SWGLH Sample Requirements and Transport

Sample Requirements

1. Please ensure that the patient identity has been verified before taking the sample.
2. For the majority of molecular genetics analysis tests, blood samples in EDTA tubes (2 x 4ml for adults, 2-5ml for children and 1-2ml for neonates) is required.
3. For cytogenetic analysis, for example karyotyping or Fluorescent in situ hybridisation, a blood sample in Lithium Heparin (2-5ml for adults/children and 1-2ml for neonates) is required.
4. Chorionic villus samples or products of conception should be sent in transport media if you require this please contact the laboratory. Please see guidance for Solid Tissue Biopsy.
5. Testing for facioscapulohumeral muscular dystrophy requires a larger volume of blood - minimum of 8ml in EDTA tube is requested
6. For samples requiring RNA analysis there is a 72 hour cut-off for receipt of samples as reliable quantitation is not possible from follow-up samples older than 72 hours. Samples received that are older than 72 hours will not be processed and a repeat sample will be requested.
7. For inherited cancer testing blood samples should be kept at room temperature or at 4oC and not be frozen before dispatch. They should be sent to the SWGLH to arrive within 1-3 days of sample collection.
8. For other types of sample please contact the laboratory.

If any of the above requirements are not adhered to, this may result in rejection of the sample.

Packaging

Unless advised otherwise samples should be sent at room temperature. If there is a delay in sending most samples can be refrigerated at +4 degree Celsius for a few days without affecting quality.Amniotic fluid and chorionic villus samples should be transported to the laboratory urgently and should not be refrigerated.

Failure to adhere to this guidance or delays in transit could result in failure of the test.

The sample container should be leak-proof and must be placed in a transparent sample bag with the paperwork attached but not in the same compartment as the container. The outer sample packaging must comply with PI 650 for category B substances. The package should be clearly labelled 'diagnostic specimen UN3373'.

High Risk Specimens

If the sample is known to be high risk this should be clearly stated on the request form and sample container. Please contact the laboratory with any queries regarding the appropriateness of sending any potentially high risk samples.

Last updated 09/04/2024

Please note that failure to use SWGLH referral forms for requesting tests will lead to a delay of genetic results and therefore could adversely affect patient management.

1. The editable request form is for use for the majority of Rare Disease clinical indications. It may also be used for phlebotomy and requests for DPYD. 

2. For non-haematological cancers the request forms are:

• Solid tumour

• Sarcoma

• Circulating DNA

• Neuropathology

3. Haematological cancers 

• Bristol Haemato-Oncology Diagnostic Request Form

4. Request forms for Whole Genome Sequencing

• Curated on NHS England Resource Pages
  • NHS Genomic Medicine Service test order form- Cancer
  • NHS Genomic Medicine Service test order form-Rare Disease

5. Facioscapulohumeral muscular dystrophy (FSHD) Clinical Proforma

6. Combined HNF1B Patient and Clinical Information Sheet

7.  Familial Chylomicronaemia (FCS) Genetic Testing Request Form

Quick links to guidance documents can be found below. Please also visit the sections on the left hand menu for further information.

Haematology

Guidance for the Management of possible Germline Variants Identified During Routine Genomic Testing in Haematology

• Guidance for the Management of possible Germline Variants Identified During Routine Genomic Testing in Haematology360.5 KB

The minimum labelling requirements for the sample container are

• Full Name (forename and surname)
• One other unique identifier (Date of Birth/Unit No./NHS No.)

The request form must also include the same identifiers.

In addition the request form should include the following information:

• Patient Forename
• Patient Surname
• NHS Number
• 1st Line of Patient Address
• Patient Postcode
• Patient Date of Birth
• Referrer Name (surname and first initial)
• Referrer Facility
• Hospital Number (if applicable)
• National genomics test directory clinical indication code e.g. R53 Fragile X
• Full clinical details of the patient being tested
• Secure email address for return of reports

Please note any samples that do not meet the above requirements may be rejected.

For Non NHS England referrals please also provide billing information including any purchase order references.

It is the responsibility of the clinician to obtain consent for genetic testing and storage. The laboratory assume this has been done upon receipt of the request form and do not check consent has been obtained. Please refer to the guidelines from the Joint Committee on Medical Genetics.

Receipt of the sample and request form establishes an agreement to perform genetic testing.

The following must be clearly stated on the referral form:-

• Test required
• Clinical features
• Relevant family history
• Mother’s details for prenatal testing requests

For the majority of routine priority specimens Royal Mail can be used. For urgent specimens where there is no inter site transport it is recommended that an approved courier service be used. For Rare Disease tests please send the sample to your nearest Genetics Laboratory (in the South West this will be Bristol genetics Laboratory or Exeter Genomics Laboratory (addresses below).

For samples requiring RNA analysis there is a 72 hour cut-off for receipt of samples as reliable quantitation is not possible from follow-up samples older than 72 hours. Samples received that are older than 72 hours will not be processed and a repeat sample will be requested.

For the Trusts in the north of our region (Gloucestershire Royal Hospital to Weston General Hospital) there is inter site transport – please contact your Pathology Logistics Lead for information.

For Trusts in the south of the region Bristol Genetics Laboratory use the Cervical Screening (HPV) Transport service provided by City Sprint.

If you have any enquiries please contact: SWGLHenquiries@nbt.nhs.uk

Please address samples to:

Bristol Genetics Laboratory
Pathology Sciences Building
Southmead Hospital
Westbury-On-Trym
Bristol
BS10 5NB

For Rapid Whole Genome Sequencing:

Exeter Genomics Laboratory
Level 3 RILD building
Royal Devon & Exeter NHS Foundation Trust
Barrack Road
Exeter
EX2 5DW

Bristol Genetics Laboratory (BGL) Standard Terms For The Supply Of Genetic Laboratory Testing Services

Please note these terms and conditions solely apply to requests made outside of any dedicated contract or SLA that may have been agreed.

Agreement for the supply of genetic laboratory testing services by Bristol Genetic Laboratory (“BGL”) as part of North Bristol NHS Trust (“Provider") at Southmead Hospital, Southmead Road, Bristol BS10 5NB to you, the purchaser of such services ("Purchaser")

(A) You have submitted a request to the Provider, via a form contained at SWGLH Sample Requirements and Transport | North Bristol NHS Trust (nbt.nhs.uk) (“Request Form”), for the provision of specific genetic laboratory tests (“Services”).

(B) Each Request Form (howsoever sent to the Provider) shall be deemed to be an offer by the Purchaser to purchase the Services pursuant to the terms of this Agreement.  The Provider may, at its complete discretion, refuse to accept any Request Form.

(C) Each accepted Request Form shall constitute a separate Agreement, which shall expire on completion of the provision of the relevant Services by the Provider.

(D) The Purchaser shall be responsible for ensuring the accuracy of the content of any Request Form (including the Services requested and any test directory clinical indication code/name).

(E) Notwithstanding its acceptance of any Request Form, the Provider may cancel this Agreement at any time before the Services are delivered by giving written notice to the Purchaser.  The Provider shall not be liable for any loss or damage whatever arising from such cancellation.

(F) In submitting a Request Form, you are confirming your acceptance of the terms and conditions contained within this Agreement.

(G) This Agreement shall apply to the Services provided to you by the Provider to the exclusion of all other terms and conditions, including any terms and conditions which you may purport to apply to any order (including the Request Form), confirmation of any order (including any Purchase Order) or similar document or in any correspondence.

(H) No variation to the terms of this Agreement shall be binding unless agreed in writing by an authorised representative of the Provider.

(I) This Agreement (including the documents referred to in this Agreement) supersedes all prior representations and agreements between the Parties (whether written or oral) relating to the Services and sets forth the entire agreement and understanding between the Parties.  Each Party warrants to the other that it has not relied on any representation or agreement (whether written or oral) not expressly set out or referred to in the Agreement. 

IT IS AGREED as follows:

1 Defined Terms and Interpretation

1.1 In this Agreement, save where the context requires otherwise, the following words, terms and expressions shall have the following meanings:

“2000 Act”

means the Freedom of Information Act 2000;

“2004 Regulations”

means the Environmental Information Regulations 2004;

“Assigned Role” 

means the profession, employment, office, works, duty, position and/or licence held by a member of the Provider Staff from time to time assigned by the Provider for the purpose of performing its obligations under this Agreement;

"Confidential Information"

any information or data in whatever form disclosed, which by its nature is confidential or which the disclosing Party acting reasonably states in writing to the receiving Party is to be regarded as confidential, or which the disclosing Party acting reasonably has marked ‘confidential’ (including, financial information, or marketing or development or workforce plans and information, and information relating to services or products) but excluding Personal Data (to which the provisions of Clause 18.5 and 18.6 shall be applied), or information which is disclosed in accordance with 2000 Act or 2004 Regulations or information which is published as a result of government policy in relation to transparency;

"Contract Price"

means the sums detailed in the price list for the Services (as updated from time to time), which is available from the Provider on request;

“Data Controller”

has the meaning given in Data Protection Legislation;

“Data Processor”

has the meaning given in Data Protection Legislation;

“Data Protection Legislation”

means:

(a) UK GDPR and the Data Protection Act 2018 to the extent that each relates to processing of personal data and privacy; and

(b) all applicable Law about the processing of personal data and privacy;

"Dispute Resolution Procedure"

means the procedure set out in Clause 17;

“Equality Legislation”

means any and all legislation, applicable guidance and statutory codes of practice relating to equality, diversity, non-discrimination and human rights as may be in force in England and Wales from time to time including, but not limited to, the Equality Act 2010, the Part-time Workers (Prevention of Less Favourable Treatment) Regulations 2000 and the Fixed-term Employees (Prevention of Less Favourable Treatment) Regulations 2002 (SI 2002/2034) and the Human Rights Act 1998;

"Force Majeure Event" 

means an event or circumstance which is beyond the reasonable control of the Provider, including war, civil war, armed conflict or terrorism, strikes or lock outs, riot, fire, flood or earthquake and which directly causes the Provider to be unable to comply with all or a material part of its obligations under this Agreement in relation to the Services;

“GDPR”

means the General Data Protection Regulation (Regulation (EU) 2016/679);

"Good Clinical Practice"

means using standards, practices, methods and procedures conforming to the Law and reflecting up-to-date published evidence and using that degree of skill and care, diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled, efficient and experienced clinical services provider and a person providing services the same as or similar to the Services at the time the Services are provided;

"Good Industry Practice" 

means the exercise of that degree of skill, diligence and foresight which would reasonably and ordinarily be expected from a skilled and experienced service provider engaged in the provision of services similar to the Services under the same or similar circumstances as those applicable to the Agreement and which are in accordance with any codes of practice published by relevant trade associations;

“Good Practice”

means Good Clinical Practice and/or Good Industry Practice, as appropriate;

“Guidance”

means any applicable health or social care guidance, guidelines, direction or determination, framework, standard or requirement to which the Purchaser and/or the Provider have a duty to have regard (and whether specifically mentioned in this Agreement or not), to the extent that the same are published and publicly available or the existence or contents of them have been notified to the Provider by the Purchaser and/or any relevant Regulatory or Supervisory Body;

“Indemnity Arrangements”

means:

(a) a policy of insurance (with an insurer of good repute);

(b) an arrangement made for the purposes of indemnifying a person or organisation; or

(c) a combination of (a) and (b);

"Indirect Losses"

means loss of profits (other than profits directly attributable to the provision of the Services), loss of use, loss of production, loss of business, loss of business opportunity, loss of reputation or goodwill or any other consequential or indirect loss of any nature, whether arising in tort or on any other basis;

"IPR"

means inventions, copyright, patents, database right, trademarks, designs and confidential know-how and any similar rights anywhere in the world whether registered or not, including applications and the right to apply for any such rights;

"Law"

means:

(a)          any statute or proclamation or any delegated or subordinate legislation;

(b)         any enforceable community right within the meaning of section 2(1) European Communities Act 1972;

(c)          Guidance;

(d)         any judgment of a relevant court of law which is a binding precedent in England; 

 (f)         any relevant code of practice,

in each case applicable and in force in England;

“Losses”

means all damage, losses, indebtedness, claims, actions, cash, expenses (including the cost of legal or professional services, legal costs being an agent/client, client paying basis), proceedings, demands and charges whether arising under statute, contract or at common law but excluding Indirect Losses;

"Month"

means a calendar month;

"Party"

means either the Provider or the Purchaser individually and "Parties" refers to both the Provider and the Purchaser together. A Party shall include all permitted assigns of the Party in question;

“Patient Safety Incident”

means any unintended or unexpected incident which could have or did lead to harm to one or more patients or service users;

“Personal Data”

has the meaning given in Data Protection Legislation;

“Process”

has the meaning given in the Data Protection Legislation and “Processed” and “Processing” shall be construed accordingly;

"Prohibited Act"

means that Party:

(a) offering, giving, or agreeing to give the other (or any of their officers, employees or agents) any gift or consideration of any kind as an inducement or reward for doing or not doing or for having done or not having done any act in relation to the obtaining of performance of this Agreement or any other agreement with the other Party, or for showing or not showing favour or disfavour to any person in relation to those agreements; and 

(b) in connection with this Agreement or any other agreement with the other Party, paying or agreeing to pay any commission, other than a payment, particulars of which (including the terms and conditions of the agreement for its payment) have been disclosed in writing to the other; or 

(c) committing an offence under the Bribery Act 2010;

“Provider Staff”

means all persons (whether clinical or non-clinical) employed or engaged by the Provider (including volunteers, agency, locums, casual or seconded personnel) in the delivery of the Services and/or the performance of its obligations under this Agreement; 

“Purchaser Staff”

means all persons (whether clinical or non-clinical) employed or engaged by the Purchaser including volunteers, agency, locums, casual or seconded personnel in the performance of its obligations under this Agreement; 

“Quarter”

means a period of three (3) Months commencing on 1 April, 1 July, 1 October and 1 January, and “Quarterly” shall be interpreted accordingly;

“Regulatory or Supervisory Body”

means any statutory or other body having authority to issue guidance, standards, or recommendations with which the relevant Party must comply or to which it must or should have regard, including:

(a) Care Quality Commission;

(b) NHS England & NHS Improvement;

(c) Department of Health;

(d) NICE; 

(e) Information Commissioner; and

(f) Healthwatch England,

including any successor body or bodies of the above;

“Serious Incident”

has the meaning given to it in the NHS Serious Incident Framework (available at: http://www.England.nhs.uk/ourwork/patientsafety/);

"Service Location"

means the location, premises and/or facilities identified in the Specification;

"Specification"

means the service specification set out in the Appendix;

“Staff”

means Purchaser Staff and/or Provider Staff as the context requires;

“UK GDPR”

the GDPR as incorporated into UK legislation by way of the European Union (Withdrawal Agreement) Act 2020 and as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019; 

“VAT”

means Value Added Tax or any successor tax from time to time;

"Working Day"

means a day (other than a Saturday or Sunday) on which banks are open for business in the City of London;

"Working Hours"

means 9am to 5pm on a Working Day.

1.2 In this Agreement, all references to any statute or statutory provision shall be deemed to include references to any statute or statutory provision which amends, extends, consolidates, or replaces the same and shall include any orders, regulations, codes of practice, instruments or other subordinate legislation made thereunder and any conditions attaching thereto. 

1.3 Unless the context otherwise requires, any reference to European Union law that is directly applicable or directly effective in the UK at any time is a reference to it as it applies in England and Wales from time to time including as retained, amended, extended, or re-enacted on or after 1 January 2021.

1.4 In this Agreement, any headings to Clauses and Paragraphs are for convenience only and shall not affect the meaning of this Agreement. Unless the contrary is stated, references to Clauses, Paragraphs and Appendices shall mean the clauses, paragraphs and appendices of or to this Agreement.

1.5 In the event of a conflict between the parts of this Agreement, the main body shall take priority over the Appendix.

1.6 Where a term of this Agreement provides for a list of items following the word "including" or "includes", then such list is not to be interpreted as being an exhaustive list.

1.7 In this Agreement, words importing any particular gender include all other genders, and the term "person" includes any individual, partnership, firm, body corporate, government, governmental body, trust, agency, unincorporated body of persons or association and a reference to a person includes a reference to that person's successors and permitted assigns.

1.8 In this Agreement, words importing the singular only shall include the plural and vice versa.

1.9 In this Agreement, reference to any body, organisation or office shall include reference to any other body, organisation, or office to which all or part of their respective functions are transferred from time to time (namely a successor body, organisation, or office). 

1.10 Except where an express provision of this Agreement states the contrary, each and every obligation of a Party under this Agreement is to be performed at that Party's cost.

1.11 In this Agreement, any obligation on any Party not to do or omit to do anything shall include an obligation not to allow that thing to be done or omitted to be done.

2 Services

2.1 In performing their respective obligations under this Agreement, each Party shall act in a timely manner and use all reasonable care, skill, and diligence in accordance with Good Practice.

2.2 The Parties shall ascertain, observe, perform, and comply with all relevant Laws, and shall do and execute or cause to be done and executed all acts required to be done under or by virtue of any Laws.

2.3 Subject to Clauses 2.7 and 12, the Provider will be responsible for providing the Services in accordance with the Specification. 

2.4 The Purchaser shall be responsible for meeting its obligations as detailed in the Specification.

2.5 The Parties will co-operate with each other in good faith, will comply with the reasonable requests of the other and will take all reasonable action as is necessary for the efficient transmission of information and instructions and to enable the Parties to perform their respective obligations in this Agreement.

2.6 If either Party becomes aware of any actual or potential problems that affect or might affect the performance of obligations under this Agreement, it shall notify the other Party as soon as reasonably practicable.

2.7 To the extent any act or omission of the Purchaser or Purchaser Staff prevents or delays the Provider from providing all or any part of the Services (and subject to the Provider taking reasonable steps to minimise and mitigate the impact of such prevention or delay), the Provider shall be relieved from meeting its obligations under this Agreement and the Purchaser shall not be entitled to bring a claim for breach of obligations under the Agreement insofar as such claim relates to such prevention or delay.

3 Equipment, Materials and Consumables

3.1 The Provider shall provide all equipment, materials, consumables, and other items required for the provision of the Services.

3.2 The Provider shall keep and maintain all equipment provided and/or used by the Provider in the provision of the Services in good repair and condition as necessary for the proper and satisfactory provision of the Services.

4 Use of the Service Location 

4.1 The Services shall be provided by the Provider from the Service Location.

5 Staff

5.1 The Provider shall assign to the Services at all times sufficient adequately qualified and trained individuals to provide the Services, who shall have the skills, competence, and expertise necessary and appropriate for the proper performance of the Services.

5.2 Prior to their engagement in the provision of the Services, the Provider must ensure that all of the Provider Staff:

5.2.1 have had their identity checked against original documentation to ensure that the information they have given to the Provider about their identity is genuine;

5.2.2 have the right to work in the United Kingdom;

5.2.3 have been subject to reasonable checks to ensure their suitability for the Assigned Role;

5.2.4 are capable and fit to undertake the Assigned Role, taking into account the requirements and risk associated with such role and the individuals with whom they may have contact;

5.2.5 are qualified and competent for the Assigned Role and (if applicable) are registered with any relevant professional body or bodies; and

5.2.6 meet the required standards of training, competency and conduct to safely undertake the Assigned Role.

5.3 In connection with the provision of the Services, the Provider must ensure that all of the Provider Staff:

5.3.1 where registered with any relevant professional body, (if applicable) have completed their revalidations by the appropriate professional regulatory body;

5.3.2 are appropriately supervised (including where appropriate through preceptorship, clinical supervision, and rotations arrangements), managerially and professionally;

5.3.3 are covered by the arrangements made by the Provider pursuant to Clause 11; and

5.3.4 are aware of and respect equality and human rights of colleagues, service users, carers, and the public. 

6 Monitoring

6.1 The Provider must comply with all reasonable written requests made by any relevant Regulatory or Supervisory Body (or its authorised representatives), the National Audit Office, the Audit Commission or its appointed auditors for entry to the Provider’s premises and/or any premises from which the Services are provided by it (including the Service Location) for the purposes of auditing, viewing, observing or inspecting those premises and/or the provision of the Services, and for information relating to the provision of the Services.

6.2 Subject to compliance with Law and Good Practice, the Parties must implement and/or respond to all relevant recommendations: 

6.2.1 made in any report by a relevant Regulatory or Supervisory Body;

6.2.2 of the National Audit Office or its appointed auditors following any audit; and

6.2.3 of any clinical audit (to the extent applicable to the Services). 

7 Records

7.1 The Parties agree to retain records relating to or generated through the provision of the Services in accordance with the requirements of Law.

8 Price and Payment

8.1 As consideration for the provision of the Services, the Purchaser shall pay the Provider the Contract Price.

8.2 Unless otherwise provided in this Agreement or agreed in writing by the Purchaser, the Contract Price shall include every cost and expense of the Provider directly or indirectly incurred in connection with the performance of its obligations under this Agreement, including the provision of the Services. 

8.3 The Contract Price shall be invoiced by the Provider Quarterly in arrears.  Each invoice shall be rendered on the Provider’s own invoice form and the following supporting information will be available:

8.3.1 the Services for which payment is claimed;

8.3.2 patient details and corresponding tests carried out (sent as a separate document via encrypted email to the email address detailed in the Request Form); and

8.4 any VAT payable in accordance with Clause 8.9,

together with such other information as may be required by Law, any Regulatory or Supervisory Body, or which may be reasonably required by the Purchaser.

8.5 Each invoice shall be issued by post to the Purchaser at the address detailed in the Request Form.

8.6 The Purchaser shall pay the Provider all invoiced amounts (excluding any bona fide disputed sums) no later than thirty (30) days after receipt of a valid invoice. An e-invoice may be validly disputed if the e-invoicing system operated by the Purchaser does not comply with European Standards on electronic invoicing.

8.7 Any disputed amounts shall be resolved through the Dispute Resolution Procedure. In the event that payment of disputed sums is agreed to be made pending resolution, such payment shall be without prejudice to the rights of the Purchaser to recover such sum in the event that the dispute is resolved or determined in favour of the Purchaser. Where it is agreed or determined that an amount withheld was payable or an amount paid was not payable then such amount shall be paid by the Purchaser or repaid by the Provider (as applicable) within ten (10) Working Days of the dispute being resolved or determined.

8.8 If payment of any invoiced amount (excluding any bona fide disputed sum) is not made by the Purchaser by the due date, then the Provider may apply interest at the rate determined under the Late Payment of Commercial Debts (Interest Rate) Act 1998 accruing on a daily basis until payment is made.

8.9 All amounts stated to be payable under this Agreement are exclusive of any VAT properly chargeable on any amount. Each Party shall pay to the other Party any VAT properly chargeable on any supply made to it under this Agreement provided that it shall first have received from the relevant Party a valid tax invoice in respect of that supply.

8.10 All sums shall be paid without deduction or set off.

9 Assignment and Sub-Contracting

9.1 Subject to Clause 9.2 and the Specification, the Purchaser shall not assign, sub-contract, novate or in any way dispose of the benefit and/or the burden of this Agreement without the prior written consent of the Provider (such consent not to be unreasonably withheld or delayed).

9.2 Nothing in Clause 9.1 shall prevent either Party that is a statutory body from assigning, novating, or otherwise disposing of its rights and obligations under this Agreement to its statutory successors or assigns including any successor of all or part of its functions, property, rights, and liabilities.

10 Liability 

10.1 Without affecting its liability for breach of any of its obligations under this Agreement, the Purchaser will be liable to the Provider for and must indemnify and keep the Provider indemnified against any Losses whatsoever in respect of:

10.1.1 any loss of or damage to property (whether real or personal);

10.1.2 any injury to any person, including injury resulting in death; and/or

10.1.3 a breach of Data Protection Legislation

that results from or arises out of the Purchaser’s negligence or breach of contract in connection with the performance of this Agreement (including the acts and omissions of the Purchaser Staff) except to the extent such loss, damage or injury has been caused by any act or omission by or on the part of, or in accordance with the instructions of, the Provider or the Provider Staff.

10.2 Without affecting its liability for breach of any of its obligations under this Agreement, the Provider will be liable to the Purchaser for and must indemnify and keep the Purchaser indemnified against any Losses whatsoever in respect of:

10.2.1 any loss of or damage to property (whether real or personal);

10.2.2 any injury to any person, including injury resulting in death; and/or

10.2.3 a breach of Data Protection Legislation

that result from or arise out of the Provider’s negligence or breach of contract in connection with the performance of this Agreement or the provision of the Services (including its use of equipment or other materials or products and the acts and omissions of the Provider Staff), except to the extent such loss, damage or injury has been caused by any act or omission by or on the part of, or in accordance with the instructions of, the Purchaser or the Purchaser Staff.

10.3 Nothing in this Agreement shall exclude or limit the liability of either Party to the other Party for: 

10.3.1 any liability in respect of claims relating to death or personal injury caused by the negligent acts or omissions of such Party;

10.3.2 any liability arising out of fraud or fraudulent misrepresentation by such Party or any of its Staff; and

10.3.3 any other liability which cannot be excluded by Law.

10.4 Subject to Clause 10.3, neither Party shall under any circumstances whatsoever be liable to the other Party, whether in contract, tort (including negligence), breach of statutory duty, or otherwise, for any Indirect Losses arising under or in connection with this Agreement.

10.5 Subject to Clause 10.3, the Provider’s total liability to the Purchaser under or in connection with this Agreement, whether in contract, tort (including negligence), breach of statutory duty or otherwise will not exceed a sum equal to the total Contract Price payable for the Services.

10.6 Each Party will at all times take all reasonable steps to minimise and mitigate any losses or other matters for which one Party is entitled to be indemnified by or to bring a claim against the other under this Agreement. 

11 Indemnity Arrangements 

11.1 The Provider must put in place and maintain in force at its own cost (and not that of any employee) appropriate Indemnity Arrangements in respect of:

11.1.1 employers’ liability;

11.1.2 clinical negligence, where the provision or non-provision of any part of the Services (or any other services under this Agreement) may result in a clinical negligence claim; and

11.1.3 public liability.

11.2 Indemnity Arrangements made in accordance with Clause 11.1 shall be sufficient to meet the requirements of Law and the potential liabilities of the Provider under this Agreement.

11.3 Subject to Clause 10, if the proceeds of any Indemnity Arrangements are insufficient to cover the settlement of any claim relating to this Agreement, the Provider must make good any deficiency.

11.4 The Provider must not take any action or fail to take any reasonable action nor (in so far as it is reasonable and within its power) allow others to take action or fail to take any reasonable action, as a result of which any Indemnity Arrangements put in place in accordance with Clause 11.1 may be rendered wholly or partly void, voidable, unenforceable, or be suspended or impaired, or which may otherwise render any sum paid out under those Indemnity Arrangements wholly or partly repayable.

11.5 Where provision of all or part of the Services includes the care and treatment of patients or service users of the Purchaser, the Provider shall, on and following expiry or termination of this Agreement, procure that any ongoing liability it has or may have in negligence to the Purchaser arising out of such care and treatment under this Agreement will continue to be the subject of appropriate Indemnity Arrangements for twenty one (21) years following termination or expiry of this Agreement or (if earlier) until that liability may reasonably be considered to have ceased.

12 Force Majeure

12.1 The Purchaser shall not be entitled to bring a claim for a breach of obligations under this Agreement nor shall the Provider incur any liability for any losses or damages incurred by the Purchaser to the extent that a Force Majeure Event occurs and the Provider is prevented from carrying out its obligations by that Force Majeure Event.

12.2 On the occurrence of a Force Majeure Event, the Provider shall notify the Purchaser as soon as practicable. Such notification shall include details of the Force Majeure Event, including how it will affect its performance under this Agreement, evidence of the effect on the obligations of the Provider and any action proposed to mitigate its effect.

12.3 The Provider shall use all reasonable endeavours to mitigate the effects of the Force Majeure Event and, subject to Clause 12.4, facilitate the continued performance of the Agreement.

12.4 If the Provider is prevented from performing its obligations under this Agreement as a consequence of a Force Majeure Event for a period of more than thirty (30) days, it shall have the right to terminate the Agreement by giving seven (7) days written notice of termination to the Purchaser. No compensation shall be payable by the Provider as a direct consequence of this Agreement being terminated in accordance with this Clause.

13 Termination

Without prejudice to any other right or remedy it may possess, the Provider shall be entitled in the following circumstances to terminate this Agreement by written notice in accordance with Clause 14.1:

13.1 the Purchaser commits a material breach of this Agreement which:

13.1.1 where capable of remedy, is not remedied within five (5) Working Days of the Provider serving notice of such breach on the Purchaser (or such longer period as is agreed between the Parties); or

13.1.2 is not capable of remedy;

13.2 the Purchaser commits a serious and fundamental breach of this Agreement; 

13.3 the Purchaser commits a breach of Clause 15.1 and Clause 15.4.1 applies,

all of the above constituting an event of default, by the Provider, for the purposes of this Agreement. 

14 Effects and Arrangements on Termination or Expiry

14.1 In the event that the Provider has the right to terminate this Agreement pursuant to Clause 13 and wishes to exercise that right then, without prejudice to any other rights or remedies in this Agreement, the Provider will notify the Purchaser in writing of its intention to terminate this Agreement, specifying the date upon which this Agreement will terminate ("Termination Date").

14.2 Upon expiry of the Agreement through effluxion of time or on earlier termination of the Agreement in accordance with any of its terms, the Purchaser shall immediately pay to the Provider all sums due under this Agreement. 

14.3 Any rights, duties, or obligations of either of the Parties which are expressed to survive, or which otherwise by necessary implication survive the expiry or termination for any reason of this Agreement, together with all indemnities, will continue after expiry or termination, subject to any limitations of time expressed in this Agreement. 

14.4 Any expiry or termination of the Agreement will not prejudice the rights, obligations and duties of the Parties arising prior to such expiry or termination taking effect and shall be without prejudice to any right or remedy which has already accrued or subsequently accrues.

15 Prevention of Corruption

15.1 Each Party: 

15.1.1 agrees that it shall not (and shall procure that its Staff and any sub-contractors shall not), in connection with this Agreement, commit a Prohibited Act; and

15.1.2 warrants, represents, and undertakes that it is not aware of any Prohibited Act in connection with the execution of this Agreement, excluding any arrangement of which full details have been disclosed in writing to the other Party before execution of this Agreement.

15.2 Each Party shall: 

15.2.1 if requested, provide the other Party (“Other Party”) with any reasonable assistance, at the Other Party’s reasonable cost, to enable the Other Party to perform any activity required by any relevant government or agency in any relevant jurisdiction for the purpose of compliance with the Bribery Act 2010; and 

15.2.2 have an anti-bribery policy (which shall be disclosed to the Other Party) to prevent it (or any of its Staff or sub-contractors) from committing a Prohibited Act and shall enforce it where appropriate.

15.3 If any breach of Clause 15.1 is suspected or known, the breaching Party must notify the other Party immediately. Where such notification is given, the breaching Party must respond promptly to the other Party’s enquiries, co-operate with any investigation, and allow the other Party to audit books, records, and any other relevant documentation. 

15.4 Without prejudice to Clause 15.3, if either Party or any of its Staff or sub-contractors commits a breach of Clause 15.1 (with or without the knowledge of the other Party), the other Party shall be entitled to:

15.4.1 terminate this Agreement and recover from the breaching Party the amount of any loss resulting from such termination;

15.4.2 recover from the breaching Party the amount or value of any gift, consideration or commission concerned; and

15.4.3 recover from the breaching Party any other loss or expense sustained in consequence of any breach of Clause 15.1

16 Complaints and Incident Reporting

16.1 A record of all complaints received by the Provider of whatever nature regarding the provision of the Services shall be kept by the Provider.

16.2 All complaints received by either Party in relation to this Agreement shall be notified to the other Party as soon as reasonably practicable and in any event within five (5) Working Days of receipt.

16.3 The Parties shall co-operate fully with each other in investigating and resolving any such complaints made. In respect of any complaints arising out of this Agreement which fall within the terms of the Purchaser's complaints procedure, the Provider shall also comply with the Purchaser’s complaints procedure (as notified to the Provider in writing from time to time) to the extent it applies to the relevant complaint.

16.4 The Parties shall comply with the arrangements for notification of Patient Safety Incidents and Serious Incidents to any Regulatory or Supervisory Body, in accordance with Law.

16.5 Each Party shall send the other Party a copy of any notification it gives to a Regulatory or Supervisory Body where that notification directly or indirectly relates to the Services.

17 Dispute Resolution Procedure

17.1 In the event of a dispute arising between the Parties out of this Agreement (which those involved in the day to day management of this Agreement have been unable to resolve), either Party may serve written notice of the dispute on the other Party, setting out full details of such dispute.

17.2 The Parties respective Finance Directors (or their nominated deputies) shall meet in good faith as soon as possible and in any event within ten (10) Working Days’ notice of the dispute being served pursuant to Clause 17.1, at a meeting convened for the purpose of resolving the dispute.

17.3 If the dispute remains after the meeting detailed in Clause 17.2 has taken place,then:

17.3.1 where the Parties are within the same Integrated Care System (“ICS”), they shall participate within an ICS mediation process, whereby further routes to resolve the issue informally (and in the spirit of systems working) shall be undertaken. This process will be chaired by the nominated senior manager from within the relevant ICS and attended by both suitably senior members of both Parties. This process shall have ten (10) Working Days allocated, by which time if there is not resolution, either Party may refer the matter in accordance with Clause 17.3.2 as a matter of last resort;

17.3.2 where the Parties are not within the same ICS, they may, by agreement, attempt to settle such dispute by mediation in accordance with the Model Mediation Procedure of the Centre for Effective Dispute Resolution (“CEDR”) or any other model mediation procedure as agreed by the Parties. To initiate a mediation, either Party may give notice in writing (a "Mediation Notice") to the other requesting mediation of the dispute and shall send a copy thereof to CEDR or an equivalent mediation organisation as agreed by the Parties asking them to nominate a mediator. The mediation shall commence within twenty (20) Working Days of the Mediation Notice being served.  Neither Party will terminate such mediation until each of them has made its opening presentation and the mediator has met each of them separately for at least one (1) hour. Thereafter, paragraph 14 of the Model Mediation Procedure will apply (or the equivalent paragraph of any other model mediation procedure agreed by the Parties).  The Parties will co-operate with any person appointed as mediator, providing them with such information and other assistance as they shall require and will pay their costs as the mediator shall determine or in the absence of such determination such costs will be shared equally.

17.4 Nothing in the Dispute Resolution Procedure shall in any way affect either Party's right to terminate this Agreement in accordance with any of its terms or take immediate legal action, acknowledging that where this is an agreement between NHS bodies it shall fall under section 9 of the National Health Service Act 2006.

18 Confidentiality and Data Protection

Confidentiality

18.1 Subject to Clauses 18.2 to 18.4, where one Party (the “Recipient”) receives Confidential Information from the other Party (the "Discloser") or its representatives, the Recipient undertakes to keep such Confidential Information secret and strictly confidential and not to disclose such Confidential Information to any third party without the Discloser’s prior written consent.

18.2 Nothing in Clause 18.1 shall prevent the Recipient from:

18.2.1 using any general knowledge, experience or skills which were in its possession prior to the commencement of the Agreement;

18.2.2 disclosing Confidential Information where it is required to do so by: (i) judicial, administrative, governmental or regulatory process in connection with any action, suit, proceedings or claim; (ii) any Regulatory or Supervisory Body; (iii) for the purpose of the examination and certification of the Recipient’s accounts; or (iv) otherwise by applicable Law; and/or

18.2.3 without prejudice to the generality of Clause 18.2.2, disclosing Confidential Information in compliance with the 2000 Act and/or the 2004 Regulations; 

18.3 Clause 18.1 shall not apply to:

18.3.1 any Confidential Information which is in or enters the public domain other than by breach of this Agreement or other act or omission of the Recipient;

18.3.2 any Confidential Information disclosed to any person engaged in the performance of this Agreement to the extent that such disclosure is reasonably necessary for the proper performance of this Agreement and the disclosee is contractually bound on terms the same, or substantially the same, as those relating to Confidential Information in this Agreement;

18.3.3 any Confidential Information which is already lawfully in the possession of the Recipient prior to its disclosure by the Discloser; and/or

18.3.4 any Confidential Information which is obtained by a third party who is lawfully authorised to disclose such information.

18.4 The Parties agree that the provisions of this Agreement shall not be treated as commercially sensitive for the purposes of the 2000 Act or 2004 Regulations.

Data Protection

18.5 Each Party shall (and shall procure that its Staff and sub-contractors shall):

18.5.1 comply with its obligations (and comply with any requirements imposed on it) under the Data Protection Legislation which arise in connection with this Agreement (including the provision of the Services); 

18.5.2 disclose Confidential Information where it is required to do so by: (i) judicial, administrative, governmental or regulatory process in connection with any action, suit, proceedings or claim; (ii) any Regulatory or Supervisory Body; (iii) for the purpose of the examination and certification of the Recipient’s accounts; or (iv) otherwise by applicable Law; and/or

18.5.3 without prejudice to the generality of Clause 18.2.2, disclose Confidential Information in compliance with the 2000 Act and/or the 2004 Regulations.

18.6 For the purposes of this Agreement, it has been identified that the Provider will Process Personal Data in respect of which the Purchaser is the Data Controller. Details of such Processing and the terms on which it has been permitted by the Data Controller are as set out below: 

A The following specifies the terms on which the Data Controller permits the Data Processor to Process the specified categories of Personal Data for the purposes of this Agreement.

B The Controlling Party permits the Processing Party to Process the Relevant Personal Data. Such permission is strictly limited to the purposes and for the duration specified below. 

C The Controlling Party will ensure that it has a lawful basis on which to share the Relevant Personal Data with the Processing Party and shall satisfy itself that the Permitted Purpose is consistent with that lawful basis. Details of this lawful basis are as set out below and will be reflected by the Controlling Party in its Privacy Notices: 

19 Freedom of Information Act and Environmental Information Regulations

19.1 Subject to Clause 19.2, where a Party (“Recipient Party”) receives a request for information pursuant to the 2000 Act or the 2004 Regulations and such request relates to this Agreement it shall:

19.1.1 notify the other Party as soon as practicable; 

19.1.2 before responding, give the other Party an opportunity to comment on the request and the information to be disclosed; and

19.1.3 without prejudice to the Recipient Party’s rights and obligations to make the final decision, consider comments provided by the other Party pursuant to Clause 19.1.2,

and the other Party agrees to provide the Recipient Party with reasonable assistance in complying with such request.

19.2 Where Clause 19.1 applies, if the Recipient Party is not subject to the 2000 Act or the 2004 Regulations but the other Party is, the Recipient Party shall:

19.2.1 as soon as is practically possible, and in any event within no more than two (2) Working Days, deliver to the other Party the original request for information; and

19.2.2 assist the other Party in responding to the request for information in accordance with Clause 19.1.

20 Intellectual Property Rights

20.1 Neither Party will acquire the IPR of the other Party pursuant to this Agreement.

21 Equality and Human Rights

21.1 Each Party shall ensure that:

21.1.1 it does not, whether as an employer or as a provider of services, engage in any act or omission that would contravene the Equality Legislation; and

21.1.2 it complies with all its obligations as an employer or as a provider of services as set out in the Equality Legislation and takes reasonable endeavours to ensure its Staff do not unlawfully discriminate within the meaning of the Equality Legislation.

21.2 The Provider shall:

21.2.1 in the management of its affairs and the development of its equality and diversity policies, cooperate with the Purchaser to support and facilitate compliance, by the Purchaser, with its own duties of equality whether under Equality Legislation or otherwise;

21.2.2 take such reasonable and proportionate steps as the Purchaser considers appropriate to promote equality and diversity, including race equality, equality of opportunity for disabled people, gender equality, and equality relating to religion and belief, sexual orientation, and age; and

21.2.3 impose on all its sub-contractors and suppliers, obligations substantially similar to those imposed on the Provider by this Clause 21. 

22 Third Party Rights

A person who is not a party to this Agreement shall have no rights pursuant to the Contracts (Rights of Third Parties) Act 1999 or otherwise to enforce any of the terms of this Agreement.

23 Waiver

No failure or delay by either Party to exercise any right, power or remedy will operate as a waiver of it nor will any partial exercise preclude any further exercise of the same or of some other right or remedy.

24 Severance

If any provision of this Agreement, not being of a fundamental nature, shall be held to be illegal or unenforceable, the enforceability of the remainder of this Agreement shall not thereby be affected.

25 Relationship of the Parties

At all times in connection with this Agreement, the Provider shall be an independent contractor and nothing in this Agreement shall create a relationship of agency or partnership or a joint venture as between the Parties, and accordingly the Provider shall not be authorised to bind the Purchaser. For the avoidance of doubt, unless expressly stated to the contrary, nothing in this Agreement will be construed as, or have effect as, construing any relationship of employer and employee between the Provider and the Purchaser.

26 Notices

26.1 Any notice to be given under this Agreement shall either be delivered personally or sent by first class post (or airmail).  The name and address for service on the Provider shall be Lorraine Warne, South West GLH Business Operations Manager, Bristol Genetics Laboratory, North Bristol NHS Trust, Pathology Sciences Building, Southmead Hospital, Westbury-on-Trym, Bristol BS10 5NB.  The name and address for service on the Purchaser shall be as detailed in the Request Form.

26.2 A notice shall be deemed to have been served if:

26.2.1 delivered personally, at the time of delivery; 

26.2.2 sent by first class post, at the expiration of forty-eight (48) hours after the envelope containing the same was delivered into the custody of the postal authorities; and

26.2.3 sent by airmail, at the expiration of five (5) days after the envelope containing the same was delivered into the custody of the postal authorities.

26.3 A copy of all notices personally delivered or posted by the Purchaser shall be sent by email to lorraine.warne@nbt.nhs.uk.

26.4 In proving such service, it shall be sufficient to prove that personal delivery was made, or that the envelope containing such notice was properly addressed and delivered into the custody of the postal authority as prepaid first class letter (or airmail) (as the case may be).

26.5 This Clause does not apply to the service of any proceedings or any documents in any legal action or, where applicable, any arbitration or other method of dispute resolution.

27 Governing Law and Jurisdiction

27.1 This Agreement and any non-contractual obligations arising out of or in connection with it shall be governed by and construed in all respects in accordance with the laws of England.

27.2 Subject to Clause 17, the courts of England shall have exclusive jurisdiction to hear and settle any action, suit, proceeding or dispute which may arise out of or in connection with this Agreement (including non-contractual disputes or claims) and the Parties irrevocably submit to the jurisdiction of those courts.

APPENDIX: SPECIFICATION

1 Description of the Services

Provider Obligations

• The Provider will provide a genetics laboratory service (processing, examination and reporting of samples) to the Purchaser, in respect of the tests detailed in the Request Form.
• The preferred means of reporting test results is by email. The reports will be sent by secure email in adherence to the Provider’s IM&T policies. The Purchaser’s email address for reports is as detailed in the Request Form. Where secure email is not possible, the Provider will provide hard copy reports to the Purchaser by second class post to the postal address detailed in the Request Form. Where appropriate, reports will include full interpretation of genetic results, advice on diagnosis, follow-up test and genetic risks.
• The Provider’s Consultant Clinical Scientists shall provide advice and clinical management of patients to the Purchaser during Working Hours.
• Upon request, the Provider will supply a copy of the Quality Manual (or similar documentation) that describes the organisation and quality system of the laboratory.
• The Provider will provide testing according to accredited UKAS ISO15189:2022 standards for medical laboratories and relevant best practice guidelines. Where any quality issues may affect the provision of the Services to the Purchaser, the Purchaser will be informed as soon as possible.
• Certain business interruption events may require the processing and testing of samples by a mutual aid partner laboratory. Should it be necessary to invoke the Provider’s Business Continuity Plan, including such “mutual aid” arrangements, the Provider will notify the Purchaser as soon as possible. 

Purchaser Obligations

• The Purchaser will obtain informed consent from patients in respect of collection, storage, and disposal of Pathology specimens in compliance with national standards and guidance.
• The Purchaser shall follow the sample and transport guidance for each patient test request (as detailed in the Request Form and website SWGLH Sample and Test Information | North Bristol NHS Trust).
• The Provider shall have completed the Request Form with the following information:

- Patient/participant name/ID

- DOB (if available)

- Other numerical ID for example sample number, Hospital number or NHS number

- Examinations required

- Referring organisation

- Referring clinician

• The Purchaser acknowledges that failure to comply with any of the above obligations may result in a delay to the provision of the Services or, in some specific circumstances, a rejection of the Request Form by the Provider.

General Quality Standards

The Provider will have policies, procedures, and quality systems (as appropriate) to assure standards of technical, professional, and managerial competence, which include:

• Compliance with standards laid down by UK Accreditation Service (UKAS) ISO 15189 for Medical Laboratories and the Healthcare Commission including validation and business continuity
• Employment of appropriately qualified staff
• Adequate levels of staffing and skill mix
• Compliance with statutory and other national requirements
• Compliance with professional standards
• Compliance with appropriate health and safety requirements
• Participation and review of external quality assurance and internal quality control performance
• Accreditation of the department providing the Service with UKAS. In the event of any problem with accreditation, the Purchaser will be informed of the areas that have been identified as ‘non-compliant’ along with any expiry date (to the extent relevant to the Services)

Service Standards

Reports on specimen analysis will contain all necessary factual information and (where appropriate in the judgement of the Provider’s Consultants) interpretation and advice. Computer generated reports will be provided unless circumstances arise outside the Provider’s control. The Provider will maintain computer records of all reports.

Target reporting times are as specified on the SWGLH website Quality Page (see SWGLH Quality | North Bristol NHS Trust (nbt.nhs.uk)).  These may be reviewed and amended by the Provider from time to time.

Once received, all samples will by assessed by the Provider to assess their priority:

a) Samples judged medically urgent will be processed upon receipt and the results communicated as soon as possible. Samples marked “urgent” will be given priority over routine samples. It is expected that the laboratory will be notified by telephone of urgent samples and the sample will be clearly marked as “urgent”.

b) On request, clinically important urgent results will be telephoned to a designated member of the Purchaser’s clinical staff.

c) Non urgent results will be provided by post or secure email (as above).

d) Computer reports will bear the date of receipt and the date of reporting.

Access to advice for the Purchaser’s medical practitioners and nursing staff will be made available during Working Hours.

2 Service Location

Pathology Sciences Building

Southmead Hospital

Westbury-on-Trym

Bristol BS10 5NB

3 Records

The Provider shall maintain records in accordance with the guidance published by the Royal College of Pathologists – ‘Retention and Storage of Pathological Records and Archives,’ current version accessible at: 

https://www.rcpath.org/uploads/assets/049ea966-df5c-4a9f-9353ba24a69bb808/The-retention-and-storage-of-pathological-records-and-specimens-5th-edition.pdf

The Provider shall handle and retain clinical material in accordance with current guidelines in relation to patient consent from the Department of Health and the General Medical Council.

Last updated 25/02/2025