Good Documentation Practices

QSM-T13-0

Introduction

The work done in blood transfusion centres affects the safety of

donors, patients and staff and for this reason it is vital that

documentation is of the highest standard. Written procedures must be

followed, work done must be documented and records must be kept.

The following Good Documentation Practices (GDPs) should be applied

when performing daily duties across all departments.

Contents of Presentation

• Evidence• Recording Information• Legibility• Blank Spaces• Correcting Errors• Date and Time Formats• Reporting Results• Deviations• Confidentiality• Falsification• Signatures• Meeting Timelines• Record Retention• Document Media

Good

Documentation

Practices

Documentation as Evidence

If it’s not documented, it didn’t happen!

• Documentation provides proof or evidence that something was

done

• Record sufficient detail so that anyone looking at the document

in future will know exactly what happened

• Each document should be able to stand alone with all required

information

Recording Information

Record information immediately

• Don’t trust your memory because you may forget to record

the information later

• Don’t write results on loose pieces of paper as these may

get lost

• Don’t transcribe information from one form to another as

this could lead to errors

• Do not back-date documents

Legibility

All documents must be clear and legible

• Information on a document is useless if it cannot be read and

understood

• Take care to write neatly and clearly

• If your handwriting is not easy to read rather print in capital

letters

• Use black pen only, it photocopies well & is legal

• Don’t write in pencil as this can be erased

Blank Spaces

Don’t leave blank spaces on forms

• Fill in N/A if not applicable

• Or cross out section if not relevant

• Otherwise it looks as though someone has forgotten to enter

information

• Do not use ditto marks as these could be taken for number 11

Correcting Errors

Correct errors in a legible way

• Draw a single line through mistakes

• Write the correct information next to the error

• Sign and date this

• Anyone looking at the document should be able to see what

information was changed and by whom

• Do NOT try and write over the error as this makes it illegible

or difficult to read

• Do not ‘colour’ over mistakes, this makes documents messy

and illegible

• Never use correction fluid (eg. Tippex)

22 C 24 C Joe Bloggs 23/10/2019

Date and Time Formats

Standardise date and time formats

• Standardise and stipulate format for recording dates

• e.g. dd/mm/yyyy

• Ensure everyone records dates in same way

• Check that dates on computer system match date format

used on forms

• Record times using 24 hour clock ie. 15:30 (not 3.30)

Reporting of Results

Standardise the reporting of test results

• Report results to same number of decimal places as

in specification

• Labs to round off results as follows, when required:

- if number is below 5, round down

- if number is 5 and above, round up

• Apply relevant correction factors for equipment to

results before rounding off (as above)

Deviations

If you deviate from procedure, record details

• If anything out of the ordinary occurs make comments as

to what happened

• Months/years from now you may not remember the exact

details so write them down

• Document should be able to ‘tell all’ in future

• Explain deviation and why it occurred

• Remember to sign and date your comments

Confidentiality

Confidentiality is crucial

• Blood transfusion facilities must have a policy to ensure

information relating to donors, patients or staff is kept

confidential

• This information may not be disclosed to any outside parties

• Access to certain information should be restricted

• Don’t share your PIN or password with anyone

Falsification

Falsification must not be tolerated

• Information entered on a form must be true and accurate

• Results should be reviewed and checked by a second

independent person, where possible

• All errors should be corrected immediately

• Action should be taken if staff are deliberately falsifying

documents

Signatures

Signatures must be traceable

• One must always be able to determine who signed a document

• Always sign your name in the same way

• A signature list of all staff signatures (and initials) should be

kept in each department

• This list should be updated when staff leave or new employees

join the organisation

Signature Fatigue

Be aware of signature fatigue

• In blood transfusion work we sign lots of documents so take

care not to become complacent

• Double check any document before you add your signature

• If something goes wrong and you end up in court you must be

able to justify why you signed something and what your

signature means

Meeting Timelines

Complete/ submit required documents on time

• Procrastination causes problems for all

• Don’t let paperwork pile up in your mailbox

• Process documents promptly and get them off your back

• Review and update SOPs when due

• Complete internal audit reports on time

• Process corrective action reports as quickly as possible

Record Retention

• There must be a document stating how long records

should be kept for according to the Standards/ legal

requirements

• Don’t store records for longer than required

• Avoid duplication, don’t store documents if someone

else is already keeping them

• Document storage areas should be secure

• Storage methods must prevent possible damage

• One must be able to retrieve documents from storage

in reasonable time if needed

Store records safely for stipulated periods

Document Media

GDPs apply to all types of document media

• Includes paper/ hardcopy records with written data and a

handwritten signature

• Also includes electronic records which are completed on-line

and signed electronically

• Same applies to hybrid documents ie. electronic documents

filled in on-line but then printed out for a written signature

• With time more & more of our documents will become

electronic. Hooray!

For the safety of staff, donors

and patients:

Do what you document and

document what you do !

Thank you