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Standards › Standard 2D › Standard operating procedures (SOPs)

Standard operating procedure (SOP) · DIG-SOP-002 · Version 1.1 · Approved by the ASF Expert Committee

Supports: 2D.1

At a glance

  • Assess every digital care system before it is introduced: costs, benefits, interoperability and possible unintended effects.
  • Record the assessment on DIG-FRM-002, signed by the clinical and IT leads.
  • Do not adopt a system on vendor claims alone.
  • Review each system after go-live and at least yearly.
  • Stop and get help straight away if: a system is in clinical use with no completed assessment.

1. Purpose

To make sure every digital care system (telehealth, remote monitoring, patient-facing app, clinical software) is assessed, implemented and managed through a defined process, not adopted on a vendor pitch [EC].

2. Scope

Applies to Clinical leads, IT lead, procurement lead, chief executive
Locations All clinical and patient-facing digital systems at the facility
When Before introduction, at go-live, and yearly
Does not apply to Standard office software with no clinical use (covered by IT policy DIG-POL-001)

3. Definitions

Term Meaning
Digital care system Any software or device that supports diagnosis, treatment, monitoring or communication with patients
Interoperability The ability of two systems to exchange and use data correctly
Unintended consequence An effect not planned, such as extra workload, duplicate records or missed alerts

4. Background

Digital tools can improve care but also create new risks: extra workload, data errors, failed links between systems and missed alerts. Criterion 2D.1 asks for an internal assessment and management, not reliance on a vendor’s claims.

5. Responsibilities

Role Responsibility Competence
Chief executive Approves systems with a major clinical impact Executive
Clinical lead for the area Defines the clinical need; signs the assessment Clinical
IT lead Assesses interoperability and security Health informatics (EC)
Procurement lead Collects vendor information; keeps the contract Procurement

6. Materials and equipment

Item Requirement Condition
Digital tool assessment template (DIG-FRM-002) Current Available to project leads
Vendor information and evidence From the vendor, dated On file

7. Safety

8. Before you start

9. Procedure

Step 1. Define the need.

  • Write the clinical problem the system will solve, the patients affected, and how success will be measured.

Key point: A system without a stated problem will be hard to evaluate later.

Step 2. Assess costs and benefits.

  • Estimate costs: purchase, training, support, interfaces, and staff time.
  • Estimate benefits and how they will be measured.
  • Record the comparison on DIG-FRM-002.

Key point: Cost and benefit must be compared with real figures, not the vendor brochure.

Step 3. Assess interoperability.

  • List every system the new tool must exchange data with.
  • Test each link in a non-live environment.
  • Record each risk from non-interoperability and its mitigation.

Key point: Two systems that do not talk create the most common data errors.

Step 4. Assess unintended consequences.

  • Ask the clinical lead and two front-line staff what could go wrong: extra workload, duplication, alert fatigue, data errors or delay.
  • Record each possible effect and how it will be prevented or checked.

Key point: Ask the people who will use it, not only the people who buy it.

Step 5. Decide and manage implementation.

  • The approver decides on the basis of the record.
  • Manage go-live with a named owner, training, a fall-back plan and a support route.

Key point: A fall-back plan is needed before go-live, not after the first failure.

Step 6. Review.

  • Review the system after three months of use, and yearly after that.
  • Record the findings and actions.

Key point: Systems change, and so do the risks.

10. Decision points

11. Special situations

Situation Action
Urgent need (for example, during an outbreak) Use a temporary, reviewed approval with a time limit set by the chief executive, then complete the assessment.

12. Escalation

13. Monitoring

Measure Target Frequency Owner If not met
Systems in clinical use with completed assessment 100% Yearly IT lead Stop use until assessed
Post-implementation reviews done at 3 months 100% Each system Clinical lead Escalate to chief executive
Interface failures logged and reviewed 100% Quarterly IT lead Escalate

14. Records

Record Kept in Retention
DIG-FRM-002 Digital Tool Assessment IT governance file the period set by the facility’s records policy years after the system is retired

15. Training

16. Related documents

ID Title Use
DIG-FRM-002 Digital Tool Assessment Template Used in steps 2 to 4
DIG-POL-001 Information Security and Access Control Policy Security rules
DIG-FRM-004 Digital System Test and Support Record Test records

17. Evidence

Reference Note
E-006 ASF Policy Framework v1.2. Adapted.
E-009 ASF Expert Committee consensus. Assessment thresholds to be set by the committee.

18. Change history

Version Date What changed Approval
1.0 the date of approval First version Approved by the ASF Expert Committee
1.1 the date of approval Internal quality review: corrected cross-references, status wording and document control Approved by the ASF Expert Committee

E-learning for this document

Planned course: Digital care assessment and management process. New course planned.

References

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