01.03_Teleradiology PWS.docx

PERFORMANCE WORK STATEMENT (PWS)

TELERADIOLOGY DIGITAL X‐RAY SERVICE

March 30, 2020

DHS/ICE/IHSC

PWS IHSC Teleradiology Services

1. BACKGROUND

The U.S. Immigration & Customs Enforcement (ICE) Health Service Corps (IHSC) provides and arranges for health care services for non-US citizens being detained by ICE. As ICE’s medical authority for detainee health care, IHSC provides health care delivery and oversight to individuals in ICE custody that may be housed in Service Processing Centers (SPC), Contract Detention Facilities (CDF) and Staging Facilities located throughout the country. Twenty (20) IHSC facilities are staffed with Public Health Service Commissioned Officers, Federal employees and contractors. These facilities are directly under the supervision of IHSC. Thirteen (13) of the IHSC facilities require teleradiology services under this requirement.

Provision of health care to this population is critical to the law enforcement mission of ICE. Of utmost importance is the rapid detection and treatment of communicable diseases, including pulmonary tuberculosis (TB), in order to prevent cases of these diseases from being transmitted to staff, other detainees or be released to the citizens of the United States. It is also an essential provision for providing a safe and humane environment for the detained aliens.

2. SCOPE OF WORK

IHSC is seeking to procure a coordinated, comprehensive system for the provision of teleradiology digital imaging services within designated IHSC detention facilities. These services may be provided using on-site equipment or via the use of mobile radiology equipment and technologists. For the purpose of this solicitation, the term “teleradiology” will be used in reference to any radiograph taken digitally and transmitted for reading at a remote site(s) by a licensed and qualified radiologist. The majority of teleradiology images will be single view chest X-ray images to screen detainees for pulmonary TB; however, plain radiographic imaging of any body part will be utilized as needed in the management of illness and injury.

The Contractor shall provide delivery, installation, testing and maintenance of the digital X‐ray equipment in addition to procurement of mobile radiology services when indicated. The fixed equipment shall be inspected by a physicist upon installation and receive certification in the state the equipment is located. Onsite face‐to‐face training shall be provided by the Contractor to all designated IHSC personnel in operating the digital X‐ray equipment. Teleradiology services will include interpretation of radiographs, providing reports on the results, availability for consultation, providing the digital interface and compatibility necessary to transmit images and reports to and from IHSC’s electronic health record, storing of images in a rapidly retrievable format, and annual certification/calibration of X‐ray machine unit containment.

The Contractor shall ensure radiologic technologists (RT) staffed at each IHSC location receive an orientation and annual training to any radiology equipment they will operate, and that a competency assessment of their practice is documented. The orientation and competency assessment documentation will be provided to IHSC for the RT’s credential file.

3. APPLICABLE DOCUMENTS

The following documents provide specifications, standards, or compliance guidelines in order to meet the requirements of this contract:

· Health Level Seven International (HL7) http://www.hl7.org/

· The Joint Commission: National Patient Safety Goals 2019 https://www.jointcommission.org/standards/national-patient-safety-goals/ American College of Radiology http://www.acr.org/

The Contractor shall also adhere to the latest version of all technology standards and architecture policies, processes, and procedures applicable to the ICE IT environment when the teleradiology services have information technology components. These publications are available on request and include, but are not limited to the following:

· Department of Homeland Security (DHS) 4300A Sensitive Systems Handbook

· DHS 4300A Sensitive Systems Policy Directive

· DHS 4300B National Security Systems Handbook

· DHS Management Directive (MD) 4300, IT Systems Security Publication

· DHS MD 4010.2, Section 508 Program Management Office & Electronic and Information Technology Accessibility

· Section 508 1194.2, Section 508 of the Rehabilitation Act (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220)

· National Institute of Standards and Technology (NIST) Computer Security Resources Center (CSRC) standards, guidelines, and special publications

· Privacy Act of 1974

4. PERFORMANCE REQUIREMENTS

The objective of this project is to procure coordinated, teleradiology services for the purpose of medical screening of TB through digital chest X‐rays as well as the routine care of illness and injury through other digital radiographs of the body. Services will include TeleRadiology equipment purchase, installation, maintenance and technical support, TeleRadiology onsite equipment training to all designated staff, X‐ray interpretation, consultation, reporting, and storage of images offsite. Other routine digital radiographs include hand x-ray or joint x-ray. See Attachment 2 - X-Ray Historical Data for full list.

The Contractor shall provide all supervision, administrative and technical support, labor, subcontractors, tools, transportation, materials, supplies and equipment, and shall plan, schedule, coordinate and assure effective completion of all services described herein.

For purposes of this contract, any requirement due by “close of business” shall be provided no later than 5:00 pm, Eastern Standard Time on the date or day specified under each requirement.

Teleradiology Services

The Contractor shall provide a sufficient number of board‐certified radiologists necessary to provide remote interpretation image reads, for coverage 24 hours a day, 7 days a week, 365 days per year (24/7/365) and can support licensure requirements for practice in the following states (CA, TX, FL, AZ, and LA). The Services shall include any necessary consultation, and all required transition in and transition out activities.

Teleradiology Equipment

The Contractor shall deliver current state‐of‐the‐art commercial teleradiology X‐ray equipment required to perform services under this agreement. This includes X-ray tables or other equipment that may be needed to properly position patients for radiography (chest, abdomen, pelvis and skeletal) and capture the image. The Contractor shall also provide all required hardware and software installation and related testing, maintenance, technical support, image storage, system integration, final testing, and training. The following equipment specifications apply to both the mobile and permanent equipment solutions. IHSC provides on‐ site direct patient care to an average detained population of 15,000 per day at twenty (20) detention facilities throughout the country.

The detainee population is fluid and the throughput is extremely high in response to applicable ICE and correctional health care standards and the immigration process. It is not uncommon to receive up to 100 detainees for intake at a single facility who all need timely health screening which includes screening for TB through digital chest X‐rays. The chest X‐ray is typically completed on the patient in a standing position. During the course of routine medical care other films may be requested, including axial skeleton and limb radiographs. For these reasons the equipment solution should be versatile enough to accommodate any situation in short periods of time.

The Contractor shall also deliver and install one Hand-Held Unit at each site during the Transition Period.

Digital Chest X-Ray Equipment Specifications The diagnostic radiographic equipment for chest X-ray should be DIGITAL with a rotating anode tube with a 1.0-millimeter (mm) source (focal spot), if available and capable of sufficient output. The focal spot should be no larger than a 2.0 mm. The voltage, current, and regulation of the electric power supply for the X‐ray generator should comply with the manufacturer’s specification. Standard beam filters should be included to assure an appropriate energy profile. If the manufacturer or installer of the radiographic equipment recommends equipment for control of electrical power fluctuations, this should also be installed and utilized. The generators of units should have a minimum rating of 300 mill amperes (mA) at 125 kVp or 35 kW, ratings of 65 kW can increase image sharpness for larger patients.

To ensure high quality chest radiographs, the distance from source or focal spot to digital detector should be at least 70 inches (180 cm). Examinations should utilize at least the minimum voltage recommended by the digital imaging system manufacturer for chest radiography, preferably using high kV technique (up to 125 kVp), and at least 90 kVp, while minimizing radiation exposure.

Image Capture Hardware and Software The imaging plate should be a minimum of 35×43 centimeter (cm) or 1505 cm2, with maximum pixel pitch of 200 micrometers (μm), and a minimum matrix size of 3.75 megapixels (MP), with a minimum bit depth of 10. Spatial resolution should be at least 2.5-line pairs per mm in both vertical and horizontal directions. Detector signals should undergo routine amplification as well as standard image post‐processing. Image signal‐to‐noise and detective quantum efficiency should meet or exceed current professional recommendations as appropriate for the body part being radiographed.

The image data file and associated transmission and storage should conform to the current DICOM® (Digital Imaging and Communication in Medicine) standard and relevant substandard. Data systems should have error‐checking capability, reliability, and redundancy sufficient to assure integrity of information, and sufficient physical, technical, and administrative controls to prevent unauthorized access to protected health information and confidential medical findings during data transfers.

The Picture Archiving Communication System (PAC) provided shall be compliant with the DICOM standard and HL7 standards. Products shall be integrated with the electronic Health Records system (eHRs) and produce quality images. The eHR is a tailor version of the eClinicalWorks system.

The Contractor shall utilize HIPAA compliant systems with web viewing capability tool, encrypted data transmission, and cloud storage. The systems shall provide quality assurance solutions with community radiologist level review. The contractor shall certify in their submission they are and will maintain HIPAA compliance.

There may be occasions when the Contractor will be required to remove or install teleradiology equipment from one or more of the IHSC facilities as directed by the Government, and either relocate the equipment to new facilities or store the equipment for a specified period. This removal and relocation requirement will be specified and authorized under the “Changes” provision of the contract.

Network Connections

The Contractor shall be responsible for all Information Technology (IT) connections between the X-ray device and the Radiologists’ workstations. The Contractor shall be required to work with the ICE IT Field Office support at each facility to set up connectivity that does not interface with ICE’s secure network. The Contractor shall be responsible for configuring, installing and maintaining its secure network from the X-ray devices to all software residing on the remote radiologists’ workstation. The Contractor shall also have an Interconnection Security Agreement (ISA) between their Teleradiology system and ICE’s electronic Health Records (eHR) system that will transmit HL7 X-ray requests from eHR to their teleradiology system and HL7 X-ray results from teleradiology to the detainee’s medical record within ICE’s eHR.

IHSC may require other medical devices to connect to the network installed by the Contractor in the future.

Continuation of Services

The Contractor shall provide uninterrupted transitioning in support services and equipment, such as onsite mobile units and/or onsite local vendors, X‐ray interpretation services, and any additional operational and technical support as needed to preserve the integrity of the service during the transition in period while the current incumbent’s equipment is being removed and the Contractor’s equipment is being installed at each of the thirteen (13) IHSC facilities. (Attachment 1 - IHSC Facility Locations).

The Contractor shall also provide uninterrupted transition-out support services as will be specified in its Transition-Out Plan.

Interpretations (Radiologist)

The Contractor shall provide qualified and trained personnel who are fully competent to perform the work required under this agreement. All radiologists proposed under this agreement shall maintain current certifications and insurance as follows:

(a) Board Certification in Diagnostic Radiology Medicine by the American Board of Radiology;

(b) Contractor will ensure radiologists/physicians comply with all licensure and State law requirements.

(c) General liability and malpractice insurance as required by industry (see Appendix 1 Provisions and Clauses; Federal Acquisition Regulation (FAR) 52.237-7 Indemnification and Medical Liability Insurance.

The Contractor shall provide proof of these documents with the proposal and when radiologists are added to the staffing plan, as applicable. Should the Government elect to exercise any options under the resulting contract, upon Contractor’s receipt of notice to exercise an option, the Contractor is required to provide updated certifications and proof of insurance to the ICE Contracting Officer (CO) and the IHSC Contracting Officer’s representative (COR). This shall be accomplished before the option is exercised.

The Contractor shall provide the staffing necessary to accomplish all x‐ray interpretations within the timeframes required by the contract with sufficient licensed staff to allow for coverage of high-volume states, such as Texas. Attachment 2 - X-Ray Historical Data, provides radiology study estimates for planning purposes. While these numbers are not definitive, they represent a reasonable guide to the current radiology imaging workload by an IHSC facility.

If / when there is a change to this list after contract award, a modification will not be required. The Contractor will provide the COR an up to date monthly spreadsheet with the names of all current radiologists that are performing work under this contract and have access to detainee proprietary information. The list shall include the radiologists’ licenses’ expiration dates, as well as concurrence that the radiologists holds general and malpractice insurance. Within one (1) business days after a license expires, the Contractor shall provide proof of an updated license.

The Contractor will provide notice of 30 days prior to a major shift in staffing (e.g., change in radiologist sub-contractor) as an influx of new radiologist can impact facility operations as they are acclimating to our specific TB screening templates and procedures.

If the radiologist with an expired license does not renew his/her license in a particular state, the Contractor shall provide a memo to the CO and COR within one, (1) business day, after expiration date, stating that the radiologist in question will no longer be reading any x-ray studies in the state where he/she does not have a current active Medical License and insurance.

Critical Imaging Results

National Patient Safety Goal 2 requires timely communication of critical imaging results. Once an interpreting radiologist identifies critical imaging results, the interpreting radiologist shall communicate this result by telephone to the ordering IHSC facility staff and document the contact and the provider’s “read back” of the results in the official exam report. This communication shall be conducted telephonically by the appropriate radiologist or nurse (not an automatic or computer‐generated contact) using the English language, and shall occur immediately, but no later than 15 minutes of identification of a critical result. This includes significant abnormal findings on routine studies that may impact a patient’s care or treatment. See http://www.jointcommission.org/assets/1/6/HAP_NPSG_Chapter_2014.pdf. More effective alternative means of communication may be proposed but shall be approved by the Government prior to implementation.

The Contractor shall also immediately telephone the sending site clinician to verbally communicate any concerns and/or discrepancies between preliminary interpretations and final interpretations.

Final Interpretations

The Contractor is required to provide final interpretations to the requesting facility within four (4) hours of taking the x‐ray study, regardless of when preliminary interpretations were provided. If unable to speak directly with the appropriate IHSC staff from the respective site, the Contractor shall leave a voice mail message with the results and shall follow up with an email.

IHSC Chest X-Ray Results Template

Attachment 3 - Chest X-Ray Templates is the template for the chest X-ray impression that shall be utilized by the radiologist to better inform and direct IHSC staff in TB screening management. There is currently no template for other than chest x-rays.

Negative screening for Active TB disease by radiographic criteria: normal CXR. Requires nurse review; Clear for general population.

POSITIVE screening for Active TB disease by radiographic criteria: pulmonary parenchymal and/or pleural finding(s) and/or mediastinal lymphadenopathy, cannot exclude Active TB; findings as noted above. A provider should apply IHSC TB Clinical Guideline screening algorithm (Category A, B or C) for further action, if necessary.

Reports

The Contractor shall utilize the Daily, Weekly, and Monthly Reports that are generated by the eClinicalWorks (ICE eHR version) interface (eCW), at each site

With regards to any issues that are discovered by the Contractor, (e.g., outage, downtime, etc.) the Contractor shall notify the site POC the moment that it is discovered, resolve the issue immediately, and inform the COR via email, as well as include the issue on the Weekly, and Monthly Report for the Office of Acquisition Management. Any issues shall be discovered by the Contractor within 4 hours.

Consultation

The Contractor shall provide professional consultation, in real time by phone, for discussion and/or consultation. The Contractor's radiologists shall be readily available to provide oral, telephonic consultation to physicians and technologists twenty‐four hours a day and seven days a week including weekends and holidays. If not available immediately, the Contractor shall provide a response to the appropriate IHSC contact within fifteen (15) minutes of request for consultation.

The Contractor must notify the Nursing Coordinator at the site within fifteen (15) minutes of identifying a radiograph with a critical value (e.g., the chest X-ray has a finding consistent with TB) and requires further urgent management decisions.

Comparison Requirement Sequential chest radiographs with direct comparison are part of clinical management and decision making in cases of confirmed or possible tuberculosis. As such we request that the Contractor provide comparison studies between their own studies as well as between the Contractor’s and outside institution studies (health departments, hospitals, other radiology contractors). Such reports should be requested as “comparison read” by providers when ordering the study.

1. Compare images created within the Contractor’s environment (i.e., 2 or more studies at different points in time).

2. Compare image/s received from outside Contractor’s environment (uploaded into their system in DICOM format), to image/s created w/in the Contractor’s environment

3. Compare image/s received from outside the Contractor’s environment (uploaded into their system in DICOM format), to another image/s received from outside the Contractor’s environment (uploaded into the Contractor’s system in DICOM format)

4. The Contractor’s radiologist shall provide one of the following impressions for comparison chest films: 1) Unchanged, 2) overall worse, or 3) overall improved

5. Provide said report and interpretation to the requesting clinician within 1 business day of receipt of both studies (baseline and comparison)

Facility Access

The Contractor is required to provide to the COR, a list of all personnel who require access to IHSC facilities, including access during the Transition‐In phase, installation of equipment, training, testing, and etcetera. All applicable Contractor personnel shall be capable of passing the ICE‐required building access procedures and vendor authorization in order to enter IHSC facilities.

The Contractor’s personnel shall be required to obtain the necessary clearance required under this PWS to be granted access to the facility and its grounds. Contractor’s personnel criminal history checks shall be part of the general background check for performance of services in and around the facility. This process is strictly confidential, and access to the information must be limited to the Agency. The contractor employees are required to complete the Building Access Request Form, prior to facility access granted.

See Appendix B: Building Access Request form

Coverage (Hours of Operation)

The Contractor shall provide adequate coverage for each of the thirteen (13) IHSC facilities. The hours of operation at all sites utilizing teleradiology services operate 24/7.

Maintenance and Technical Support The Contractor shall:

(a) Provide all Maintenance and Technical Support on Contractor’s installed equipment,

(b) Ensure the Teleradiology services are fully operable, able to stand alone, and able to integrate with ICE’s eHR,

(c) Provide 24/7/365 technical support,

(d) Provide a 1‐800/866 number available for technical support 24/7/365,

(e) Provide all network capabilities, hardware, and software installation,

(f) Provide network connectivity. Full connectivity and testing of equipment shall be established and verified during the transition period, and

(g) Provide a system that maintains at least a 99% uptime performance rate.

Equipment repair shall not exceed four (4) hours in any 24‐hour period. The four (4) hours begins upon the notice to contractor via telephonic and email contact. In the event an equipment repair exceeds this four (4) hour requirement, the Contractor will provide resources to ensure there is no gap in service.

The Contractor shall be responsible for all Information Technology (IT) connections and shall be required to work with the ICE IT department at each facility to set up connectivity. The Contractor shall be responsible for configuring, installing, and maintaining the secure remote connectivity and all remote workstation software residing on the remote radiologists’ workstation. Equipment shall be reliable and functional to prevent disruption in the delivery of services. The radiologist review stations shall meet all specifications required by the ACR for primary image interpretation. Data transmission security shall always be maintained.

Hardware and Software Computer monitors utilized by the Contractor for purposes of radiograph interpretations shall be calibrated in a timely fashion consistent with proper quality control procedures at the reading site. This calibration shall be in compliance with Food and Drug Administration (FDA) recommendations for monitor calibration. The Contractor shall provide the IHSC with documentation of equipment quality control policies and certifications upon request.

Image Storage and Integration The Contractor must certify in writing at submission they will only utilize a GSA FedRAMP certified environment.

(a) FedRAMP certification must be maintained continuously throughout the life of the contract. If the Contractor (or its FedRAMP provider) loses its FedRAMP certification, the Contractor must report this information to the Government immediately in writing. The Contractor must, within thirty (30) days after losing FedRAMP certification, re‐certify or contract with an authorized FedRAMP provider. Failure to comply will result in termination of the contract.

(b) The image files and interpretation reports shall be stored solely in a GSA FedRAMP compliant environment (see http://cloud.cio.gov/fedramp/cloud‐systems). Non‐compliant FedRAMP systems will result in proposals being evaluated as technically unacceptable. The contractor shall provide certificate or evidence of compliant Ramp system. The Contractor shall only store images in a single location, and support integration of the interpretation reports via an interface to the ICE electronic Health Records system via an HL7 interface. The Contractor shall propose an integrated solution that eClinicalWorks (eHR software vendor) has reviewed and approved for implementation. This effort will include project management, development, testing, and deployment. The Government will provide the appropriate access and permissions to complete this task. Stored Images by the Contractor will be readily available to the Government and to the radiologists (if subcontracted). The Contractor shall provide a notification each time interpretation reports are transmitted to the ICE eHR (eClinicalWorks).

The eClinicalWorks (ICE eHR version) interface shall follow the order and response HL7 message pattern similar to the CIPS interface.

The Contractor shall accept HL7 Request for Material or Services (ORM) messages from eCW over a TCP/IP via a VPN tunnel. The Contractor shall return an HL7 Observation Result message (ORU) with final interpretation results, including a link to the image which will be maintained and stored by the Contractor. The Contractor shall provide access to the link to IHSC users communicating through the ICE network. The Contractor shall utilize the Alien Number (A#) as a main patient identifier and be capable of using the eClinicalWorks (ICE eHR version) order number.

Service Provider (Azure) Figure 1 - Conceptual Architecture eClinicalWorks may be contacted via web: http://www.eclinicalworks.com, or e-mail: sales@eclinicalworks.com, or phone: (508) 836-2700. Reference DHS / ICE eCW Teleradiology Integration.

The Contractor shall support Certification and Accreditation (C&A) efforts to ensure Federal Information Security Management Act (FISMA) compliance to ICE. The images files and interpretation reports are the exclusive property of the Government. The Contractor shall support the Government in accessing the raw data and assisting with extracting, transferring, and loading the image files and reports to another storage location within seven (7) days after notification. Additionally, the Contractor shall provide written notification to the Government ninety (90) days prior to changing an image file location and shall assume all related transition costs to include certifications and approvals updates.

The images files shall be saved for the duration of the contract period of performance, organized in a rapidly retrievable way such as to facilitate comparison studies. Upon completion of the contract, the Contractor shall transfer all images to the Government.

The online storage of the image files will also be required for the duration of the contract.

Training At no additional cost to the Government, the Contractor shall provide the following training as required during the term of this agreement:

Initial Training

The Contractor will provide initial training on the Contractor’s installed equipment operation and Contractor’s TeleRadiology workflow. Initial training is required upon installation of equipment to IHSC staff at each of the facilities. The Contractor shall provide training packages, user manuals and any other materials reasonably necessary to assist in the training process

New Hire Training

The Contractor shall provide training for new hires (i.e. radiology technicians) within 2 business days of notification by the Government. The Contractor shall provide training packages and materials, such as training manuals, PowerPoint presentations and any other training tool designed to assist in the learning method

Training for Upgrades

Contractor shall provide additional training that may be required by the Government as the result of software and/or hardware upgrades. The Contractor shall provide modifications to user manuals if required by an upgrade

Refresher Training

Contractor shall provide annual refresher training sessions for all IHSC radiology technicians to comply with all state certification requirements. Training shall include;

(a) A brief orientation on digital radiography (DR), clinical DR system uses and applications, digital radiography (DR) room and radiation safety,

(b) DR system troubleshooting basics; and

(c) An IHSC field radiology technicians Hands – On – The – Job– skills application section

5. DELIVERABLES AND DELIVERY SCHEDULE

This contract includes a Performance Requirements Summary (PRS) in Section 10. The PRS plays an integral role in the administration of the contract. In addition to any applicable inspection clauses or other related terms and conditions contained in the contract, the PRS shall serve as a primary tool for inspection and acceptance of services as facilitated by the Contracting Officer’s Representative (COR). Evaluation of the Contractor’s overall performance shall be in accordance with the performance standards set forth in the PRS, and shall be conducted by the COR. The PRS constitutes a material aspect of the contract and shall not be changed or otherwise modified without prior written approval of the Contracting Officer.

The Contractor shall provide each of the following deliverables under the terms of the contract:

ITEM

DELIVERABLE / EVENT

DUE BY

DISTRIBUTION

COR and CO

/Award and Annually prior to each option exercised

COR / CO

Weekly status report and telecoms during transition in-out phases

COR / CO

Facilities

6. GOVERNMENT FURNISHED EQUIPMENT

This contract does not include any government‐furnished equipment.

7. PERIOD OF PERFORMANCE

The period of performance for this contract includes a base period of one year (with transition included) and four one‐year option periods.

8. PLACE OF PERFORMANCE

Work performed during the transitioning in and transitioning out periods and some technical support may be required onsite at various Government facilities. All other support shall be provided at the Contractor’s locations.

9. QUALITY CONTROL PLAN (QCP)

The Contractor shall develop and maintain an effective Quality Control Plan (QCP) to ensure services are performed in accordance with this PWS and in compliance with metrics identified in Attachment Placeholder Quality Assurance Surveillance Plan (QASP) and Section 10.

The Contractor shall develop and implement procedures to identify and mitigate risk of non‐compliant performance. The Contractor’s QCP is the means by which it assures that their work complies with the requirements of the contract. The Contractor shall submit the QCP with the proposal and update as needed upon request, and approved by the CO and COR.

10. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

The Government shall evaluate the contractor’s performance under this contract in accordance with the QASP. This plan is primarily focused on what the Contractor shall do to ensure that the service has performed in accordance with the performance standards. It defines how the performance standards shall be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

Contractor shall maintain a QASP related to the teleradiology services covered under this contract. The results of all Quality Improvement activities performed by the Contractor shall be shared with IHSC staff. This shall include, but not be limited to: quality improvement plans, minutes of staff meetings where quality improvement has been discussed and which include radiologist‐specific findings, conclusions, recommendations, written plans for actions taken in response to such conclusions and recommendations, and evaluation of those actions taken.

Copies of radiologist licensure are required to be submitted annually to the COR thirty days after the Notice of Intent to Exercise an Option. In addition, updated Joint Commission survey results for the contractor, if Joint Commission certified, shall be forwarded to the COR upon receipt.

The Contractor shall meet or communicate with the IHSC staff for process review and improvement of contract performance on an as needed basis.

Quality factors that IHSC may consider when monitoring quality of service may include, but are not limited to: security/privacy, availability, adverse event reporting, turn‐around times, access, quality of work and timeliness.

The PRS establishes key elements of Contractor performance that represent “mission essential” service requirements, which are identified in the table below:

Table 1

Repairs & Technical Support Downtime shall not exceed 4 hours after notification of problem >99.0%

after hours as needed 24/7/365 >99.0%

Radiology Reports of Finding, Standard Final interpretations completed within the 4-hour timeframe.

>95.0%

imaging results >99.0%

Daily Volume & Status Report and Monthly Volume Image Report

Transition Weekly Status Report Submission of Report in accordance with requirements >95.0%

11. USE OF PROPRIETARY SOFTWARE

The Contractor shall NOT use, as part of the solution, any proprietary software that is not commercially available.

12. INTELLECTUAL PROPERTY OWNERSHIP

Any forms of intellectual property first developed under this contract shall be considered government property. All TeleRadiology data shall be the property of DHS and will be returned in the manner specified by the government.

13. DATA EXCHANGES / INTERFACES

The Contractor’s solution shall:

(a) Support integration with the medical X-ray images with the ICE eHRs (eClinicalWorks) through the cloud service provider through a reference link (note: images shall not be copied to the ICE eHR system);

(b) Support integration with the image interpretation data via an interface with the ICE eHRs (eClinicalWorks). The data shall be stored as part of the detainee medical record; and

(c) Include the capabilities and necessary protocols to interface with Government’s Electronic Health Record version (eCW). Contractor shall be able to establish all necessary requirements and operational procedures to interface with the Government Electronic Health Record System (eCW) 180 days after contract award.

14. CONNECTIVITY SUPPORT

The Contractor’s solution shall support:

(a) HL7 Version 3 CCD, and

(b) American Society for Testing and Materials (ASTM) International CCR Standard E2369.0

15. MEET INDUSTRY CERTIFICATION STANDARDS

The Contractor shall meet the following industry standards:

(a) Physicians/Radiologist resources shall have appropriate licensures both in the state where physician/radiologist is reading the images and in the state where images originated. (http://www.acr.org/Advocacy/State-Local- Relations/Legislative-Issues/TeleRadiology/TeleRadiology-Licensing- Requirements-by-State)

(b) The Contractor is ultimately responsible for compliance for all applicable laws, rules, and regulations regarding licensure of its staff.

(c) In keeping with its commitment to reform the immigration detention system, ICE has revised its detention standards. These new standards, are known as Performance Based National Detention Standards (PBNDS) www.ice.gov/detention- standards/2011

(d) Any licensing Changes and or allegations of malpractice or medical negligence shall be reported immediately to the Government verbally and in writing.

16. GOVERNMENT FURNISHED INFORMATION (GFI)

The Government will provide a Reference Document Library.

17. ACCESSIBILITY REQUIREMENTS (Section 508)

(a) Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use electronic and information technology, they shall ensure that it is accessible to people with disabilities. Federal employees and members of the public who have disabilities shall have equal access to and use of information and data that is comparable to that enjoyed by nondisabled Federal employees and members of the public.

(b) All EIT deliverables within this work statement shall comply with the applicable technical and functional performance criteria of Section 508 unless exempt. Specifically, the following applicable standards have been identified:

(c) 36 CFR 1194.21 – Software Applications and Operating Systems, applies to all EIT software applications and operating systems procured or developed under this work statement including but not limited to GOTS and COTS software. In addition, this standard is to be applied to Web-based applications when needed to fulfill the functional performance criteria. This standard also applies to some Web based applications as described within 36 CFR 1194.22.

(d) 36 CFR 1194.22 – Web-based Intranet and Internet Information and Applications, applies to all Web-based deliverables, including documentation and reports procured or developed under this work statement. When any Web application uses a dynamic (non-static) interface, embeds custom user control(s), embeds video or multimedia, uses proprietary or technical approaches such as, but not limited to, Flash or Asynchronous Javascript and XML (AJAX) then “1194.21 Software” standards also apply to fulfill functional performance criteria.

(e) 36 CFR 1194.24 – Video and Multimedia Products, applies to all video and multimedia products that are procured or developed under this work statement. Any video or multimedia presentation shall also comply with the software standards (1194.21) when the presentation is through the use of a Web or Software application interface having user controls available. This standard applies to any training videos provided under this work statement.

(f) 36 CFR 1194.25 – Self Contained, Closed Products, applies to all EIT products such as scanners, printers, copiers, fax machines, kiosks, etc. that are procured or developed under this work statement.

(g) 36 CFR 1194.26 – Desktop and Portable Computers, applies to all desktop, servers, and portable computers, including but not limited to laptops and personal data assistants (PDA) that are procured or developed under this work statement.

(h) 36 CFR 1194.31 – Functional Performance Criteria applies to all EIT deliverables regardless of delivery method. All EIT deliverable shall use technical standards, regardless of technology, to fulfill the functional performance criteria.

(i) 36 CFR 1194.41 – Information Documentation and Support, applies to all documents, reports, as well as help and support services. To ensure that documents and reports fulfill the required “1194.31 Functional Performance Criteria”, they shall comply with the technical standard associated with Web-based Intranet and Internet Information and Applications at a minimum. In addition, any help or support provided in this work statement that offer telephone support, such as, but not limited to, a help desk shall have the ability to transmit and receive messages using TTY.

Exceptions for this work statement have been determined by DHS and only the exceptions described herein may be applied. Any request for additional exceptions shall be sent to the COR and determination will be made in accordance with DHS MD 4010.2. DHS has identified the following exceptions that may apply:

36 CFR 1194.2(b) – (COTS/GOTS products), When procuring a product, each agency shall procure products which comply with the provisions in this part when such products are available in the commercial marketplace or when such products are developed in response to a Government solicitation. Agencies cannot claim a product as a whole is not commercially available because no product in the marketplace meets all the standards. If products are commercially available that meets some but not all of the standards, the agency shall procure the product that best meets the standards

When applying this standard, all procurements of EIT shall have documentation of market research that identify a list of products or services that first meet the agency business needs, and from that list of products or services, an analysis that the selected product met more of the accessibility requirements than the non-selected products as required by FAR 39.2. Any selection of a product or service that meets less accessibility standards due to a significant difficulty or expense shall only be permitted under an undue burden claim and requires approval from the DHS Office on Accessible Systems and Technology (OAST) in accordance with DHS MD 4010.2.

36 CFR 1194.3(b) – Incidental to Contract, all EIT that is exclusively owned and used by the contractor to fulfill this work statement does not require compliance with Section 508. This exception does not apply to any EIT deliverable, service or item that will be used by any Federal Employee(s) or member(s) of the public. This exception only applies to those contractors assigned to fulfill the obligations of this work statement and for the purposes of this requirement, are not considered members of the public.

18. PRIMARY ROLES AND RESPONSIBILITIES

The following subsections describe the roles and responsibilities of individuals and/or authorized users who will be the primary Points of Contact (POC) for the Government on matters regarding contract administration as well as other administrative information. The Government reserves the right to unilaterally change any of these individual assignments at any time.

Contracting Officer’s Representative (COR)

The COR within the IHSC is responsible for the receipt and acceptance of the contract-level deliverables and reports and past performance reporting. The COR supports the CO in the general management of the acquisition.

The COR for this contract will be identified by the CO through a written designation. A copy of the letter of designation with specific duties and responsibilities will be provided to the Contractor.

The COR will represent the CO in the administration of technical details within the scope of the task order. The COR is also responsible for the final inspection and acceptance of all task order deliverables and reports. The COR is not otherwise authorized to make any representations or commitments of any kind on behalf of the CO or the Government. The COR does not have authority to alter the Contractor’s obligations or to change the contract specifications, price, terms or conditions. If, as a result of technical discussions, it is desirable to modify task order obligations or the specification, changes will be issued in writing and signed by the CO.

Contracting Officer (CO)

The CO, without right of delegation, is the only authorized individual to take actions on behalf of the Government to amend, modify or deviate from the contract terms, conditions, requirements, specifications, details and/or delivery schedules. The CO for this contract is:

Name: Brittany Tobias Phone: 202-732-2408 Email: Brittany.Tobias@ice.dhs.gov

19. REFERENCE DOCUMENTS

Listed below are the documents associated with this requirement. Also see document marked “Index” for a complete list of all of the documents:

· Attachment 1 - IHSC Facility Locations

· Attachment 2 - X-Ray Historical Data

· Attachment 3 - Chest X-Ray Templates

· Attachment 4 – Placeholder

· Attachment 5 – Placeholder

· Attachment 6 – Placeholder

APPENDIX A: GENERAL CYBERSECURITY REQUIREMENTS

ITAR 4.5.3.1 Compliance with DHS Security Policy Terms and Conditions All hardware, software, and services provided under this task order must be compliant with DHS 4300A DHS Sensitive System Policy and DHS 4300A Sensitive Systems Handbook.

ITAR 4.5.3.4 and ITAR 4.5.4.4 – Security Review The Government may elect to conduct periodic reviews to ensure that the security requirements contained in this contract are being implemented and enforced. The Contractor shall afford ICE, including the organization of ICE Office of the Chief Information Officer, the Office of the Inspector General, authorized Contracting Officer Technical Representative (COTR), and other government oversight organizations, access to the Contractor's facilities, installations, operations, documentation, databases and personnel used in the performance of this contract. The Contractor will contact ICE Chief Information Security Officer to coordinate and participate in the review and inspection activity of government oversight organizations external to ICE. Access shall be provided to the extent necessary for the government to carry out a program of inspection, investigation, and audit to safeguard against threats and hazards to the integrity, availability, and confidentiality of ICE data or the function of computer system operated on behalf of ICE, and to preserve evidence of computer crime.

ITAR 4.5.3.5 and ITAR 4.5.4.5 – Interconnection Security Agreement (ISA) Interconnections between DHS/ICE and non-DHS/ICE IT systems shall be established only through controlled interfaces and via approved service providers. The controlled interfaces shall be authorized at the highest security level of information on the network. Connections with other Federal agencies shall be documented based on interagency agreements; memoranda of understanding, service level agreements or interconnection security agreements ITAR 4.5.3.7 – Supply Chain Risk Management The Contractors supplying the Government hardware and software shall provide the manufacturer's name, address, state and/or domain of registration, and the Data Universal Numbering System (DUNS) number for all components comprising the hardware and software. If subcontractors or subcomponents are used, the name, address, state, and/or domain of registration and DUNs number of those suppliers must also be provided.

Subcontractors are subject to the same general requirements and standards as prime contractors. Contractors employing subcontractors shall perform due diligence to ensure that these standards are met.

The Government shall be notified when a new contractor/subcontractor/service provider is introduced to the supply chain, or when suppliers of parts or subcomponents are changed.

Contractors shall provide, implement, and maintain a Supply Chain Risk Management Plan that addresses internal and external practices and controls employed to minimize the risk posed by counterfeits and vulnerabilities in systems, components, and software.

The Plan shall describe the processes and procedures that will be followed to ensure appropriate supply chain protection of information system resources developed, processed, or used under this contract.

The Supply Chain Risk Management Plan shall address the following elements:

(i) How risks from the supply chain will be identified;

(ii) What processes and security measures will be adopted to manage these risks to the system or system components; and How the risks and associated security measures will be updated and monitored.

The Supply Chain Risk Management Plan shall remain current through the life of the contract or period of performance. The Supply Chain Risk Management Plan shall be provided to the Contracting Officer Representative (COR/CO) 30 days post award.

The Contractor acknowledges the Government's requirement to assess the Contractors Supply Chain Risk posture. The Contractor understands and agrees that the Government retains the right to cancel or terminate the contract, if the Government determines that continuing the contract presents a risk to national security.

The Contractor shall disclose, and the Government will consider, relevant industry standard certifications, recognitions and awards, and acknowledgments.

The Contractor shall provide only new equipment unless otherwise expressly…