accepted. This is in accordance with ‘Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories’ BCSH Guidelines November 2012. Zero Tolerance: Examples of where samples will not be accepted: Unlabelled samples Illegible samples Pre labelled samples Samples with adhesive labels Samples with information scribbled out Handwritten samples where 2 different pen types have been use (indicates two people involved in blood collection process) Staff will not be allowed to add or amend details on Blood transfusion samples once received into the laboratory. New or First Time Patients If the laboratory does not hold a historical blood group for a patient i.e. the patient is a first time patient a second sample will be required before blood components can be provided. Only a registered Medical Practitioner may make transfusion requests. Failure to provide adequate information may result in a delay in providing blood for the patient, as inadequately labelled samples will not be processed. Cross-matched blood will be labelled with a self-adhesive label, which must not be removed. Only details from the specimen will be printed on the label. These labels cannot be altered; it is therefore essential that the request details and specimen details are correct. If a discrepancy is found, it may be necessary to repeat the entire request, causing considerable delay. Cross-matched blood will be held for 48 hours after the operation unless a special request is made to the Laboratory. This procedure will also be dependent on validity of original sample used for the crossmatching procedure, Emergencies In the event of an extreme emergency, two units of confirmed Group O Rh D Negative, Kell negative blood (Flying Squad) are always available in the blood bank in theatres. These may be used in an extreme emergency but, in such circumstances, the degree of urgency must justify their use and every effort should

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be made to maintain the patient until group compatible cross-matched blood can be given. If Flying Squad is used during routine working hours laboratory staff must be notified of this. If used out of hours, the On-Call BMS should be notified If the patient has atypical antibodies present these units may not be safe to give. Requests for blood products, such as fresh frozen plasma, platelets and cryoprecipitate should be made with reference to the Transfusion Policy. Advice on blood transfusion may be obtained from the Haematology Consultant, via the laboratory / switchboard. Collection of Blood Products [TH-PATH31] All staff involved in any part of the blood transfusion process must hold a GMP training certificate. Suitably trained and assessed as competent Ward and Theatre staff may collect blood from the Blood Bank; ONE unit at a time. The prescription chart is to be taken to the Theatre Blood bank fridge and the details matched to those in the Blood Bank Register and the blood pack label. The details to be verified are: Patient’s name, date of birth and hospital number Patient’s Blood group and blood pack Unit number of blood pack. The person collecting the blood is to sign for each pack in the Blood Bank Register together with the date and time. Provided the details are correct, the blood is to be taken for transfusion immediately. Under no circumstances may blood be kept at room temperature or in any refrigerator other than that of the Pathology Blood Bank. The laboratory is to be contacted in the event of any doubt or seeming anomaly regarding transfusion. If units are replaced in the fridge, the date and time must be recorded in the blood bank register. Any units that have been out of the fridge for longer than 30 minutes must to be marked as unsuitable for use and will be destroyed by the laboratory.

6.14 MICROBIOLOGY All specimens must be fully labelled with patient’s name, date of birth, hospital number, ward or source and date. A fully completed request form giving appropriate clinical details, including site of specimen and antibiotic therapy must accompany the specimen. Cultures are normally incubated for 24 to 48 hours depending on the sample and site. Sensitivity testing requires a further 24 hours. However further incubation may be required by some samples. Blood Cultures are incubated for 5 days. Microscopy results are given upon completion if urgent or grossly abnormal.

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BLOOD CULTURES Culture and antibiotic sensitivity (if indicated). Blood Culture bottles are provided on request from the Pathology Department. In order to increase the chance of detecting bacteraemia whilst minimising problems of contamination, please note the following points:

Choose an area of intact clean skin.

Swab the venepuncture site with a mediswab and leave for a short time whilst the antiseptic acts and evaporates.

Cultures taken from I.V. lines should be marked as such and accompanied by peripheral cultures.

To maximise recovery of bacteria two blood culture bottles should be inoculated with each patient’s blood whenever practicable.

Each blood culture bottle (this bottle allows growth of both aerobic and anaerobic organisms) should be taken at a time.

Remove the green plastic, flip-off cap and disinfect the exposed part of the rubber stopper.

Aseptically inject 10ml of blood taken from the patient through the central ring of the rubber stopper

Thoroughly mix the blood with the broth in the bottle

Write the patient’s details on the label on the bottle

The specimens should be taken directly to the laboratory.

If the cultures are taken out of hours the RMO should take the sample and place it in the incubator in pathology (part of RMO induction), leave the request form on the bench and phone on call BMS to inform them that blood cultures have been taken

Blood Cultures are routinely monitored daily for 5 days, sub culturing at 24 hrs, 48 hrs and after 5 days incubation. Any positives are immediately reported

ANTIBIOTIC – MONITORING LEVELS The measurement of blood level is necessary during treatment with some antibiotics. The time at which the specimen was taken must be clearly indicated on the request form and specimen and whether the specimen is pre or post dose. If the specimen is a pre dose please clearly indicate whether a post dose specimen will follow.

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ANTIBIOTIC - REPORTING Susceptibility testing is undertaken at The Holly Pathology Laboratory utilising a long- reliable method. Our performance has been excellent in external established quality assurance. In the interests of international standardisation of reporting of susceptibility, a new test methodology is being introduced which has not been implemented so far in this laboratory. Unfortunately, this methodology does not cover all organism – antibiotic combinations. As a consequence, we have had to take some tests ‘out of the scope’ of our accreditation. This does not reduce the accuracy or reliability of our tests in any way. All results continue to be reviewed by Dr AJ Mifsud, our consultant microbiologist, who may be contacted should you have any queries. C.S.F. Samples are referred out to TDL. SPUTUM Sputum for culture should be an early morning deep cough specimen or obtained by the physiotherapy department. Salivary specimens are quite unsuitable as the organisms present do not in any way represent the pathogens responsible for chest infections. If Tuberculosis is considered to be a possible diagnosis, even if a TB test is not being requested at this time, please ensure that the laboratory is notified at the time. If Tuberculosis (TB) culture is required, three consecutive early morning deep cough sputum samples are normally required. FAECES Specimens for faecal examination should be sent to the Laboratory in a securely capped container. As culture methods are sometimes determined by the history, please give the following information: Age, Foreign Travel, Animal Contact, Suspicion of Food Poisoning, Recent Antimicrobial Therapy and History of Illness. Tests include Culture (for enteric pathogens), Antibiotic Sensitivities if indicated, Ova, Cysts and Parasites. Occult Blood and C. difficile toxin A. Virology can also be performed on request.

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URINE For routine culture and sensitivity of an MSU, use a sterile universal container (do NOT overfill) and send to the Laboratory as soon as possible. This should not be an early morning sample. CSU specimens should be collected fresh and NOT taken from bag. 2 – 5 mls are sufficient in this case. Overnight samples should be refrigerated. For TB cultures, three whole void consecutive early morning samples are always required. For pregnancy tests, an early morning specimen is preferable in a plain sterile universal container. SWABS HVS, ECS, LVS, Wound, pus and throat swabs etc. must be taken using a trans-swab (blue top) as the tube contains a transport medium, which sustains the growth of any organisms which may be present. Tissue or pus for culture and sensitivity must be placed in a sterile universal container and taken immediately to the laboratory. Swabs for Chlamydia and / or Neisseria gonorrhoea examination should be taken using the lilac (female)/ blue (male) PCR swab containers*. Swabs for viral investigation should be taken using swabs with a green top or PCR swabs. Ear swabs are collected using the Orange swabs.

SEMEN SCREENING

Semen analysis (for fertility or post vasectomy) is referred to TDL. The TDL Andrology department can be contacted for appointments on 0207 0257940.

6.15 SEROLOGY For serological investigations, e.g. Hepatitis, HIV, Rubella etc., 7.5 mls of clotted blood is required.

Hepatitis Serology Hepatitis B surface antigen (HBsAg) (Referral)

Hepatitis B surface antibody (HBAb) (Referral)

Hepatitis A antibody (total) ) (Referral)

Hepatitis A antibody (IgM) ) (Referral)

Hepatitis C antibody (In house)

Human Immunodeficiency virus (HIV) 1/ 2 antibodies (p24 antigen) (Referral)

Rubella IgG antibody status (immune status) (Referral)

Syphilis serology (VDRL and TPHA) (Referral) Referral tests are sent daily to a CPA/UKAS registered laboratory

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VIROLOGY In most instances, a suitable sample should be collected for virus detection by PCR. In some situations, the diagnosis of some viral infections depends on determining if the antibody level to a particular virus has appeared or has increased during the episode of infection. Therefore two samples of clotted blood (paired serum) are required, taken about ten days apart. Faeces, C.S.F. and urine specimens for virology testing should be sent in sterile screw-capped containers. Throat swabs, nasal swabs and swabs from other sites, must be taken using a viral or PCR swab. All testing is now carried out by PCR. Please indicate sample site on the request form. MICROBIOLOGY ADVICE Dr A. Mifsud oversees the Microbiology service. He may be contacted for advice via the laboratory. INFECTION PREVENTION and CONTROL (IPC) The Microbiology Advisor in Infection Control for The Holly Private Hospital is Dr A. Mifsud. Infection Control queries/problems should initially be referred to the designated infection control nurse who will contact the laboratory or Dr Mifsud as required

6.16 REFERRAL WORK All specialised work, not available from The Holly Private laboratory, is sent to Reference Centres or hospital departments that meet our accreditation standards. In addition, our Consultants approve the referral laboratories. Users are encouraged to contact the laboratory to discuss the provision of such tests and to highlight any new diagnostic advances. Hard copy reports are provided as soon as they become available, usually within two working days. Urgent results are faxed or telephoned to The Holly Private Hospital or directly to the requesting Consultant. The list of all tests and investigations that are available is by no means comprehensive; however, the network of accredited laboratories ensures that practically any tests can be performed. The following is a list of laboratories that the department routinely sends Referral work to:

The Doctors Laboratory

Haematology, Chemistry, Endocrinology, Immunology, Microbiology, Virology, Cytology, Genetic testing.

Whipps Cross Hospital (Barts Health)

Haematology, Blood Transfusion,

The Royal London Hospital (Barts Health)

Histopathology, Immunohaematology

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St Thomas’ Hospital

Histopathology (IMF specimens)

Princess Alexandra Hospital

Histopathology,

Queens Hospital

Histopathology

Addenbrookes Hospital Immunohaematology

The above list is not comprehensive. A full list and contact details for all referral laboratories are held in the department and are available on request. All genetic tests require a TDL consent form signed by the patient and the consultant complete with full clinical details. For more details of specimen requirements and tests available refer to the Pathology Tests List.

6.17 HISTOLOGY/CYTOLOGY General Guidelines The following guidelines should be followed when submitting tissue for histological examination:

The specimen must be accompanied by a fully completed request form, which should include all relevant clinical details. Including patient address and name of GP. If full details are not included, the relevant laboratory will not process the sample until this information is available.

Tissue specimens for histological examination must be placed in a suitable size specimen pot or bucket containing sufficient formalin fixative to cover the specimen. Fixation preserves and hardens the tissue; therefore specimens should not be forced into a container, which is too small and must contain adequate formalin. Failure to comply could result in tissue distortion. Any leaking specimen pots will be returned to source to be properly secured.

Ensure that the specimen pot is adequately labelled (addressograph labels are ideal).

These specimens must not be refrigerated as this causes the formation of formalin artefact in the tissue.

NOTE: Care must be taken in handling formalin fixative to avoid the dangers of inhalation or splashing. See COSHH assessment for further information Urgent Biopsies By arrangement with the laboratory, it is possible to process small biopsies rapidly in order to facilitate speedy diagnosis in cases of genuine urgency.

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Thin Preps (Liquid Based Cytology) Liquid based cytology (LBC) is an alternative method of slide preparation and involves collection of specimen in a similar way to taking a conventional smear. One vial can be used for PAP, Chlamydia Trachomatis PCR, HPV and N. Gonorrhoea. Specimen containers and collections kits are obtainable from the OPD department. It facilitates reporting if the request form provides adequate details such as: Previous cytology – date of test and reference number, if known Date of birth Date of L.M.P. Details of any past abnormal smears Details of any hormone therapy Appearance of cervix on examination Additional tests from Thin Prep Vials (after LBC) may be requested up to 21 days after the sample has been taken. E.g. HPV, 7 STD profile. Chlamydia, Gonorrhoea. Conventional PAP slides are no longer accepted. Urine Cytology A random sample in a universal container is required and sent to the laboratory as soon as possible with a fully completed request form. Overnight samples should be placed in the overnight sample fridge sited in OPD or Cedar ward. Body Fluids Specimens such as ascitic, pleural, or cyst fluid etc. should be immediately sent to the laboratory in universal containers together with a fully completed request form. Overnight samples should be placed in the overnight sample fridge. Fine Needle Aspirates (FNA) Material from FNA should be placed on a frosted slide, labelled and sent to the laboratory with a fully completed request form. Histology Specimens Histopathology and Cytology work is not processed at The Holly Private Hospital. We have SLA’s with the following hospitals: Princess Alexandra Hospital, Barts and Royal London (inc Whipps Cross Hospital), Queens Hospital and TDL.

7. TRAINING All staff who perform any of the activities outlined in this procedure shall be required to carry out training and competency assessment. All staff work under supervision until they are trained and competency assessed

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8. MONITORING AND REVIEW Any non-conformities raised in conjunction with the procedures in this policy shall be monitored using the Datix reporting system. Examples of this are: Sample rejections, Sample labelling anomalies, delayed transportation times.

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9. EQUALITY IMPACT ASSESSMENT

Yes/No Comments

1. Does the policy affect any group less or more favourably than another on the basis of:

No

Gender No

Race No

Ethnic Origins No

Nationality No

Culture No

Religion or Belief No

Sexual Orientation No

Age No

Disability - learning disabilities, sensory, impairment and mental health problems, physical disabilities

No This policy will be available electronically so the font and background colour can be adjusted to accommodate visual impairment.

2. Is there any evidence that some groups are affected differently?

No

3. If you have identified potential discrimination, are there exceptions valid, legal and/or justifiable?

No

4. Is the impact of the policy likely to be negative? No

5. If so can the impact be avoided? N/A

6. What alternative is there to achieving the requirements of the policy without impact?

N/A

7. Can we reduce the impact by taking different action? N/A

8. Please list any staff training on equalities issues arising from this assessment.

N/A

Completed by: Martin Mensik Date: October 2018 Equality Impact Assessed As (please highlight): Low Medium High

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10. REFERENCES/BIBLIOGRAPHY

The Doctors Laboratory, Laboratory Guide- Current version The Doctors Laboratory User Guide Current Version Sarstedt Home Page Sarstedt Tips and techniques in pre-analytics available at: https://dafxbb5uxjcds.cloudfront.net/fileadmin/user_upload/99_Literatur/US/453_a_TippsTricks_USA_0114.pdf ‘Guidelines for pre-transfusion compatibility procedures in blood transfusion laboratories’ BCSH Guidelines November 2012.

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11 APPENDIX

Appendix 1 Sample Types

CONTAINER ANTICOAGULANT CODE PINK EDTA (2.6ml) A

WHITE/BROWN GEL NONE B

BLOOD TRANSFUSION EDTA (7.5ml) BT

GREEN SODIUM CITRATE C

PURPLE ESR ONLY D

YELLOW FLUORIDE OXALATE G

DARK GREEN LITHIUM HEPARIN (VACUTAINER)

H

DARK BLUE SODIUM HEPARIN (VACUTAINER)

K

BLOOD CULTURE

BC

CONTACT LABORATORY J

RANDOM FAECES RF

RANDOM URINE RU

24 HOUR URINE CU

24 hour acidified URINE PU

EARLY MORNING URINE use 24hr container EMU

STERILE CONTAINER SC

THIN PREP VIAL TPV

BLUE SWAB (swab in transport medium) STM

GREEN VIRAL SWAB VS

PCR SWAB FOR CHLAMYDIA / PCR INFECTION SCREENING

Lilac/Blue swab CHLS

EAR SWAB (ORANGE) EAR

CYTOLOGY URINE CYT

FINE NEEDLE ASPIRATE FNA

ASPIRATE ASP

FORMALIN POT HIS

Killer cell Cyto-chex container CHEX

First catch random urine FCRU

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Appendix 2 Pathology Investigations - Alphabetical Listing

Availability: IH - In House

R - Referred to other laboratories Days – Working Days Hours – During working day Test Specimen IH

or R

TAT Sex Age Reference Range

Comments/ Requirements

17-hydroxyprogesterone

B

R 7 days nmol/L

5H1AA PU

R 5 days 5.2 -36.6 umol/24

hr Sample should be returned by 9.30am

Acetyl Choline Receptor Abs

B

R 4 days

Take to laboratory immediately after collection

Acid Phosphatase Total

B

R 6 days

Take to laboratory immediately after collection

Activated Partial Thromboplastin Time (APTT)

C

IH

4 hours 22-34 seconds

Filled to the 2.9 line

Activated Protein C Resistance

C x3

R 4 days 0.9 – 1.2 Filled to the 2.9

line /Directly to lab Adenovirus Antibodies

B

R 4 days

Adrenal Antibodies B R 28 days

Adrenocorticotrophic Hormone (ACTH)

J

R 3 days Contact laboratory

Alanine Amino Transferase (ALT)

B IH

4 hours F M

10 – 28 U/l 13 – 40 U/l

Albumin B IH 4 hours 35 – 50 g/L

Alcohol (Urine) RU R 2 days

Aldolase B R 4 days 9m <30.4

24m <15.2

16 <13.7

<7.6 Aldosterone B R 4 days Contact laboratory Alkaline Phosphatase (ALP)

B IH

4 hours 38 – 126 U/I

Alkaline Phosphatase Isoenzymes

B R 4 days

Allergy Screen 1 (Inhalants and foods)

B x2 R 4 days Graded 0 - 6

Allergy Screen 2 (Mixed Inhalants)

B

R 4 days Graded 0 – 6

Allergy Screen 3 (Foods)

B

R 4 days Graded 0 – 6

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Allergy Screen 4 (Nut and Seed)

B

R 4 days Graded 0 – 6

Allergy Screen 5 (Child panel )

B

R 4 days Graded 0 – 6

Allergy Screen 6 (Shellfish)

B

R 4 days Graded 0 – 6

Allergy Screen 7 (Finfish)

B R 4 days Graded 0 – 6

Allergy Screen 8 (Cereal)

B

R 4 days Graded 0 – 6

Allergy Screen 9 (Antibiotics)

B

R 4 days Graded 0 - 6

Alpha 1 Antitrypsin (serum)

B

R 4 days 0.9 – 2.0

Alpha Fetoprotein B

R 2 days 0 – 6 KIU/L

Amino Acids RU or B

R 8 days

Phone lab for ranges on individual amino acids

Amoebic Antibodies B R 3 days Amylase B

IH 4 hours 30 – 110 U/L ANCA (Anti-neutrophil cytoplasmic Abs)

B

R

2 days

Androstenedione B R 3 days M F

2.1 – 12.9 1.0 – 12.9

Take to laboratory immediately after collection – Frozen Serum

Angiotensin Converting Enzyme (ACE)

B R 3 days 8 - 52

Anti-mullerian Hormone

B R 3 days F 29 13.1 – 53.8 pmol/L

F 34 6.8 – 47.8 pmol/L

F 39 5.5 -37.4 pmol/L

F 44 0.7 – 21.2 pmol/L

F 50 0.3 – 14.7 pmol/L

Antinuclear Antibodies

B R 3 days

Antibody Screen BT IH 1 day Anti-staphylococcal Titre

B R 3 days 0 - 2

Anti-streptolysin O titre (ASOT)

B R 3 days 0 - 200

Antithrombin III Cx3 R 4 days 0.78-1.09 IU/ml Filled to the 2.9 line straight to lab Frozen Plasma

Apo A1 (lipoprotein) B R 4 days M 1.10 – 2.05 F 1.25 – 2.15 Apo B (lipoprotein) B R 4 days M 0.55 – 1.40 F 0.55 – 1.25 Aspartate Amino Transferase (AST)

B IH 4 hours 15 – 48 UI/L

Aspergillus Precipitins

B R 4 days 0-24 mg/l

Asp. Niger IgG 0 – 24mg/l Asp.fumigatis IgG 0 – 39mg/l Aspirates SC IH 2-3

days

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Atypical Antibody Identification

BTx2 R 5 days

Auto Antibody Screen Gastric Parietal cell ANF Mitochondrial Smooth muscle Thyroid LKM Reticulum

B R 3 days

Bence-Jones Protein EMU R 4 days 0 – 0.14 g/l Minimum 60ml

Beta 2 Microglobulin B R 3 days 1.10 – 2.40 Beta 2 Microglobulin RU R 3 days Less than 300 Beta hCG (Qualitative - pregnancy test)

B or EMU IH 4 hours IU/L

Beta HCG (Quantitative)

B R 2 days

Bicarbonate (serum) B R 2 days Bilharzia Antibodies B R 3 days 8.5 =- 11.5 Travel details

required Bilirubin (Total) B IH 4

hours 3.0 – 22.0 uMol/l

Bilirubin (Conjugated) B R 1 day Biochemistry Profile B IH 4 hours Blood Cultures BC IH 7 days Contact laboratory Blood Film Examination

A IH 5-7 Working

days

Put note under clinical details

Blood Group BT IH 1 day Bone Marrow Aspiration

IH Contact Consultant Haematologist

Bone Marrow Trephine Biopsy

IH Contact Consultant Haematologist

Bone Profile B IH 4 hours Borrelia Antibodies (Lyme)

B R 3 days IgG Pos=>15

IgM B-TYPE Natriuretic Peptide

B R 2 days

Brucella Agglutinins B R 3 days C1 Esterase Inhibitor B/C R 6 days 210 - 390 C1 Esterase: Function and Total

Cx3 R 16 days Filled to the 2.9 line straight to lab Frozen Plasma

CA 125 B R 1 day 0 – 35 KIU/L CA 153 B R 1 day 0 – 25 KIU/L CA 199 B R 1 day 0 – 27 KIU/L Caeruloplasmin

B R 2 days

Calcitonin B R 6 days M F

<8.4 ng/L <5.0 ng/L

Take to laboratory immediately after collection Frozen Serum

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Calcium B IH 4 hours 2.10 – 2.55 mMol/l Minimal venous stasis

Candida Antibody B R 6 days Carbamezepine B R 2 days Carcino Embryonic Antigen (CEA)

B R 1 day 0-5 ug/L

Cardiac Enzymes (CPK,AST, LDH)

B IH 4 hours

Cardiolipin Antibodies B R 3 days IgG <10 GpLu/ml IgM <7 MpLu/ml

CD16/56/69 H R 3 days Monday - Thursday only

Chlamydia Antibodies B R 3 days Chlamydia PCR SC R 4 days FCRU, SEMEN,TPV

Chlamydia Swab SPCR R 3 days Chloride B IH 4 hours 95 – 108 mMol/l Cholesterol B IH 4 hours <5.0 mmol/l Cholinesterase (red cell)

H R 6 days 26.7 – 50.9

Cholinesterase (serum)

B R 4 days

Chromosome Studies (Blood)

H R 20 days Contact lab inc clinical history

Clostridium difficile RF R 2 days Coagulation Screen A & C IH 4 hours C Filled to the 2.9

line Coeliac Profile B R 3 days Cold Agglutinins R 3 days Contact laboratory

Complement C3 B R 4 days 0.9 – 1.80 g/L Complement C4 B R 4 days 0.10 – 0.40 g/L Conjugated Bilirubin B IH 1 day Copper B R 4 days M 14

19 60

12.6–19.0umol/L 10 – 26.8 umol/L 11.0–22.0umol/L

Copper B R 4 days F 14 19 60

10.4–21.4umol/L 11.3–25.1umol/L 12.6–24.3umol/L

Cortisol B R 1 day 1.71-536nmol/L 9.00AM specimen preferred

Coxsackie B Antibodies

B R 12 days

Creatine Kinase (CK) B IH 4 hours 30 – 135 U/L Creatinine B IH 4 hours 46 – 92 mMol/l Creatinine Clearance 24 hr + B R 1 day 70 - 152 Crossmatch BT IH 1 day C Reactive Protein B IH 4 hours <6 mg/l Cryoglobulins J R 5 days Contact laboratory Crystal Examination SC R 1 day CSF Culture CSF R 2-3

days

CSF Glucose G R 1 day 0.11-41.6mmol/L CSF Oligoclonal bands

CSF + B R 6 days

CSF Protein CSF R 1 day 0.13 – 0.40 g/l

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Cytomegalovirus (CMV)

B R 2 days IgG <6 AU/ml

Dehydroepiandosterone (DHEA)

B R 8 days M F

3.1 – 20.8nmol/L 1.7 – 19.0nmol/L

DHEAS B R 2 days M F

0.44 – 13.4 nmol/L 0.26 – 11.0 nmol/L

Digoxin B R 2 days 0.9 – 2.0 Collect specimen 6 hours post dose

Dihydrotestosterone (DHT)

2xB R 6 days M F

0.34 – 2.06 <0.17

Direct Antiglobulin Test

A R 4 hours

DNA Double stranded Antibodies

B R 3 days <10 IU/ml

DNA Single stranded Antibodies

B R 6 days <68.6

Drug Screen RU R 2-6 days Random

EBV Antibodies IgG B R 3 days <5 EBV Antibodies Early IgG

B R 3 days <10

EBV Antibodies IgM B R 3 days <20 Echinococcus Antibodies

B R 3 days

eGFR B IH 4 hours mL/min ENA (Ro, La, Sm, RNP)

B R 3 days

Endomysial Antibodies

B R 3 days

Epstein Barr Virus (EBV)

B R 3 days

Erythrocyte Sedimentation Rate (ESR)

D IH 4 hours 2 – 12 mm/hr

Factor Assays (Clotting)

C x 3 R Filled to the 2.9 line /Directly to lab

Factor V Leiden A x2 R 4 days Clinical history required

Factor VIII C x 3 R 4 days Filled to the 2.9 line /Directly to lab

Faecal Culture RF R 4 days To lab ASAP Ferritin B IH 2 days M

F 17.9 – 464 ng/ml

11.1 – 264 ng/ml Please note that Iron deficiency can occur with Ferritin levels less than 30 ng/ml. Please interpret Ferritin results together with other laboratory parameters and clinical picture

Fibrin Degradation Products (FDP’s)

C R 2 days 1.5-4 g/L Filled to the 2.9 line

Filarial Antibodies B R 12 days Clinical & travel history required

Folic Acid (red cell) A R 3 days 285.4 – 1474.7 nmol/L

Folic Acid (serum) B R 2 days 4.6 – 18.7

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Fructosamine B R 4 days <285 FSH: Follicular Mid-cycle Luteal Post-menopausal

B IH 2 days 4 – 13 IU/L 5 – 22 IU/L 2 – 13 IU/L 20 – 138 IU/L

Fungal Culture FC R 20 D Full Blood Count (FBC): Haemoglobin Haematocrit RBC MCV MCH MCHC Platelets White blood cells: Neutrophils Lymphocytes Monocytes Eosinophil Basophils

A IH 4 hours M F M F M F M F M F M F M F

125 – 175 g/L 115 – 165 g/L 0.40- 0.52 L/L 0.37 – 0.47 L/L 4.5 – 6.5 106/ul 3.8 – 5.8 106/ul 77 – 96 fl 77 – 96 fl 27 – 3 2pg 27 -32 pg 310 – 350 g/L 310 – 350 g/L 150 – 400 103/ul 150 – 400 103/ul 2.0 – 7.5 103/ul 1.5 – 4.00 103/ul 0.00 – 0.8 103/ul 0.00 - 0.45103/ul 0.00 – 0.2103/ul

Gamma Glutamyl Transferase (GGT)

B IH 4 hours M F

15 – 73 U/l 12 – 53 U/l

Gastrin B R 4 days 13 – 115 ng/l Take to laboratory immediately after collection Frozen Sample

Gentamicin B R 1 day State time and dose

Gliadin Antibodies B R 3 days Glucose G/B IH 4 hours 3 - 6 mMol/l

11.1 mMol/l Fasting Random

Glucose Tolerance Test

Gx2 IH 1 day Fasting 12 hours. See protocol

Growth Hormone - Fasting

B R 2 days M F

Up to 0.8 Up to 8.0

Fasting and rest for 30 mins, Straight to Lab Frozen Serum

Gut Hormone Screen R 12 days Contact laboratory

Haemoglobin A IH 4 hours 115 - 165

Haemoglobin Electrophoresis

A R 4 days %

Haptoglobin B R 3 days

HbA1c (Glycosylated haemoglobin)

A R 2 days 4.0 – 6.0 %

HCG (pregnancy test) B/U IH Up to 4H Qualitative. EMU if urine

HDL Cholesterol B IH 4 hours M F

>1.0 >0.9

Patient should fast for 12 hours

Helicobacter Antibodies

B R 3 days

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Helicobacter Breath Test

HBQT R 3 days Contact laboratory

Helicobacter Stool RF R 2 days

Hepatitis A Screen (IgG / IgM)

B R 2 days

Hepatitis B DNA (Quant)

B R 6 days

Hepatitis B Screen B R 2 days

Hepatitis B e Antigen B R 2 days

Hepatitis B Surface Antibody

B R 2 days mIU/ml Immunity

Hepatitis B Surface Antigen

B R 2 days

Hepatitis C Antibody B IH 2 days

Hepatitis C RNA PCR B R 8 days

Hepatitis C Quantification by PCR

Ax2 R 6 days

Herpes Simplex I/II PCR

PCR/FCRU /TPV

R 6 days

Herpes Simplex I/II Antibodies IgM

B R 3 days

Histoplasma Antibodies

B R 6 days

HIV 1 & 11 Antibodies (inc P24)

B R 2 days

HLA/B27 A x 4 R 4 days Clinical history

Human Chorionic Gonadotrophin (quantitative)

B R 2 days 0-3 IU/L Tumour marker

HVS STM IH up to 3D

Hydatid Antibodies B R 3 days

IGF-1 (Somatomedin) B R 4 days 12.6 – 35.5 nmol/l Take to laboratory immediately after collection Frozen Serum

Immunoglobulins : IgA IgG IgM

B R 3 days 0.7 – 4.0 g/L 7.0 – 16 g/L 0.4 – 2.30 g/L

Total Immunoglobulin E

B R 3 days 1 0 -15 kIU/L

5 0 -60 IU/L

9 0 – 90 IU/L

15 0 – 200 IU/L

0 – 100 IU/L

Inhibin B B R 5 days Day 3 of cycle Insulin B R 2 days 2.6 – 24.9 mIU/L

Intrinsic Factor Antibodies

B R 4 days Normal <6U/ml

Iron B R 2 days M 10.6 – 28.3 umol/L

F 6.6 – 26.0 umol/L

Iron Binding Capacity (TIBC)

B R 2 days 41 – 77 umol/L

Islet Cell Antibodies B R 3 days

Jo-1 Antibodies B R 3 days

Lactate Dehydrogenase

B R 4 hours 230 - 460 IU/L

Lead A or RU R 4 days Clinical history Legionella Antibodies B R 3 days

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Legionella Antigen urine

RU R 2 days

Leishmania Antibodies

B R 3 days

Leptospiral Antibodies

B R 4 days

Lipase B R 2 days Lipid Profile : Cholesterol Triglycerides HDL LDL

B IH 4 hours <5.0 mmol/l 0.40–1.53mmol/l >0.9 mmol/l Less than 3.0 mmol/l

Patient should fast for 12 hours

Lipoprotein (a) B R 2 days 0.0 – 0.300 Lipoprotein Electrophoresis

B R 4 days

Lithium B R 2 days 0.6–1.0mmol/L

Liver Function Tests : Bilirubin Alkaline phosphatase Aspartate transaminase Alanine transaminase Gamma GT Total protein Albumin

B

IH

4 hours 3.0 – 22.0 umol/l 38 – 126U/L 9 – 36 U/I 10 – 28 U/I 12 – 53 U/I 60 – 80 g/l 35 – 50 g/l

Liver/Kidney Microsomal Ab’s

B R 3 days

Lupus Anticoagulant C x 3

R 3 days

Filled to the 2.9 line /Directly to lab/Frozen Plasma

Luteinising Hormone (LH): Follicular Mid-cycle Luteal Post-menopausal

B

IH 2 days

2.58 – 12.1 IU/L 27.3 – 96.8 IU/L 0.833 – 15.5IU/L 13.1 – 86.5 IU/L

Lymphocyte Immunophenotyping

BT R 4 days

Lymphocyte Subsets BT R 3 days Contact laboratory Magnesium B R 1 day 0.60 – 1.0

Malaria Antibodies (Pl. falciparum)

B R 3 days

Malarial Parasites A R 1 day

Measles Antibodies IgM

B R 6 days

<13.3

Measles , Mumps, Rubella antibody

B

R 3 days

>=16.5 AU/ml = positive 13..5-16.4 AU/ml =Equivocal <13.5 AU/ml =Negative Rubella: >10IU/mL = positive

Microalbumin (Creatinine/Albumin ratio)

RU

R 3 days

Mitochondrial Antibodies

B R 3 days

MRSA Screen STM IH 3 days Nose and groin

Mumps Antibodies B R 3 days

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IgG and IgM Mycoplasma pneumoniae Abs IgG / IgM

B

R 4 days

<10 AU/ml Negative

Neutrophil Cytoplasmic Ab’s (ANCA)

B

R 3 days

NK Cytotoxicity Assay

3 x H

R 6 days

AM Mon - Thurs

NK profile (Natural Killer cells)

2A/CHEX R 3 days

Contact laboratory

Neuronal Antibody B R 4 days

Occult Blood RFx3 IH 1 day

Oestradiol (E2) Follicular Mid-cycle Luteal Post-menopausal

B

R 2 days

M F

44–156 pmol/L 98 – 571 pmol/L 177 – 1153 pmol/L 122 – 1094 pmol/L <183 pmol/L

Oligoclonal Studies CSF+B R 5 days

Osmolality (serum & Plasma)

B R 2 days

285 - 295 mosmo/kg

Osmolality (urine) RU R 2 days

80–1200 mosmo/kg

Ova, Cysts and Parasites

RF R 3 days

Ovarian Antibodies B R 3 days

Paraproteins B R 5 days

Parathyroid Hormone (PTH)

BT B

R 2 days

1.6 – 6.9 pmol/L Take to laboratory immediately, Freeze B sample

Parietal Cell Antibodies

B R 3 days

Parvovirus Antibody IgG / IgM

B R 3 days

Paul Bunnell (Infectious Mononucleosis)

A,B&D

IH

4 hours

PCA3 R 7 days Contact laboratory

Pertussis PCR R 6 days Contact laboratory

Phenobarbitone B R 2 days 10 - 30

Phenytoin B R 2 days 10 - 20

Phosphate B IH 4 hours 0.8 – 1.5 mMol/l

Pleural Fluid - Culture SC IH 2 days

Porphyrin Screen (Blood)

Ax2 R 12 days

Protect from light

Porphyrin Screen (Faecal)

RF R 12 days

Protect from light

Potassium B IH

4 hours 3.5 – 5.3 mMol/l Must be received within 3 hours

Pregnancy Test B/EMU IH 4 hours

Progesterone B R 2 days M 0.7 – 4.3nmol/L

Prolactin B R 2 days

M F

86 – 324mIU/L 102 – 496mIU/L

Prostate Specific Antigen (free)

B R 2 days

0 – 0.90 ug/l

Prostate Specific Antigen (Total)

B IH 2 days

<4.0

Protein (Total) B IH 4 hours 60 – 80 g/L

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Protein C C x 3

R

4 days 0.7 – 1.40 Filled to the 2.9 line /Directly to lab Frozen Pl.

Protein/Creatinine Ratio Urine

RU R

2 days

Protein Electrophoresis (PEP)

B R 3 days

%

Protein S – free C x 3 R 4 days

M F

0.68 – 1.39 0.6 – 1.14

Filled to the 2.9 line /Directly to lab

Prothrombin Time (INR)

C IH

4 hours Control: 10.3 – 12.2

Filled to the 2.9 line

Psittacosis/LGV Antibodies

B R 4 days

Q Fever – Coxiella burnetii

B R 4 days

Clinical history required

Reducing Substances U R 2 days

Reducing Substances RF R 2 days Contact laboratory

Renal Stone Profile CU&2B R 6 days

Renin Ax2

R 4 days

Patient should Upright or resting for 3hrs/sample directly to lab/frozen

Respiratory Viral Screen : Influenza A Influenza B Adenovirus RSV Para-influenzae mix

B R 3 days

Reticulin Antibodies B R 3 days

M F

16.7 – 112.5 19.6 – 101.9

Reticulocyte Count A

R 1 day

M F

0.38 – 2.64 0.45 – 2.42

Mon – Fri Before 4pm Sat Before 11am

Rheumatoid Factor B R 2 days <14 IU/mL

Rickettsial Antibodies B R 3 days

Rotavirus Screen RF R 2 days Contact laboratory

RPR/TPHA Serology B R 3 days

Rubella IgG Antibody B R 2 days

Rubella IgM Antibody B R 3 days

Schistosomal Antibodies

B R 3 days

Travel details required

Selenium (red cell) H R 5 days 76 - 140

Selenium (serum) B R 5 days 40 - 107

Serotonin H

R 4 days

50 - 300 Take to laboratory immediately after collection Frozen Plasma

Sex Hormone Binding Globulin

B R 2 days

M F

16 – 55 nmol/L 27 - 146 nmol/L

Sexual Health screen (7 STD profile)

TPV/FCRU/CHLS

Semen & 6 days

Sickle Cell Screen A

IH 4 hours

If positive the sample will be sent for Hb electrophoresis

Smooth Muscle Antibodies

B R 3 days

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Sodium B IH 4 hours 133 – 146 mMol/l

Sputum Culture (routine)

SC R

up to 3D

Sputum Culture (TB) SC R

6 – 8 weeks

Stone Analysis SC R 6 days

Swabs M,C&S (all sites)

STM IH

up to 3D

Synacthen Stimulation Test

Bx3 R 2 days

By appointment In patient

Synacthen Stimulation Test (Long)

Bx5

R 2 days

By appointment In patient

Syphilis IgG/IgM B R 2 days

TB Culture (urine) 3xEMU R

6 – 8 weeks

Testosterone B R 2 days

M F

7.6–31.4 nmol/L 0 – 1.8 nmol/L

Theophylline B R 2 days

Thin Prep TVP R 4 days

Thin Prep (Chlamydia) TVP R 4 days

Thin Prep (Gonorrhoea)

TVP R 4 days

Thin Prep (HPV) TVP R 6 days

Thrombin Time C R 2 days

Filled to the 2.9 line /Directly to lab

Thrombophilia Screen Cx5/A/B R 5 days

IU/ml C Filled to the 2.9 line /Directly to lab

Thyroglobulin Assay B R 2 days 5.6 – 59.9

Thyroid Antibodies : Thyroglobulin Ab Thyroid peroxidase

B

R 3 days

0 – 115 IU/mL 0 – 34 IU/mL

Thyroid Profile B IH 2 days

TSH Receptor Antibodies

B R 5 days

0.47 – 4.68 IU/L

Thyroxine (free) (FT4) B IH 2 days 10.0 – 32.1 pmol/L

Tissue Transglutaminase

B R 3 days

0-10 U/mL

Total Free 4 (Total Thyroxine)

B R 2 days

59 – 154 nmol/L

Toxocara Antibodies IgG

B R 6 days

Clinical history required

Toxoplasma Antibodies IgG / IgM

B R 2 days

Clinical history required

TPHA B R 3 days

Transferrin B R 2 days

M F

1.68 – 2.87 1.68 – 3.07

Transferrin Saturation B R 2 days 20-55 %

Transfusion Reaction Investigation

B, BT, Urine R

Contact laboratory

Tropical Screen: Amoebic Abs Schistosomal Abs Echinococcal Abs Leishmania Abs Toxoplasma Abs IgG/IgM

B

R 3 days

Clinical history required

Troponin T B R 1 day 0 - 14 Red Bag

TSH B IH 2 days 0.47 – 4.68mIU/L

Urate (uric acid) B IH 4 hours 155 - 360

Urea B IH 4 hours 2.5 – 6.1 mMol/l

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Urea and Electrolytes: Sodium Potassium Chloride/serum Urea Creatinine Glucose

B

IH

4 hours 133–146 mMol/l 3.5 – 5.3 mMol/l 95 – 108 mMol/l 2.5 – 6.1 mMol/l 46 – 92 mMol/l

Uric Acid (Urate) B IH 4 hours 155 – 360 umol/L

Urinary Free Cortisol CU R 4 days

Sample should be returned by 9.30am

Urine Amino Acids RU R 8 days

Urine Amylase CU R 2 days

Sample should be returned by 9.30am

Urine Calcium CU R 2 days

2.5 – 8.0 nmol/24hrs

Sample should be returned by 9.30am

Urine Catecholamines PU R 6 days

Sample should be returned by 9.30am

Urine Copper CU R 4 days

24 HR: 10 - 80

Sample should be returned by 9.30am

Urine Creatinine CU +B R 2 days

Umol/L Sample should be returned by 9.30am

Urine Culture SC IH 2 days To laboratory ASAP

Urine Cystine CU R 6 days

10-100 mg/24hrs Sample should be returned by 9.30am

Urine Drug Screen RU R

2-6 days Maybe Random or Chain of Custody

Urine Electrolytes (Sodium/Potassium)

CU R 2 days

Sample should be returned by 9.30am

Urine Metanephrines PU R 6 days

nmol/24hr

<3751 Sample should be returned by 9.30am

Urine Osmolality RU R 2 days

Urine Oxalate CU R 4 days

M F

78 – 489 44 - 344

Sample should be returned by 9.30am

Urine Phosphate CU R 2 days

24 HR: 16 - 35

Sample should be returned by 9.30am

Urine Porphyrin Screen

RU R 12 days Protect from light

Urine Protein CU R 2 days

24HR: 0.0 – 0.15

Sample should be returned by 9.30am

Urine Urate (uric acid) CU R

2 days 2 – 7 mmol/24hrs Sample should be returned by 9.30am

Urine Urea CU R 2 days

24 HR: 170 - 580

Sample should be returned by 9.30am

Valproic Acid (Epilim) B R 2 days

Vancomycin B R 1 day

Pre >20mg/l Post >40 mg/l

State time and dose

Varicella zoster Antibodies (IgG)

B R 2 days

Varicella zoster Antibodies (IgM)

B R 3 days

VD Serology B R 2 days

Viral Screen: Influenza A Influenza B Chlamydia Measles Mumps Adenovirus CMV Herpes Q Fever

B R 2 days

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Mycoplasma

Vitamin A B R 6 days 1.05 – 3.84 Protect from light

Vitamin B12 B IH 2 days 197 – 866 pg/ml

Vitamin D (25 OH) B R 2 days 50 – 200nmol/L

Vitamin E

R R 8 days 9.5 – 26.9 Protect from light

Vitamin Profile 1 2 XA, 2XB, R 6 days Protect from light

VMA CU R 4 days 0.0–30.2umol/24hr Sample should be returned by 9.30am DIET sheet

Yersinia Antibodies B R 4 days

Zinc blood/serum K R 2 days 11 - 18

If you require any further information for reference ranges or units please contact the

pathology department.

For sampling and handling requirements for tests not listed please contact the laboratory.

For non-insured prices please contact the laboratory office on ext. 4321 or 02089361204

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Appendix 3 STORAGE OF PATHOLOGY SAMPLES

Aspirate Store in Fridge

Biochemistry Do not take or leave overnight

Chlamydia Room Temperature – Red Sample Box

FBC/ESR Do not take or leave overnight or put in Fridge

FNA Slides Room Temperature – Red Sample Box

FNA Fluid Fridge (as aspirate)

Histology Room Temperature – Red Sample Box

Hormones, PSA or Tumour Markers May be taken and left overnight in Fridge

Immunofluorescence Samples Room Temperature Red Sample Box

MSU Store in Fridge

Semen for Culture & Sensitivity Store overnight in Fridge

Smears Room Temperature – Red Sample Box

Sputum Store overnight in Fridge

Stools Store overnight in Fridge

General Swabs Store overnight in Fridge

HVS Swabs Store at room temperature overnight

Thin Prep Room Temperature – Red Sample Box

Urine Cytology Store in Fridge

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Appendix 4 Critical reporting levels Biochemistry

Test If result is less than If result is greater than

AST/ALT 1000 IU/L

Amylase 500 IU/L

Bicarbonate 15 mmol/L 40 mmol/L

Calcium(corrected) 2.0 mmol/l 2.8 mmolL

Creatinine 500 umol/L

Digoxin 2.0 ng/mL

Free T4 30 nmol/L

Gentamicin (pre) >2mg/L

Gentamicin (post) <2 mg/L >10 mg/L

Fasting Glucose 3.0 mmol/L 10.0 mmol/L

Lithium 1.2 mmol/l

Magnesium 0.6 mmol/L 2.0 mmol/L

Phosphate 0.4 mmol/L 2.0mmol/L

Potassium 2.5 mmol/L 6.0 mmol/L

Sodium 125 mmol/L 150 mmol/L

TSH 30 U/L

Urea 25.0 mmol/L

Vancomycin (pre) >20 mg/L

Vancomycin (post) >40 mg/L

Haematology These will also be influenced by the availability of previous results, together with the findings of a delta check of the relevant abnormality. Grossly abnormal results should be telephoned by BMS staff only. If the results have not been validated then only qualified BMS staff should give the results.

1. Haemoglobin <80 g/L 2. WBC > 20 x 10 9/L 3. Neutrophils <1.0 x 10 9/L

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4. Platelets <50 x 10 9/L (check sample to ensure no clots in sample or clumping in blood film)

5. Platelets >1000 x 10 9/L (check sample to ensure no clots in sample or clumping in blood film)

6. Sickle Test – Positive in patients about to undergo anaesthesia 7. INR >5.0 8. APTT ratio >1.5 (unless patient anticoagulated) 9. Fibrinogen <1.5 g/L 10. Malaria parasites – Positive

The following clinical problems should be referred to the Consultant Haematologist before phoning results to the requester.

1. Suspected haemolytic transfusion reactions 2. Patient requiring massive transfusions, e.g. 10 units within 10 hours 3. Platelet counts <20 x 10 12/L (in non-oncology patients)

N.B. the blood film must be checked first to ensure that the result is not spurious due to clumping

4. New patients with prolonged PT, APTT, low platelets and low fibrinogen

5. Malaria positive films 6. Newly presenting or suspected leukaemias.

Microbiology The following results are of an urgent nature and are to be communicated by qualified BMS staff to the Pathology Microbiology Consultant as soon as is practically possible (prior to contacting the referring clinician).

1. Positive blood cultures (except likely contaminants, e.g. coagulase negative

staphylococci) 2. CSF microscopy (white cell counts >10) 3. Salmonella, Shigella and Campylobacter and E.coli O157 isolates 4. Clostridium difficile toxin positive results 5. Positive AAFB smears and cultures

The Pathology Microbiology Consultant shall then liaise with the referring clinician or direct the BMS staff member on how to proceed with communication to the requestor.

The following should be communicated to the requesting clinician as soon as is practically possible.

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6. STD’s (e.g. Neisseria Gonorrhoea isolates) 7. Multi-resistant coliforms, especially Amikacin resistant and ESBL / AMP

C producing organisms 8. Positive Rotavirus results

The Pathology Microbiology Consultant should also be made aware of these on a non-urgent basis. The following results may be given by BMS and specifically trained MLA staff to the requesting clinician as required:

Microscopy results – urine preparations, cell counts and gram stains

Mycobacterium culture with “ no growth so far”

Any results requiring clinical interpretation or clarification of clinical details are referred to the Pathology Microbiology Consultant.

Referral laboratories Phoned critical results from referral laboratories will be relayed to the requesting clinician as soon as possible.

12 FLOWCHARTS N/A

13 FORMS N/A