These procedures should incorporate not only necessary operational steps but safety steps. The computer system along with these written procedures should form part of a quality management system. Subject this system to external auditing by a suitable quality standards authority.

Derived from identified safety considerations , your procedures should incorporate and address the following safety points presented in the form of a check list by functional area. This list is not intended as a complete and exhaustive list. Each user must determine their own safety procedures and ensure that they are operated correctly and consistently.

The checklists are in two sections as follows, one for the routine users of the system:

And secondly, there are separate check lists for system managers to consider.

• Dose/interval settings

• Data and operational integrity

• Diary Settings

A user check list

• This data must be entered and be correct.
  Prime Anticoagulation Reason (mandatory).

• Is the patient a “problem”, i.e. on concurrent drugs, elderly (optional).

• Correct Dosing Regime i.e. the instruction of the tablets or pills to be taken by the patient (mandatory).

• Start date (mandatory).

• If short term, treatment duration in weeks (mandatory for short term patients).

• Target INR Range (mandatory).

• Dosage Safety Range (optional).

A user check list You MUST check that the previous treatment history has been entered correctly.

• Correct dosage results and INRs for this patient.

• Use “Current treatment plan report” to validate data entry.

A user check list

• Ensure that the patient has a next test date/time.
  

• Run a report to ensure that all active patients have a next test date.

A user check list

• Correct INR entered.

• Check manual override of dose and next visit date, always add a comment to say why the change was made.

• Check manual override of missing days, always add a comment.

• Patient MUST be stable and reached a maintenance dose before using automatic dosing in the Maintenance Module.

• Check that all patients (including non attendees) due on a particular day have been dosed or dealt with completely.

• Validate each dose and next date BEFORE “informing the patient”.

• The wrong sample number is not entered.

• The wrong dosage instruction report is not stuck in the wrong patient’s record book.

• The wrong information is not copied by hand to the wrong book or patient report.

• The wrong information is not communicated to a patient by telephone.

A user check list

• Test all new or altered user letters before using them in a live situation.
  

• Check correctness of all user letters printed out from the system.
  

• To avoid the wrong information being communicated in writing to a patient, include a patient identifier in any printed dose instruction.
  

• To prevent the wrong dose instruction being communicated to a patient, include the current test date alongside the dose instruction.
  

• To prevent untested user letters being sent out to patients by mistake, use the approved flag, marking only fully tested and authorised letters as such
  

• Where printing user letters for a group of patients, have a tally of the number of user letters you expect to produce and match that to the number of user letters actually produced, to avoid missing anyone out.

A system manager’s check list

• Validate dosage instructions i.e. tablet instructions on system set-up or on changing.

• Validate Target INR Range

• For each range:

• Are the INR limits correct.

• Are all the trends and triggers identified.

• Are the interval settings valid.

• Are all the alarms present. Limits should not be set to zero or checks will not be performed

• Are the missing days correct.

A system manager’s check list.

Do you have written procedures and physical arrangements for:

• Checking routinely the database for possible errors.

• Setting up the maintenance scheduler to automate database maintenance

• Checking routinely the system keys to optimise system performance within your organisation

• Checking the hardware for possible errors especially the data disk storage.

• Replacing backup media regularly - media only has a set storage life.

• Backing up routinely at appropriate intervals and being able to restore the data and programs if required.

• Ensuring backup media is stored safely in a separate place from the computer system and is readily referenced.

Providing adequate protection from:

• power failures, notebook/laptop battery discharge and interruptions.

• staff inadvertently switching power off at the mains.

• staff switching off the system if they have difficulty using the program.

• Checking for computer virus violation.

• Documenting and reporting software and operational problems or ‘near misses’ to Dawn Clinical Software and their own management.

• Documenting all changes to system set-up to show they are properly controlled and validated.

• Ensuring the manual and your procedures are complete i.e. no sections have been removed, and are kept in a safe and accessible place for ready reference by your users. Make frequent checks that this is the case.

• Preventing and not allowing adding or editing of data in the underlying database by using a third party program or tool. All data access must be done through Dawn AC.

• Keeping all the system files complete and together. Do not copy files from previous copies of the system into the current set of files. The system files have a high inter-dependency and require absolute referential integrity.

• Ensuring that if a practice system is created that users do not enter ‘real or live’ data into it and use it operationally.

• Encouraging use of the practice system to rehearse any infrequently used procedures before live execution.

• Ensuring any old, out of date manual versions, or sections of manuals are destroyed.

A system manager’s check list.

• Where you use timed appointments, consider the number of clinics you need.

• Are there adequate time slots for a typical day’s patients

• Have you entered your excluded days to cover the next planned extension of the diary

• Do your excluded days include known staff absences etc.

• Ensure the above points are considered before extending the diary – extend only to just beyond the latest possible appointment that will be given this month or however frequently you extend the diary.

• Only you should delete a diary under strictly controlled conditions

• Don’t forget to back up the system before deleting a diary

© 2001 4S Information Systems Ltd