Standards and Guidelines Conformance

This page outlines the standards and guidelines applicable to a digital operation note platform in the UK, and demonstrates how MyOpNotes adheres to these requirements.

General Medical Council

The GMC provides a comprehensive set of guidelines in their 'Good Medical Practice' and 'Record keeping' standards. MyOpNotes aligns with the following domains and their related principles:

  1. Knowledge, skills and performance - Domain 1 (Good Medical Practice, Paragraph 14a): MyOpNotes helps doctors to effectively apply their knowledge and skills by streamlining the process of recording surgical notes, ensuring they are accurate, comprehensive and contemporaneous.
  2. Safety and quality - Domain 2 (Good Medical Practice, Paragraphs 21-24): MyOpNotes ensures patient safety and promotes quality of care by enabling clear, secure, and accurate record keeping.
  3. Communication, partnership and teamwork - Domain 3 (Good Medical Practice, Paragraphs 32-34, 35a and 35c): MyOpNotes promotes effective and efficient communication among healthcare professionals by providing a platform for the collaborative generation of operation notes.
  4. Maintaining trust - Domain 4 (Good Medical Practice, Paragraphs 65-68): MyOpNotes maintains patient trust by ensuring secure storage and confidentiality of patient information.
  5. Record keeping - (Record keeping, Paragraphs 1-3): MyOpNotes adheres to these standards by facilitating the creation and maintenance of clear, accurate, and readily accessible clinical records. It assists clinicians in making records at the time or as soon as possible after an event, recording relevant clinical findings and details of all the information given to patients.

Royal College of Surgeons of England

The RCS England provides standards and guidance for surgical practice in the UK. MyOpNotes adheres to these standards as follows:

  1. Good Surgical Practice (2014): MyOpNotes is developed in line with the key domains of Good Surgical Practice, which include knowledge, skills and performance; safety and quality; communication, partnership and teamwork; and maintaining trust.
  2. The RCS guidelines for clinical records and record keeping (2008): MyOpNotes supports the principles of record keeping outlined by the RCS, such as contemporaneity, completeness, legibility, storage, and access to records.
  3. Consent: Supported Decision-Making: A guide to good practice (2016): While MyOpNotes is not specifically a consent platform, it does facilitate clear documentation of the discussions and decisions made regarding a patient’s care, supporting informed consent processes.
  4. Commissioning Guide: Delivering a Modern Surgical Service (2006): MyOpNotes aligns with the guide's recommendation for the use of integrated IT systems in managing and improving surgical services.

By adhering to these guidelines, MyOpNotes ensures it supports safe, effective, and high-quality surgical practice.

NHS Digital

MyOpNotes is developed in alignment with the framework for key standards set out by the NHS Digital Data and Technology Standards Framework, encompassing clinical safety, data usage, interoperability, and design interaction.

Below are relevant principles from NHS Digital’s guidance with the corresponding adherence standard of MyOpNotes.

  1. Patient records for all health and care settings must use the NHS Number wherever possible: MyOpNotes supports search by NHS number, often in conjunction with a local identifier where this is commonly used.
  2. Logging in to NHS systems should be through an approved authentication system: MyOpNotes offers single-sign on authentication, and is developing integration with NHS CIS2 for seamless and secure access.
  3. Patient information held in electronic health records should comply with NHS clinical information standards: MyOpNotes upholds these standards, including hosting, data security at rest, data security in transit, and data archival, retention, and disposal. Comprehensive details are provided within our technical information documentation.
  4. NHS Digital Reference Data Registers are the preferred reference data source in NHS systems: MyOpNotes uses these registers for both patient identifier naming structure and the coding of specialties in operation notes.
  5. All health software and health IT systems must be designed, developed, and operated safely to conform with clinical safety standards: MyOpNotes aligns with the DCB0129 standards for clinical safety, supported by a publicly available clinical safety case report.
  6. All NHS digital, data and technology services should achieve the Data Security Standards required through the Data Security and Protection Toolkit (DSPT): MyOpNotes maintains a DSPT for the system, exceeding the standards. The assessment is available for review.
  7. All NHS digital, data and technology services should support FHIR-based APIs to enable the delivery of seamless care across organisational boundaries: MyOpNotes employs a flexible integration approach, as described in our integration overview, depending on local configuration. A FHIR-based approach is available.
  8. All NHS digital, data and technology services should be designed to meet user needs in line with the principles of the Digital Service Standard and Technology Code of Practice: MyOpNotes aligns with the code of practice. Our privacy notice details how patient data is managed and used, and for what purposes.

Care Quality Commission

The requirements set out by the Care Quality Commission (CQC) relating to accurate and comprehensive record-keeping are met by MyOpNotes' design. These are set out in Regulation 17 of the Health and Social Care Act 2008 (Regulated Activities) (Regulations 2014). This requires that a system must be able to demonstrate the accurate, complete, legible and contemporaneous record of treatment.

National Cyber Security Centre

MyOpNotes maintains Cyber Essentials Plus certification, which includes hands-on technical verification. Additional independent penetration testing is undertaken by a CREST approved penetration testing provider, ensuring the highest level of cybersecurity.

The Information Standard Principles

The Information Standard’s quality statements are met by MyOpNotes:

a) There is a defined process for producing and storing operation notes, including identifying the need for a note, checking stages, final sign-off, review, version control, and archiving.

b) All individuals involved in the information process have relevant, up-to-date training/experience and follow the defined process for all information products.

c) Information is created using high-quality evidence (where it exists) and is presented in a balanced manner.

d) Operation notes are reviewed by relevant professionals/peers before they are approved for use.

e) Information is created considering the health literacy and/or accessibility needs of the user.

f) The effectiveness of the operation note is routinely assessed and demonstrated as part of continuous improvement.

g) Users are given the opportunity to feedback on information products and this is acted upon. Feedback is stored and tracked for auditing purposes.

By adhering to these guidelines, MyOpNotes ensures the accuracy, safety, and integrity of digital surgical notes.

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