Step 5: Service Specification
Tool 1: Example Service Specification
This tool is for use in conjunction with Step 5 of the Commissioning Toolkit document

Assumptions
This Example Service Specification (Specification) has been drafted for use in conjunction with the Toolkit. 
This Specification has been produced following widespread consultation with pathologists, pathology laboratory managers, clinical commissioning groups, PCT Directors of Commissioning and the Department of Health Pathology Programme. The intention is to provide commissioners with a basis upon which to produce a locally tailored service specification which meets their local objectives and the needs of their Community Users.
The Specification should be adapted locally for use when undertaking local negotiations or a competitive tender process (see Toolkit Introduction). In addition, commissioners are advised to use aspects of the Specification when commissioning other clinical services where pathology services are included within them. For example, commissioners should consider the inclusion of Section 2 (Analytical Service) when commissioning a diabetes service which includes pathology testing for diagnosis and management.  
The Specification covers the following disciplines:
•	Integrated Blood Sciences service (includes Clinical Biochemistry, Haematology and Immunology) 
•	Microbiology service (includes Virology and Mycology)
•	Histopathology
It should be noted that this Specification does not include:
Other pathology services (e.g. Community anticoagulation services and National, screening programmes), which should be considered when commissioning Community Pathology Services. The service needs of other clinical networks should also be taken into consideration.

CLINICAL REQUIREMENTS OF SPECIFICATION
1	Aim of the Specification
1.1	The aim of the Specification is to ensure that there is consistent and affordable provision of high quality, safe and compliant Community Pathology Services [in name area / across name region]. The Community Pathology Services shall be delivered efficiently and effectively to support wider clinical services. 
1.2	The outcome must ensure comprehensive access to pathology services for all Community Users and their patients [in name area / across name region]. Bidders must reflect on the impact of their proposals on the wider system as a whole and must recognise, manage and limit the potential for unintended consequences on patient care. 
2	Service requirements
[Note:  This section should describe in detail the services you expect the bidders to provide.  This is likely to include: (i) high-level requirements such as improving patient experience and improving clinical outcomes; (ii) specific requirements relating to service delivery such as efficient delivery, capacity and capability; and (iii) an overview of the service specification.] 

2.1	The Provider shall provide a comprehensive Community Pathology Service within an overall system of resilient pathology service provision that must: 
•	meet the service needs of Community Users; 
•	act as an enabler for the delivery of clinical services in the community; 
•	improve overall user and patient experience and optimise the patient journey; and
•	improve clinical outcomes and streamline clinical pathways. 
2.2	The Provider must: 
•	provide high quality laboratory output through robust and standardised laboratory processes and a specialist consultant-led service; 
•	deliver efficient and highly productive services meeting the resource constraints of Commissioners including support to manage the demand for pathology services and ensuring appropriate requesting of tests; 
•	support the sustainability and resilience of pathology services across [area/region] health economy; 
•	have capability to respond to future changes in service demand, the impact of new technologies and changes in national guidance and NICE Quality Standards; 
•	ensure robust and secure information channels to improve communication of pathology results across healthcare providers in the best interest of patients which includes enabling GPs and other clinicians to view all relevant patient results; 
2.3	The Clinical Requirements of the Specification require the Provider to deliver the following key services to support and enable the care provided by Community Users to their patients:
•	consultant-led Integrated Blood Sciences service for Clinical Biochemistry, Haematology, Immunology; 
•	consultant-led Microbiology (including Virology and Mycology) service;
•	[community phlebotomy service (including domiciliary phlebotomy service) to improve access and convenience for patients]; and
•	[insert others as appropriate].
2.4	The service requirements for Community Pathology Services (see the Specification contained in the Step 10 Commissioning Contract) include, but may not be limited to: 
•	analytical service for test requests from Community Users in the following disciplines: 
•	Integrated Blood Sciences (including Clinical Biochemistry, Haematology and Immunology); 
•	Microbiology (including Bacteriology, Virology and Mycology); 
•	other specialist clinical services related to the above disciplines; 
•	[community-based phlebotomy service (including a domiciliary service);]
•	specialist support related to test requesting, interpretation of results and other relevant clinical advice when required; 
•	electronic system to order tests and receive results with rapid access to all relevant results across the health system served in a safe and controlled manner; 
•	provision of transparent datasets for users and commissioners demonstrating service use, costs and health outcomes where possible; 
•	support for primary care clinicians to ensure appropriate use of diagnostics and in the development of care pathways; and 
•	facilitate the appropriate, safe and effective local uptake of point of care testing in primary care.]
3	Safe and effective service provision
3.1	The clinical objective is for the Provider to deliver a high quality Community Pathology Service that meets the needs of Community Users and is delivered in a safe and effective manner, through a learning environment, which includes the training of doctors and other healthcare professionals.
3.2	The purpose of this section set out the clinical requirements that Providers must meet to demonstrate that the Community Pathology Service will be safe and effective. 
[Note: This section should detail the various aspects of improving clinical outcomes, streamlining the services etc.  Consider including detail on the importance of medical leadership, integrated governance, the reporting of adverse incidents, accreditation, quality assurance and key performance indicators.]
4	General
4.1	The Clinical Requirements of the specification require the Provider to deliver three key services to support and enable the care provided by Community Users to their patients:
•	Specialist-led Integrated Blood Sciences service (including Clinical Biochemistry, Haematology, Immunology);
•	Specialist-led Microbiology service (including Virology and Mycology); 
•	Community phlebotomy service (including domiciliary phlebotomy service) to improve access and convenience for patients
4.2	The Provider shall provide a Community Pathology Service that, if required, is accessible to Community Users 24 hours a day, 7 days a week, including an appropriate service to manage collection and integrity of samples during the weekend to support clinical services provided by Community Users.
4.3	The Provider shall provide Community Users with appropriate access to haematology, clinical biochemistry, immunology and microbiology (including virology and mycology) specialist expertise at all times to:
•	undertake urgent test analysis, when clinically indicated, to aid in the clinical management of a patient or prevent an avoidable inpatient admission; or 
•	provide appropriate clinical advice within 30 minutes of the request.
4.4	The Integrated Blood Science service shall include the provision of a comprehensive haematology, clinical biochemistry and immunology service which includes microscopy, blood coagulation, anticoagulation monitoring and dosing where required, specialist investigations and the review of abnormal results including blood films and results.
4.5	The Provider shall have Specialist-reviewed protocols in place for:
•	follow on investigations where clinically appropriate; and 
•	amendments to test requests depending on the clinical indications after discussion with the requestor; and
•	supporting Community Users to manage demand and ensure appropriate test requests.
4.6	The Provider shall have a pathway in place for onward referrals to specialist laboratories for specialist investigations.
4.7	The Provider shall:
•	Ensure that any reorganisation of pathology services takes account of:
(i)	the requirement for adequate laboratory test support for the various infection control obligations that exist for all affected organisations; and
(ii)	existing and anticipated community infection control obligations across the affected organisations including, but not limited to, SLAs for community infection control services or expertise in the form of ICD or ICN.
•	Ensure it has a system and processes in place to continually improve communication between affected organisations and consistency of infection prevention and control services including the standardisation of practices.
•	Provide a comprehensive microbiology service to meet the microbiology needs of Community Users and their patients which must include the provision of bacteriology, virology and mycology testing.
•	The microbiology service shall provide laboratory support to Community Users and provide advice on infection control, prevention and the management of healthcare associated infections in the community.
•	Provide an on-call medical and infection control service outside core hours for the immediate management of the patient in the community or have immediate public health implications.
•	The microbiology service should have provisions in place to deal with emergency service response and increase capacity due to unplanned operational demand variations e.g. communicable disease outbreaks.
5	Quality Requirements
5.1	The Provider shall:
•		comply with the registration and regulatory compliance guidance of CQC; or recommendations issued by CQC from time to time (where applicable);
•	respond to CQC requirements and any CQC enforcement action;
•	meet the UKAS, CPA or equivalent accreditation criteria; 
•	comply with MHRA guidelines;
•	comply with the guidance and recommendations from time to time issued by Monitor (where applicable);
•		consider and respond to the recommendations arising from any audit, Serious Incident report or Patient Safety Incident report;
•		comply with the guidance and recommendations issued from time to time by any relevant professional body in agreement with commissioners;
•	comply with the recommendations from time to time contained in technology appraisals issued by the National Institute for Health and Clinical Excellence (or any successor);
6	Analytical Service
Test Requirements
6.1	The Provider shall: 
•	Deliver the specialist-led analytical service from a single multidisciplinary laboratory for requests from Community Users for each of the following disciplines:
(i)	Integrated Blood Sciences including Clinical Biochemistry, Haematology and Immunology;
(ii)	Microbiology including Bacteriology, Virology and Mycology;
•	Provide the analytical service for the whole repertoire of tests that may legitimately be requested by Community Users for all of their clinical needs including screening, diagnosis, monitoring and therapeutic management of patients.  
•	deliver an analytical service which includes the full range of activities from the collection of the sample to the issue of the validated result and must include relevant interpretive clinical advice to the requestor;
•	supply all standardised request forms, or electronic requesting documentation, and the necessary standardised consumables including, but not limited to, all appropriate sample containers;
•	supply Community Users with centrifugation equipment and training for its use where these users are in remote areas and where there is, in exceptional circumstances, an increased potential for clinically significant delays in transporting specimens; 
•	validate and authorise all test results by a Specialist, or have a process in place to validate and authorise test results that has been approved by a Specialist,  prior to the secure issue to the requestor or patient if agreed and appropriate;
•	have appropriate and necessary facilities and equipment for the safe, effective, efficient and timely delivery of the analytical service;
•	agree test naming conventions in accordance with current guidelines and future National Laboratory Medicine Catalogue;
•	have standardised test profiles, scientific units, methodologies and reference ranges, in accordance with the National Laboratory Medicine Catalogue and the DH HARMONY project, consistent with other organisations in the region;
•	have a robust plan in place to ensure service continuity and service resilience across all pathology disciplines, in the event of an unexpected service failure and transportation issues;
•	participate in a joint process between the Provider, Community Users and Commissioners to agree the provision of new tests, previously not provided , and for the removal and decommissioning of obsolete and redundant tests;
•	provide Community Users with a single point of contact for all enquiries relating to the Community Pathology Service;
•	monitor against NICE Quality Standards and other relevant national, regional and local guidance of best practice to ensure appropriate use and pattern of test requesting from Community Users; and
•	advise and report to Community Users and Commissioners when test request trending data suggests inappropriate use of tests.   
	Sample Handling
6.2	The Provider shall: 
•	have a robust system in place for the proper handling, storage and security of all samples and documentation at all times in accordance with national guidelines and regulatory and legal requirements;
•	store blood samples for a sufficient period of time to maintain the stability of the sample and to reduce the need for re-sampling patients:
(i)	To enable addition of further tests by the requestor or other clinicians;
(ii)	In the case of errors and shall analyse repeat samples in this case without charge; and
•	have a robust system in place for the proper handling and disposal of waste at all times, meeting at least the minimum national requirements for their handling and disposal.
Results
6.3	The Provider shall:
•	provide the requesting Community User, or appropriate clinician in their absence, with an clinical interpretation of results, or trends in results, and advise on further tests where clinically appropriate;
•	telephone the requesting Community User, or appropriate clinician in their absence, with unexpected or unusual results to the requestor and/or the responsible clinician where clinically indicated in a timeframe that is clinically appropriate and follow up by electronic communication as per reporting requirements;
•	telephone unexpected or unusual results to the appropriate Out of Hours provider, in accordance with the Royal College of Pathologists guidance “Out of hours reporting of lab results requiring urgent clinical action to primary care: advice to pathologists and those working in laboratory medicine (November 2010), when there are results that require urgent clinical action outside the core hours of routine general practice;
•	flag clearly any abnormal results and provide interpretive comments, where possible, on all issued test result reports; and
•	provide interpretive comments in addition to reference ranges which could be standardised if validated after Specialist review. 
	Reports
6.4	The Provider shall:
•	agree a common dataset from Community Users to accompany test requests; 
•	issue reports for routine test results in accordance with the maximum turnaround times in Annex C from the sample being taken from the patient to the issue of the report to the requestor;
•	issue reports for urgent test requests within 1 hour of receiving the sample , or as soon as practicable (whichever is sooner);
•	provide monthly exception reports for all breaches in the turnaround times for each Reporting Time Category in Annex C;  
•	undertake authorisation of all test results issued by the Provider after technical validation and clinical validation, when appropriate, and including the addition of comments to aid clinical interpretation and patient management;
•	combine individual results or groups of results on issue of the final report or clearly indicate outstanding results when awaiting outstanding results;
•	indicate clearly where results are provisional or interim reports are issued and provide the expected date of the final report;
•	inform and update the requesting Community User, or appropriate clinician in their absence, about the appropriate clinical decisions or actions to take as part of their management plan;
•	issue cumulative tests results to view trends where the requested tests are repeated.
•	issue all test results and reports electronically to the requester (by paper report if requestor cannot receive electronic reports) or by telephone if an urgent request;
•	report results of urgent test requests and abnormal results to the requesting clinician as soon as is practicable within the requested timeframe; if the requesting clinician is unavailable these results must be reported to a designated alternate;
•	report a provisional result without delay when it is considered that its immediate availability may impact on the management of a patient whilst making clear that this result may change in the final report;
•	confirm provisional results as soon as practicable and ensure any significant change to a provisional or final report likely to alter the management of the patient must be notified to the user by telephone followed up by the issue of an amended report;
•	issue interim reports in lieu of a final report when waiting to confirm one or more test results requested as a set; this shall be superseded by a final report once all of the results are available; and
•	issue amended reports that are clearly labelled and include the reason for the amendment when:
(i)	provisional results have changed;
(ii)	results previously reported are subsequently found to be erroneous; or 
(iii)	results and/or clinical comments are added or deleted. 
Critical Reporting
6.5	The Provider shall have a robust system in place to manage critical reporting including:
•	establishment and implementation of a list of critical results which might need immediate action according to clinical need;
•	telephoning critical results to the requestor or responsible healthcare professional including out-of-hours providers when outside core hours of general practice;
•	providing clinical advice to help the requestor and other Community Users including clinician in out-of-hours services to interpret the critical results; and
•	telephoning results when there is a trend suggestive of patient deterioration requiring immediate action
•	working with GPs and commissioners to have robust referral pathways in place clearly identifying where patients shall be referred urgently for further opinion, if clinically indicated and in accordance with patient choice.
Errors
6.6	The Provider shall have a robust system in place to monitor and learn from laboratory based errors which shall include, but not be limited to:
•	logging and categorisation of all errors based on Goods Industry best practice; and
•	review errors and demonstrate actions taken to reduce the chance of similar future errors; and
•	issuing an annual report of laboratory errors and the actions taken to reduce subsequent risk of same reason repeating the error.
 Onward test referrals
6.7	Where Community Users requests tests that the Provider is unable to analyse the Provider shall: 
•	refer specimens for testing by a CPA accredited (or equivalent) third party laboratory;
•	send the tests which require a second clinical opinion or analytical qualification to a Reference Laboratory that is approved by the Provider and the respective lead Specialist for that pathology discipline;
•	ensure that the third party pathology provider meets the same quality and performance criteria as the Provider as outlined in the Contract;
•	review the contracts for esoteric analysis on an annual basis to ensure appropriate quality is continually met and compliance with national accreditation requirements and best practice;
•	inform Community Users and Commissioners about all third party providers in partnership with the Provider and gain agreement for any changes to these partners.
Specimen collection & transportation
6.8	The Provider shall:
•	have a transport and logistics service in place with the necessary capacity and capability to support the delivery of the Community Pathology Services;
•	collect specimens from designated collection points identified by Community Users, including, GP practices and the community-based phlebotomy centres and transport them to the relevant analytical laboratory or laboratories ready for processing within 4 hours of the sample being taken; and 
•	offer at least two sample collections per day to each Community User from their designated collection site(s) at a time which is agreed with, and is suitable for, the Community User and which: 
(i)	meets their clinical requirement;
(ii)	maintains the viability of individual samples; and 
(iii)	delivers the results within the required turnaround times.
•	agree additional sample collections with Commissioners on behalf of Community Users when clinically appropriate and improves care delivered to patients;
•	be responsible for sorting the specimens after collection and delivering to the appropriate laboratory where the test is requested as urgent; 
•	deliver all consumable supplies required by Community Users to take specimens for the Community Pathology Service;
•	transport specimens in suitable vehicles with the appropriate temperature controlled environment and in accordance with statutory requirements and Goods Industry best practice and which maintain the integrity of samples and data confidentiality;  
•	ensure that samples are delivered within a timeframe appropriate to the nature of the requested investigations and protects the sample from deterioration;
•	employ drivers that are suitably trained to handle biological specimens in accordance with best practice and statutory legislation; 
•	make equipment and training available at community-based collection sites for on-site pre analytical processing prior to the sample transportation if this is required to ensure sample integrity;
•	have an electronic tracking system in place to enable the tracking of specimens in real time from time of sample collection; 
•	have robust contingency plans in place to ensure continuity of specimen collections; and 
•	monitor and report incidents during sample transportation that may have affected the quality of the sample.
7	Specialist pathology support for Community Users
7.1	The Provider shall:
•	provide Specialist-led  advice to Community Users on the appropriate use of tests (pre-analytical advice) and on the appropriate interpretation of results (post analytical advice) to ensure best practice;
•	operate Specialist-led (virtual) clinics to allow open access for advice and queries from Community Users;
•	provide advice on the most appropriate use of pathology testing within clinical pathways and agree protocols with users to ensure appropriate test requesting;
•	use evidence-based practice, national and local guidance with Specialist-led review to develop recommendations for pathology testing;
•	offer clinical interpretation of results and advice on suitable further testing if appropriate to benefit patients;
•	suggest relevant additional tests to pre-received specimens where clinically appropriate or as part of an agreed clinical pathway;
•	agree standardised test profiles for investigations with Community Users to ensure clinical and cost effectiveness;
•	provide liaison with Community Users, interpretation of results and other clinical advice for Integrated Blood Sciences and Microbiology; and
•	provide on-call advice to Community Users available 24 hours per day, 7 days per week, for Integrated Blood Sciences and Microbiology by a Specialist within 30 minutes of the request for advice;
7.2	The Provider shall:
•	provide expert guidance to Commissioners on the commissioning of new tests based on an evaluation of their analytical and clinical validity as well as its clinical utility; 
•	monitor the efficacy and impact of the introduction of all new tests to assess the benefit to patients and advise Community Users to adopt new tests where clinically appropriate and improves value for money for Commissioners;
•	implement appropriate mechanisms for quality control and assurance before introducing a new test;
•	advise Community Users and Commissioners to review the use of tests that are outdated and have no clinical utility and suggest appropriate alternative tests;
•	audit the usefulness of all outdated tests that do not deliver clinically useful results to inform Community Users of their use in clinical practice; and
•	advise Community Users and Commissioners on appropriate retesting frequencies for patients with long term conditions
•	have measures in place to monitor Community Users against appropriate retesting frequencies for managing patients with long term conditions and feedback significant variances in practice to Community Users and Commissioners.
7.3	The Provider shall:
•	Provide Community Users through the single point of contact (see Para 2.1k) across the service responses to queries and to access results for their patients by telephone; 
•	provide access to specialist telephone advice to supplement the user guide and deal with specific clinical queries; 
•	have a uniform protocol for handling urgent requests at all times including from out-of-hours providers and results that require immediate action outside core hours; 
•	the Provider shall agree with Commissioners to support community care provision thorough specialist outreach clinics and domiciliary visits where this provides benefit for patients and is agreed with Commissioners; and
•	provide specialist microbiology medical advice through telephone discussions. 
7.4	The Provider shall:
•	produce a comprehensive pathology user handbook for Community Users which includes, but is not limited to:
(i)	key contact information;
(ii)	sampling instructions;
(iii)	guidance on choice of appropriate container;
(iv)	reference ranges for tests;
(v)	advice on maintaining sample integrity;
(vi)	advice on common interferences;
(vii)	appropriateness and timeliness of tests; and
(viii)	any special handling needs;
•	produce regular educational and training updates for Community Users and Commissioners on the use of pathology services.
7.5	The Provider shall provide specialist advice to Community Users and public health teams relating to, but not limited to:
•	infection prevention and control;
•	surveillance for infectious disease and monitoring of communicable disease outbreaks;
•	health and safety in the use of diagnostic testing and equipment; and
•	education and training in the use of pathology services
7.6	The Provider shall: 
•	establish links with Community Users, academic institutions and other centres for research and development;
•	carry out appropriate research and development to facilitate service development and staff training such as participation in clinical trials and the evaluation of new technologies; and
•	ensure that staff, who participate in research projects, have been properly resourced and the project has been agreed by local and other appropriate clinical research ethics committees. 
7.7	The Provider shall ensure that evidence based research findings generated locally or from other sources are evaluated for future service development.
8	 [Community-based phlebotomy service]
[DN: This section should be used if commissioners are including phlebotomy services within their service specification] 
8.1	The Provider shall provide a community based phlebotomy service for patients in the relevant area which consists of:
•	community-based walk-in phlebotomy centres in accessible and convenient locations within 30 minutes of every GP practice across the relevant area and agreed with the Commissioners;
•	domiciliary phlebotomy service for housebound patients or those with mobility challenges identified by Community Users; 
•	The community-based walk-in phlebotomy centres shall:
operate between 07.30 and 19.30 on weekdays and at least four hours on each day of the weekend and bank holidays; 
•	see patients that walk-in to the community-based phlebotomy centre within 30 minutes of attendance; 
•	act as a collection centre for all types of specimens collected by patients and Community Users; and
•	be responsible for maintaining the integrity of samples that are collected from the service and from patients. 
8.2	The Provider shall:
•	provide advice on sample collection to Community Users that undertake phlebotomy in community settings to ensure safe delivery in accordance with national guidelines;
•	undertake blood collection by professional staff trained and competent in phlebotomy in accordance with national and regional guidance;
•	provide users with guidance and advice on the sample collection, timing of sample, appropriateness of specimen container and any special patient preparation, if required;
•	provide all of the necessary equipment for phlebotomy to Community Users that undertake phlebotomy including but not limited to sample tubes, bottles, containers and blood collection kits; and
•	utilise a standardised test request form until a common system for electronic ordering is in place for all Community Users across the relevant area.
9	Electronic systems to support users in test ordering and receipt of results
9.1	See ITT Template (Step 9) for more details. This section should include, as a minimum, the requirement for:
•	electronic requesting of tests by Community Users;
•	electronic receipt of validated test results by Community Users;
•	community Users to access all results held for their patients regardless of the requestor; and
•	all laboratories, if working together as part of a consortium, to access results held for their patients.  
10	Information about usage, costs and outcomes
10.1	The Provider shall provide comprehensive monthly reports to Commissioners and Community Users on the use of the Community Pathology Service. This shall include, but is not limited to:
•	information about use, activity levels by location and spend for the phlebotomy service;
•	information about use, activity levels and spend by Community User and GP practice for the Community Pathology Service;
•	benchmarking information comparing Community Users and Commissioners within the region; and
•	information about the use of pathology services against key outcomes to be agreed with Commissioners e.g. mapping pathology usage to prevalence of long term conditions, prescribing data, clinical outcomes and urgent admissions.
10.2	The Provider shall undertake annual benchmarking of its service against other providers within the region and nationally through a recognised national industry benchmarking service such as the National Pathology Benchmarking Service provided by Keele University.
11	Support on the use of diagnostics and development of care pathways
11.1	The Provider shall work with Community Users and Commissioners to:
•	work with Community Users to agree care pathways to ensure the most appropriate, safe and cost-effective use of pathology testing;
•	work with Commissioners and Community Users to optimise the patient pathway and, where possible, improve accessibility and convenience for patients, reduce the number of patient interactions with healthcare professionals and improve patient experience;
•	support Commissioners and Community Users to audit the effectiveness of care pathways in relation to the use of pathology tests and implement relevant service improvements as recommended;
•	provide expert, professional advice and guidance on the withdrawal of those tests considered to be obsolete or of limited clinical utility; and
•	explore opportunities where the Provider operates registers for long term conditions. 
11.2	The Provider shall work with Community Users to ensure appropriate utilisation of pathology services and reduce the inappropriate use of tests by measures including, but not limited to, providing:
•	advise Community Users and Commissioners on appropriate demand management processes and controls;
•	feedback about requesting behaviour to Community Users; 
•	targeted clinical education for Community Users through guidelines and protocols for appropriate testing;
•	use information technology solutions to support evidence-based decision making by Community Users on the appropriate use of tests within local care pathways; and
•	benchmarking information to Community Users and their use of pathology tests especially when tests have been identified to have limited or no clinical utility.
11.3	The Integrated Blood Science service shall support Community Users to:
•	optimise care for patients with long term conditions including, but not limited to, diabetes mellitus, thyroid disease, heart failure, lipid disorders and osteoporosis;
•	diagnose and manage patients with cancer, where appropriate in conjunction with the specialist/secondary care centre and include appropriate tumour markers for monitoring cancers in accordance with national and international best practice guidelines; 
•	innovate to improve the clinical service provided by Community Users to their patients in the community; and
•	care for patients receiving total parenteral nutrition.

11.4	The Cellular Pathology Service shall support community users by ensuring that their service provides urgent and routine analysis for Community Cellular Pathology Referrals and supporting multidisciplinary teams (MDT) in patient management decisions.
12	Support for point of care testing
12.1	The Provider shall:
•	support Community Users and Commissioners in the introduction of POCT in appropriate community settings;
•	provide independent advice and guidance on the suitability and appropriateness of third party point of care testing (POCT) equipment and the process used to deliver the POCT service;
•	oversee equipment maintenance, training and quality assurance / quality control for POCT;
•	advise Commissioners and Community Users on the following key areas:
(i)	provision of safe, effective and high-quality POCT service in the community;
(ii)	undertaking of POCT in accordance with professional, national and regulatory guidance to meet best practice;
(iii)	monitoring of POCT use and equipment within a robust quality management system;
(iv)	promote the use of POCT where they provide similar results to laboratory methods; and
(v)	compliance of POCT equipment and practices with professional, national and regulatory guidelines including, but not limited to, MHRA and working towards meeting CPA criteria and guidance; and
(vi)	Support Commissioners to audit the use of POCT to ensure POC tests are used appropriately.
13	User and patient experience
13.1	The Provider shall:
•	offer all Community Users that user the Community Pathology Service to participate in a standardised user experience survey, such as the Royal College of Pathologists User Satisfaction Survey, to highlight strengths and weaknesses of service provision from a user perspective;
•	offer all patients that use the community phlebotomy service and domiciliary phlebotomy service to participate in a standardised patient experience survey to highlight strengths and weaknesses of service provision from a user perspective; and
•	review the outcomes of the user and patients biannually to identify areas of service development and improvements.