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Clinical governance and patient safety records in pharmacy

Published Last updated See all updates
Topics: Record keeping

Recommendations for the retention of clinical governance and incident records in all hospital pharmacy, community pharmacy and secure environment settings.

Contents

  1. Understanding clinical governance
  2. Clinical governance records
    1. Clinical audit
    2. Clinical protocols
    3. Competency/training records
    4. External quality control records
    5. Patient complaints
    6. Patient Group Directions (PGDs)
    7. Patient surveys
    8. Policies, strategies and SOPs
    9. Responsible Pharmacist logs
  4. Clinical intervention records
    1. Medicines Reconciliation (MR) documentation
    2. Minor clinical interventions
    3. Significant clinical interventions
  6. Patient safety incident records
    1. Non-serious incidents
    2. Serious incidents
  8. Other record keeping resources
  9. All record keeping resources
  10. Update history

Understanding clinical governance

Accurate and timely records are part of robust clinical governance. Everyone within a health and care organisation is responsible for managing records appropriately. It is therefore important that you understand how records should be managed appropriately. This includes how records are created, maintained, accessed and disposed of.

Clinical governance records

Clinical governance encompasses quality assurance, quality improvement and risk and incident management. Therefore, clinical governance records relate to those activities undertaken by NHS organisations to demonstrate accountability for continuously improving the quality of their services and safeguarding high standards of care.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for reference.

Minimum period

Retain for 5 years.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

No, there is likely to be more than one copy.

Reason for keeping

Keep for reference.

Minimum period

Retain for 25 years.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for reference

Minimum period

Clinical training

Retain until 75th birthday or duration of employment plus 6 years, whichever is longer.

Statutory and mandatory training

Retain for 10 years after training completed.

Declaration of competence

Retain until 75th birthday or duration of employment plus 6 years, whichever is longer.

Other training

Retain for 6 years after training completed.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 12 years.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 10 years.

Comment

Where a legal action has commenced, keep as advised by legal representative.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

No, there is likely to be more than one copy.

Reason for keeping

This is a legal requirement. Documents should also be kept for reference.

Minimum period

For adults aged 18 yrs and over

Retain for 8 years (10 years in cases of implant insertion)

For a child

Retain until the 25th birthday or for 8 years after a child’s death, or 10 years in the case of implant insertion.

Provenance

Retaining legal mechanism documentation (SPS page)

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 5 years.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

No, there is likely to be more than one copy.

Reason for keeping

Keep for reference.

Minimum period

Retain for the life of organisation, plus 6 years.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 5 years.

Comment

Can be in hard copy or electronic.

Provenance

The Medicines (Pharmacies) (Responsible Pharmacist) Regulations

Clinical intervention records

Clinical intervention records relate to the documentation of any professional activity intended to improve the use of medicines, which may result in a recommendation for a change in the patient’s medication therapy.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 2 years.

Comment

Where the electronic system has the capacity to destroy records in line with the retention schedule, and where a metadata stub can remain demonstrating that a record has been destroyed, then the Records Management Code should be followed in the same way for electronic records as for paper records with a log being kept of the records destroyed.

If the system does not have this capacity, then once the records have reached the end of their retention periods, they should be inaccessible to users of the system and upon decommissioning, the system (along with audit trails) should be retained for the retention period of the last entry related to the schedule.

Provenance

All relevant records must be managed in line with RMCoP.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 2 years.

Comment

Where paper records are used, a two part form is recommended: original to be added to the patient record; duplicate kept for 2 years.

Entries made on an electronic database should be reviewed after 2 years and if no longer needed, the record should be destroyed or permanently deleted.

Provenance

This is a best practice recommendation.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Retain for 10 years after the death of the patient.

Comment

Entries should be recorded directly in the patient notes / Patient Medication Record (PMR).

Provenance

All relevant records must be managed in line with RMCoP.

Patient safety incident records

Unique record

Yes, this is likely to be the only record.

Reason for keeping

Keep for audit purposes.

Minimum period

Minor harm incidents

Retain for 10 years

No harm incidents

Retain for 1 year plus current year.

Comment

Recommendations only apply to paper records; entries made on electronic databases should be kept permanently.

These recommendation also apply to any associated statistics gathered in relation to non-serious incidents.

Provenance

  • This is a best practice recommendation.
  • All relevant records must be managed in line with RMCoP.

Unique record

Yes, this is likely to be the only record.

Reason for keeping

This is a legal requirement.

Minimum period

Retain for 20 years.

Provenance

All relevant records must be managed in line with RMCoP.

Other record keeping resources

All record keeping resources

Record keeping

Advice and guidance to support appropriate retention and storage of pharmacy-related records.

Update history

  1. Link updated for the Records Management Code of Practice (RMCoP).
  1. Republished
  1. Published