Quality Assurance Guidance

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 paperbased 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. Page 1

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. Page 2

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. Page 3

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. Page 4

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 postcapture 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 Page 5

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 Page 6

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 Authentic Authorising Disposal Officer Complete means able to be read or interpreted as having meaning. means the digitised version replicates the attributes of the source record and can be proven to be what it purports to be. is a person responsible for assessing the quality of a digitised record to the source record before authorisation is given to destroy the source record. means the digitised version has all the necessary or component parts of the source record. Page 7

Data Custodian Destruction or Disposal Digitised Patient Record (DPR) Dots per Inch (dpi) 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. means a process of eliminating or destroying records, beyond any possible reconstruction. is an electronic record that is reproduced from a paper-based record (source) by scanning. Digitised patient record and scanned patient record are synonymous in this document. 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 Scanner-Generated Speckle Scanning Officer Sharpening Skew Source Record means the contents of the digitised version can be trusted to be a full and accurate representation of the contents of the source record. means extra pixels or collections of extra pixels that can occur in scanned images because of imperfections in the scanner hardware, dirt or dust on the scanning surface or document being scanned. 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. is the process of enhancing image detail by emphasising edges in the image. is the amount of rotation required to return an image to horizontal and vertical alignment. 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 Page 8

Usability information is documented, in the first instance, on paper and filed in the patient s medical record. 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 Page 9

Quality Assurance Form 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. Affix Patient Label Here Appendix A 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. Page 10

A decision flow diagram for the quality assurance process Patient source record received for scanning. Appendix B 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 between the source record and the digitised copy. Source record is required to be re-imaged. Scanning Officer confirms that the digitised copy is identical to the source record. Scanning Officer re-scans the image and confirms that the digitised copy is consistent with the source record. Scanning Officer completes the Quality Assurance Form. Source record and digitised record is sent to the Authorising Disposal Officer for comparison. Authorising Disposal Officer identifies an inconsistency between the source record and the digitised copy. Source record is required to be reimaged. Authorising Disposal Officer checks that the digitised record is identical to the source record. 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. Page 11

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This document is available in different formats, upon request from a person with disability. Department of Health 2014