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Clinical governance and patient safety records in pharmacy

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Topics: Record keeping

Recommendations on retaining pharmacy records for clinical governance, quality assurance, risk management and patient safety.

This article forms part of a series
  1. Retaining and storing pharmacy records in England
    1. Additional services records in community pharmacy
    2. Clinical governance and patient safety records in pharmacy
    3. Clinical trial records in hospital pharmacy
    4. Controlled Drugs (CD) records in pharmacy
    5. Prescription and dispensing records in community pharmacy
    6. Prescription and dispensing records in hospital pharmacy
    7. Stock management, waste and recall records in pharmacy
    8. Supply and distribution records in pharmacy
    9. Technical service records in hospital pharmacy

Contents

  1. Using our advice
  2. Specific records
    1. Clinical audit
    2. Clinical protocols
    3. External quality assurance
    4. Governance committee
    5. Patient complaints
    6. Patient Group Directions (PGDs)
    7. Patient safety incident
    8. Patient surveys
    9. Policies, strategies and SOPs
    10. Responsible Pharmacist logs
  4. Update history

Using our advice

Clinical governance and patient safety records provide evidence that pharmacy services are safe, effective and well managed. These records support quality improvement, risk management, patient safety, regulatory compliance and organisational assurance activities.

Retention requirements may arise from the Records Management Code of Practice (RMCoP), legislation or established governance practice.

Where multiple retention periods apply, organisations should normally retain records for the longest applicable period. See Retaining and storing pharmacy records in England (SPS page) for factors that may justify longer retention.

Specific records

Record description

Records such as audit plans, data collection tools, and audit reports.

Minimum retention time

  • retain audit reports and supporting records for at least 5 years from the year in which the audit was conducted
  • retain audit data containing clinical information relating to adults aged 18 years and over for at least 8 years
  • retain audit data containing clinical information relating to children until their 25th birthday or until their 26th birthday if they were 17 years when the treatment ended

Supporting source

The RMCoP advises on audit related records.

Record description

Records such as protocols, practice guidance and superseded protocol versions.

Minimum retention time

  • retain records for at least 20 years

Supporting source

The RMCoP notes that clinical protocols may have long-term value and may form part of the organisation’s permanent governance record.

Record description

Records such as accreditation, performance reviews, reports and corrective action.

Minimum retention time

  • retain records for at least 12 years from the end of the year the assurance activity relates to

Supporting source

The RMCoP advises on assurance related records.

Record description

Records such as agendas, minutes, action logs, and decisions.

Minimum retention time

  • retain records for at least 6 years

Supporting source

The RMCoP applies this retention period to minor committees, projects and departmental business meetings. Some governance records may have historical value and require permanent preservation in accordance with local records management procedures.

Record description

Records relating to formal complaints, responses, investigation reports, witness statements, action plans and correspondence.

Minimum retention time

  • retain records for at least 10 years after closure of the complaint

Supporting source

The RMCoP states that retention begins when the complaint is closed. A complaint is not considered closed until all complaint processes, appeals and actual or potential litigation have ended.

Keep complaint records separate from the patient record.

Our article on Retaining legal mechanism documentation (SPS page) advises on the retention of all records relating to legal mechanisms, such as Patient Specific Directions (PSDs), Patient Group Direction (PGDs), Vaccine Group Direction (VGD) and Written Instructions (WI).

Record description

Records such as incident reports, investigation reports, root cause analysis, learning reviews, action plans and safety recommendations.

Minimum retention time

  • retain records relating to serious incidents or incidents requiring formal investigation for at least 20 years
  • retain records relating to other patient safety incidents for at least 10 years

Retention begins from the date of the incident rather than the date the incident was reported.

Supporting source

The RMCoP recognises that serious incidents may generate long-term legal, regulatory and organisational learning requirements.

Record description

Records such as survey responses, raw data, data analysis, reports and service evaluations.

Minimum retention time

  • retain survey returns and raw data for at least 1 year after survey return
  • retain final survey reports for at least 10 years

Supporting source

The RMCoP recognises that organisations may wish to use reports for long-term trend analysis and service improvement. This time period can be extended, provided there is justification and organisational approval.

Record description

Records such as policies, strategies, standard operating procedures (SOPs), version histories and approval.

Minimum retention time

  • retain records for the life of the organisation plus at least 6 years

Supporting source

The RMCoP states that retention begins when the document is approved and continues until it is superseded.

Record description

Records such as log books, correction and absence.

Minimum retention time

  • retain records for at least 5 years

Supporting source

The Medicines (Pharmacies) (Responsible Pharmacist) Regulations 2008 require the person carrying on the pharmacy business to preserve the pharmacy record.

Update history

  1. Republished
  2. Full review and update
  1. Link updated for the Records Management Code of Practice (RMCoP).
  1. Published