Atch D- Statement of Work MammoREV3.pdf

STATEMENT OF WORK FOR MAMMOGRAPHY QUALITY CONTROL AND QUALITY

ASSURANCE AT THE PHOENIX INDIAN MEDICAL CENTER

A. PURPOSE OF CONTRACT:

The Phoenix Area Indian Health Service (IHS) Phoenix Indian Medical Center (PIMC) depends on contracting outside resources with a wide range of expertise in order to provide products and services not readily available within IHS. This firm-fixed service contract will provide for a Mammography quality control and quality assurance software to work with a Hologic 2D and 3D Dimensions system.

B. BACKGROUND INFORMATION:

The Phoenix Area Indian Health Service serves forty-three (43) Tribal nations in the States of Arizona, Nevada and Utah. The user populations are approximately 850,000 patient visits annually; the Area Office facility is located in the central down town area of Phoenix, Arizona. There are fourteen ambulatory care hospitals and health centers located on/or around the reservations and 15 Tribally run ambulatory care hospitals and health centers.

PIMC is a 110-bed (approx.) inpatient community hospital associated with a busy Emergency Department and numerous busy outpatient clinics.

C. Scope of Work

1. Mammography Quality Control and Quality Assurance Software:

Contractor to provide a Mammography quality control and quality assurance software to work with a Hologic 2D and 3D Dimensions system. In addition, this software will need to be compatible with the Indian Health Services Resource Patient Management System (RPMS) and Electric Health Records (EHR) systems. These systems shall be utilized by Registered Radiologic Technologists and Radiologists. The contractor shall demonstrate with the Contracting Officer and COR that the system has connectivity and is functioning with all PIMC systems.

System Minimum Requirements:

a. Breast Imaging Reporting and Data System (Bi-Rads) reports to Radiologists

b. Risk Assessments in Mammography

c. Mammography Technologist workflow tools and Quality Control (QC) /

Quality Assurance (QA) reports

d. Food and Drug Administration (FDA) Mammography Quality Standards

Act and Program (MQSA) Compliance

e. Breast Analytics

f. Software must be installed on PIMC Server (no cloud-based services)

g. Patient tracking and follow up

h. Risk Assessment

i. Patient result letters generated

j. Patient recall letters generated

k. Report extraction

l. Custom reports

m. Hologic 2D and 3d Dimensions Systems compatible

n. American College of Radiology (ACR) compliance

o. Licensing

p. Workstation installs

q. Service support

r. MQSA patient racking and patient contact

s. MQSA pathology tracking

t. MQSA quality assurance reporting

u. FDA updates as required.

In addition, the contractor shall provide the following:

a. Complete the Indian Health Service Network Interconnection Security

Agreement (ISA) for remote access.

b. Contractor shall provide Remote Access (if available)

c. Contractor to include all FDA Cybersecurity compliance software patches

(if available)

d. Software installed on site at PIMC (not cloud-based services).

e. HL7 interface (coding) on contractor and government side of interface.

Contactor is to cover all HL7 interface and associated costs.

f. Compatible interface with Indian Health Services Resource Patient

Management System (RPMS)

g. Compatible interface with Electric Health Records (EHR) systems.

h. Compatible interface with Hologic 3Dimensions (Genius) system.

i. Compatible interface with ISI Radiology (Formally Vista Radiology/Vista

Imaging).

2. DELIVERY/INSTALLATION

Contractor shall include software installation to be performed by an OEM-certified service and installation engineer(s) to ensure a safe and functional installation.

A. Contractor shall provide software installation.

B. Contractor shall transfer all Quality Assurance and Quality Control data from the current Hologic mammography system to the new software and Indian Health Services (IHS) Phoenix Indian Medical Center (PIMC) RPMS and EHR systems.

C. Contactor to provide all passwords to the Diagnostic Radiologic Technologist and Radiologist.

D. All data will be the property of the Government and retrievable by the Government. No patient information shall leave PIMC at any time.

E. Contractor is responsible for HL7 interface and associated costs. The contractor shall implement an end-to-end HL7 interface, including both vendor and RPMS side of the interface. PIMC has used Cimarron Medical Informatics, LLC to create RPMS HL7 interfaces in the past.

3. TRAINING

The purpose of this section is to understand the vendors Training Program throughout and after this procurement. The training audience shall include Radiologic Technologists (Mammography), Radiologists, and supporting imaging staff within the institution. PIMC seeks the costs of onsite training that follows the initial equipment install, in addition to the supplemental training. Include distance learning, Computer-Based Training, and/or web meetings if available.

Contractor training programs include the following minimum requirements:

A. One (1) eight-hour of onsite training on the Mammography software and all components following the initial installation and acceptance testing for (2) two Radiologic Technologists, and Radiologists as pertinent:

a. As a minimum, Mammography unit training should include: application training, any proprietary QA/QC testing procedures, and system administrative configuration procedures;

B. One (1) eight-hour onsite training on the Mammography software and all components following integration to Radiology Information System Package (RPMS) and PACS and/or as needed for advanced follow-up training for (4) four Information Technology Representatives, Mammography Radiologic Technologists, and Radiologists as pertinent:

a. As a minimum, Mammography unit training should include: functionality training, application training, any proprietary QA/QC testing in digital environment, server system setup and maintenance and system administrative configuration procedures;

C. Training associated with proprietary service call systems, if applicable.

D. Remote/Online/Web training as needed.

4. MAINTENANCE AND SUPPORT

Contractor to provide maintenance and support to include system support, interface support and software version upgrades. This include trouble shooting error notices and synchronization of software with PIMC RPMS and EHR systems. Contractor will confirm that all features are operational and system output follows FDA and MQSA standards. Updated FDA lay letters as required.

Support will be by phone and if approved by remote access to the PIMC network to address software issues. Support services are from Monday through Friday from 8 am to 3 pm, excluding Federal Holidays.

F. PERIOD OF PERFORMANCE:

Contract performance shall be for 12 months from the effective date of the award of the contract and that include four (4) one (1) year options to renew. Option year renewals are not executed unless by written modification to the contract and approved by the Contracting Officer.

G. SITE LOCATION:

Phoenix Indian Medical Center Medical Imaging Department 4212 N. 16th Street Phoenix, AZ 85016

H. HOURS OF OPERATION:

Services shall take place between the hours of 8 am to 3:00 pm Monday through Friday, excluding Federal Holidays.

I. MINIMUM QUALIFICATIONS:

Contractor shall have 5 years of installation, set-up, configuration of Mammography Quality Control and Quality Assurance FDA and MQSA software experience.

END OF STATEMENT OF WORK