PACS Specification by mikeholy

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									Specification for RADIOLOGY PACS
Introduction: The below document describes specifications for a radiology PACS for
storage & appropriate display of radiology images (CR/DR, CT, MRI, US, Fluoroscopy, etc).
If the same PACS is used for display of other images—ophthalmology, cardiology etc, please
ensure standards for storage & display of the types of medical images are reviewed &
incorporated into the specification.
Current day Radiology PACS Systems perform 2 basic functions
1. DICOM Image Archive & Manager—i.e. long term store of images—(this can be either
provided by a Vendor Neutral Archive or the PACS)
2. DICOM Image Display—display of images stored in the image archive above---This can
be either a part of PACS or a separate image viewer.

PACS= DICOM Image Archive/Manager + DICOM Image Display
PACS integrates with the following IT systems :
   PAS (Patient Administration System) for demographics, current location, current
      responsible consultant/GP
   RIS (Radiology Information System) for scheduling information & report information
   Modalities—receives images & image related information

1. DEMOGRAPHICS & ADT INFORMATION CONSISTENCY—All demographics &
ADT (Admission Discharge & Transfer information) must be kept up-to-date on all clinical
IT systems within any organization. Any demographics update or patient merges on PAS
must realtime update PACS systems.
IHE Standards--Patient Information Reconcilliation (PIR) Profile: ―PIR handles:
unidentified/emergency patient, demographic information updates ( e.g patient name changes
(marriage, etc.) , correction of mistakes, ID space mergers). Such changes are reliably
propagated to all affected systems, which update all affected data. The result is a complete
patient record. ―
   a) PACS
   b) RIS
   c) PAS
   Must all comply with PIR Profile of IHE.


2. PATIENT BANNER INFORMATION---The patient demographics and ADT
information for a patient MUST be consistently displayed on the top demographic banner of
any clinical system (PACS, RIS & Ordercomms)---realtime demographics synchronization
with PAS is mentioned above. This is hugely important for patient safety & care –ensure that
timely communication, ensuring correct ID, timely action can be taken:
                  a. Name
                  b. DOB
                  c. Sex
                  d. NHS No.
                  e. PAS No.
                  f. Current Patient Location
                  g. Current Responsible Consultant


3. SEARCH CRITERIA FOR A SINGLE PATIENT or GROUP OF PATIENTS: It
should be possible to search for a single/group patients using one or any combination of the
following criteria:
                  a. Name
                  b. DOB
                  c. Sex
                  d. NHS No.
                  e. PAS No.
                  f. Current Responsible Consultant
                  g. Requesting Responsible Consultant
                  h. Current Patient Location
                  i. Operator
                  j. Reporter
                  k. Workflow Status of study (see section--)
                  l. Modality
                  m. Exam Description
                  n. Exam Room

                  o. Date or date Range (for exams)


4. CLINICAL DATA FIELDS DISPLAY on Images: Below describes Information that
needs to be stored & available for display for the clinical user/Radiologist viewing the PACS
image. This also identifies what clinical data fields should be transmitted as metadata fields
or tags to XDS registry/repository (if XDS is made the standard for including radiology
images into the EPR). The terms used for describing data fields must reflect terms in use in
NHS ( e.g.—Responsible Consultant/GP etc)

       A. PATIENT DEMOGRAPHICS (synchronized with PAS)
                    Name,
                      a.
                    DOB,
                      b.
                    Sex,
                      c.
                    PAS No.,
                      d.
                    NHS No. (CHI number for Scotland)—NHS number may not be
                      e.
                    present in 100%exams sent to PACS
     B. REQUESTER—synchronized with RIS
              a. Name of Requester
              b. Grade of requester
              c. Contact number of requester
                  d. Requesting **Responsible Consultant/GP (Team)—(Also
RECIPIENT)
                   e. Requesting Speciality/Department/GP surgery
                   f. Requesting Institution
                   g. Date & time of request made
      C. IMAGE DOCUMENT—synchronized with RIS & modalities
                   a. Modality
                   b. Exam Description---(National Exam Codes & Descriptions)
                   c. Date & Time image acquired on modality
                   d. Date & time of image sent from modality
                   e. Date & time received on PACS
                   f. Exam Room (where the exam has been performed)
      D. OPERATOR/IMAGE CREATOR –synchronized with RIS & modality
                   a. Name of Operator
                   b. Grade of Operator
                   c. Contact number of Operator
                   d. Performing Responsible Consultant
                   e. Performing Department/Speciality--Radiology
                   f. Performing Institution/NHS Trust
      E. REPORTER—synchronized with RIS
                   a. Name of Reporter
                   b. Grade of reporter
                   c. Contact number of reporter
                   d. Reporting Responsible Consultant
                   e. Reporting Department/Speciality
                   f. Reporting Institution/NHS Trust
                   g. Date & time report verified
     F. WORKFLOW data fields
                       a. Workflow status
                       b. Workflow priority
   It is important that the relevant data fields are synchronized between PAS, RIS,
   modalities & PACS.


5. WORKFLOW STATUS: This is a key concept for driving a workflow within the
radiology department. The status must be synchronised between Ordercomms, RIS, PACS &
Results Acknowledgement systems.
                  a. Requested (ORDERCOMMS)
                  b. Request Vetted (RIS)
                  c. Request held/deferred--with reason (RIS)
                  d. Scheduled or appointment given (RIS)
                  e. Cancelled (RIS/ORDERCOMMS) with reason
                  f. Arrived (RIS)
                  g. Did Not Attend (RIS)
                  h. Exam started (RIS)
                  i. Exam Completed (RIS)
                  j. Exam not performed --with reason (RIS)
                  k. Report Dictated (RIS)
                  l. Unauthorised report (RIS)
                  m. Authorised/Verified Report(RIS)
                  n. Amended Report (RIS)
                  o. Report Viewed (Ordercomms/RAS)
                  p. Report acknowledged (ORDERCOMMS/RAS)
                  q. Review requested (Ordercomms)
                  r. Was not brought (RIS)
                  s. Housekeeping (RIS)




6. CULLING OF IMAGES
The system must be able to get information about date of death from PAS systems. All
images related to the patient must be automatically culled 3 years after death.
Automatic culling of images should be possible 7 years after an image is acquired
However, there needs to be protection flags in the following circumstances:.
a. Automated Protection flags—for those less than 25 years
b. Manual Protection flags—cancer, medicolegal cases etc
Please see the DOH guidance on records retention for details.

7. IMAGE RETRIEVAL & DISPLAY PERFORMANCE: Display of images for
reporting & comparison should be within 3-5secs on all radiologists workstations. This is a
well-accepted clinical standard. Thus all images within 7years clinical period should be
accessible within 3-5secs to radiologists. Access to images is dependent on server capacity,
network, display hardware spec etc. PACS vendor must specify network, server capacity,
display hardware appropriately.

However, if we are storing images simply for legal reasons then we need to store them as
cheaply as possible---e.g DVDs in a locked cabinet etc. As there is more time available to
retrieve images for medico-legal purposes---1-2 weeks. Number of retrievals required for
medico-legal reasons will be minute (compared to retrievals required for clinical assessment).
We need to inform radiologists & clinical community that images stored are not for clinical
usage.


8. DICOM MODALITY WORKLIST—When a patient arrives within a department a
modality (CT, MR, US etc) needs to be ―aware‖ that the patient is in the department & pull
the relevant demographics & study information across to the modality (to avoid manual data
entry on the modality). In simplistic terms, DICOM Modality Worklist(DMWL) is a list of
patients on RIS who have an ―arrived‖ status. As the scheduling system RIS is responsible
for scheduling patients & ensuring logging patients arrival into the department. Each
modality will continuously query the RIS (which should provide a DMWL) for any exams
–based on modality & Exam Room. Normally the DMWL provider is the scheduling system
used for scheduling information to a modality (In Radiology RIS provides a DMWL for
radiology modalities). The following information needs to be provided by RIS to
modalities.
       a. Patient Demographics
              i. Name,
              ii. DOB,
              iii. Sex,
               iv. PAS No.,
       b.   Modality
       c.   Exam Description---(usually National/Local Exam Codes & Descriptions)
       d.   Exam Room
       e.   Accession No. (RIS generates this for every exam)
       f.   Study UID (RIS generates this for every exam)

The modalities query the RIS & display a list of patients--- related to one or more Exam
rooms who have ―arrived‖ workflow status. Once the status is changed to ―exam performed‖
or ―exam not performed‖ on RIS,-- the exam should drop off the DMWL and no longer be
visible to modalities.

Once the exam is completed on the modality, radiographers must be able to send images to
PACS.

“IHE Standard—Scheduled Workflow Profile-- Scheduled Workflow establishes a
seamless flow of information that supports efficient patient care workflow in a typical
imaging encounter. It specifies transactions that maintain the consistency of patient
information from registration through ordering, scheduling, imaging acquisition, storage and
viewing.

          Modalities (as acquisition modality actor),
          RIS (as departmental system scheduler actor),
          PACS (as Image Manager & Image display)
must all support to Scheduled Worklfow Profile of IHE‖

A standardised approach to DMWL provision is key to supporting long term storage of
DICOM images from non-radiology modalities like—cardiology, retinal images etc

Current Situation in NHS--In many hospitals in NHS, PACS Brokers (often called
Connectivity Managers, RIS Gateway, PACS Broker etc) provide DMWL functionality. This
could be related to the inability of RIS to provide a DMWL or PACS vendors insist on
including brokers as part of their PACS solution. However, if a RIS is capable of providing a
DMWL there is no need for creating a additional weak link between RIS and modalities---
thus introducing an additional point of failure. Use of PACS Brokers is a non-standard
implementation. Hence, PACS replacement is a time for NHS to review their PACS
implementations so that they adopt global standards—which are key to ensuring plug & play
interoperability & reducing price of NHS IT.

Exceptional circumstances where a PACS broker may be required: If there are 2 or more
separate information system scheduling for the same modality—e.g. NBSS & RIS for a
mammography modality, Ultrasound modality used for cardiac echoes & radiology i.e.---
scheduled by RIS for radiology & CIS for Cardiac Echoes. Use of brokers should only be on
exceptional circumstances.



9. CONSISTENT IMAGE QUALITY (FROM MODALITIES to PACS)---Images once
created in modalities will be sent to PACS for long term storage. Radiographers ensure that
images are of good quality before transmitting to PACS. It is important that image quality is
kept intact during transmission from the modality to PACS. Adherence to DICOM standards
& IHE will ensure that quality of images & data are not compromised.

IHE Standards— Consistent Presentation of Images Profile of IHE
 “Consistent Presentation of Images maintains the consistency of presentation for grayscale
images and their presentation state information (including user an notations, shutters,
flip/rotate, display area, and zoom). It also defines a standard contrast curve, the Grayscale
Standard Display Function, against which different types of display and hardcopy output
devices can be calibrated. Thus it supports hardcopy, softcopy and mixed environments.”

Acquisition Modalities &
PACS (as Image Manager & Image Display Actor)
must support Consistent Presentation of Images Profile of IHE


10. THREE CLICK REPORTING WORKFLOW---SINGLE SIGN-ON (SSO) , DESKTOP
INTEGRATION (DTI) OR CONTEXT SYNCHRONIZATION, AUTOMATIC DISPLAY RELEVANT
PRIOR—

3 click reporting workflow should be possible from the RIS & PACS integration.
        a. Draw up a RIS worklist for reporting
        b. Launch a patient’s exam for reporting on RIS on left RIS monitor—automatic
            display of current images on PACS on middle monitor with automatic display of
            relevant prior on right monitor---dictate/VR a report on RIS
        c. Click on the next exam on RIS worklist—which closes the previous PACS images
            & launches the next patient on RIS & PACS

SSO-Process of logging in should be quick & slick. The system should support single sign-on
process as used in a hospital. As a minimum, additional user name and password should not
be required when using RIS & PACS. When a user logs into RIS for reporting the user
credentials must be passed onto PACS with no need for additional user name and password
input.

Desktop Integration (DTI) must be at EXAM level with Information Systems: Desktop
Integration with RIS is well established with PACS.
           a. Automatic RIS to PACS Integration. In most NHS Trusts RIS is used for
               reporting of radiology images. For clinical reasons there should be automatic
               display of relevant radiology images when an exam is picked up for
               reporting on RIS.
           b. Manual PACS to RIS integration—when images are displayed on PACS, it
               should be able to display the RIS for that episode. This would be important at
               MDTMs, or when a request is made for a 2nd opinion etc, to allow for an
               addendum to be recorded on RIS.

     Similarly DTI is required with other Information Systems, CIS, Ophthalmology
     System, Breast Screening System, Endoscopy Systems, if these images get stored on
     the same PACS.

Automatic Display of relevant prior Image & Report: This is hugely important for
reporting Chest X-rays, oncology CTs in particular. It is well recognised that prior image and
report display will increase the accuracy of radiologists report & improves patient care. A
good dynamic display protocol is required which automatically displays the prior similar
exam on the right hand monitor of PACS (with the middle monitor displaying the current
image for reporting). The associated report needs to be displayed automatically as well.
Making these display automatically increases the chance of prior images & reports being
reviewed & compared. This improves patient care & clinical quality.


11. BASIC RADIOLOGY IMAGE DISPLAY & MANIPULATION TOOLS: The type
of display dictates the user experience of PACS:
a. user must not be overwhelmed ---―‖Workflow is inversely proportional to the number of
buttons on the PACS desktop‖
b. number of steps to common tasks minimised
c. consistency of display of tools
The PACS needs to be operable by the least technically-savvy radiologist. Large number of
tools to choose from on the display can be frustrating for a user. Intelligent display of
commonly used image manipulation tools—windowing, measure, zoom, scroll etc should be
activated with 1 mouse click/step. The tools when configured by user for a modality should
be consistently displayed for each modality. (Should not require set-up every time one logs
on.)
     CR--windowing, measure, zoom etc
     CT—scroll, windows presents, link studies, measure, zoom etc
     MRI—synchronized scrolling with position between series in different planes etc
     Thumbnails should be displayed for every series
        Advice—Drive before you buy.

   However, Basic Image Review profile of IHE will ensure that your PACS display at least
   has the bare minimum features required for radiology image display.

   IHE Standard: Basic Image Review-
   "Compliant software must provide a predictable user interface and functionality sufficient
   to review images for the purpose of clinical decision-making by ordering physicians:
   display of grayscale and color images from any modality, visual navigation of the
   available series of images through the use of thumbnails, side-by-side comparison of at
   least two sets of images (with synchronized scroll, pan and zoom for cross-sectional
   modalities) annotation of laterality, orientation, and spatial localization, annotation of
   demographics, management and basic technique information for safe identification and
   usage simple measurements of linear distance and angle cine capability for images that
   involve cardiac motion (e.g., cardiac US, XA, 500 CT or MR)"
   PACS ( as Image Manager & Image Display actors) must support Basic Image Review
   Profile of IHE.

12. CT Image DISPLAY REQUIREMENTS: CT scanners are the main reason for data
volume explosion in Radiology. Cardiology, Oncology, Colon & Trauma are the specialities
where there has been CT data explosion. Storing of very thin axial slices has become the
norm and will continue.
a.PACS must have an automatic & seamless loading of MPR when thin CT slices are
loaded (stand-alone modality workstations waste radiologists time & are inefficient) –
automatic loading of MPR will save on unnecessary storage costs (currently many hospitals
store MDCT images in 3 planes—rather than have real time MPR on CT display)
b. Allow for synchronized scrolling in 3 planes for cross sectional imaging esp MRI
(CT/MRI).
c. Automatic display of relevant prior
d. Synchronized scrolling with prior scan
e. Ability to create 3D images or via a plug-in—trauma imaging, CT colonoscopy, cardiac
f. During MPR/3D viewing, super-user like radiologists should ability to save some key
images(a coronal image/sag image that shows the key lesion) as a separate series for
reference to the report.
g. User ability to define slab thickness and create images of different thickness realtime
h. Ability to measure distance, circumference, angle, and volume of lesions. This should be
easy & intuitive.
i. Ability to measure hounsefield density (e.g. average density of a lung nodule, with
maximum & minimum density). This task should be intuitive & easy for any radiologist.
j. Scrolling speed –even with >1000 images the users should be able to scroll through images
very smoothly. Cine display must be present.
k. Scrolling speed over slow networks. CT is the commonest type of imaging done on-call.
Scrolling speed over slow networks is key to useage of PACS on-call. Local caching maybe a
way to improve performance over slow networks.

13. DISPLAY for REMOTE REPORTING & ON-CALL: Remote working is no longer
limited to private teleradiology companies. Increasingly NHS Trusts are encouraging
radiologists to do on-call from home (as this is more cost-effective for a tax funded health
service). Whilst on-call radiologists MUST be able to report from home (there must be a 3
click reporting workflow for use at home as well as in the hospital as described above with
SSO, DTI etc). A verified report on PACS prevents needs of verbal reports documented on
paper notes, and mis-understandings, and thus improving patient care & safety. In the future
we will see some radiologists requesting for part working from home. Technology needs to
support this.
        a. access to any image from any location (including home)
        b. consistent user interface (in or outside hospital)--with the full set of image
        manipulation tools as if within hospital
        c. Adaptive Loading---smooth scrolling speed through CT/MRI images. It is
        important that over slow networks the solution is able to cache images (or use similar
        techonology), so that once loaded the radiologist is able to smoothly scroll through
        even 500 to 1000 images very smoothly without any ―jumps‖ or skipping of
        images. Customer may request for this to be tested prior to buying they system
        d. Consistent DICOM image quality of images (even when reporting remotely)
        e. Access to other information--Request cards, scanned doc, clinic letters etc
        f. Ability to DICOM push to other hospitals even when working remotely (neuro-
        surgical centres etc).


14. PLUG-INS & WORKFLOW SUPPORT for PLUG-INs-Integration with other
specialist display systems: PACS suppliers (which is largely a DICOM image archive with a
basic image display) should show a willingness to integrate with specialist best of breed
specialist display systems chosen by the customer. However, a 3 sec launch of images into
the specialist display systems must be maintained.
     3D display
     CT colonoscopy display
     Cardiac CT display & analysis
    Mammography display (if required)
    PET-CT fusion display (if required)
    Optical display
    Cardiology display
    CAD for mammography
    Orthopaedic templating etc
Having access to best of breed plug-ins in key to improving user experience of the display
software.

These will allow for real time 3D image, Templated image etc to be created. If a user wishes
to save an image created on the plug-in, the system should allow user to save images in a
DICOM format as a separate series within PACS. Similarities are seen with Orthopaedic
Templating display where templated images will need to be saved on PACS as a separate
series.

CONTRACT CLARITY: As part of contractual agreement there MUST be clarity on how the
system would allow to have plug-in to other best of breed display systems. What would be
the technical requirements for integrating plug-ins? What would be the cost of integrating
each plug-in? Confirm that images created in the plug-in would be saved as a separate series
on PACS.

15. NUCLEAR MEDICINE IMAGE STORAGE & DISPLAY: In most NHS hospitals
radiologists perform NM Image reporting amongst the other radiology reporting activities. It
is inefficient & costly for a tax-funded health service, if a radiologists have to move to
different workstations or equipment to report NM, Mammography, CT, MRI, CR etc. Hence,
it is vital that the PACS is able to store & display NM images adequately. There is also a
move from diagnostic display from monochrome to diagnostic display with colour which is
adequately able to display both NM & CR adequately (see section 25)

Nuclear Medicine Profile : The Nuclear Medicine profile is a set of specifications as to how
NM systems (Gamma cameras etc) and PACS systems should interact when dealing with NM
data. The primary focus deals with storage and display of such data on PACS systems.

PACS (as Image Manager & Image Display actors)
Gamma Camera etc (as Acquisition Modality actor)
must conform to of Nuclear Medicine profile of IHE.


16. MAMMOGRAPHY IMAGE STORAGE & DISPLAY: In most NHS hospitals
radiologists perform Mammography reporting amongst the other radiology reporting
activities, and also ultrasound, MRI & ultrasound form a group of modalities used in
combination for breast radiology. It brings about in efficiencies if a radiologists have to
move to different workstations or equipment to report Mammography, US, MRI, etc. Hence,
it is vital that the PACS is able to store & display Mammography images adequately.


Mammography Image Profile: Efficient mammography reading requires specific display
quality, behavior, layout and annotation of images, as well as convenient comparison
of prior with current images. The IHE Mammography Image Profile (IHE Mammo)
was developed specifically to define the necessary mammography requirements.
PACS ( as Image Manager & Image Display actors)
Mammography CR/FFDM (as Acquisition modality actor)
must conform to Mammography Image Profile of IHE.

 17. RADIOLOGY REPORT & REQUEST DISPLAY (HL7 CDA display support):
 Radiology Report & Radiology Request are documents which are created in other clinical
 systems—RIS for radiology report & Ordercomms for radiology requests. The emerging
 global document standard for clinical documents is HL7 CDA (Clinical Document
 Architecture) & is being adopted by NHS. PACS must be able to display radiology reports &
 requests as CDA documents which are transmitted to it. Radiology images, requests &
 reports must always be linked together (in the same way as the traditional film packets in
 NHS contained both these documents.) With 1 mouse click these linked documents must be
 displayed along with the images.
Displayable Reports (DRPT) Profile of IHE: manages creation and distribution of “display
ready” (PDF or CDA) clinical reports from the creating application, to the department, and
to the enterprise.
PACS must be a report reader actor for DIsplayable Report Profile (with option of report
repository)


18. VIEWING OF IMPORTED IMAGES in TEMPORARY FOLDER: Currently in
most PACS systems when images are sent from another hospital via DICOM push, they
arrive into a Temporary folder (often referred to as a unverified folder). A RIS entry (called
fixing) which validates the demographics needs to be created before it can be assimilated
properly into the PACS store. However, it is important these images (called unverified
images) can be viewed by clinical users (this is important for emergency care of patients).
An alert must pop-up warning the user that a demographic check must be performed.


19. PART of ELECTRONIC PATIENT RECORD---Radiology images must become part
of a wider clinical record (Electronic Record). With next generation PACS it is important that
we move away from a radiology data silo & make radiology a part of the holistic patient
record. Adoption of global standards is key to this concept:
        PACS must act as an XDS-I source actor of Cross Enterprise Document Sharing
        Profile-Imaging of IHE
        PACS must act as XDS &XDS-I Consumer actor of Cross Enterprise Document
        Sharing Profile-Imaging of IHE. This will allow viewing of other clinical
        documents/images that are registered on XDS registry (will allow an EPR view of the
        patient record)

       Adoption of XDS by PACS will allow radiologists & other clinical users access to
       integrated view of ALL clinical doc & images-ECG, Medical photographs, radiology
       images, Discharge summaries, through an viewer that is XDS consumer compliant.

       IHE Standard--Cross Enterprise document sharing for Imaging—XDS-I--- Sharing
       imaging documents between radiology departments, private physicians, clinics, long
       term care, acute care with different clinical IT systems & thus make it possible for
       radiology images to become part of the patient’s EPR.
20. IMAGE SHARING BEYOND INFORMATION GOVERNANCE BOUNDARIES.
Sharing of images is vital for continuity of patient care particularly with centralization of
services (cancer,stroke etc).
Current Sharing solutions beyong IG boundaries include
                a.DICOM push (direct or via IEP), &
                b.burning of encrypted CDs.
                c.Import of CDs containing DICOM images
There needs to be transparency on costs if new DICOM push links are required & these
costs are clearly defined in the contract.

FUTURE IMAGE SHARING NEEDS: DICOM push & IEP require prior knowledge and
requires huge manual process for sharing. As we move into next generation PACS—adoption
of XCA-I will enable secure exchange of images beyond IG boundaries, which are timely &
automatic & easy---at the time of reporting of images. PACS images must be able to follow a
patients journey. XCA-I concept is key to this approach.
IHE Standard—Cross Community Access for Imaging—―The Cross-Community Access
profile supports the means to query and retrieve patient relevant medical data held by other
communities.”

21. TEACHING FILES CREATION: NHS Radiologists support patient management, but
also provide another important function --train the radiologists of the future. Hence teaching
files is integral to NHS radiology work. Interoperability standards are key to creation of
teaching files. If a non-standard approach is adopted, then there is a good chance that
radiologists will lose their teaching files, if the PACS vendor is replaced at the end of a
10year contract.

IHE Standard --- Teaching Files & Clinical Trials Export Profile (TCE Profile) of IHE. The
IHE TCE profile describes a method for using existing standards to simplify and standardise
the export of key medical images for education, research, and publication.
 To ensure teaching files are future proofed:
PACS MUST be compliant with Export Selector & Export Manager Actors of TCE Profile of
IHE

If a Radiology PACS is going to be used as a teaching files server, then make sure that it is
specified that it is Receiver actor for TCE Profile. (Alternatively one could use the free
MIRC (from RSNA) --http://mircwiki.rsna.org/index.php?title=Main_Page as the teaching
file server which is compliant with receiver actor of TCE profile of IHE.)

22. AUDIT TRAILS/VIEW LOG—every time a patient’s image is accessed by a user. This
should be logged and the ―view log‖ should be accessible to any user to see. This will remind
users that their data access is logged & thus improve patient confidentiality.

IHE Standard: PACS must support Audit Trail & Node Authenication Profile of IHE
“The Audit Trail and Node Authentication (ATNA) Integration Profile establishes security
measures which, together with the Security Policy and Procedures, provide patient
information confidentiality, data integrity and user accountability. “
23. RADIATION DOSE MONITORING---It is important that radiology departments are
able to monitor doses to an individual patient, group of patients (e.g. children, women,)
specific modality, specific exam type etc--- to compare with national averages/standards.

 IHE Standards: ―Radiation Exposure Monitoring (REM) facilitates the collection and
distribution of information about estimated patient radiation exposure resulting from imaging
procedures. The REM Profile requires imaging modalities to export radiation exposure
details in a standard format. Radiation reporting systems can either query for these "dose
objects" periodically from an archive, or receive them directly from the modalities.‖

Modalities (as Acquisition modality actor)
PACS (as Image Manager actor)
Must support Radiation Exposure Monitoring Profile of IHE.

This will allow feeding of such information into a national radiation monitoring registry for
NHS in the future.

Current situation in the NHS: Currently radiation dose information is entered in RIS
manually. Support of this profile will provide more accurate information as there wont be any
errors related to manual data entry into RIS & will also improve efficient working for
radiographers who will no longer be required to enter that data manually.

24. PACS DATA MINING: In addition to the DICOM image with DICOM tags, the
following data also need to be sent to PACS from modalities.
       a. Date & Time image acquired on modality
       b. Date & time of image sent from modality

   PACS should also record the time images arrive on PACS. This information is important
   for auditing the performance of PACS & networks---
   time it takes for images to arrive on PACS after they are sent,
   quantify PACS downtime etc.

It is important that the following data is easily available for System Administrator/PACS
Managers—
   a. time of image creation to arrival on PACS,
   b. number of exams of a modality per room
   c. time from image arrival on PACS to verified report etc

25. PACS HARDWARE: STORAGE & DISPLAY :
Storage Hardware: The PACS vendors can define the specifications of the storage
hardware—to ensure that image display parameters & performance can be achieved.
However, they should not insist on being the supplier of storage hardware. NHS Trusts must
be able to look at storage with a holistic view, for all storage requirements.

Display Hardware: PACS vendors need to specify the display hardware requirement for
adequate display of the images—grey scale, graphics card etc. However, Trusts must be able
to must be able to buy the hardware at open market competition. The PCs must not be limited
to PACS display only. It must be a multipurpose equipment.

Diagnostic Display Hardware Specification: Current (2011) specification for a multi-
purpose diagnostic radiology reporting workstations (to enable reporting of CR, PET-CT,
NM, CT on the same workstation) should meet the following minimum hardware
specifications:
        a. Windows 7 OS (64 bit only)
        b. Graphics 2GB
        c. RAM 6 GB with ECC
        d. Quad-core CPU of at least 3 GHz.
        e. 3MP colour diagnostic monitors


26. PACS CLIENT SOFTWARE DISPLAY & dependencies---
PACS client software (or any 3D, or any other plug-ins) must be able to take advantage 64 bit
CPU & Operating System Software. It is well known that PACS display client will be present
on the same workstation as RIS, EPR, VR/DD etc. If the PACS client is dependent on OS,
Java, Internet explorer etc, then this may result in conflict with different versions used by
other software used on the same workstation. This issue needs to be managed in a mature
way by the PACS supplier (PACS supplier must not simply ask the user to remove all other
software). One suggestion maybe to encapsulate the client with its required browser/Java/OS
patch and run as a virtual machine.


27. PACS STORAGE ASSESSMENT—PACS supplier will make as an assessment of the
volume of storage required
a. Duration of storage—(7years of on-line storage as per DOH requirements)
b. Number & type of modalities connected
c. Number of exams performed per modality type

However, 10-year contract is a long time. Within a department new modalities will be added
in radiology. Alternatively, there maybe a requirement to store & display non-radiology
images in DICOM--cardiac, retinal images, endoscopy images etc . Adoption of standards is
key to scalability of the PACS solution. Adopting a broker-less solution for PACS will allow
scheduling to be done on scheduling systems (Cardiac Information System, Ophthalmology
Information System etc)The contract should be transparent on this issue & both sides aware
of additional costs of DICOM connectivity of additional modalities.

28. USE OF PRIVATE DICOM TAGS (by PACS & Modality vendors)--Vendors must
use standard DICOM tags as far as possible. In exceptional circumstances when standards
tags are not available, then private DICOM tags maybe required. The vendors must provide
FULL documentation for ALL private elements they generate, including the circumstances in
which it is added, and the exact meaning and purpose of every individual element. When a
standard tag become available then PACS supplier must convert the private tag to a standard
one. Customer should be able to get the private DICOM documentation analysed by an
independent DICOM expert.

29. END OF CONTRACT DATA MIGRATION—All image data must be kept in standard
DICOM format using standard DICOM tags as far as possible. The PACS vendor must
provide support for the migration of DICOM data into another vendors DICOM archive at
the end of contract. If PACS vendor chooses to store radiology reports & radiology requests,
then they must be stored in standard CDA format. This will ensure that reports & requests
can also be migrated into the new vendors PACS.


30. TESTING & TRAINING SYSTEM: There should be a separate test & training system
which is separate from the live environment. This should act as a test-bed for
integration/testing new feature prior to roll out into live environment

For training—
   a. There should be an e-learning tool provided. The system should be intuitive enough
       so as require minimal training.
   b. Single user interface –this is key to reducing the training and support needs for
       customer & suppliers. (Separate radiology PACS display for radiologists & other
       clinical users are more cumbersome for training).
   c. Separate test system available for training (so that training does not need to be
       performed on a live system)

31. LOCAL CONFIGURATION OF USER ROLES- User roles should be defined
locally:
         a. Clinical Users: All medical users should be able to view images & Reports
         b. Radiologists & Radiographers should be able to send images to another
            DICOM destination (on-call neurosurgical unit)
         c. System Administrators-delete images, correct attributes etc

32. SUPPORT, BUSINESS CONTINUITY & DISASTER RECOVERY
            a. Support
                    i. 24/7 support
                    ii. 1 phone number to call
                    iii. Dedicated team of qualified engineers receiving call with ability to
    directly deal with Network manager to distinguish whether network or PACS issue
                    iv. On-line tracking of issues raised
                    v. Transparency on response time to type of support calls
                    vi. Remote & on-site support capabilities
                    vii. Support should include integration to 3rd party systems
            b. Business Continuity & Disaster Recovery: there should be no need for a
                planned or unplanned downtime. Business continuity should be aimed for.
                There should be a disaster recovery plan identified in the contract



33. STABILITY: Software display should be stable & show a consistent display once a
display protocol is set-up by the user. Software errors may occur, but there needs motivation
within the supplier to correct the errors in a timely manner. The supplier must have local
developers who are involved in the product development, who will be able to understand the
user needs & correct errors that maybe present.
34. USER GROUP MEETINGS & PRODUCT DEVELOPMENT during contract
lifetime:
a. The customers must have input into future system design/ functionality
updates. The supplier MUST have a vibrant user group including an electronic forum (with
both clinical users & system administrators involved) which suggests & votes on product
enhancement features
b. There MUST be a rolling agenda for product enhancement during the 10year contract.
How many product development days will be allocated for every year for every NHS Trust
that contracts with the PACS supplier must be defined at the start of the contract period.
c. Clarity on how will the next upgrade version of the product be rolled out. (customers must
make sure there isn't a charge for software upgrade & that it is built into the revenue
expenditure)
d. A product developer must be present at the User Group meetings and involved in the
electronic discussions to have an honest dialogue between users & suppliers about what
enhancement suggestions are viable for the supplier.


35. PACS HOUSEKEEPING WORKFLOW---
Sometimes images may arrive into PACS for an exam episode after an exam has acquired a
dictated/unauthorised/authorised workflow status.

This maybe due to
a. Radiographer completing exam on RIS prior to sending complete set of images to PACS
(requires user training)
b. Network delays/problems from modality to PACS
In both these cases, radiologists are reporting on an incomplete set of images & thus an
incorrect report maybe issued. PACS supplier must provide a solution to address this issue.
Option may include the ability to put exams into a housekeeping folder or change the status
to ―housekeeping‖ for issues to be sorted. The PACS manager/administrator can decide to
either fix it with the study or change the RIS status to ―exam completed/unreported‖ so that
the reporter has the opportunity to change the report if required.

PACS solution must be able to distinguish between the above scenario & post-processing
workflow- (where additional images added as part of post processing (orthopaedic
templating, MPR/3D images, are added) to just enter into PACS as a separate series after the
study has acquired a dictated/authorised/unauthorised status. Ideally, PACS should be able
recognise additional images arising from post-processing software without any problems.




Compiled by Dr. Neelam Dugar
Chairman of RCR Imaging Informatics Group
22/5/11
   Acknowledgements: the content of the document is largely provided by members of the
   RCR Imaging Informatics Group discussions. Special mention given to the following
   PACS Managers: Mr. Parveaz Khan, Mr. Glyn Davies, Mr. Simon Waddington, Mr. John
   Parker, & Richard Bulmer & the following radiologists, Dr. William Saywell, Dr. Jon
   Benham, Dr. Mark Griffiths, Dr. Peng Hui Lee, Dr. David Robinson, Dr. Andrew
   Downie & Dr. Padhriac Connelly who were speakers at the Group meeting on the
   topic—Next Generation PACS –‖What Radiologists & PACS Managers need‖. Other
   members who have participated in the forum discussions include Mr. John Skinner, Dr.
   Dave Harvey, Mr. Ed Mcdonagh, Mr. Gareth James, Mr. Grant Shaw, Mr. Ben Johnson,
   Mr. David Granger, Mr. Paul Ganney, Dr. Mark Radon, Mr. Oliver Daly, Mr. Adam
   Davis and many others who contribute to forum discussions




   APPENDIX 1
   Specifying the IHE standards for PACS
1. PACS must be an Image Manager actor for PIR profile of IHE
Patient Information Reconcilliation (PIR) Profile: ―PIR handles: unidentified/emergency
patient, demographic information updates ( e.g patient name changes (marriage, etc.) ,
correction of mistakes, ID space mergers). Such changes are reliably propagated to all
affected systems, which update all affected data. The result is a complete patient record.‖


2. PACS must conform to Image Manager & Image Display actor for SWF profile of IHE
Scheduled Workflow Profile-- Scheduled Workflow establishes a seamless flow of
information that supports efficient patient care workflow in a typical imaging encounter. It
specifies transactions that maintain the consistency of patient information from registration
through ordering, scheduling, imaging acquisition, storage and viewing.


3. PACS must conform to Image Manager & Image Display actors for Basic Image Display
profile of IHE
Basic Image Review Profile:
"Compliant software must provide a predictable user interface and functionality sufficient to
review images for the purpose of clinical decision-making by ordering physicians: display of
grayscale and color images from any modality, visual navigation of the available series of
images through the use of thumbnails, side-by-side comparison of at least two sets of images
(with synchronized scroll, pan and zoom for cross-sectional modalities) annotation of
laterality, orientation, and spatial localization, annotation of demographics, management
and basic technique information for safe identification and usage simple measurements of
linear distance and angle cine capability for images that involve cardiac motion (e.g.,
cardiac US, XA, 500 CT or MR)"

4. PACS must conform to Image Manager & Image Display actors of Consistent Presentation
of Images Profile of IHE.
Consistent Presentation of Images Profile of IHE
 “Consistent Presentation of Images maintains the consistency of presentation for grayscale
images and their presentation state information (including user an notations, shutters,
flip/rotate, display area, and zoom). It also defines a standard contrast curve, the Grayscale
Standard Display Function, against which different types of display and hardcopy output
devices can be calibrated. Thus it supports hardcopy, softcopy and mixed environments.”

5. PACS must conform to Secure Node/Secure application actor of Audit Trail & Node
Authentication profile of IHE.

“The Audit Trail and Node Authentication (ATNA) Integration Profile establishes security
measures which, together with the Security Policy and Procedures, provide patient
information confidentiality, data integrity and user accountability.”


6. PACS must conform to XDS-I source & XDS/XDS-I consumer actors of Cross Enterprise
document sharing profile of IHE.
Cross Enterprise document sharing for Imaging—XDS-I--- Sharing imaging documents
between radiology departments, private physicians, clinics, long term care, acute care with
different clinical IT systems—thus contributing to the development of an electronic patient
record concept.


7. PACS must conform to Export Selector & Export Manager actors of Teaching Files &
Clinical Trials Export Profile (TCE Profile) of IHE

The Teaching Files & Clinical Trials Export Profile TCE profile describes a method for
using existing standards to simplify and standardise the export of key medical images for
education, research, and publication.

8. PACS must conform to Image Manager Actor of Radiation Exposure monitoring profile
of IHE

―Radiation Exposure Monitoring (REM) facilitates the collection and distribution of
information about estimated patient radiation exposure resulting from imaging procedures.
The REM Profile requires imaging modalities to export radiation exposure details in a
standard format. Radiation reporting systems can either query for these "dose objects"
periodically from an archive, or receive them directly from the modalities.‖

9. PACS must conform to Image Manager & Image Display actors of Nuclear Medicine
profile of IHE.

Nuclear Medicine Profile : The Nuclear Medicine profile is a set of specifications as to how
NM systems (Gamma cameras etc) and PACS systems should interact when dealing with NM
data. The primary focus deals with storage and display of such data on PACS systems.


10. PACS must conform to Image Manager & Image Display actors of Mammography Image
profile of IHE.
Mammography Image Profile: Efficient mammography reading requires specific display
quality, behavior, layout and annotation of images, as well as convenient comparison
of prior with current images. The IHE Mammography Image Profile (IHE Mammo)
was developed specifically to define the necessary mammography requirements.

11. DICOM     TAGS (Standard & Private)—Images must be stored in DICOM format.
Vendors must use standard DICOM tags as far as possible. In exceptional circumstances
when standards tags are not available, then private DICOM tags maybe required. The vendors
must provide FULL documentation for ALL private elements they generate, including the
circumstances in which it is added, and the exact meaning and purpose of every individual
element. When a standard tag become available then PACS supplier must convert the private
tag to a standard one ASAP.


12. PACS must be a report reader actor for DIsplayable Report Profile (with option of report
repository)
Displayable Reports (DRPT) Profile of IHE: manages creation and distribution of “display
ready” (PDF or CDA) clinical reports from the creating application, to the department, and
to the enterprise.
 HL7 CDA display: PACS must be able to display radiology reports & requests as CDA
 documents which are transmitted to it. Radiology images, requests & reports must always be
 linked together.



http://www.ihe-europe.net/external/framework.htm
This link identifies number of vendors participating in worldwide connectathons to show interoperability.




APPENDIX 2
IHE Specifications for RIS
1. RIS must be an Department System Scheduler actor for PIR profile of IHE
Patient Information Reconcilliation (PIR) Profile: ―PIR handles: unidentified/emergency
patient, demographic information updates ( e.g patient name changes (marriage, etc.) ,
correction of mistakes, ID space mergers). Such changes are reliably propagated to all
affected systems, which update all affected data. The result is a complete patient record.‖


2. RIS must conform to Department System Scheduler actor for SWF profile of IHE
Scheduled Workflow Profile-- Scheduled Workflow establishes a seamless flow of
information that supports efficient patient care workflow in a typical imaging encounter. It
specifies transactions that maintain the consistency of patient information from registration
through ordering, scheduling, imaging acquisition, storage and viewing.


3. HL7 CDA support—RIS must be able to create & transmit radiology reports in HL7 CDA
format. RIS must be able to display HL7 CDA request document produced in an
ordercomms.


http://www.ihe-europe.net/external/framework.htm
This link identifies number of vendors participating in worldwide connectathons to show interoperability.




APPENDIX 3
IHE Specification of Acquisition Modalities
1. Modalities must conform to Acquisition Modality actor for SWF profile of IHE
Scheduled Workflow Profile-- Scheduled Workflow establishes a seamless flow of
information that supports efficient patient care workflow in a typical imaging encounter. It
specifies transactions that maintain the consistency of patient information from registration
through ordering, scheduling, imaging acquisition, storage and viewing.


2. Modalities must conform to Acquisition Modality actor of Consistent Presentation of
Images Profile of IHE.
Consistent Presentation of Images Profile of IHE
 “Consistent Presentation of Images maintains the consistency of presentation for grayscale
images and their presentation state information (including user an notations, shutters,
flip/rotate, display area, and zoom). It also defines a standard contrast curve, the Grayscale
Standard Display Function, against which different types of display and hardcopy output
devices can be calibrated. Thus it supports hardcopy, softcopy and mixed environments.”


3. Nuclear Medicine modality must conform to Acquisition Modality actor of Nuclear
Medicine profile of IHE.

Nuclear Medicine Profile : The Nuclear Medicine profile is a set of specifications as to how
NM systems (Gamma cameras etc) and PACS systems should interact when dealing with NM
data. The primary focus deals with storage and display of such data on PACS systems

4. Mammography modality (CR/FFDM) must conform to Acquisition Modality actor of
Mammography Image profile of IHE.
Mammography Image Profile: Efficient mammography reading requires specific
display quality, behaviour, layout and annotation of images, as well as convenient
comparison of prior with current images. The IHE Mammography Image Profile (IHE
Mammo) was developed specifically to define the necessary mammography
requirements.


5. Modalities must conform to Acquisition Modality Actor of Radiation Exposure
monitoring profile of IHE

“Radiation Exposure Monitoring (REM) facilitates the collection and distribution of
information about estimated patient radiation exposure resulting from imaging procedures.
The REM Profile requires imaging modalities to export radiation exposure details in a
standard format. Radiation reporting systems can either query for these "dose objects"
periodically from an archive, or receive them directly from the modalities.”



http://www.ihe-europe.net/external/framework.htm
This link identifies number of vendors participating in worldwide connectathons to show interoperability.

								
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