Quality Assurance

Guidance
Digitisation and Disposal of Patient
Records Policy Toolkit

December 2014
 Effective: December 2014

TITLE: QUALITY ASSURANCE GUIDANCE

1. BACKGROUND

WA Health is reliant on access to relevant and accurate patient health information for
individual health care and to plan for future health services. The digitisation of paper-
based patient records (source records) offers a strategy for improved access, reduced
storage costs and long term preservation of patient health information.

The WA Health Digitisation and Disposal of Patient Records Policy (Policy) outlines
best practice principles relating to the digitisation of source records, the preservation of
the digitised copies and the early disposal of the source records. Principle 4 (Quality
Assurance) of the Policy is concerned with quality assurance procedures for the
capture and management of digitised patient records (DPRs).

Effective quality assurance procedures for digitisation are essential, especially where
the DPRs are intended to stand in place of the source records as the record of
business. Where the DPRs are to replace the source records, robust quality assurance
procedures are important to produce high quality DPRs and to ensure the authenticity,
completeness, reliability and usability of the digitised version.

2. SCOPE

This Quality Assurance Guidance document forms part of the Policy Toolkit and
addresses quality assurance processes relating to the digitisation and early disposal of
source records that are collected, stored, used and managed by WA Health.1 The
source record is the systematic documentation of a single patient’s medical history and
includes, but is not limited to, notes captured at examination, treatment plans,
medication charts, correspondence between treating clinicians and diagnostic reports.2
This information is documented, in the first instance, on paper and filed in the patient’s
medical record. The DPR is the digitised equivalent of the source record.

The document is intended to be used in conjunction with the Policy, other Policy
Toolkit documents and the WA Health Patient Information Retention and Disposal
Schedule (Schedule).

3. PURPOSE

This document provides comprehensive guidance for the development and

implementation of quality assurance procedures relating to the digitisation of source
records. This will ensure that WA Health produces DPRs that are authentic, complete,
reliable and meet the requirements of their intended use. The document has been
developed to assist WA Health meet the minimum requirements of Principle 4 - Quality
1
Including any person or organisation contracted by WA Health to provide health care services to the people
of Western Australia.
2
Refer to the WA Health Patient Information Retention and Disposal Schedule for a comprehensive list of
source records eligible for digitisation.

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 Assurance and Principle 8 - Authorisation for Disposal of Source Records, of the
Policy.

4. RELIABILITY OF DIGITISED RECORDS

Quality assurance is not simply a check on the output of digitisation, but a process that
should be built into and maintained in the ongoing operation of the digitisation work.
Quality assurance procedures must be in place to ensure the reliability of the DPR.

Requirements for achieving reliable DPRs include:

 Authentic – the product of routine, documented, authorised copying and
registration processes.
 Complete – an accurate and legible reproduction of the source record that
contains all components of the original without alterations to content.
 Accessible – available, searchable and readable to all those with the right to
access it, for as long as it is required.

5. QUALITY ASSURANCE FOR DIGITISATION

Quality assurance processes are important to ensure the DPRs meet the requirements
of their intended use and remain legible and accessible over time.

The International Standard Organisation’s (ISO) series on quality management,

referred to as ISO 9000 family of standards, provides guidance on introducing a quality
assurance system. This includes identifying the quality measures and processes,
ensuring staff are adequately trained in the monitoring, reviewing and improvement of
existing processes.

Consistent with these standards, quality assurance processes should be established

and maintained with respect to:
 assessing the quality of scanning equipment
 assessing the suitability of the paper records and ensuring records undergo a
pre-digitisation preparation process
 business processes for creating and checking DPRs
 accurate capture of quality control documentation (e.g. logs, reports, metadata).

Guidance for the implementation of these quality assurance processes are outlined
below.

5.1 Assessment of Scanning Equipment and Specifications

The equipment and software used in the digitisation of source records needs to
operate effectively to satisfy the minimum requirements of the digitisation specification
for source records outlined in the Policy Toolkit document – Technical Standards for
Digitisation. The scanning hardware and software should be regularly maintained and
correctly calibrated to facilitate the creation of high quality DPRs that satisfy business
requirements. Regular servicing of scanners must be scheduled and performed by an
authorised servicing operator and the service history documented. The frequency of
services will depend on the volume of use.

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Before beginning daily scanning operations, routine scanner maintenance must be
carried out by the Scanning Officer. These procedures include, for example, cleaning
the rollers and glass plate. For further advice about appropriate scanner maintenance
practices refer to the instruction or operating manual that is supplied with the scanning
technology.

The scanner should be regularly calibrated to ensure the image capture satisfies the
requirements of the technical specifications. When the machine has been calibrated
the scanner number, username, date and time should be recorded for auditing
purposes. These audit records are to provide evidence that quality control procedures
are being followed and the equipment is calibrated in accordance with the digitisation
specification for source records.

5.2 Business Processes for Preparing and Checking Patient Records Prior
to Digitisation

Converting source records into readable and accessible DPRs involves separate
stages, with each stage requiring a quality assurance assessment process. The quality
process pertaining to each stage must be performed before the next stage is
commenced.

The quality assessment checks to be conducted prior to the digitisation process are
outlined below.

5.2.1 Preparing Physical Files for Scanning

An initial assessment is required to gauge the eligibility of the source record for
digitisation and early disposal according to the Schedule. This should then be followed
by an assessment of the physical capability of the source records to sustain a
digitisation process (e.g. paper quality, creasing, stapling, tears). If the source record
is eligible and physically suitable for digitisation, then the source record must be
prepared for digitisation.

Source record preparation guidelines should address as a minimum:

 removal of materials from the source record (e.g. file clips, staples, plastic
sleeves and metal clips). To keep the paper record in the relevant sections (e.g.
correspondance, outpatients, admissions etc.) clips can be used to secure the
section together but must be removed prior to scanning
 ensuring that any tears are repaired, both sides of the paper have labels to
identify which patient the documents belong to and ensuring all paperwork
contained in the file belongs to the patient record
 removal of plastic or cardboard section dividers from the source records. If the
section divider contains relevant information, make a photocopy and place in
file to be scanned
 removal of coloured tags and post-it notes from the source records. If these
contain relevant information, make a photocopy and place in file to be scanned
 removal of the thermal paper if found on file, remove the paper and make a
photocopy. Place a copy in the file to be scanned. The original thermal paper
should be destroyed.

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Processes for dealing with source records should also address:
 managing source records containing handwritten annotations, marginalia, white
opaque paint or highlighted areas
 distinguishing between original source records and photocopies
 physical preparation for digitisation (e.g. alignment of single pages, batching of
like documents – size, technical settings, shared indexing fields)
 assigning links between associated documents to be regarded as a single item,
so that the digitised image can faithfully represent the source record
 assigning links between the source record and the digitised copy – such links
will usually be documented using identification protocols, in some applications
barcode technology could be used to link paper and digitised versions
 checking and verification that all source records have been included in the
digitisation process
 principles governing the assembly of batches or groups of source records
suitable for digitisation at the same time.

5.3 Business Processes for Creating and Checking Digitised Patient

Records

Checking the quality of the DPR should form part of workflows and involves
establishing and documenting quality assurance measures and procedures, including
re-imaging processes where quality standards are not met.

5.3.1 Quality checking the Digitised Image

In the first instance checking the quality of the DPR should be performed by the
Scanning Officer. The checking process should be undertaken to ensure:
 the smallest detail has been legibly captured (e.g. smallest type size for text,
clarity of punctuation marks, including decimal points)
 details are complete (e.g. broken characters, missing segments of lines)
 dimensional accuracy matches the original
 no scanner generated speckle
 completeness of the overall image are (i.e. missing information at the edges of
the image area)
 colours or tones are consistent with the original (e.g. density of solid black
areas, colour captured in colour, colour fidelity, correctness of tonal values and
colour balances, correctness of brightness and contrast)
 sharpness of the image matches the original (e.g. lack of sharpening, too much
sharpening, unnatural appearance, halos around dark edges)
 accuracy of captured text.

The quality check should ascertain if all the essential characteristics from source
records have been fully represented. Checks should also be performed on the number
of input source documents versus the number of digitised images created to ensure
the complete record has been digitised.

5.3.2 Re-Imaging

Where a digitised image does not meet quality standards, the source record will need
to be re-scanned.

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 Table 1 summarises problems that may arise when scanning source documents and
presents options for re-imaging. Any additional problems that arise during the
scanning process should be documented and re-image options incorporated in the
business process.

Table 1. Scanning troubleshooting options

Problem with scanned
image
Speckles or spots on the
scanned image.
Skewed images that are
not properly aligned.
Only part of the source
document is captured by
the scanner.
Scanned image is poor
quality.
The use of halftones has
caused a distracting
pattern of lines to appear
on the digitised copy.
Re-imaging options
Clean the glass on the scanner and re-scan the source
record.
Re-scan the paper so that the image appears straight.
All portrait orientation pages should be rotated to read
from left to right. All landscape orientation pages should
be rotated the top of the page facing the left.
Re-scan the paper so that it is properly aligned and the
entire page is included in the scanned image.
Re-set the dots per inch (dpi) setting on the scanner to a
setting higher than 300 dpi and scan again. Keep
increasing the dpi until the record is as readable as
possible.
Use the de-screen function during scanning or post-
capture image processing software to correct the image.
Processes for correcting the image should be
documented.

5.3.3 Training Requirements

Appropriate training should be provided to all staff that create, manage or work with
digitised records. A training programme should be developed and documented that
addresses the following issues:
 overview of the digitisation initiative, its size, timeframe, purpose of digitising
and the decision of outcomes
 proper use of digitisation hardware and software
 use of digital image formats
 proper records handling techniques to avoid damage to records
 maintaining the records in their original order
 digitisation documentation requirements
 parameters for quality control
 how to identify and process records that require specialised digitisation
techniques, such as photographs
 standards and procedures for quality control checking
 varying work to avoid fatigue from repetition.

6. QUALITY ASSURANCE DOCUMENTATION

6.1 Documentation Relating to Business Processes

Quality assurance processes need to be documented, either manually or automatically

through metadata to include both routine activities and audit activities. Routine

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activities are those that are conducted routinely as part of the digitisation workflow
(e.g. daily or on every document). Audit activities are those that are conducted
periodically by a person other than the scanning operator to independently confirm
correct process.

Quality assurance documentation should include as a minimum:

 instructions for the preparation of source documents for digitisation
 instructions for dealing with non-standard documents
 scanner servicing history
 scanner calibration log (e.g. scanner number, username, date and time)
 instructions for the use of scanning hardware including scanning settings
 instructions for how scanned records may be enhanced to create a more
readable image
 steps that need to be taken to correct a scanned record that is not clear and is
difficult to read (e.g. not complete, blurry, or otherwise illegible)
 checks performed on the number of input source documents versus the number
of digitised images created
 business rules for the correction of errors and re-imaging
 documented procedures for periodic checking of all types of metadata
(manually or automatically collected)
 documentation on the level and the frequency of training.

6.2 Accurate Metadata

Written procedures should specify the quality assurance checks required for metadata.
Metadata is defined as data describing the context, content and structure of records
and their management through time. Metadata associated with the digitisation of
source records provides context to the records, and attests to their authenticity and
integrity. WA Health must ensure that the minimum recordkeeping metadata are
accurately captured in accordance with the Policy Toolkit document - Metadata
Guidance.

Quality assurance checks should be undertaken to ensure the reliability and validity of
metadata pertaining to DPRs.

Issues which relate to the quality checking of metadata are:

 checks for grammar, spelling and punctuation
 consistency in the creation and the interpretation
 evaluation of the usefulness of metadata being collected
 completeness of metadata.

6.3 Documentation Relating to Verification Process

This section describes the verification process associated with the quality checking of
DPRs and associated documentation pertaining to this process. It also addresses the
roles and responsibilities of the Scanning Officer, the Authorising Disposal Officer and
the Data Custodian throughout the verification process.

In accordance with the Policy and Schedule, source records must be retained for 6
months following successful digitisation and may be destroyed thereafter if all quality
assurance checks have been performed and Data Custodian authorisation has been

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 received. The verification process is intended to check the DPR for authenticity,
completeness, reliability and suitability to stand in place of the source record as the
official record of business.

The Scanning Officer is responsible for completing the Quality Assurance Form for
Source Records (Quality Assurance Form, Appendix A) for each source record (i.e.
paper-based patient file) or each batch of documents once it is digitised.

The Quality Assurance Form will not be required to be completed manually if there is
the ability to capture this process through the scanning database or via electronic
methods.

When completing the paper version of the Quality Assurance Form, the Scanning
Officer must complete the quality assurance questions and comments section after
digitising the file or batch of documents. The Scanning Officer will attach the
completed Quality Assurance Form to the source record or the batch of documents for
review by the Authorising Disposal Officer.

The Authorising Disposal Officer will then compare the digitised record with the source
record for inconsistencies, taking note of any relevant information contained on the
Quality Assurance Form. Once the Authorising Disposal Officer is satisfied that the
record complies with quality requirements the Quality Assurance Form is signed-off by
the designated officer. The record or documents are then placed in a secure storage
area for the duration of the 6 months retention period awaiting destruction.

During the 6 months retention period a representative sample of digitised documents

may be selected at random for visual inspection by supervisory staff. If a sample is
tested, care must be taken to ensure that the sample is representative of the range of
records digitised.

After the retention period has elapsed, the completed Compliance Declaration Form
(as per the Digitisation and Disposal of Patient Records Policy) is used as evidence of
authorisation for disposal of the source records by the Data Custodian of DPRs.

Completed Compliance Declaration Forms are to be retained indefinitely (can be in

digitised form), in accordance with the Schedule.

Refer to Appendix B for a decision flow diagram for the verification process.

7. DEFINITIONS

Accessible means able to be read or interpreted as having

meaning.
Authentic means the digitised version replicates the attributes of
the source record and can be proven to be what it
purports to be.
Authorising Disposal is a person responsible for assessing the quality of a
Officer digitised record to the source record before
authorisation is given to destroy the source record.
Complete means the digitised version has all the necessary or
component parts of the source record.

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Data Custodian is responsible for the day-to-day management of data
from a business perspective. The Data Custodian
aims to improve the accuracy, usability and
accessibility of data with the data collection.
Destruction or Disposal means a process of eliminating or destroying records,
beyond any possible reconstruction.
Digitised Patient Record is an electronic record that is reproduced from a
(DPR) paper-based record (source) by scanning. Digitised
patient record and scanned patient record are
synonymous in this document.
Dots per Inch (dpi) is a measurement of the resolution of a printer or
scanner that refers to the number of dots the printer or
scanner is able to place in a linear 1 inch (2.54cm)
space. The more dots per inch, the higher the
resolution and the higher the print or scan quality.
Early Disposal refers to the destruction of source records at least 6
months after digitisation.
Half-Tone is a printed image where the density and pattern of
black and white dots are varied giving the appearance
of a continuous tone and image when viewed from a
distance.
Integrity means the digitised version has the same degree of
completeness as the source record, so that it is able to
be used for the same purposes as the source record.
Metadata describes the context, content, quality and structure of
records and their management through time.
Reliable means the contents of the digitised version can be
trusted to be a full and accurate representation of the
contents of the source record.
Scanner-Generated means extra pixels or collections of extra pixels that
Speckle can occur in scanned images because of
imperfections in the scanner hardware, dirt or dust on
the scanning surface or document being scanned.
Scanning Officer is responsible for preparing the files for scanning and
ensuring the scanning equipment is operational. The
scanning officer is also responsible for assessing the
quality of the scanned document with the original
record.
Sharpening is the process of enhancing image detail by
emphasising edges in the image.
Skew is the amount of rotation required to return an image to
horizontal and vertical alignment.
Source Record in this context means a paper-based patient record
where a digitised version has been created. The
source record is the systematic documentation of a
single patient’s medical history and includes, but is not
limited to, notes captured at examination, treatment
plans, medication charts, correspondence between
treating clinicians and diagnostic reports.2 This

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 information is documented, in the first instance, on
paper and filed in the patient’s medical record.
Usability means the digitised version of the source record can
be located, retrieved, presented and interpreted, and
maintains the contextual links of the source record to
the records and activities for which the source record
was created.

8. EVALUATION

In order to ensure currency and ongoing relevance to WA Health, this Toolkit will be
reviewed every 3 years, in conjunction with the Policy and other associated Toolkits,
by the Information Development and Management Branch (IDM) within the Resourcing
and Performance Division.

9. SUPPORTING DOCUMENTS

AS 2828.2 (Int):2012. Health Records - Digitized (scanned) Health Record System

Requirements.
AS/NZS ISO 13028:2012. Information and Documentation – Implementation
Guidelines for the Digitization of Records.
ISO 15489-1:2001. Information and Documentation – Records Management – Part 1:
General.
ISO/TR 15801:2009. Document Management – Information Stored Electronically –
Part 2: Recommendations for Trustworthiness and Reliability.
Public Records Office of Western Australia. Policy Number 8 – Policy for the Ongoing
Management of Electronic Records Designated as Having Archival Value. Perth,
Western Australia.
Queensland State Archives. 2014. Digitisation Disposal Policy Toolkit – Quality
Assurance.
The State Records Authority of New South Wales. 2008. Standard on Digital
Recordkeeping.
State Records Commission of Western Australia. 2008. Standard 8 - Digital
Recordkeeping.
State Records Office of Western Australia: 2009. General Disposal Authority for
Source Records RD 2009027.
State Records Office of Western Australia. 2009. Guideline: Management of Digital
Records.

10. RELATED DOCUMENTS

Digitisation and Disposal of Patient Records Policy

Eligibility of Paper-Based (Source) Records for Early Disposal After Digitisation Toolkit
Metadata Guidance Toolkit
Patient Information Retention and Disposal Schedule
Security Protocols and Ongoing Management Toolkit
Technical Standards for Digitisation Toolkit

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 Appendix A
Quality Assurance Form Affix Patient Label Here
This form must be completed for each source record or batch of
documents that are digitised. Complete the quality control
checklist by ticking the box within each section. The completed
form is to be placed with the digitised records or documents that
are required to be checked by the Authorising Disposal Officer.

Quality Assurance Form for Source Records

Destruction Report Approval Date:

Number:
Name of Scanning Disposal Date:
Officer:
Quality Control Checklist
1.1 The original source record been assessed to ensure it is capable to 
sustain the digitisation process and provide an adequate image.
1.2 The record has been adequately prepared for scanning (e.g. staples 
removed, divider removed, any thermal paper photocopied).
1.3 The original and not a photocopy record is being used. 

1.4 The smallest detail has been legibly captured (e.g. smallest type size for 
text, clarity of punctuation marks, including decimal points).
1.5 Completeness of detail (e.g. acceptability of broken characters, missing 
segments of lines).
1.6 Dimensional accuracy compared with the original (e.g. alignment of 
single pages, replicated size of paper).
1.7 Scanner-generated speckle has been removed (i.e. speckle not present 
on the original).
1.8 Completeness of the overall image area (i.e. missing information at the 
edges of the image area).
1.9 Colours or tones in comparison with the original (e.g. density of solid 
black areas, colour captured in colour, colour fidelity, correctness of tonal
values and colour balances, correctness of brightness and contrast).
1.10 Sharpness of the image compared to the original (e.g. lack of sharpening, 
too much sharpening, unnatural appearance, halos around dark edges).
1.11 Accuracy of captured text. 

1.12 All mandatory metadata fields are complete. 

Comments:

Signature of Scanning Officer:

I certify that the above checklist has been completed and the source record can be authorised
for destruction once the 6 month retention period has expired:
Signature and Name of
Authorising Disposal Officer:
Note: This form is to be attached to the Compliance Declaration Form when disposal is to occur. Upon destruction this form is
to be retained indefinitely (can be in digitised form) in accordance with the Patient Information Retention and Disposal Schedule.

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 Appendix B

A decision flow diagram for the quality assurance process

Patient source record received for scanning.

Scanning Officer inspects the source record to determine if it is physically suitable for scanning.

Scanning Officer prepares source record for scanning. Scanning process commences.

Scanning of source record is completed.

Scanning Officer compares the source record with the digitised copy for inconsistencies.

Scanning Officer identifies an inconsistency Scanning Officer confirms that the digitised copy is
between the source record and the digitised copy. identical to the source record.
Source record is required to be re-imaged.

Scanning Officer completes the Quality Assurance

Scanning Officer re-scans the image and confirms Form.
that the digitised copy is consistent with the source
record.

Source record and digitised record is sent to the

Authorising Disposal Officer for comparison.

Authorising Disposal Officer identifies an Authorising Disposal Officer checks that the
inconsistency between the source record and the digitised record is identical to the source record.
digitised copy. Source record is required to be re-
imaged.

Authorising Disposal Officer signs off on the

Quality Assurance Form.

Source record is placed in the storage area
awaiting destruction (during this time random
sampling may occur). After 6 months (minimum)
the Authorising Disposal Officer collates all of the
Quality Assurance Forms for source records
(either manually or via electronic report) for
submission to the Data Custodian.
Authorising Disposal Officer submits the Quality
Assurance Form and Compliance Declaration Form
to the Data Custodian. The Data Custodian
approves destruction of source records and signs
off on the Compliance Declaration Form.

Quality Assurance Form and the Compliance Declaration Form are to be retained indefinitely in
accordance with the Schedule.

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 This document is available in
different formats, upon request from
a person with disability.

© Department of Health 2014