MECS_final.pdf

Minimum Essential Characteristics

Background

Naval Medical Center San Diego centrally manages the procurement of Radiology PACS and software products that operate in conjunction with the PACS Systems. Naval Hospital Twenty-nine Palms (NHTP) is requesting the same Mammography Reporting System (MRS) to centrally manage FDA requirements as part of the new mammography program.

Objectives

1. The goal is to bring NHTP facilities up to date with version 7 of MRS. Currently 13 facilities operate on a lower version of MRS and 9 have no reporting system. NHTP is requesting licensing for this site in order to provide mammography reporting and tracking software.

2. Establish standardization across the Navy enterprise for Radiology on Mammography Reporting and Tracking.

3. Establish standardized maintenance and warranty and ensuring continuity.

Products and Maintenance Services The maintenance agreement will include the following: 1) Toll Free Telephone Support and 2) Renewal of Annual software and licensing for base year plus 4 option years.

The following are the Minimum Essential Characteristics for a Mammography Reporting System

Worksheets shall do:

1. Data collection through paper worksheets, tablet, touch screen, or workstation.

2. Worksheet master provided by vendor. Worksheet customization is selected based on system type and workflow. Customizable worksheets available to fit any workflow.

3. Paperless patient history collection, electronic patient questionnaire with customizable consent document worksheets. Shall be compatible with all browser capable devices.

4. Worksheet printing that allows patient demographics and history to be printed on worksheets for review.

5. Separate worksheets for other procedures, such as MRI, ultrasound, biopsies.

6. Procedure order codes that trigger worksheet printing at a designated printer.

7. Ability to scan documents into the system in order to store pathology reports, notes, from outside letters and hand-written worksheets.

System features shall:

1. Track any breast-related procedure, e.g., an ultrasound, since all procedures are recorded independently.

2. Record chronological list of items in breast history.

3. Record all documents printed on patient event.

4. Record outside history entered on event list. Surgical history automatically included in the report.

Prior studies are available for comparison reference.

5. Have multi-site environments, each site set up to function independently.

6. Include utility to merge and move exam records between patients

7. Include ability to customize lists such as: procedures, assessments, recommendations, pathology codes and tissue density descriptions.

8. Include data export utility for National Mammography Database (NMD), Breast Cancer Screening

Consortiums or Cancer Registries (BCSC), Canadian Breast Cancer Screening Program, and the Chicago Breast Cancer Quality Consortium (CBCQC), and the Vermont Mammography Registry with an opt out capability for patients.

9. Have an audit trail for tracking user access to patient and procedure records viewed or modified.

10. Have HL7 real-time Bidirectional interface with CHCS to eliminate double data entry.

Exam Result Reports shall/provide:

1. Findings entered from worksheets, dictation or directly on-screen by the radiologist or transcriptionist.

2. Organize frequently used findings for rapid report generation, with unique-by-user templates.

3. Assessment(s) and recommendation(s) be made for each finding and then automatically reported as the procedure’s overall assessment.

4. Be configurable to default a recommendation for negative, benign or probably benign assessments.

5. Link multiple procedures and organize them into a single report/result letter.

6. Able to generate Text by sentence building that is able to be edited, allowing radiologist to say whatever he/she wants to say.

7. Reports able to be double read with differences recorded for statistical purposes.

8. Risk factors, surgical history and hormone history able to be included in the exam report.

9. Support new imaging procedures such as Breast Specific Gamma Imaging (BSGI) and tomosynthesis.

10. Breast diagram with a visual representation of abnormalities, while incorporating a paperless workflow.

11. Auto populate prior study dates.

Patient Result letters shall:

1. Automatically select a personalized lay-language result letter in multiple languages based on exam type, assessment and recommendation. Letters must be able to be modified to reflect patient’s risk factors.

2. Letters must reflect the outcome of more than one procedure and groups the reports.

3. Able to delay Letter generation for 2-4 days

4. Letter format and text templates user-modifiable, formatted for window envelopes, customizable by site or radiologist. Ability to utilize Print-to-Mail.

5. Be modifiable for individual exams at the time of data input.

6. Automatically remind users to print letters based on user-defined time parameters.

7. Have High risk paragraph informing patients when they have been identified to be of a higher risk for contracting breast cancer based on 7 high risk cancer models.

8. Have Breast Tissue Statements inform patients if they have been identified to have dense or very dense breast tissue.

Integrations shall:

1. Integrate with Fuji Synapse and AGFA Digital workstation without having to close systems.

2. Integrate with Powerscribe 5 and Powerscribe 360 Voice recognition software without exiting Fuji and AGFA systems

3. Have Nurse Navigation integration.

4. Have volumetric breast density measurement integrations.

5. Integrate Patient Result Letters Exam Result Reports

Recall/Reminder Letters shall:

1. Email capability for patient correspondence.

2. Expand recommendations for tracking for all modalities

3. Generate recall and reminder letters at user-defined intervals. Subsequent letters may need to contain different text than the first. The number of letters to be sent site-definable.

4. Provide user option to print only short-term letters, routine recall letters, or both.

5. Unresolved problem issues that are reflected on the Unresolved Problem Case List, including follow-up activities to date along with patient and doctor’s phone numbers.

Problem Tracking shall have/shall:

1. Problem case list may be printed or viewed on screen for selected problem types by site, radiologist or clinician.

2. Problem case list that automatically updates following entry of recommended follow-up procedure or pathology results.

3. Progress notes added to the patient record at any time including the results of attempted resolution of problem issue(s).

4. Progress notes that can be used to manually remove items from the problem case list. User ID and date are recorded and an explanatory note is required to resolve an issue.

5. Remind users automatically to print Problem Case Follow-Up letters to the clinician and/or patient if the patient does not return for recommended follow-up within a user-defined interval.

6. Clinician/Patient Reports that may be generated for each referring clinician showing his/her patient’s procedures and outcomes.

Statistical features shall:

1. Generate all required MQSA statistical reports.

2. Generate statistical reports for all breast-related procedures.

3. Be able to be further refined by filtering by site, radiologist, clinician, procedure type, assessment, recommendation, screening or diagnostic and date range.

Security shall:

1. Automatically log off after the system is idle for a specified amount of time.

2. Shut down after user inputs incorrect password three times.

3. Have User privileges and audit logs that allow sites to set permissions and track activity.

4. Limit access to confidential patient and statistical information and can restrict user access by site.

Risk Modeling shall:

1. Have Updated Risk Dashboard, with BRCAPRO and Tyrer-Cuzick Risk Model Options.

2. Have Myriad Prevalence Table for BRCA gene risk.

3. Be Expandable to Patient and Family History collection for additional risk models.

4. Have High Risk Reports that can be sent to referring physicians for patients at high risk.

Training on Software 5 days of onsite training