ID | STD016 |
|---|---|
External ID | N/A |
Version | 0.1 |
Link to standard | DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems |
Standard Type | Data Standard (NHS) |
Status | Draft |
Effective Date | TBC |
Description
This standard provides a set of requirements suitably structured to promote and ensure the effective application of clinical risk management by those health organisations that are responsible for the deployment, use, maintenance or decommissioning of Health IT Systems within the health and care environment.
The standard includes implementation guidance and is supported by the related standard for the application of clinical risk management in the manufacture of Health IT Systems - DCB0129 (STD017)
Applicability
This standard is addressed to Manufacturer personnel who are responsible for ensuring clinical safety in the development and modification of Health IT Systems through the application of clinical risk management. This standard applies to all Health IT Systems including those that are also controlled by medical device regulations , though the requirements defined in this standard are broadly consistent with the requirements of ISO 14971.
Requirement ID | Requirement Text | Level |
|---|---|---|
STD016-1 | Organisations that deploy and modify IT Systems used in a healthcare setting MUST ensure that effective clinical risk management is carried out. Full details of the required specifications is detailed here Within this standard the term ‘clinical risk’ is used to emphasise that the scope is limited to the management of risks related to patient safety as distinct from other types of risk such as financial. | MUST |
ID | STD017 |
|---|---|
External ID | N/A |
Version | 0.1 |
Link to standard | DCB0129: Clinical Risk Management: its Application in the Manufacture of Health IT Systems |
Standard Type | Data Standard (NHS) |
Status | Draft |
Effective Date | TBC |
Description
This standard provides a set of requirements suitably structured to promote and ensure the effective application of clinical risk management by those organisations that are responsible for the development and maintenance of Health IT Systems for use within the health and care environment.
The standard includes implementation guidance and is supported by the related standard for the application of clinical risk management in the deployment and use of Health IT Systems - DCB0160.(STD016)
Applicability
This standard is addressed to Manufacturer personnel who are responsible for ensuring clinical safety in the development and modification of Health IT Systems through the application of clinical risk management. This standard applies to all Health IT Systems including those that are also controlled by medical device regulations , though the requirements defined in this standard are broadly consistent with the requirements of ISO 14971.
Requirement ID | Requirement Text | Level |
|---|---|---|
STD017-1 | The manufacturer of IT Systems used in a healthcare setting MUST ensure that effective clinical risk management is carried out. Full details of the required specifications is detailed here | MUST |
ID | STD090 |
|---|---|
External ID | n/a |
Version | 0.1 |
Link to standard | |
Standard Type | Guidance |
Status | Draft |
Effective Date | TBC |
Description
To ensure the highest quality of clinical care for patients attending Emergency Departments in the UK, the Clinical Effectiveness Committee (CEC) of the College of Emergency Medicine (CEM) needs to adopt an implementation framework that not only reflects the CEC’s role in promoting clinical effectiveness
Applicability
Organisations involved in the provision of emergency care
Requirements
Requirement ID | Requirement Text | Level |
|---|---|---|
STD90-1 | RCEM Framework For the purposes of ensuring clinical effectiveness at every level, ranging from national policy-making to local implementation, the following framework is proposed. The guidance document contains a wide range of best practice guidelines for a range of situations that may arise in emergency care. A full list can be found here under College Guidelines > Best Practice Guidelines | SHOULD |
ID | STD085 |
|---|---|
External ID | N/A |
Version | 0.1 |
Link to standard | |
Standard Type | Guidance |
Status | Draft |
Effective Date |
Description
The Core information standard defines a set of information that can potentially be shared between systems in different sites and settings, among professionals and people using services.
Applicability
This guidance is intended for anyone implementing the core information standard. This will include project teams (including clinicians, other care professionals and people who use services) involved in building systems that will use the core information standard and system suppliers.
Requirements
Requirement ID | Requirement Text | Level | |
|---|---|---|---|
STD0085-1 | Information Components | Model Description | SHOULD |
Section | A section groups together all the information related to a specific topic e.g. ‘Medications and medical devices’ and ‘Person demographics’. It is the highest level to logically group data elements that may be independent or related. For example:
| ||
Record entry | A record entry within a section is used where a set of information is repeated for a particular item, and there can be multiple items. For example, for each medication there is a set of information associated with that medication. Other examples are allergies or adverse reactions and procedures. | ||
Cluster | This is a set of elements put together as a group and which relate to each other; e.g. medication course details cluster which is the set of elements describing the course of the medication. | ||
Element | The data item. An element can appear in one or more sections e.g. name, date. | ||
Information model rules and instructions | Explanations | ||
Description | This is the description of the section, record entry, cluster or element. For an element, it describes the information that the element should contain in as plain English as possible. | ||
Cardinality | Each section, record entry, cluster and element will have a statement of cardinality. This clarifies how many entries can be made i.e. zero, one or many entries. The number of records expected and allowed are displayed as: 0……* = zero to many record entries are allowed 0……1 = zero to one record entry is allowed 1……1 = one record is expected 1……* = one to many records are expected For example, the ‘Medications and medical devices’ section may have zero to many medication item records in it and is displayed as 0…… *. | ||
Conformance | Conformance defines what information is ‘mandatory’, ‘required’ or ‘optional’ and applies to sections, record entries, clusters and elements. The IT system must be developed to handle all the information elements that are defined in the Standard but not all the information is required for every individual record or information transfer. The following set of rules apply to enable implementers to cater for the end users (senders and receivers) requirements:
These rules apply at all levels and give the flexibility to allow local clinical or professional decisions on some information that is included, while being clear on what is important information to include. For example, a person subject to a referral may have many assessments, but not all of these will be relevant to the referral. The conformance can be used to allow just relevant assessments to be included. Assessment Section – Required – i.e. its important information you must include if you have it. Record entry level – Optional – allows a local decision on what assessments are included, so only relevant ones are included based on clinical or professional needs. Assessment elements – Conformance set on the normal basis of which elements for an assessment are mandatory, required or optional. NB: It is permitted to upgrade a conformance rule but not to down grade one. For instance, a section that is classed as optional in the standard can be upgraded to required or mandatory in local implementations. However, one that is classed mandatory or required cannot be downgraded to required or optional. | ||
Valuesets | Valuesets describe precisely how the information is recorded in the system and communicated between systems. This is required for interoperability (for information to flow between one IT system and another). The information can be text, multi-media or in a coded format. If coded it can be constrained to SNOMED CT and specific SNOMED CT reference sets, NHS Data Dictionary values or other code sets. | ||