TeleRadiology_Services_Performance_Work_Statement_PWS_Final_sds_(8-18-14).doc

TELERADIOLOGY SERVICE

PERFORMANCE WORK STATEMENT (PWS)

1. Background:

The U.S. Immigration Customs & Enforcement (ICE) Health Service Corps (IHSC) provides and arranges for health care services for undocumented immigrants detained by ICE. As ICE’s medical authority, 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), state, county or local inter-governmental service agreement (IGSA) correctional facilities located throughout the country.

IHSC 19 facilities are staffed with Public Health Service Commissioned Officers, Federal employees and contractors. These facilities are directly under the supervision of IHSC

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 United States. It is also an essential provision for providing a safe and humane environment for the detained aliens.

2. Scope:

The health care service provided by IHSC includes screening for infectious diseases, primary treatment, mental and dental healthcare. After the initial intake screening, medical care is provided to this population, either directly by IHSC staff or by referral for necessary and appropriate care while they remain under ICE jurisdiction. Chest X-ray images are the most reliable method to quickly screen and detect active pulmonary TB. IHSC is seeking to procure a coordinated, comprehensive system for the provision of TB Tele-Radiology screening. The Contractor must provide delivery, installation, testing, maintenance and training of on-site of IHSC personnel in the operation of the X-ray equipment to take chest X-rays and transmittal of the X-ray images to an off-site location. Radiology services will include interpretation of radiographs, providing reports on the results, availability for consultation, storing of images, and annual certification of X-ray machine unit containment. The contract will be awarded as a hybrid contract, Firm Fixed Price and Indefinite Delivery Indefinite Quantity (IDIQ) with Firm Fixed Price Contract Line Items.

3. APPLICABLE DOCUMENTS:

The Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities The following documents provide specifications, standards, or guidelines that must be complied with in order to meet the requirements of this contract:

Health Level Seven International (HL7) http://www.hl7.org/ HIPAA (Health Insurance Portability and Accountability Act of 1996) http://www.hhs.gov/ocr/privacy/ The Joint Commission: National Patient Safety Goals Effective January 1, 2014 http://www.jointcommission.org/assets/1/6/HAP_NPSG_Chapter_2014.pdf American College of Radiology http://www.acr.org/

4. PERFORMANCE REQUIREMENTS:

The objective of this project is to procure a coordinated, comprehensive TeleRadiology Services. Services. Services will include teleradiology equipment maintenance and technical support, teleradiology onsite equipment training, X-ray interpretation, consultation; reporting, and storages of images offsite.

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.

4.1 TeleRadiology Services

The Contractor must deliver commercial current teleradiology X-ray equipment, installation, board certified radiologists necessary to provide remote interpretation image reads for TB reports, coverage 24 hours a day 7 days a week, 365 days per year (24/7/365), consultation, maintenance, technical support, hardware, software, image storage, integration, testing, training, invoicing, transition in and transition out activities.

4.1.1 TeleRadiology Equipment

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 insure 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 for chest radiography.

The image data file and associated transmission and storage should conform to the current DICOM® 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 must be compliant with the DICOM (Digital Imaging and Communication in Medicine Standard) standard and HL7 standards. Products must be integrated with the electronic Health Records system (eHRs) and produce quality images. The eHR is a tailor version of the eClinical Works systems.

The Contractor must utilize HIPAA compliant systems with web viewing capability tool, encrypted data transmission, and cloud storage. The systems must provide quality assurance solutions with community radiologist level review.

There may be occasions when the Contractor will be required to remove teleradiology equipment from one or more of the IHSC facilities.

4.1.2 Transition In Plan:

The Contractor must communicate a detailed narrative of the transition plan implementation and completion in a coherent and concise manner. The Microsoft Project 2010 Gantt chart must show the coordination of the delivery, installation, training and testing of the X-ray equipment. The Contractor must provide a proposed schedule to show how the Contractor intends to perform the work within and at each of the 19 IHSC facilities within the proposed transition timeline of 90 days. The Contractor must clearly label each facility.

How the Contractor plans to provide Continuation of Services (see below), network access, and network monitoring must also be addressed in their Transition In Plan. (See Attachment 1a Facilities Floor Plans. Attachment 1b Transition In & Interim Service Plan is provided as an example only and does not have to be used by the Contractor. However, the proposed plan must accomplish the Transition In & Interim Support within 90 days.”

4.1.2.1 Continuation of Services:

The Contractor must provide uninterrupted transitioning support service (i.e. mobile units and/or local vendors) while equipment is being installed/removed at each of the 19 IHSC facilities during the transition period of 90 days. The contactor must provide uninterrupted TeleRadiology services at each facility until the Contractor’s installation/removal is complete. (See Attachment #2 Facilities Location).

4.1.3 Interpretations (Radiologist):

The Contractor will be responsible to ensure that Contractor’s personnel providing work are fully trained and completely competent to perform the required work, and meet ICE-required vendor authorization to enter IHSC facilities. Prospective providers must present appropriate credentialing information including but not limited to the following:

· Board Certification in Diagnostic Radiology Medicine by the American Board of Radiology

· 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 must provide proof of these documents with the proposal. Upon the notice to exercise an option, the Contractor is required to provide updated certifications and proof of insurance to the IHSC Headquarters Credentialing Unit. This must be accomplished before the option will be exercised. The point of contact information for the Credentialing Unit will be provided upon contract award.

The estimated workload identified in Attachment #3 Historical Monthly and Daily Volumes, is an estimate of the radiology study workload by IHSC facilities. While these numbers should not be understood as definitive, they represent a reasonable guide to the workload.

4.1.3.1 Findings/Reports:

Final interpretations are required. Should the Contractor provide preliminary interpretations, the final interpretation must be provided to the sending facility within 2 hours.

· Daily Status Report

The Contractor must prepare a daily status report for each of the facilities. The reports must include the number of images read for that particular facility on that particular day. The report is due by close of business the following business day.

· Weekly

During the Transition In-Out Phases, the Contractor must provide a weekly status report and a weekly telecom to discuss progress. Weekly telecoms will include affected facilities to participate in these telecoms.

· Monthly Status Report

The Contractor must prepare a monthly report for the Contracting Officer’s Representative (COR) and the Contracting Officer (CO) that consists of each facility and total number of images read for the month. The monthly status report is due not later than the close of business the 5th day of the following month.

4.1.3.2 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 must telephonically communicate this result to the ordering provider and document the contact and the provider’s “read back” of the results in the official exam report. This communication will occur within 2 hours 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 The Contractor must also immediately notify the sending site clinician via telephone concerning any and all discrepancies between preliminary interpretations and final interpretations.

4.1.3.3 Consultation:

The Contractor must provide professional consultation in real time, by phone for discussion and/or consultation. The Contractor's radiologists must be readily available to provide oral consultation to physicians and technologists twenty-four hours a day and seven days a week including weekends and holidays. If not available immediately, contractor must provide a response within fifteen (15) minutes. The IHSC credentialing Unit will request updated credentials, as necessary.

4.1.3.4 Coverage (Hours of Operations)

The Contractor must provide coverage for each of the 19 IHSC facilities. The hours of operation are defined in the document marked “Facilities Hours of Operations.” (See Attachment #4 Facilities Hours of Operation)

4.1.4 Maintenance and Technical Support

The Contractor must provide all Maintenance and Technical Support on Contractor’s installed equipment.

Ensuring that the TeleRadiology services are fully operable, able to stand alone, and able to integrate with ICE’s eHRs.

The Contractor must provide 24/7/365 technical support

The Contractor must provide a 1-800/866 number available for technical support 24/7/365.

The Contractor must provide all network capabilities, hardware, and software installation.

Network connectivity will not be provided by the Government. Full connectivity and testing of equipment must be established and verified during the transition period.

The Contractor must provide a system that maintains at least a 99% uptime performance rate.

Equipment repair must not exceed 4 hours in any 24-hour period (The 4 hours start upon the arrival of the technician) as this would severely impact the ability of IHSC to provide care to detainees. In the event an equipment repair exceeds this four-hour requirement, the Contractor will provide resources to ensure there is no gap in service.

The Contractor must be responsible for all Information Technology (IT) connections and must be required to work with the IT department at each facility to set up connectivity.

The Contractor must be responsible for configuring, installing, and maintaining the secure remote connectivity and all remote workstation software residing on the remote radiologists’ workstation.

Equipment must be reliable and functional to prevent disruption in the delivery of services.

The radiologist review stations must meet all specifications required by the ACR for primary image interpretation. Data transmission security must be maintained at all times.

4.1.5 Hardware and Software

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

4.1.6 Image Storage and Integration

The image files and interpretation reports must be stored in a GSA FedRAMP certified environment. The Contractor shall support Certification and Accreditation (C&A) efforts to ensure Federal Information Security Management Act (FISMA) compliance to ICE. The Contractor shall develop an interface to the e-Health Records (eHRs) for integrating the interpretation reports into the detainee eHRs. 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 provider. The Contractor must provide a notification each time interpretation reports are transmitted to the ICE eHRs (eClinical Works).

The image 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 must provide written notification to the Government ninety (90) days prior to changing an image file location. and must assume all related transition costs to include certifications and approvals updates.

The image files must be saved for the duration of the contract period of performance. The Contractor must provide for the transfer of all images taken, upon the completion of the contract to the Government. The online storage will also be required for the duration of the contract.

4.1.7 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. New hires will receive training within 2 business days. Additional training may be required by the contractor when software and/or hardware upgrades are performed. This training will be provided at no cost to the Government. Refresher training must be provided. The Contractor shall provide a training package or a mechanism in place to train new staff, as they get hired (For example a training manual, PowerPoint presentation, etc. Training shall include at least two (2) yearly refresher “Train-the Trainer” sessions. All training must meet minimum registered nurse and licensed vocational nurse state requirements.

5. PERFORMANCE STANDARDS:

This contract includes a Performance Requirements Summary (PRS) at PWS paragraph 13. 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.

6. DELIVERABLES AND DELIVERY SCHEDULE:

The Contractor shall consider all items below as being mandatory.

General Liability and Malpractice Insurance

Weekly status report and telecoms during transition in-out phases

COR / CO

7. GOVERNMENT FURNISHED EQUIPMENT AND INFORMATION:

The Government will not furnish equipment

8. Period of Performance:

The period of performance for this contract is a one-year base period with four one-year option periods as follows:

Base Year

October 7, 2014 through October 6, 2015

Option Year 1

October 7, 2015 through October 6, 2016

Option Year 2

October 7, 2016 through October 6, 2017

Option Year 3

October 7, 2017 through October 6, 2018

Option Year 4

October 7, 2018 through October 6, 2019 FAR 52.217-9 (6 months) October 7, 2019 through April 6, 2020

9. PLACE OF PERFORMANCE:

For the purpose of this PWS, radiology interpretations will not be performed at the Government’s location.

10. 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. 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 Draft QCP with the proposal and final copy 5 working days after contract award. A copy shall be emailed to the COR and the CO. After acceptance of the QCP, the contractor shall receive the CO’s acceptance in writing five days after submission.

11. 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 must 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).

a.

Contractor shall maintain a QASP related to the Tele-radiology 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.

b. 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.

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

d. Quality factors that IHSC may consider in addition to the list below 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, timeliness, etc.

12. 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

Facility Map Attachment 1a

Facility Floor Plan

Attachment 1b Transition In & Support Services Plan

Attachment 2

Facility Locations Attachment 3

Historical Monthly and Daily Volumes

Attachment 4

Facilities Hours of Operation

Attachment 5

Electrical Information

Attachment 6

Draft Quality Surveillance Plan Attachment 7

Past Performance

13. PERFORMANCE REQUIREMENTS SUMMARY (PRS).

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

14. Use of Proprietary Software

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

15. 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.

16. Data Exchange/Interfaces

The Contractor’s solution 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)

· 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.

17. Connectivity Support

The Contractor’s solution shall support:

· HL7 Version 3 CCD, and

· American Society for Testing and Materials (ASTM) International CCR Standard E2369-05.

18. Meet Industry Certification Standards

The Contractor must meet the following industry standards:

· Physicians/Radiologist resources must have appropriate licensure 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)

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

· 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.

19. OTHER CONSTRAINTS

The Contractor must satisfy the following technical constraints:

· System Integration Compliance

The Contractor shall comply with the latest version of all technology standards and architecture policies, processes, and procedures applicable to the IHSC IT environment, including those defined in ICE OCIO Architecture Division publications. These publications include but are not limited to the following:

· DHS 4300A Sensitive Systems Handbook, http://www.uscg.mil/acquisition/nais/RFP/SectionJ/dhs-4300A-handbook.pdf

· DHS 4300A Sensitive Systems Policy Directive, http://www.dhs.gov/xlibrary/assets/foia/mgmt_directive_4300a_policy_v8.pdf

· DHS 4300B National Security Systems Handbook, (see attachment marked SLM Handbook)

· DHS MD 4300.1, IT Systems Security, (see attachment marked DHS-MD 4300-1)

· DHS MD 4010.2 (DRAFT), Section 508 Program Management Office & Electronic and Information Technology Accessibility, (see attachment marked Section 508)

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

· Privacy Act of 1974 http://www.hhs.gov/foia/privacy/

20. Government Furnished Information (GFI)

The government will provide a Reference Document Library.

21. Government Furnished Equipment (GFE)

Network connectivity will not be provided.

22. Accessibility Requirements (Section 508)

· 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 must ensure that it is accessible to people with disabilities. Federal employees and members of the public who have disabilities must have equal access to and use of information and data that is comparable to that enjoyed by non-disabled Federal employees and members of the public.

· 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:

· 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.

· 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.

· 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.

· 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.

· 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.

· 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.

· 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 must 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.

ACRONYMS

8/18/2014