Requirements for the Retention of Laboratory Records and Diagnostic Materials, 5th Edition - Draft for Consultation

Appendix A (Normative)

A draft document, provided by the National Pathology Accreditation Advisory Council for public consultation, of the updated requirements for the retention of records and diagnostic materials by pathology laboratories.

Page last updated: 22 October 2012

Notice of Information Technology (IT) Standards under the Electronic Transactions Act 1999 for Electronic and Paper

  • Referrals to consultant physicians or specialists
  • Requests and confirmations of requests for pathology services to approved pathology practitioners
  • Requests for diagnostic imaging services

This notice specifies the IT standards the Medicare Australia (formerly Health Insurance Commission, HIC) requirements for the electronic transmission, scanning, and storage of:
  • Referrals to consultant physicians or specialists pursuant to ss20BA and 133(2) of the Health Insurance Act (1973) (‘the Act’).
  • Requests for, and confirmation of requests for, pathology services to approved pathology practitioners pursuant to ss16A and 23DK(1) of the Act, Reg,9A, Health Insurance Regulations (the regulations) and the Health Insurance (Pathology Services) Regulations (the HI(PS) regulations);
  • Requests for diagnostic imaging services pursuant to ss23DR and 23DS of the Act and Reg.19 of the regulations.

In this notice:
  • Any reference to a ‘request’ for a pathology service includes a confirmation of the request.
  • Medicare Australia Standards’ means the standards for PKI, certificate recognition, and EDI formats set out at www.medicareaustralia.gov.au, professional stream under ‘e-business’. Non-digital images, such as microfilm, are not supported as IT standards.

These IT standards address:

1. Fully electronic referrals or requests

2. Scanning of paper referrals or requests for electronic storage

3. Storage of referrals or requests (wholly electronic or scanned)

1. Fully electronic referrals or requests
1.1 Where a medical practitioner:
  • Refers a patient to a specialist or consultant physician: or
  • Requests a pathology service; or
  • Requests a diagnostic imaging service,

by electronic means, Medicare Australia requires that the referral or requests:
a) Consist of either a standard e-mail message*, or a recognised EDI format, that is transmitted using Medicare Australia’s PKI standards;

b) Meet all the requirements for a referral or request provided in the Act, the regulations and the HI(PS) regulations; and

c) Be digitally signed by the referring/requesting practitioner using an individual private key for which there is a current public key certificate recognised by Medicare Australia (in accordance with Medicare Australia’s PKI standards), to allow a specialist, consultant physician, or approved pathology practitioner or medical practitioner to verify the authenticity of the referral or request upon receipt.

*For text or email referrals, any text format in common use on English-language websites is acceptable, including plain text, hypertext markup language (HTML), Microsoft Word (DOC), rich text format (RTF), and portable document file (PDF).


2. Scanning of paper referrals or requests for electronic storage

2.1 Where an image of a paper referral or request is scanned for electronic storage:

Medicare Australia requires that:
a) The scanned image be unaltered and unalterable from the moment scanning is finished, including confirmed as completed at batch or individual level:

b) The image have appended to it, or associated with it, by the system, a unique reference number (reference number)

c) Consecutively created images have consecutive reference numbers;

d) The date and time the image was converted to digital form be recorded;

e) The whole digital image, including the reference number, date and time as requested in 2(b) and 2(c), is digitally signed as a true copy under Medicare Australia’s PKI Standards by a person independent of the referring specialist or consultant physician, the rendering approved pathology practitioner or medical practitioner; and

f) In cases where a group of images are digitally signed simultaneously, the digital representation of all images in the group be able to be produced in full along with the individual requested image, so as to permit verification of the digital signature. Acceptable image formats include those in common use on websites and popular scanning software.

2.2 Where an image of a paper referral or request is scanned for electronic storage,
Medicare Australia permits:
a) De-speckling, de-skewing, and minor cropping to the extent that this does not compromise the image;

b) Superimposition of the sequential number and date/time on the scanned image provided the original details are not concealed by the superimposition.

c) The digital signature required by 2.1(e) is to be applied after all such operations are completed.

3. Storage of referrals or requests (wholly electronic or scanned)

3.1 Where an image of a paper referral or request is stored electronically, Medicare Australia requires that:
a) a stored referral or request be retrievable in a legible form that:
i. provides a complete, accurate and legible paper reproduction copy of the referral or request at its original size, and
ii. contains, where a signature was required on the original referral, a complete and accurate representation of the original signature/s on the original referral;

3.2 Any system that electronically retains and stores referrals or requests must not permit any loss, improper disclosure, destruction, addition, or alteration of the electronically scanned image of the referral or request, nor any compromise of stored information affecting the verification of any digital signatures.

3.3 (a) Specialists, consultant physicians, approved pathology practitioners and medical practitioners using electronic storage must ensure the adequacy of:
i. physical security;
ii. logical information security;
iii. information security and record retention policies;
iv. information privacy, confidentiality and release policies;
v. back-up and recovery policies, procedures and practices covering data, software and essential equipment;
vi. archiving processes;
vii. redundancy, recovery and auditability of systems (including ability to trace activities and events), and
viii. business continuity strategies.

(b) A back-up copy of the digitally signed scanned image and electronically
received referrals or requests, are to be electronically stored in a physically separate secure location.

(c) Electronic referrals or requests, and scanned images of paper referrals or
requests must be retained unencrypted with the authors’ digital signatures intact and verifiable.

(d) In satisfying the requirements set out in 3.3(a), Medicare Australia requires that documentation and records demonstrating compliance be made available promptly to Medicare Australia on request.

(e) The storage system must enable all electronically stored referrals or requests for a particular:
i. Period, including a particular date; or
ii. Requestor of a medical service


To be identified and produced to Medicare Australia on request.