PWS_TELERAD.docx

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Bemidji Area Indian Health Service 2225 Cooperative Ct. NW Bemidji, MN 56601

PERFORMANCE WORK STATEMENT

Teleradiology Services for Diagnostic Interpretation of Radiologic Studies

Indian Health Service Bemidji Area:

Cass Lake IHS Hospital, Red Lake IHS Hospital, and White Earth Health Center

1. Purpose of Contract The purpose of this contract is to provide teleradiology services for diagnostic interpretation of radiologic examinations. Under the guidance of the Bemidji Area Office, teleradiology services will be provided to: Red Lake IHS Hospital, Cass Lake IHS Hospital, and White Earth Health Center, all located in Minnesota.

2. Background Indian Health Service (IHS) provides healthcare to approximately 2.8 million American Indians and Alaska Natives from 574 federally recognized Tribes across 37 states. Many IHS and Tribal health facilities lack on-site radiology services, making remote interpretation critical to timely diagnosis and treatment.

Red Lake IHS Hospital anticipates performing approximately 9,100 examinations during the first contract year, including 5,500 general X-rays,1,000 ultrasounds, 600 mammograms, and 2,000 CT exams. RLSU expects an annual increase of one percent (1%) in examination volume in subsequent years; however, actual numbers may vary. This includes a hospital which operates 24 hours per day, seven days per week.

Cass Lake IHS Hospital estimates approximately 7,600 examinations in the first contract year, including 5,000 general X-rays, 1,500 ultrasounds, 400 CT scans, 500 mammograms, and 200 DEXA scans. CLSU anticipates a one percent (1%) annual growth in volume in subsequent years, though actual numbers may fluctuate. This includes a hospital, which operates 24 hours a day, seven days a week.

White Earth Health Center projects approximately 5,500 examinations during the first contract year, including 3,000 general X-rays, 750 ultrasounds, 500 mammograms, 550 MRI scans, 500 CT scans, and 200 DEXA scans. An annual increase of one percent (1%) is anticipated in subsequent years, but actual numbers may vary. This Service Unit is an ambulatory clinic which operates Monday through Friday, from 8:00 a.m. to 4:30 p.m., excluding Federal holidays (holiday schedule provided below).

Exam numbers above are estimates and subject to change.

FEDERAL HOLIDAYS

New Year’s Day Martin Luther King Jr. Day President’s Day Memorial Day Juneteenth Independence Day Independence Day Labor Day Columbus Day/Indigenous Peoples’ Day Veterans Day Thanksgiving Day Christmas Day

3. Period of Performance Base year with four (4) option years.

· Base Period: 10/01/2026 – 09/30/2027

· Option Year 1: 10/01/2027 – 09/30/2028

· Option Year 2: 10/01/2028 – 09/30/2029

· Option Year 3: 10/01/2029 – 09/30/2030

· Option Year 4: 10/01/2030 – 09/30/2031

4. Scope of Work Services will include:

· Routine and STAT interpretations of general diagnostic imaging: X-rays, CT, MRI, ultrasound, and other modalities as required.

· Subspecialty reads as needed (e.g., neuroradiology, musculoskeletal, pediatric).

· After-hours, weekend, and holiday coverage, as defined in the clinical performance requirements section.

· Electronic delivery of final signed radiology reports via secure and HIPAA-compliant systems.

· Real-time availability for consultation with IHS providers when clinically necessary.

5. Personnel Requirements

· All interpreting radiologists:

· Must be board certified or board eligible by the American Board of Radiology or equivalent institution.

· Must possess an active, current, unrestricted license to practice medicine in a US state, if required.

· Must possess a current teleradiology certification per Minnesota state requirements.

· Must become credentialed and privileged by IHS prior to performing services.

· Have no sanctions from Medicare or Medicaid, or other federal agencies;

· Have no reports from the Office of Inspector General (OIG) for civil or criminal charges.

· Background checks, conflict of interest disclosures, and HIPAA training are required per federal guidelines.

6. Contractor Performance Requirements

a. Contractor will provide all labor, equipment, electronic circuits and interfaces, and materials to interpret radiologic studies.

b. Contractor to provide an up-to-date roster and schedule of credentialled radiologists working under the terms of the contract.

c. Contractor to provide a monthly report of service volume of all modalities and over-read activities. These reports are to be provided to the COR.

d. The Contractor shall participate in performance reviews and quality assurance audits in coordination with IHS leadership.

e. Contractor attend quarterly meetings scheduled by the COR to address areas of concern and exchange information to ensure consistent communication.

f. Contractor to be accredited by The Joint Commission or other relevant accreditation organization.

g. Minimum of two (2) radiologists required and must maintain MQSA certification (Mammography Quality Standards Act of 1992).

h. Contractor to process any request for focused case review for concerns relating to a disagreement or significant discrepancy in radiologist reading or interpretation by providing a written case review by another qualified radiologist within one (1) week of request.

i. Contractor to be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English fluently.

j. Complaints concerning Contractor relations with government employees and/or patients will be resolved with the assistances of the contract officer. The contract officer has final authority on validating complaints. In the event the Contractor is involved and named in a validated patient complaint, the government reserves the right to refuse acceptance of the services of such personnel. This does not preclude refusal in the event of incidents involving physical or verbal abuse.

7. Radiologist Performance Requirements

a. Radiologists to furnish proof of a minimum of 20 peer case review (over-reads) for each service unit semi-annually in accordance to the ACR guidelines. These peer reviews will be a sampling of each service unit’s imaging and all modalities from each service unit.

b. Radiologists to provide the services described independent of government supervision.

c. Radiologists to provide qualified radiologists that will assume the Lead Interpreting Physician (LIP) duties for all three service unit’s mammography program as specified by MQSA regulation for the ACR and MQSA inspections.

d. Radiologists to possess a minimum of two (2) years’ of experience in teleradiology.

e. Mammography DBT turnaround time between the initial receipt of the imaging study as well as prior breast-related studies, delivery of a signed radiologic interpretation of twenty-four (24) hours or less.

f. Final interpretation shall be electronically transmitted into the RPMS radiology package and electronically signed by interpreting radiologist within 24 hours of the study being transmitted to the reading site.

g. Radiologist will immediately notify the site clinician via telephone concerning any results deemed critical to patient care.

h. Radiologist will immediately notify the site clinician via telephone concerning any and all discrepancies between preliminary interpretations and final interpretations.

i. If a serious life-threating medical condition is identified during the interpretation, radiologist will immediately notify the site clinician via telephone.

j. Radiologists may provide preliminary interpretations (so-called "wet readings") for radiology studies sent after-hours, and final interpretations will be provided as outlined herein.

k. Radiologists must be in compliance with all requirements for medical staff appointment and clinical privileges described in the Medical Staff Bylaws at each service unit, including participation in both focused professional practice evaluation and ongoing professional practice evaluation. Failure to maintain active medical staff appointment and clinical privileges could result to suspension or termination of this contract.

l. Radiologists to be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English fluently.

m. Radiologists to provide copies of current CMEs as required by appropriate associations. Radiologists to report CME hours to the credential office. These documents are required for both privileging and re-privileging. Failure to provide may result in loss of radiologist’s privileges.

n. Radiologists to meet all IHS mandatory training requirements for Contractors. All training to be completed prior to network access. Failure to complete the mandatory training course may result in temporary suspension until the courses are completed.

8. Technical Requirements

a. All services must be delivered via a HIPAA-compliant, FDA-approved teleradiology platform.

b. Contractor is responsible for ensuring secure data transmission and storage, in compliance with Federal Information Security Management Act (FISMA) and NIST 800-53 standards.

c. Contractor will support integration with existing IHS systems, including PACS, EHR (e.g., RPMS or Cerner/IHS Health IT), and secure messaging.

d. The government will work with the Contractor to establish secured connectivity to required systems and provide technical support contacts.

e. Contractor will provide ALL necessary monitor QC control records and ALL physicist quality control testing for all qualified radiologist(s) that will be reading mammography studies. This will be provided to each facility quarterly. The assigned LIP will be required to be available by phone for each service unit’s annual MQSA inspection (annual MQSA inspection are completed in three consecutive days for the three service units).

f. Contractor shall provide training and support to participating IHS staff for any secure platform or software used by the Contractor to transmit work orders and images between Contractor and service units, within fourteen (14) days of the contract award date.

g. Contractor to possess a DICOM teleradiology system capable of interfacing with each service unit’s Picture Archiving and Communication System (PACS) and DICOM imaging network.

h. Computer monitors utilized by Contractor for purposes of study interpretation need to be calibrated in a timely fashion consistent with proper quality control procedures at the reading site. This calibration needs to be in compliance with ACR and FDA recommendations for monitor calibration. Documentation of equipment quality control policies and certifications, provided upon request.

i. Contractor’s network must have established firewalls and procedures to ensure patient confidentiality and meet all security compliance requirements with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), and applicable IHS security standards.

j. All digital images provided to the Contractor are for interpretation service only.

k. All patient information remains the sole property of the government and may not be used for any purpose other than those stipulated in this agreement.

l. Any delays or downtime due to Contractor equipment failure must be communicated to the COR or their designee within ten (10) minutes via telephone. Contractor shall not be penalized for transcription delays due to equipment failure beyond the Contractor’s control.

m. Data transmission security must be maintained at all times. IHS personnel needs to be notified immediately of any equipment, software or system malfunctions that would delay the transmission of images.

n. Connectivity will be approved and verified by each service unit prior to acceptance. The teleradiology equipment, diagnostic workstations, firewalls, switches, routers, and servers on the Contractor’s side will be provided by the Contractor.

o. If Contractor does not have capability to interface with the software IHS utilizes, it will be Contractor’s responsibility to develop an interface.

p. If Contractor uses alternate voice recognition software programs, the product shall be integrated into the IHS Vista/CPRS, meeting the approved VHA HL7 format.

9. Security and Security Agreements

a. Contractor to complete an Interconnection Security Agreement and Business Associate Agreement with IHS, prior to the performance of any actions related to the contract.

b. Contractor to describe the security plan for patient data. This includes location of physical servers and reading centers supporting Contractor’s services. Include in the plan any encrypted wireless systems used by radiologists. All wireless systems shall be FIPS-140 compliant.

c. Contractor will provide the ability to comply with internet protocol security (lPSec) VPN standards for encrypting protocols. All communications between participating facilities and Contractor that are transmitted outside the IHS network must be encrypted.

d. IHS credentialing process will begin at minimum 90 days in advance of estimated entry on duty.

10. Invoicing and Payment

· Invoices will detail costs per study/exam, or flat monthly rate, as specified in the contract.

· Contractor will submit monthly invoices through Invoice Processing Platform (IPP) or as directed by the Contracting Officer.

· FAR (52.232-25) has defined a proper invoice to include the following:

· Contractor name and address

· Invoice date and invoice number

· Contract number

· Description, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed

· Shipping and payment terms

· Name and address of contractor official to whom payment will be sent

· Name, title, phone number and mailing address of person to notify in the event of a defective invoice

· EIN/TIN (banking information will be entered into the portal when account is registered)

Contracting Officer Representative (COR) The COR will be appointed in writing by the contracting officer after the contract is awarded. COR designation letter will be provided to the Contractor. The COR does not have the authority to change or modify the terms or conditions of a contract.

COR Responsibilities

a. Providing technical monitoring during contract performance and communicating with the contracting officer regarding delivery, acceptance, or rejection of deliverables in accordance with the terms of the contract;

b. Monitoring and assessing Contractor performance;

c. Reviewing invoices and recommending approval or disapproval;

c. Assisting the Contractor in the resolution of technical problems encountered during performance;

d. Maintain a thorough and complete file of all correspondence, meeting notes and other documentation relating to the contract and Contractor;

e. The COR will be responsible for coordinating and scheduling meetings.

SECTION 508 AND ACCESSIBILITY

This product must conform to the Revised Section 508 (https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines) and WCAG 2.0 Level AA standards as outlined below 352.239-73 Electronic Information and Technology Accessibility Notice.

(a) As prescribed in HHSAR 339.203-70(a), the Contracting Officer shall insert the following provision:

Electronic and Information Technology Accessibility Notice (December 18, 2015)

(a) Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

(b) Accordingly, any offeror responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards.

(c) The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government’s determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, offerors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows offerors or developers to self-evaluate their supplies and document—in detail—whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS website http://www.hhs.gov/web/508.

In order to facilitate the Government’s determination whether proposed EIT services meet applicable Section 508 accessibility standards, offerors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

(d) Respondents to this solicitation must identify any exception to Section 508 requirements. If a offeror claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

Standards The included standards that must be met for this contract are taken from the following two resources. Compliance with these standards is mandatory for Federal agencies subject to Section 508 of the Rehabilitation Act of 1973, as amended (29 U.S.C. 794d).

· Section 508 Standards and Guidelines: https://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-ict-refresh/final-rule/text-of-the-standards-and-guidelines

· Web Content Accessibility Guidelines (WCAG) 2.0: https://www.w3.org/TR/WCAG20/ Electronic content must be accessible to HHS acceptance criteria Checklist for various formats are available at http://508.hhs.gov, or from the IHS Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html, (email: IHSSection508@ihs.gov). Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Electronic Content Accessibility - Web Based

· 602 Support Documentation

· 603 Support Services

· All WCAG A & AA Success Criteria Support Documentation Accessibility

· E602.1 General - Documentation that supports the use of ICT shall conform to 602.

· E602.2 Accessibility and Compatibility Features - Documentation shall list and explain how to use the accessibility and compatibility features required by Chapters 4 and 5. Documentation shall include accessibility features that are built-in and accessibility features that provide compatibility with assistive technology.

· E602.3 Electronic Support Documentation - Documentation in electronic format, including Web-based self-service support, shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

· E602.4 Alternate Formats for Non-Electronic Support Documentation - Where support documentation is only provided in non-electronic formats, alternate formats usable by individuals with disabilities shall be provided upon request.

· E602.3 Electronic Support Documentation - Documentation in electronic format, including Web-based self-service support, shall conform to Level A and Level AA Success Criteria and Conformance Requirements in WCAG 2.0 (incorporated by reference, see 702.10.1).

· E602.4 Alternate Formats for Non-Electronic Support Documentation - Where support documentation is only provided in non-electronic formats, alternate formats usable by individuals with disabilities shall be provided upon request.

· E603.1 General - ICT support services including, but not limited to, help desks, call centers, training services, and automated self-service technical support, shall conform to 603.

· E603.2 Information on Accessibility and Compatibility Features - ICT support services shall include information on the accessibility and compatibility features required by 602.2.

· E603.3 Accommodation of Communication Needs - Support services shall be provided directly to the user or through a referral to a point of contact. Such ICT support services shall accommodate the communication needs of individuals with disabilities.

· WCAG – All WCAG 2.0 A & AA Success Criteria

EXCEPTION:

· Non-Web documents shall not be required to conform to the following four WCAG 2.0 Success Criteria: 2.4.1 Bypass Blocks, 2.4.5 Multiple Ways, 3.2.3 Consistent Navigation, and 3.2.4 Consistent Identification.

· E205.4.1 Word Substitution when Applying WCAG to Non-Web Documents. For non-Web documents, wherever the term "Web page" or "page" appears in WCAG 2.0 Level A and AA Success Criteria and Conformance Requirements, the term "document" shall be substituted for the terms "Web page" and "page". In addition, in Success Criterion in 1.4.2, the phrase "in a document" shall be substituted for the phrase "on a Web page".

· Appendix A – Section 508 of the Rehabilitation Act: Application and Scoping Requirements

· E208 Support Documentation and Services

· Appendix C – Functional Performance Criteria and Technical Requirements

· 302 - Functional Performance Criteria

· 602 – Support Documentation

· 603 – Support Services Functional Performance Criteria

· 301.1 Scope - The requirements of Chapter 3 shall apply to ICT where required by 508 Chapter 2 (Scoping Requirements), 255 Chapter 2 (Scoping Requirements), and where otherwise referenced in any other chapter of the Revised 508 Standards or Revised 255 Guidelines.

· 302.1 Without Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that does not require user vision.

· 302.2 With Limited Vision - Where a visual mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited vision.

· 302.3 Without Perception of Color - Where a visual mode of operation is provided, ICT shall provide at least one visual mode of operation that does not require user perception of color.

· 302.4 Without Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that does not require user hearing.

· 302.5 With Limited Hearing - Where an audible mode of operation is provided, ICT shall provide at least one mode of operation that enables users to make use of limited hearing.

· 302.6 Without Speech - Where speech is used for input, control, or operation, ICT shall provide at least one mode of operation that does not require user speech.

· 302.7 With Limited Manipulation - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that does not require fine motor control or simultaneous manual operations.

· 302.8 With Limited Reach and Strength - Where a manual mode of operation is provided, ICT shall provide at least one mode of operation that is operable with limited reach and limited strength.

· 302.9 With Limited Language, Cognitive, and Learning Abilities - ICT shall provide features making its use by individuals with limited cognitive, language, and learning abilities simpler and easier.

image1.bin