Docstoc

GUIDELINES FOR DEVELOPING PROCEDURAL DOCUMENTS TO MANAGE

Document Sample
GUIDELINES FOR DEVELOPING PROCEDURAL DOCUMENTS TO MANAGE Powered By Docstoc
					      GUIDELINES FOR DEVELOPING PROCEDURAL
   DOCUMENTS TO MANAGE DIAGNOSTIC TESTING AND
              SCREENING PROCEDURES




                                            MARCH 2009




                                                                    APOP 018
                                                                 Page 1 of 13
                                                          Issue date Mar 2009
NHS Havering is the brand name of Havering PCT           Review date Mar 2012
1.      Executive Summary Sheet and Version Control

 Policy Reference:                        APOP 018

 Policy Title:                            Guidelines for Developing Procedural Documents to
                                          Manage     Diagnostic   Testing   and   Screening
                                          Procedures

 Review Date:                             March 2012

 Approval:                                Governance and Standards Committee

 Author(s)/Further                        Vicky Corcoran, Senior Manager, Urgent Care.
 Information:
                                          This document describes the process for developing
 Summary:
                                          local policies to manage the risks associated with
                                          clinical diagnostic tests and screening procedures.
                                          It outlines the process for staff involved in
                                          undertaking clinical diagnostic testing and screening.
                                          It also provides direction for those required to
                                          produce local guidelines or Standard Operating
                                          Procedures in relation to clinical diagnostic testing
                                          and clinical screening
 Implementation:                          This policy will be disseminated to all staff via the
                                          trust intranet in a read only file. It will also be sent to
                                          all service managers/clinical leads, with a
                                          responsibility for the development of local guidance
                                          on the management of clinical diagnostic testing and
                                          clinical screening, who will need to return a signed
                                          form stating that they have read the document and
                                          understand it’s implication for their service area

 Impact:                                  NHSLA Risk Management Standards 1.4.10
                                          Local Risk Management Procedures


 Version Control Summary

 Version          Date                     Status              Comment Changes
 1                March 2009               Ratified




                                                                                               APOP 018
                                                                                            Page 2 of 13
                                                                                     Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                                      Review date Mar 2012
CONTENTS

                                                                         Page No.
1.   Executive Summary Sheet & Version Control                                         2
2.   Policy Statement and Trust Guiding Principles                                     4
3.   Introduction                                                                      4
4.   Scope of Guidance                                                                 4
5.   Definitions                                                                       4
6.   Policy Development, Approval and Consultation                                     5
7.   Responsibilities for Healthcare Staff                                             6
8.   Process for Staff Involved in Clinical Diagnostic Testing and                     8
     Screening Procedures
9.   Training and Competencies                                                         9
10. Consent to Examination, Care or Treatment                                        10
11. Content of Local Procedural Documents/Guidelines                                 10
12. Incident Reporting                                                               11
13. Audit                                                                            11
14. Associated Trust Policies                                                        12
     Appendix A                                                                      13




                                                                                APOP 018
                                                                             Page 3 of 13
                                                                      Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                       Review date Mar 2012
2.      Policy Statement and Trust Guiding Principles

2.1     NHS Havering Policies and Guidelines are produced in conjunction with the
        following vision, which underpins the development of the organisation.

        •    People are at the centre of what we are doing
        •    We can demonstrate a truly corporate spirit and collective responsibility
        •    We are clinically driven with managerial support
        •    We take responsibility for identifying and responding to need
        •    We seek to be fair and equal to all
        •    We seek to achieve our goals in partnership with others


3.      Introduction

        This document acknowledges the risks associated with the process of clinical
        diagnostics and screening and provides robust organisational wide guidance
        for the development of local policies to manage these risks.

        All services involved with the management of the processes around clinical
        diagnostics and screening are required to produce local procedural documents
        and guidelines. The purpose of which is to inform and direct staff in on the
        duties and procedures to be adopted when involved in any stage of clinical
        diagnostic testing and screening. This document will direct the development of
        all local guidance and procedural documents

        Individual services are required to carryout a baseline assessment of all
        clinical diagnostic testing and screening undertaken to facilitate the
        development local procedural documents


4.      Scope of Guidance

        This procedural document applies to all Trust employed staff, responsible for
        diagnostic testing and/or clinical screening on behalf of Havering APO.


5.      Definitions

5.1     Diagnostic Tests

        A diagnostic test is any kind of medical test performed to aid in the diagnosis
        or detection of disease. For example:

        •    to diagnose diseases
        •    to measure the progress or recovery from disease
        •    to confirm that a person is free from disease



                                                                                     APOP 018
                                                                                  Page 4 of 13
                                                                           Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                            Review date Mar 2012
5.2     Screening Procedures

        Testing or examination of people with no symptoms who do not necessarily
        perceive that they are at risk of, or are already affected by a disease or
        condition or it’s complications, to detect unsuspected disease/condition or to
        identify those individuals who are more likely to be helped than harmed by
        further tests or treatment to reduce the risk of a disease/condition or it’s
        complications.

5.3     Classification of procedures

        Diagnostic testing and clinical screening can be further classified as
        • Invasive
        • Minimal Invasive
        • Non Invasive

        This document recommends that local guidelines outline the classification of
        individual testing and screening procedures and reflect the risks associated in
        accordance with the classification also considers the requirements of other
        relevant policies such as Infection Control

5.4     Clinical Diagnostics and Clinical Screening Provided

        Clinical diagnostic tests and screening currently employed are numerous and
        take a variety of forms such as laboratory testing, near patient testing,
        radiology and monitoring. Appendix A lists some of the tests currently
        undertaken by Havering APO staff. However, the organisation acknowledges
        this list is not exhaustive and may be subject to change in line with local and
        national updates and recommendations on best practice. Staff responsible for
        service delivery must update/amend their own local policies to support this
        and changes reported to the clinical governance department.


6.      Policy Development, Approval and Consultation


6.1     Responsibility for Document Development

        It is the responsibility of each Clinical Lead or Service Manager to develop and
        review policy and procedural documents relating to Clinical Diagnostic Testing
        and Screening used within their service.

        All policies and procedural documents must developed and written
        accordance with the Trust Policy on Policies and Other Procedural Documents

6.2     Approval of Policies and Procedural Documents

        The policy approval process is outlined in the Trust Policy on Policies and
        Other Procedural Documents. Most local procedural documents and

                                                                                    APOP 018
                                                                                 Page 5 of 13
                                                                          Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                           Review date Mar 2012
        guidelines will not require board approval and the relevant accountable
        director will identify the body which will approve any local documents.

        Once approved a copy of the local procedural document must be sent
        electronically to the Clinical Governance Department for storage on a central
        data base

6.3     Style and Format of Policy and Procedural Documents

        Documents should be written and reviewed in accordance with the Trust
        Policy on Policies and other Procedural Documents.

6.4     Consultation and Communication with Stakeholders

        Relevant stakeholders include commissioned services, support services and
        service users and should be appropriately involved in the development,
        consultation, approval, ratification and implementation of local policies.

6.5     Standard Operating Procedures

        It may be appropriate that local and support services develop standard
        operating procedures (SOP’s), particularly in relation to clinical diagnostic tests
        and screening. Any such SOP’s must be documented and may, for example,
        include agreement on a timely response to requests for clinical diagnostics
        and assurance on prompt reporting of diagnostic tests and screening results.

        These SOP’s may take the form of locally written protocols and clearly outline
        the process required by staff to ensure SOP’s are met. Approved SOP’s must
        be forwarded to the Clinical Governance Department


7.      Responsibilities for Healthcare Staff

7.1     Directors of Healthcare Provision

        Directors of Community Services are responsible for
        • Ensuring that local policies and procedural documents to manage the risks
           associated with Clinical Diagnostic Testing and Screening are supported
           and ratified by relevant committees and organisational boards.
        • Ensuring that approved policies are implemented and reviewed
           appropriately

7.2     Clinical Leads and Service Managers

        Clinical leads and service managers are responsible for ensuring
        • Staff involved in all stages of the process for clinical diagnostic testing and
            screening are aware of local policies/ procedures and adhere to same
        • All staff undertaking clinical diagnostic testing and screening have
            undergone appropriate training and can demonstrate competency
                                                                                      APOP 018
                                                                                   Page 6 of 13
                                                                            Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                             Review date Mar 2012
        •    Patients are informed of the outcome of their investigation in a timely
             manner and by a person qualified to support and assist with any further
             information or treatment required.
        •    Robust systems are in place which involve the receipt and filing of paper
             records or that electronic records are updated as outlined in the Record’s
             Management Policy
        •    All equipment utilised for diagnostic testing and screening is maintained in
             line with the Trust Guidelines for the Management of Medical Devices

7.3     Responsibilities External to the Organisation

        The Trust will ensure that any external body responsible for the delivery or
        management of clinical diagnostic tests and screening procedures on its
        behalf will be able to provide assurances on the management of the risks
        associated with diagnostic testing and screening procedures.


8.      Process for Staff Involved in Clinical Diagnostic Testing and Screening
        Procedures

        All staff involved in this process should as a minimum adhere to the following

8.1     Identify that the clinical diagnostic test/screening procedure is appropriate for
        the patient and consider its purpose. Staff should question the need for testing
        and ask if a diagnosis can be made on clinical presentation alone prior to
        proceeding with a clinical diagnostic test or screening procedure.

        Staff must understand the procedures/policies in place to support clinical
        diagnostic testing/screening procedures and know what is involved at all
        stages of the testing or procedure. Local guidelines/procedural documents
        should be available for all staff involved in the process of managing clinical
        diagnostic testing and screening procedures.

        Only those staff with authority to authorise/proceed with the test or screening
        procedures, are permitted to make a request. Local documents must outline
        the appropriate method for requesting individual procedures. This may be in
        the form of a verbal request, e.g. requesting an ECG or blood glucose
        monitoring for an inpatient, or written requests for radiology or laboratory
        testing

        All staff requesting clinical diagnostic testing or clinical screening must know
        what is in place within services to support informed consent and demonstrate
        the ability to obtain consent.

        Systems must be in place to ensure that the testing/screening has been
        identified correctly and clearly documented once undertaken. Staff
        undertaking any testing or procedure must satisfy themselves that the correct
        patient has been identified and patient samples/specimens and associate
        documents must include the correct patient demographics, tests or analysis
        required and contact or return details of the referrer.
                                                                                    APOP 018
                                                                                 Page 7 of 13
                                                                          Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                           Review date Mar 2012
        All equipment used in the process of clinical diagnostic testing or clinical
        screening must be stored, decontaminated and/or disposed of in line with trust
        guidance on Management of Medical Devices and the Cleaning, Disinfection
        and Sterilisation Policy.

        Services that require specimens/samples to be transported to another support
        service for analysis or processing, must outline the arrangements in place with
        partners to ensure safe and effective transfer of patient specimens/samples

        Appropriate reporting and dissemination of the test or screening result must be
        identified by individual services documents and recorded onto the patient’s
        paper or electronic notes. All persons with the responsibility for follow up of a
        diagnostic test or procedure must clearly document when the results have
        been reviewed and any further actions taken.

        Review of test or screening results may only be undertaken by staff who are
        competent in the interpretation of the clinical diagnostic testing or clinical
        screening.

        Service users who have undergone a test or procedure must be informed of
        the result in a timely manner. They should be made aware of any known time
        scales associated with the availability of test or screen results and be
        encouraged to contact the service if results are not received within an agreed
        timeframe.

        Agreements should be in place to ensure that service users who receive a
        positive or high risk result have access to an appropriate healthcare
        professional to discuss options for further management and such decisions to
        refer to another professional must be discussed with the service user and
        documented accordingly.

        The method by which the service user has been informed of their test or
        screening result must also be recorded i.e. face to face consultation,
        telephone consultation, email or letter. The consultation or notification
        must also include any subsequent outcome or follow up required, the patient’s
        GP must also to be informed of all diagnostic tests/screening and follow up.


9.      Training and Competencies

9.1     Training Needs Analysis
        Clinical Leads and service managers must ensure training needs analysis
        (TNA) have been undertaken. Any identified training or competencies issues
        must be highlighted. Subsequent development of staff in the area of clinical
        diagnostic testing or screening procedures must where appropriate be
        supported by the organisation

        The TNA should clearly define the expected proficiency of staff groups and
        also identify training requirements, e.g. mandatory, additional awareness/skills
                                                                                    APOP 018
                                                                                 Page 8 of 13
                                                                          Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                           Review date Mar 2012
        and or supervised practice required to carry out local clinical diagnostic testing
        and screening procedures.

9.2     Competency

        When competencies are developed they should, whenever possible, be
        evidence based.

        All policy and procedural documents relating to clinical diagnostic testing and
        screening procedures must identify the level of training needs associated with
        the implementation of the test or screening procedure. Competency
        associated with the procedure and process may be assessed on three levels

9.2.1 Awareness - applies to staff who need to know the document exists. These
      staff must be sent notification of the document once ratified

9.2.2 Understanding - required by managers who need to understand how the
      document should be applied to their team. These managers should where
      possible be involved in the document development and also sent a copy of the
      ratified document for implementation

9.2.3 Competency- applies to all staff using the policy or procedural document on a
      regular basis. The competency section of local procedural documents should
      include a list of those competencies required by staff to carry out clinical
      diagnostic testing and screening procedures. Once a procedural document
      has been developed or updated all staff must discuss this with their line
      manager and at that stage the manager must agree one of the following

        -     Already competent to apply the document
        -     Have self assessed own competence and agreed own learning
        -     Need to attend Trust recognised training programme to achieve
              competence


10.     Consent to Treatment and Examination

10.1    The Organisation expects that all services responsible for the delivery of
        clinical diagnostic testing and screening procedures obtain consent of the
        person they are testing and must be in accordance with both the Trust Policies
        on Consent to Treatment and Examination and the Mental Capacity Act 2005.
        All procedural documents must outline this and clearly state the level of
        consent required for individual testing and screening procedures

10.2    Consideration must be made regarding the amount of written and verbal
        information a person should receive prior to and following diagnostic testing
        and clinical screening and appropriate associated time scales for the provision
        of information to enable informed consent.



                                                                                     APOP 018
                                                                                  Page 9 of 13
                                                                           Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                            Review date Mar 2012
10.3    Local procedural documents must also outline the systems in place to support
        those who choose not to undergo clinical diagnostic testing or clinical
        screening


11.     Content of Local Procedural Documentation/Guidelines

        This policy has identified areas which must be included on all local procedural
        documents and in addition recommends the following

11.1    Local Process Documentation Development

        Documents should be written and reviewed in accordance with the Trust
        Policy on Policies and other Procedural Documents. Managers and Clinicians
        should ensure that local guidance documents do not duplicate the work of
        other accepted local or national policies/procedural documents, such as, The
        Royal Marsden Hospital Manual of Clinical Nursing Procedures Guide (6TH Ed)
        which has been adopted as a clinical procedures document by the Trust.

11.2    Accountability/Authority

        A section on Accountability and authority for the process of requesting clinical
        diagnostic testing and screening procedures must be included and clearly
        identify those who are authorised to request and carry out individual tests and
        screening procedures. This section must also include the how the test or
        screening procedure is requested and give clear instruction on the information
        required on request forms and on samples and specimens.

        •        Patient demographics- surname, forename, date of birth, NHS number
        •        Details of the requester and contact information
        •        Clinical details, including current treatment and/or drug therapy
        •        Investigations Required
        •        Indication of Urgency

11.3    Patient Identification

        Local process for clear patient identification on all test and screening
        samples/specimens or other diagnostic media must be highlighted in the
        document. Minimum patient identification and referrer/screener information
        should be included. If a patient is required to collect their/our sample for
        testing/screening the request initiator must inform them of the correct
        sampling, storage and transport requirements. All patient samples/specimens
        must contain

        •        Patient demographics- surname, forename, date of birth, NHS number
        •        Date and time of sample
        •        Signature of healthcare professional who took the sample


                                                                                   APOP 018
                                                                               Page 10 of 13
                                                                         Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                          Review date Mar 2012
11.4    Transport of Patient Specimens/Samples

        Arrangements for the safe and effective transfer of specimens/samples must
        be in place. If a service does not require transport of a specimen but may
        need to send other patient identifiable information this must be inline with
        Trust policy and outlined in the local document.

11.5    Infection Control

        Disposal and decontamination of equipment required to perform a clinical
        diagnostic test or clinical screening procedure must be outlined along with any
        other infection control issues surrounding the process

11.6    Local process for receipt of test results

        Systems must be identified in relation to the receipt and storage of a test or
        screen result

11.7    Taking Action on Test Results

        Process for taking action on test or screening results must be outlined and
        include how the results are recorded, disseminated and who is responsible for
        subsequent actions. In all cases the referrer should ensure that results are
        acted upon and appropriate clinical intervention undertaken when indicated.
        This should also be clearly documented

11.8    Local Documentation

        Documentation must be in line with guidance from the Trust Standards for
        Clinical Record Keeping and recommendations from professional bodies such
        as the Nursing Midwifery Council, the Health Professional’s Council, the
        General Medical Council and the Medical Protection Society. All local
        procedural documents must state the agreed process for record keeping at all
        stages of the clinical diagnostic test or screening procedure

11.9    Communication

        Communication relating to clinical diagnostic tests or screening must be in
        accordance with the Trust Confidentiality Policy. This section must consider
        issues surrounding sensitivity of information and results given to the service
        user. If there is an approved local process for results to be communicated to
        the patient by someone other than the referrer this must be documented.
        It must also outline the procedures in place to ensure that the service user’s
        GP receives the results of any clinical diagnostic testing or screening
        procedure.


12.     Incident Reporting

        Reporting of incidents in relation to any clinical diagnostic testing or screening
                                                                                     APOP 018
                                                                                 Page 11 of 13
                                                                           Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                            Review date Mar 2012
        procedure or breach of procedure document must be undertaken in
        accordance with Trust Incident and Near Miss Policy.

        All members of staff have an important role to play in identifying, assessing
        and managing risk. The Trust strongly encourage all staff to report any
        situation where things have or could have gone wrong, as the organisation
        has a strong desire to learn from incidents and near misses to prevent
        reoccurrence.


13.     Audit

        An annual audit, registered with the Audit Department, will be undertaken to
        ensure compliance with local procedural documents

        The clinical lead/service manager will be responsible for carrying out the audit
        or may identify an appropriate representative.

        The audit should monitor compliance with the procedure document and
        measure effectiveness of local guidelines amongst the multidisciplinary team.
        With particular emphasis on the process for

        •     Requesting tests
        •     Taking action on results
        •     Recording actions taken
        •     Communication of results

        Results of all audits will be submitted to the clinical risk department who will
        inform of any subsequent follow up


14.     Associated Trust Policies and Documents

            Policy on Policies and other Procedural Documents
            Incident and Near Miss Policy
            Confidentiality Policy
            Consent to Treatment and Examination Policy
            Mental Capacity Act 2005
            Infection Control Policy
            Cleaning, Disinfection and Sterilisation Policy
            Records Management Policy
            Standards for Clinical Record Keeping
            Guidelines for the Management of Medical Devices




                                                                                   APOP 018
                                                                               Page 12 of 13
                                                                         Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                          Review date Mar 2012
                                                                    Appendix A


Clinical Diagnostic Testing and Screening Procedures


The following are commonly requested and performed by services and can be used
as a guide to the development of local documents. All local documents must
indicated the range of tests undertaken by individual services and should also include
those who are authorised to request and carry out testing/screening

Phlebotomy
Haematology
Biochemistry
Microbiology
Histology
Diagnostic Radiology
CT Scanning
MRI Scanning
Ultrasound
Doppler Testing
Arterial Blood Gases
Blood Glucose Testing
Blood Ketone Testing
Urinalysis
Pregnancy Testing
ECG’s
Pulse Oximetry
Spirometry
Neonatal Screening




                                                                                 APOP 018
                                                                             Page 13 of 13
                                                                       Issue date Mar 2009
NHS Havering is the brand name of Havering PCT                        Review date Mar 2012

				
DOCUMENT INFO
Shared By:
Categories:
Stats:
views:37
posted:3/8/2010
language:English
pages:13
Description: GUIDELINES FOR DEVELOPING PROCEDURAL DOCUMENTS TO MANAGE