Clinical User Guide
HL7 Investigations Results and Clinical

Introduction

Generally, Investigations Results are received by Clinical after an associated request has been issued by the practitioner on behalf of a patient. However, at the time the original request is made, the requesting practitioner can select another recipient from the Clinical Address Book to receive a copy of the result(s).

The following processes are involved in the managing of Investigations Results:

1.      Downloading and decrypting of the Results batch files from the Investigations Provider's computer to the customer's computer. This is the responsibility of the provider. Results batch files may contain up to 200 results for multiple patients, although it is common for each result file to contain a single result.

2.      Importing the individual result data from the results batch files into Clinical's Holding File. Each test result is imported as a separate entry in the Holding File. Configuration of Clinical to allow for successful importing of Investigations Results is the responsibility of the receiving practitioner.

3.      Checking the results and transferring them to the associated patient record. This is the responsibility of the receiving practitioner.

4.      Notifying the patient of the outcome and completing the audit trail. This is the responsibility of the receiving practitioner and/or staff at the surgery.

This document discusses only the first two processes.

Downloading Results to the Surgery

MedicalDirector is not responsible for any communications or file transfer of results batch files between sites. It is the sole responsibility of the Investigations Results Provider to install, setup and maintain the necessary third-party software required to download Results files to their customer's computer, and such software solutions may require an Internet connection (possibly encrypted e-mail), a pre-scripted communications program or a custom written package developed by the Investigations Results Provider.

The computer which accepts the transfer of results from the lab (connected to the Internet and running the download software, for example), does not have to be the Clinical server - it can be any computer on the network, including a workstation, provided it is able to store the batch files on the server, where they can then be accessed by Clinical from all other computers. The designated download folder for results must have sharing and security settings that allow all users full control of the files.

Result batch files must be decrypted by the Investigations Results Provider’s download program and stored in a folder that has been setup in Clinical. The default folder is located on the server (shared as MSGSIN), at: C:\Program Files\Health Communication Network\Messages\In\

However, it is common practice to use one or more folders setup by the Investigations Results Provider. Such folders must be setup on all computers that need to import results (see Setting the Investigations Search Path). For example, HealthLink use a series of folders located within the HLink folder:  \\servername\HLINK\HL7_in\LAB2, or variations of this depending on the file type and content.

Running a Download Program

Result batch files should be downloaded regularly to store new results ready for the practitioner to check. There are three options:

o      Provide a 'shortcut' (icon) on the user's desktop, which runs the third-party download program. This may also be provided to allow manual downloads, as well as one of the following options.

o      Set up a scheduler to automatically transfer the results at regular intervals. As this is most frequently a part of the download program it should be configured by the Investigations Results Provider during installation of the program. The Provider will be able to confirm this facility is available and provide assistance with configuring it for the Surgery’s requirements. The Windows Scheduler may also be used, but again, must be setup by the Provider.

o      Allow Clinical to run the program when a user selects the Investigations > Download option in Clinical. This method is infrequently used today and is included for legacy support.

Scheduled Document Import (SDI)

SDI was introduced in Clinical 3.10.5 to import all stored results at 30-second intervals. Select Tools > Manage Communications and ensure the ‘Allow SDI to process MedicalDirector Clinical’s standard folder’ checkbox is ticked. The first time this is activated a test of the SDI link between the workstation and server is initiated. This may take a few minutes.

SDI will automatically import results into the Holding File from:

o      MDExchange,

o      HealthLink,

o      MedicalDirector Clinical Executive folder,

o      The downloads default folder – [server]C:\Program Files\Health Communication Network\Messages\In,

o      Folders setup in …Advanced > Third Party Import/Export Configuration that are SDI Enabled.

The practitioner is then notified that they have new results. Any non-standard folders you require must be setup in Tools > Options > Investigations > Setup Data Transfer > Advanced > Third Party Import/Export Configuration. Enter the Software Description and the Import and Export Folders and ensure the SDI Enabled checkbox is ticked.

File Formats

There are two industry standard file formats used for transferring Investigations Results information:

o      PIT: a simple, text based, space-delimited format without the advanced features of HL7. PIT files may be found embedded in an OBX segment of an HL7 message.

o      HL7: the Australian Standard for the electronic transfer of medical information, including Investigations Results. Further information about HL7 is available from Standards Australia. Other standards in the HL7 series exist for the transfer of other clinical information. An HL7 message is broken into segments, each containing specific information, and identified by an alpha/numeric coded prefix. For example, the result information is in the OBX segment(s).

 

The following standards currently apply to investigations:

o      AS 4700.2—2004 Implementation of Health Level Seven (HL7) Version 2.3.1 Part 2: Pathology orders and results

o      AS 4700.2—2007 Implementation of Health Level Seven (HL7) Version 2.4 Part 2: Pathology and medical imaging (diagnostics)

o      AS 4700.6—2004 Implementation of Health Level Seven - HL7 Version 2.3.1 - Referral and discharge summary

HL7 files may be opened in Windows Notepad, but should not be edited, as this may damage the data, preventing them being imported into Clinical. These files may be difficult to read manually as they are frequently created without line breaks between segments and they contain large numbers of non-alphanumeric characters. The files are text based, with the data delimited by pipes and carats ( | and ^ ). Currently images or hyperlinks are not able to be received by Clinical. Results containing this type of information cause errors that will abort the import process.

Importing the Result Files into Clinical

Clinical contains two menu items which, when clicked by the user will import any investigations results it detects. The files are identified by residing in the designated folder and having a designated file extension. These menu items are:

o      Investigations > Download: Selecting this menu item (or pressing F4) causes Clinical to run any third-party programs setup within Clinical, and then move any result batch files into the local computer’s Processing folder.

o      Investigations > Check Holding File: Selecting this menu item (or pressing F5) will not run any third-party programs, but will move any result batch files that have been previously downloaded into the local computer’s Processing folder.

Files are then checked to ascertain they contain valid result data. HL7 files must contain at least one OBX segment. Individual results are then extracted and imported into Clinical's Holding File before prompting the user to view or check the imported results.

The Processing folder must not be used to store downloaded results, or for any other purpose - this folder is a managed resource and will be emptied after each processing. Setting the Processing folder as a download folder will also result in Copy errors as each file is processed.

Scheduled Document Import (SDI) will import results into the Holding File automatically at 30-second intervals.

To prevent duplication of results it is imperative that Sharing and Security is set to allow all users (an ‘Everyone’ share) Full Control of these folders - users must be able to copy and delete all files.

Acknowledgments

When an HL7 result batch file is imported into Clinical the Investigations Results Provider or sender has the option to receive an acknowledgement file. There are two types of acknowledgement file depending on the type of downloaded file. These files are created automatically if the option, Tools > Options > Investigations > Generate ACK files box is ticked or Generate Acknowledgements box is ticked in …Advanced > Upload/Download software….

o      ACK: acknowledgment for all types of result, including letters, with an ORC or ORU segment – 12345.ACK for example, except,

o      RRI: an acknowledgment for Discharge Summaries sent in HL7 with an RF1 segment – 12345.RRI for example.

The acknowledgement files are stored in the folder(s) set via Tools > Options > Investigations > Setup Data Transfer in the Uploads text box, or …Advanced > Upload/Download software… for each entry.

File Naming Conventions

Clinical looks for files (in the specified paths) with a three character file extension matching any of Clinical's list of registered file extensions. While not absolutely necessary, it is recommended that result files use the 8.3 DOS naming convention (8 characters followed by a dot followed by a further 3 characters) to maintain compatibility with legacy systems. The three character file extension should be appropriate for the type of file; PIT or HL7, or the name of the provider, for example, SNP (Sullivan, & Nicolaides Pathology), QML (Queensland Medical Laboratory) and so forth.

Do not use common file types such as TXT (text file), DOC (Document) or file types which may have special meaning to your operating system such as DLL (Dynamic Link Library), CPL (Control Panel), EXE (Executable) and so forth. These files would be deleted as part of the import process which would compromise the computer’s programs.

Long file paths and names may cause problems when transferring files across a network. For example, if a file path and name exceeds 64 characters it may be truncated by SQL, resulting in an error in MedicalDirector Clinical.

Adding or Removing File Types

As mentioned above, Clinical only looks for files with a file extension corresponding to a list of registered file types. By default, this list includes common extensions such as PIT, HL7 and some of the larger or more widespread providers. This list is maintained by the user, who can add and delete file extensions as required. File extensions are managed in Clinical via Tools > Options > Investigations.

Setting the Investigations Search Path

You can specify a different search path for each provider if the default folder is not used. This is the path MedicalDirector Clinical looks to for result files when importing investigations. Each separate file path needs to be setup at least once on each workstation, therefore if a number of providers share a common download folder or the default folder is used this path will need to be setup for only one of them. There are two methods:

Normal

Select Tools > Options > Investigations > Setup Data Transfer.

Select the provider from the list and click the Browse button beside the File Path text box.

Browse across the network to the download folder used by that provider. Browsing will confirm that the folder is available across the network. This setting is stored in the Local Machine Registry, which requires Windows Administrator access when making changes. The file path will need to be setup on all computers and the folder will need to be shared with Full Control for Everyone. The Uploads path sets the storage location for acknowledgement files.

Advanced

If the surgery is using Electronic Orders or SDI, select Tools > Options > Investigations > Setup Data Transfer > Advanced and setup the folder(s) in the Upload/Download Software Installed list. Consult the provider for the details required for the Import and Export folders and HL7 data. This is a global setting and will cover this provider on all workstations on the network. UNC path names should be used instead of mapped drive letters. For example, use server\\results\in instead of Z:\ even if these are technically the same location.

Holding Files

Results are stored in the Pathol table and a flag is set to display them in either the Holding File or the patient’s record, dependent on a practitioner checking the result.

Letters, Discharge Summaries and Results

Some confusion exists as to the final destination of files that do not contain Investigations Results. There are three locations within a patient’s record where Results, Letters and Discharge Summaries are stored, depending on the content of the file and the testname used.

A recent trend has been for specialists to send their reports in either PIT or HL7 format to be processed with Investigations files. Hospitals are starting to send Discharge Summaries to surgeries in either PIT or HL7 format.

An HL7 file with the words ‘Letter’, ‘Document’, ‘Correspondence’ or ‘Summary’ in the testname or if the testname has been excluded will be stored in Letters.

Any PIT or HL7 file containing the words ‘Discharge Summary’ in the testname will be stored in Documents or Letters depending on the setting in Tools > Options > RSD. Any HL7 file that contains an RF1 segment will be stored in Documents or Letters depending on the setting in Tools > Options > RSD irrespective of the testname used. RF1 segments are only found in Discharge Summaries.

All others are regarded as investigation results and are stored in the Results page in the patient record and in the Investigation Results window.

Documents stored in the patients Letters or Documents pages do not appear in the Investigation Results window. Most frequently these are documents sent from specialists or hospitals.

Results with Numeric Data

HL7 results may contain numeric (atomised) data related to test results. If this data is contained within numeric OBX segments, associated with recognised LOINC and test names it will be displayed automatically in a number of places in Clinical.

For example, HDL, HDLCHOLESTEROL, CHOLESTEROLHDL and HDL(PROTECTIVE) results using the LOINC code 14646-4 will be added to the HDL field in the patient’s diabetes record and added to the Measures table to be displayed as a Cumulative Result. For further information see Knowledge Base Article MD2-04 - Clinical and HL7 Results – originally written for MD2 it is also relevant to Clinical.

Sequential numeric data may also be viewed in tabular form and displayed in charts by clicking the Cumulative Results button on the results page of the patient’s record.

HL7 Format Table

The following information describes how MedicalDirector Clinical processes pathology results sent in HL7 format, specifically those results containing LOINC Codes or any of the Test Names listed in the table following within a numeric OBX segment. This information relates only to results in HL7 format that include an appropriate OBX segment.

For results received that contain a LOINC code or any of the test names listed in the table below, after the results have been actioned from within the Holding File, and the Holding File closed, a value is added to the patient’s file.

Notes:

o      Spaces and other characters such as commas and colons are removed from the test name before it is checked.

o      The content in this table may be altered from time-to-time without notification.

Value Added

LOINC Code

Test Name

 

Value Added

LOINC Code

Test Name

Diabetic Notes

o      Diabetic results (eg CREATININE, HbA1c, HDL, TRIG) will be automatically transferred into the Diabetes Record inside the patient’s file.  In doing so, the information will also be displayed within the Diabetes Register (available via the Search menu) if the patient is flagged as having a diabetic condition.

o      The BSL value is for non-fasting or random glucose and is not picked up in the patient’s Diabetes Record although it is plotted on the patient’s Blood Glucose Graph.

o      Other fields in the Diabetes Register, including Fasting Blood Glucose, Protein, Glycosuria, Haematuria, Ketones & Leucoytes are not automatically transferred into the patient’s diabetes record when a result is checked off.

o      Fasting Blood Glucose results do not automatically populate the Blood Glucose Graph even though they display after being entered through the Add Values Button of the Diabetes Record.

 

INR Notes.

o      INR results (e.g. INR, PT) will be automatically transferred into the INR module inside the patient’s file.

Clinical Cumulative Pathology Results

Clinical accommodates Cumulative Results, which, if the following rules are adhered to, can be viewed from within the Results tab of the patient file.

o      Only results received in HL7 format and which include an appropriate OBX segment will be included in the cumulative results display.

o      Only results in numeric format will be stored. OBX 2 must contain NM, as shown in the following examples.

o      Clinical reads the first and third components of the OBX 3 element to determine which tests to group together:

OBX|1|NM|code^testname^coding system|…

For example: OBX|1|NM|1751-1^Albumen^LN|…(LN signifies a LOINC code).

 

o      The second component of the OBX 3 element is displayed as the Test Name on the Cumulative Results display.

o      Where different providers use different coding system numbers there will be multiple entries in the Cumulative Results table. If the code LN is used in OBX3^3 the data in OB3^1 will be regarded as a LOINC number. The LN code must not be used if an alternate coding system is used.

For example:

OBX|1|NM|1751-1^Albumen^LN|…will not be grouped with:

OBX|1|NM|1234^Albumen^XY|…even though the Cumulative Results table will display both as “Albumen”.

 

o      Similarly, if different providers use the same coding system number to represent different tests, these will be grouped. If the code LN is used in OBX3^3 the data in OB3^1 will be regarded as a LOINC number. The LN code must not be used if an alternate coding system is used.

For example, if a result arrives with:

OBX|1|NM|1751-1^Albumen^LN|…and then later a second result arrives with:

OBX|1|NM|1751-1^Platelets^LN|…then these results will be grouped together in the Cumulative Results Table, and the Test Name displayed will be the name of the first result received, i.e. “Albumen”.

 

o      The cumulative results are displayed in order of date of receipt.