RFP 75H70521R00010.docx

75H70521R00010 – Radiology Interpretation

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B – CONTINUATION BLOCK

SECTION C – CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE 19

C.2 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUES

C.10 DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION

SECTION D – CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.3 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS

(THIS PAGE LEFT INTENTIONALLY BLANK)

SECTION B - SUPPLIES OR SERVICES AND PRICE/COSTS

B.1 CONTRACT ADMINISTRATION DATA

Contract Administration: All contract administration matters will be handled by the following individuals:

CONTRACTOR NAME AND ADDRESS:

Phone: _______________________ E-Mail: ______________________

Person responsible for Contractor Performance Assessment Reporting System (CPARS) reporting if different from above:

Name: ____________________________ Title: _____________________________ E-Mail: ___________________________

CONTRACTOR REGISTRATION: All required information must be in the System for Award Management (SAM) www.beta.sam.gov

GOVERNMENT:

Karen McDonald Contract Administrator Indian Health Service 2225 Cooperative Ct. NW Rm. 200.

Bemidji. MN. 56601 E-Mail: Karen.mcdonald@ihs.gov

B.2 INVOICES: In accordance with the Prompt Payment Act, payment will be due 30 days after receipt of services or receipt of a proper invoice, whichever is later.

Invoice Instructions:

The Contractor shall prepare and submit invoices to the designated billing office specified in the contract. A proper invoice must include the items listed below. If the invoice does not comply with these requirements, the Government will return the invoice within 7 days after receipt with the reasons why it is not a proper invoice. The Government will take into account untimely notification when computing any interest penalty owed the Contractor.

E-mail Invoices to:

BEM_AOInvoices@ihs.gov Exception to e-invoices.

Invoices which contain protected information such as PII, PHI, vendor banking data must be submitted through a secure data exchange network or mailed to the address below.

Indian Health Service Accounts Payable 2225 Cooperative Ct NW Bemidji, MN 56601

An invoice must contain at a minimum:

[a] Name and address of the Contractor;

[b] Invoice date and invoice number. (The Contractor should date invoices as close as possible to the date of the mailing or transmission.);

[c] IHS Contract Number; TBD [d] Description, date of service, date of order, quantity, unit of measure, unit price, and extended price of supplies delivered or services performed;

[e] Shipping and payment terms (e.g., shipment number and date of shipment, discount for prompt payment terms). Bill of lading number and weight of shipment will be shown for shipments on Government bills of lading;

[f] Name and address of Contractor official to whom payment is to be sent (must be the same as that in the contract or in a proper notice of assignment);

[g] Name, title, phone number, and mailing address of person to notify in the event of a defective invoice;

[h] Taxpayer Identification Number (TIN);

[i] Dun & Bradstreet Number (DUNS).

** TIN & DUNS shall be the same numbers used to create the company www.sam.gov registration**

Improperly prepared invoices or statements shall be returned to the contractor and may delay payment.

CONTRACT TYPE: Indefinite Delivery- Indefinite Quantity

FAR 52.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE.

The contract resulting from this solicitation is a firm-fixed price non-personal health care services contract, as defined in 37.101, under which the contractor is an independent contractor. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered (e.g. professional judgements, diagnosis for specific medical treatment);

The contractor hereby agrees to indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance. The contractor shall maintain medical liability insurance, in a coverage amount acceptable to the contracting officer, which is not less than the amount normally prevailing within the local community for the medical specialty concerned. The contractor is required to ensure that its subcontracts for provisions of health care services, contain the requirements of the clause at 52.237-7, including the maintenance of medical liability insurance.

B.3 PERIOD OF PERFORMANCE

The Government anticipates a Base + four(4), one(1) year options.

B.4 PLACE OF PERFORMANCE (remote/offsite for multiple facilities)

B.5 PERFORMANCE WORK STATEMENT

Diagnostic Radiologic Services for Interpretation of Radiologic Studies Bemidji Area Wide to include Cass Lake IHS Hospital, Red Lake IHS Hospital, and White Earth Health Center

1. Purpose of Contract:

a. To provide diagnostic radiologic services, for the interpretation and written report of radiologic studies done at the Red Lake IHS Hospital, Cass Lake IHS Hospital, and White Earth (Health Center) Service Unit (SU). These three separate facilities (Federal Service Units) are under the guidance of the Bemidji Area Office. Each Service Unit of the Bemidji Area Office depends upon outside medical specialist (Radiologist) to provide certain types of services that are fundamental to providing medical care. This contract provides critical diagnostic services via tele-radiology twenty-four (24) hours a day and seven (7) days a week.

2. Objective/description of need:

a. A physician has been designated Medical Director of Radiology Services by the Bemidji Area Office medical staff and is not qualified as a radiologist. Contracted radiology services are therefore required to supplement and complement the hospital and health center direct care programs so that adequate radiology services are available to the medical staff to meet the requirements for patient care needs.

b. IHS is an agency within the U.S. Department of Health and Human Services and is responsible for providing federal health services to American Indians and Alaska natives. The provision of health services to members of federally recognized tribes grew out of the special government to government relationship between the federal government and Indian tribes. The IHS is the principle federal health care provider and health advocate for Indian people. The goal is to assure that comprehensive culturally acceptable personal and public health services are available and accessible to American Indians and Alaska Native people. The IHS currently provides health services to approximately 1.5 million American Indians and Alaska Natives who belong to more than 557 federally recognized tribes in 34 states.

c. The Bemidji Area Office needs the services of a contract diagnostic radiologist (“Contractor”) to interpret X-ray studies to include general radiography, ultrasound, mammogram (DBT), CT, MRI and DXA (bone densitometry) images. Imaging studies will be conveyed to the Contractor via tele-radiology. Interpretation reports will be electronically transmitted or manually entered into each Service Unit’s Electronic Health Record. The Period of Performance (POP) will be a base year with four option years to follow.

d. The Red Lake IHS Hospital estimates 8,050 examinations (6,500 general X-ray, 950 ultrasounds, 600 mammograms) during the first year of the contract. With each subsequent year the Hospital estimates the number of examinations will increase by two (2) percent. Actual numbers may be more or less than the estimate. This Service Unit is opened 24 hours a day; seven days a week.

**This Hospital may add the following services at any given time:

MRI: 360 yearly CT: 240 yearly Bone Densitometry (DXA): 200 yearly This is an estimated total. Again, these services may be added in the future based on demand.

e. The Cass Lake IHS Hospital estimates 4,950 examinations (3,500 general X-ray, 750 ultrasounds, 500 mammograms, 200 DXA scans) during the first year of the contract. With each subsequent year the Hospital estimates the number of examinations will increase by two (2) percent. Actual numbers may be more or less than the estimate. This Service Unit is opened 24 hours a day; seven days a week.

**This Hospital may add the following services at any given time:

MRI: 250 yearly CT: 200 yearly This is an estimated total. Again, these services may be added in the future based on demand.

f. The White Earth Health Center estimates 5,300 examinations to include 3,000 general X-ray, 750 ultrasounds, 500 mammograms, 550 MRI, 500 CT, 200 DXA scans) during the first year of the contract. With each subsequent year the Hospital estimates the number of examinations will increase by two (2) percent. Actual numbers may be more or less than the estimate. This Service Unit is opened Monday through Friday; 7:30am to 6:30pm.

3. Government Furnished Property, Facilities, and Services

a. The government will work with the contractor to establish secured connectivity to required systems.

b. The government will provide technical support contacts and clinical service roster of each Service Unit to contractor.

c. All digital medical imaging files provided to the Contractor for interpretation shall remain the property of the government. Contractor shall not publish and /or share outside Contractor’s organization any IHS digital or analog image or imaging study report without the express written consent of the sending IHS facility. Any publication or sharing outside of Contractor's organization of any digital or analog images or imaging study reports undertaken with the express written consent of the sending IHS facility shall be done in a manner allowed by HIPAA and all other IHS rules and regulations.

d. Joint use by the Government and the Contractor- All digital images and x-ray films shall be provided to the Contractor for interpretation service only. As clinically indicated, sending IHS facilities will forward available copies of prior radiology studies requested by the Contractor in order to assure comparison interpretations. Contractor shall securely retain digital images and x-ray films in a HIPAA-compliant manner consistent with best practices for future clinical questions that may occur from the sending IHS facilities.

e. Joint use by the Government and the Contractor- All digital images and x-ray films shall be provided to the Contractor for interpretation service only. As clinically indicated, sending IHS facilities will forward available copies of prior radiology studies requested by the Contractor in order to assure comparison interpretations. Contractor shall securely retain digital images and x-ray films in a HIPAA-compliant manner consistent with best practices for future clinical questions that may occur from the sending IHS facilities.

4. Contractor Furnished Equipment, Facilities, and Services

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

b. The Contractor shall provide, update, and maintain roster of credential radiologist(s) working under the terms of the contract.

c. The Contractor shall provide, update and maintain a schedule of reading radiologist(s)

d. Contractor shall provide DICOM compatible formatted equipment and shall provide all material, supplies, and maintenance necessary to provide the interpretation service described herein.

e. Work orders/study requests shall be received and Interpretive Reports returned to IHS facilities electronically via HL 7 format for all participating facilities capable of transmitting study information /receiving study reports in HL7 format. Except for information and property as specified as government furnished, the contractor shall provide all equipment, facilities, material, supplies, software application and maintenance necessary to provide the transcription service described herein.

f. The Contractor shall electronically or manually enter reports into each respective Service Unit’s Electronic Health Record. Locations are listed in Section B.4.

5. CLINICAL Performance Conditions

a. The Contractor shall provide the services described independent of Government supervision.

b. The Contractor will provide the Bemidji Area with a qualified radiologist that shall 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. The Contractor may provide additional Board Certified Radiologist(s) with Mammography certification in accordance with MQSA regulation, license in any state in the United States. This is subject to prior approval by the Contracting Officer and the Contracting Officer Representative. The 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).

c. The Contractor may provide more than one qualified radiologist to meet the requirements of the contract to provide coverage during periods of unavailability, e.g. holiday’s, illness, vacations. This will be subject to prior approval by the Contracting Officer or the Contract Officer’s Representative (COR). Any radiologist must be in compliance with all elements specified in the Performance Work Statement (PWS). There will be a limit of 4 Radiologists at each service unit.

d. The Red Lake Service Unit, White Earth Service Unit, and the Cass Lake Service Unit will have a Mammography DBT turnaround time between the initial receipt of the imaging study and delivery of a signed radiologic interpretation of twenty-four (24) hours or less.

e. The Cass Lake service unit and White Earth service unit will need the contractor to interpret bone densitometry (DXA) studies.

f. The Contractor must be available 24 hours a day, 7 days a week for STAT interpretations.

g. The Contractor shall be available for telephone consultations for each service unit’s provider staff as clinically needed 24 hours a day, 7 days a week.

h. All exams shall be addressed and finalized with an official report within 24 hours. All STAT exams, when properly identified, shall be performed and the results communicated within 30 minutes of receipt of images and appropriate paperwork. STAT exams shall be identified by a telephone call to contractor or by a stamp or other indication on the paperwork provided to the contractor.

i. Final interpretation and official signature shall be electronically uploaded/entered into the RPMS Radiology package and electronically signed by an attending radiologist within 24 hours of the image being transmitted to the reading site.

j. The Contractor shall ensure availability to consult with a radiologist to determine the most appropriate study for the clinical scenario involved; although for the most part, pre-defined protocols shall be used.

k. Specific Requirements: The Contractor shall provide the necessary personnel, supplies, materials and equipment to provide for the interpretation of digital exams for the Bemidji Area Indian Health Services (IHS), and professional consultation services at the Cass Lake IHS, Red Lake IHS, White Earth Health Center.

l. Routine and Emergency Study Interpretation-All radiology study interpretations are to be performed by licensed; Board¬ certified/eligible radiologists.

m. The Contractor shall provide interpretations on a routine and emergency basis. Final interpretations for studies sent as routine are to be returned to the sending IHS facility by 12:00 PM Central time of the next business day. Final interpretations for studies sent as emergency/stat are to be returned to the sending IHS facility within 30 minutes of study receipt by the Contractor.

n. Critical Results-The Contractor shall immediately notify the sending site clinician via the telephone concerning any results where the interpretation may be deemed critical to patient care. This includes significant abnormal findings on routine and emergency studies that may affect a patient's care or treatment. The Contractor shall also immediately notify the sending site clinician via the telephone concerning any and all discrepancies between preliminary interpretations and final interpretations (should the Contractor provide preliminary interpretations for after-hour emergency studies).

o. The Contractor may provide preliminary interpretations (so-called "wet readings") for radiology studies sent after-hours), as long as final interpretations are still to be returned as outlined above

p. Meetings/Conference Calls: The Contractor shall attend meetings or conference calls scheduled by the COR to address areas of concern and exchange information to ensure consistent high levels of professional services. The COR shall be responsible for scheduling and coordination of all meetings and conference calls.

q. Equipment Failure: Any delays or downtime due to Contractor equipment failure shall be communicated to the COR or their designee within ten (10) minutes via telephone. The Contractor shall not be penalized for transcription delays due to equipment failure beyond the Contractor’s control (e.g. server downtime).

6. TECHNICAL Performance Conditions:

a. The successful bidder shall possess a DICOM tele-radiology system that is capable of interfacing with EACH INDIVIDUAL service units/Government furnished Image Archive and commercial PACS (Picture Archiving and Communication System) systems (specifics below) and DICOM Imaging Network. Shall be capable of receiving/transmitting (Breast Tomography Objects, BTO file type), as well as gathering all patient information from the DICOM header of received images. The Contractor shall utilize Image Storage, Tele-radiology PACS Reading System and Reporting System that are compliant and compatible with industry standards by the American College of Radiology (ACR), HIPAA and the Food and Drug Administration (FDA). The Contractor shall specify an acceptable compression ratio for a given study before the contract is awarded. The Contractor shall be capable of receiving a 14x17 high resolution (20MB) radiology study within one (1) minute of study transmission (once the study has been successfully sent to the Contractor from the sending IHS facility). Computer monitors utilized by the Contractor for purposes of radiology study interpretation shall be calibrated in a timely fashion consistent with proper quality control procedures at the reading site. This calibration shall be in compliance with ACR and FDA recommendations for monitor calibration. The Contractor shall provide the IHS with documentation of equipment quality control policies and certifications, upon request.

Red Lake SU: Fuji/Synapse 503 or higher Workstation Specifications

Windows 10 64 bit

Google Chrome Browser

Diagnostic - 16GB (minimum) Standard VGA and PCIe video card-compliant

1. Workstations used for Digital Breast Tomosynthesis diagnosis require a PCIE3-compliant video card if not otherwise specified by the display hardware vendor.

1. Synapse 5.3 or higher workstations have two graphics options:

1. Internet Explorer in GPU render setting

0. 1 GB or greater primary card (3 megapixel support)

0. 2 GB or greater primary card (5 megapixel support)

0. PCIe 3.0 x 16 interface

1. Internet Explorer in software render setting

· Bandwidth Requirements:

2. 100 Mbit/s for 3MP operation

2. 150 Mbit/s for 5MP operation REQUIRED FOR MAMMO DIAGNOSTICS

· Sub 100 Mbit/s must use optimized network setting

Cass Lake SU: GE/Centricity

· Hardware requirements for Seno Iris Certified Mammography software.

1. Processor: 4 core CPU or better

2. Operating System Storage: 1 device with at least 40GB free space >>> Must be C drive

3. Data Storage: 1 x 1TB or more >>>> Must be D Drive

4. RAM: 32 GB or more

5. Option to connect one monitor

6. Hardware slot for graphics card

7. Graphic card: 2GB RAM and OpenGL 4.0 or higher

8. DVD+/-RW Optical Drive

9. Network interface: 1 x Ethernet

10. Control monitor: resolution of 1280×1024 pixels

11. Diagnostic monitors for primary diagnostic interpretation of mammography images

12. Seno Iris is compatible with Windows 7 64bit and Windows 10 64-bit (version 1709 or later)

· Bandwidth Requirements:

1. 100 Mbit/s for 3MP operation

2. 150 Mbit/s for 5MP operation REQUIRED FOR MAMO DIGNAOSTICS

White Earth SU: GE/Centricity

· Hardware requirements for Seno Iris Certified Mammography software.

1. Processor: 4 core CPU or better

2. Operating System Storage: 1 device with at least 40GB free space >>> Must be C drive

3. Data Storage: 1 x 1TB or more >>>> Must be D Drive

4. RAM: 32 GB or more

5. Option to connect one monitor

6. Hardware slot for graphics card

7. Graphic card: 2GB RAM and OpenGL 4.0 or higher

8. DVD+/-RW Optical Drive

9. Network interface: 1 x Ethernet

10. Control monitor: resolution of 1280×1024 pixels

11. Diagnostic monitors for primary diagnostic interpretation of mammography images

12. Seno Iris is compatible with Windows 7 64bit and Windows 10 64-bit (version 1709 or later)

· Bandwidth Requirements:

1. 100 Mbit/s for 3MP operation

2. 150 Mbit/s for 5MP operation REQUIRED FOR MAMO DIGNAOSTICS

b. All interpretations shall be performed on diagnostic, medical-grade, high resolution monitors. Digital mammography images shall be viewed on FDA/MQSA approved monitors, via a FDA/MQSA certified viewer. All monitors shall be calibrated at least semi-annually, or consistent with proper quality control procedures at the interpretation sites. The contractor must supply each Hospital with all quality control monitor records on a quarterly basis. This will be in compliance with ACR/MQSA guidelines.

Red Lake SU: Hologic Dimensions DBT

c. The Contractor’s network shall 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.

d. The Contractor may not bill or collect from other payers for these services. The IHS retains the sole and exclusive right to bill and collect for these services.

e. The Contractor shall provide a complete written report for each medical imaging study. The contractor shall maintain a process that ensures delivery of verified and completed reports through electronic communication to each service unit’s electronic health record (such as using an electronic HL7 interface). Contractor’s radiologist(s) shall have control of the reporting process from dictation to report sign-off/electronic signature/approval. The contractor’s radiologist(s) dictates self-edits and approves their reports within a contractor’s dictation system. No transcription services shall be provided by Government. Report quality/content shall follow ACR standards of report structure and communication of results. Contractor’s radiologist(s) shall notify clinicians of critical findings in accordance with ACR standards, each service unit policies and in a manner appropriate to the clinical urgency of the case. Diagnostic code shall be required to transfer over to the RPMS system for tracking purposes. If the contractor prefers to use alternate voice recognition software programs, the product shall be integrated into the IHS Vista/CPRS and function as outlined above. Please note, all bidders shall meet the approved VHA HL7 format.

f. If a serious life-threating medical condition is identified during the interpretation, the report shall be immediately called in telephonically to the ordering provider to follow each service units’ critical report policy and procedure.

g. Data transmission security shall be maintained at all times. IHS personnel shall be notified immediately of any equipment malfunctions that would hinder the transmission of images.

h. Contractor warrants that any data containing patient-specific identifiers shall be handled in such a way as to prevent disclosure to unauthorized parties. This includes transmission of the data (from the point at which the data leaves the IHS network to the point at which the images are interpreted) as well as storage of the data by the contractor. Contractor agrees to comply with all applicable data security laws and guidelines, as well as HIPAA and various accreditor provisions. The contractor shall provide utmost care and attention to patient data. All patients shall be assured of their privacy and personal dignity in accordance with applicable laws, rules and regulations. All patient information remains the sole property of the US Government and may not be used for any purpose other than those stipulated in this agreement.

i. Each service unit will act as primary custodian of the patient information (including both the image data and the report) for all purposes related to IHS and Government records retention requirements.

j. Patient medical data transfer and storage complies with ACR and Digital Imaging and Communication of Medicine (DICOM) standards and meets and anticipates all current, known CONFIDENTIALITY requirements and regulations.

k. Contractor shall provide a transcribed final report, which will be uploaded to each service unit’s hospital information system and electronically signed by the interpreting radiologists within 24 hours.

l. The connectivity/functionality shall be approved and verified by each service unit prior to acceptance. The tele-radiology equipment, such as diagnostic workstations, firewalls, switches, routers, clients, and servers on the contractor’s side will be provided by the contractor.

m. Final interpretations are preferred. Should the Contractor provide preliminary ("wet") interpretations for critical results and or stat or emergency studies, both the preliminary and the final interpretations shall be provided for the sending facility. For facilities whose information systems are unable to receive both the preliminary and final interpretations in electronic format (i.e. two reports cannot be electronically accepted for a single radiology study accession number), the contactor shall provide the final interpretation in electronic format and the preliminary interpretation via facsimile or secure internet/server-based interpretation service.

n. Contractor shall provide semi-annually calibration of equipment compliance with the DICOM part 14 standards.

o. The contractor shall have the capability to receive and send study report information in an HL7 format. If the contractor can does not have this capability to interface with the software we are working with, then it is their responsibility to develop that interface.

p. Security: The Contractor shall obtain completed IHS ISSO Security Clearance prior to the start of this contract. This clearance will establish that the Contractor has provided sufficient local telecommunication network firewalls and procedures to ensure patient confidentiality and security consistent with HIPPA (Health Insurance Portability and Accountability Act of 1996) regulations, FlPS, and ACR (American College of Radiology) Guidelines.

q. Interconnection Security Agreement (ISA): Contractor shall provide and complete an ISA with the IHS, prior to the performance of any actions related to the contract.

r. Business Associate Agreement (BAA): The Contractor shall be provided copy of a BAA to IHS, prior to performance of any actions related to the contract. This BAA will be attached to solicitation.

s. Patient data security plan: The Contractor shall describe the security plan for patient data. This includes location of physical servers and reading centers in support of contractor services. The plan should include any encrypted wireless systems used by reading providers. All wireless systems shall be FIPS-140 compliant.

t. Encryption Protocols: Contractor will provide the ability to comply with lPSec VPN standards for encrypting communications. All communications between participating facilities and contractor that are transmitted outside the IHS Wide Area Network must be encrypted.

u. Section 508 Compliance: Contractor shall conform to Federal 508 requirements which address accessibility for personnel with disabilities. Contractor shall procure a waiver if Section 508 applicability does not exist or relates to the contract. Please refer to http://www.sectio n508.gov for more information.

7. Deliverables: Roles and Responsibilities

a. The contractor shall provide a monthly report of service volume of all modalities and over-read activities. These reports shall be provided to the COR.

b. The COR reserves the right to call for additional reports on an as needed basis.

c. Key Personnel Changes: All changes that affect the contract shall be communicated to the Contracting Officer, as soon as possible. The contractor shall submit additions to staffing to the appropriate Credentialing Specialist PRIOR to the radiologist reading, who will then notify the contractor once the radiologist has been privileged to perform radiology services. The contractor shall also submit deletions from staffing to the appropriate Credentialing Specialist, as soon as possible.

d. Credentialing and Privileging: The contractor shall submit a list of radiologist(s) credentialed and privileged to provide service under this contract along with their respective documentation of credentialing and privileging approval to the appropriate Credentialing Specialist. Once the radiologist has been approved, the Credentialing Specialist will notify the contractor the radiologist has been approved to begin providing radiology services outlined in this contract. The contractor is responsible for providing the applicable Credentialing Specialist with updated information regarding the status of each radiologist(s) credentialing and privileging expiration dates and renewal status.

e. The Contractor shall also provide a mechanism for independent review of studies identified by either the IHS sending facilities and/or the Contractor as inaccurate or of concern; this information shall include all adverse events that result from the telemedicine services provided by the distant site physician or practitioner to the hospital's patients and all complaints the hospital has received about the distant¬ site physician or practitioner. IHS reserves the right to request a more focused peer review.

f. Training: The Contractor shall provide training and support to participating IHS facilities for any secure internet/server-based platform or software used to transmit work orders and teleradiology images from IHS facilities to Contractor and interpretations from Contractor back to IHS facilities, within 14 days of the contract award date. Contractor shall provide, upon request, as needed training and support based on the needs of the IHS facility, for example, when staff turnover occurs. Training and support shall be provided within 7 days of the request.

g. The Contractor shall visit each facility participating under this contract bi-annually and/or as required by Radiology or Medical staff to meet the needs of the facility.

h. The Contractor shall make an initial site visit to each facility participating under this contract within 45 days of the service start date.

i. Quarterly reports, via either hard copy or electronic mail, should be forwarded to the applicable Credentialing Specialist. The contractor shall notify the appropriate Credentialing Specialist of their quarterly review dates and shall have 10 working days to submit report. These reports shall express peer review discordance rates and any additional information that is pertinent to the Contractor's performance of quality assurance for the tele-radiology services provided. Quarterly discordant interpretation rates greater than 3% for "disagree-¬significant" category discordant interpretations require that the Contractor submit to the IHS a detailed plan for quality improvement. Persistent discordant rates greater than 3% for "disagree-significant" category may lead to discontinuation of the contract.

QUALITY MANAGEMENT.

Quality Control Plan (QC). The Contractor is required to follow the current QC programs in place at the facilities listed above, (available upon request), to ensure that the medical services are provided at a level of quality that meets IHS standards.

Quality Assessment and Improvement (QA&I). The Government will monitor the Contractor's performance under this contract using the QA&I procedures established by the medical activity and pursuant to the Contract Terms and Conditions-Commercial Items clause, paragraph entitled Inspection/Acceptance. Additionally, the Contractor's performance is subject to scheduled and unscheduled review by the QA&I Committee as defined by the medical activity Quality Assurance (QA) Plan.

ACCESS TO GOVERNMENT INFORMATION SYSTEMS

Contractor Employees Who Require Access to Government Information Systems (IS). All Contractor employees with access to a government info system must be registered in the Information Technology Access Control (ITAC ) at commencement of services, and must successfully complete the Information Systems Security Awareness (ISSA) Training prior to access to the IS and then annually thereafter.

B.6 PROFESSIONAL QUALIFICATIONS

PROFESSIONAL Performance Conditions:

a. The contractor radiologist must be Board Certified or Board Eligible Radiologists who possess an active, current, unrestricted license to practice medicine in a US State, Territory or Commonwealth, or the District of Columbia. As well as possessing Tele-radiology license certification as per state requirements (MN).

b. The contractor radiologist(s) must be responsive and 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 FPPE and OPPE. Failure to maintain active medical staff appointment and clinical privileges could result to suspension or termination of this contract.

c. The contractor radiologist(s) must maintain MQSA certification (Mammography Quality Standards Act of 1992).The contractor radiologist holds an active, current, unrestricted license to practice in a U.S. State, Territory or Commonwealth, or the District of Columbia; and is working within his/her scope of practice as established by his/her State(s) or other jurisdiction(s) of licensure.

d. The contractor radiologist shall provide all services in a manner that enables the Hospitals/Health Facility to comply with all applicable CoP of CMS, and all applicable standards of TJC, AAAHC, and IHS.

e. The contractor radiologist(s) must have no sanctions from Medicare or Medicaid, or other Federal agencies; and must have no reports from the Office of Inspector General (OIG) for civil or criminal charges.

f. The contractor radiologist(s) must qualify for, complete timely application for/and achieve Medical Staff appointment and have approved clinical privileges granted prior to providing services at each service unit.

g. The contractor shall 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.

h. The contractor shall be responsible for ensuring radiologist(s) possess the requisite credentials required for medical staff appointment and provision of clinical privileges. No services shall be provided by any radiologist(s) prior to obtaining approval by the service unit’s Medical Executive Committee and Governing Board. If contractor’s radiologist(s) are not credentialed and privileged or has credentials/privileges suspended or revoked, or has a pending security investigation (either initiated or adjudicated), the contractor shall furnish an acceptable substitute radiologist without any additional cost to the Government.

i. The credentialing process shall be started at least 60-90 days in advance of estimated entry on duty. The time required for this process may be expedited when patient care needs are urgent as per each SU’s policy on temporary clinical privileges.

j. Contractor’s radiologist(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read, and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification, and/or licensure related to the provision of care, treatment and/or services performed.

Contractor shall provide verifiable evidence of all educational and training experiences, including any gaps in educational history for all contractor’s physicians and contractor’s physicians shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

k. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested. Contractor’s radiologist(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credentials office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contractor’s radiologist(s).

l. Contractor radiologist(s) shall meet all IHS educational requirements and mandatory course requirements defined herein; all training shall be completed by the contractor’s radiologist(s) as required by each service unit, prior to network computer access, including IHS Privacy and Information Security Awareness and Contractor Rules of Behavior and Privacy and Health Information Portability Accountability Act (HIPAA) focused training. Failure to complete the mandatory training course may result in temporary suspension of the contractor’s radiologist(s) until the courses are complete or may result in the contractor’s radiologist(s) being removed from the contract.

m. Contractor radiologist(s) shall be subject to QA measures, such as timely completion of reads, accuracy and completeness of reads, and Peer Reviews.

n. The contractor radiologist(s) shall 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 1 week of request.

o. The CO will resolve complaints concerning contractor relations with the Government employees or patients. The CO is 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.

p. Quality Control: Contractor Qualifications and Relevant Experience Requirements.

q. Contractor shall possess a minimum 2 years of experience in the practice of teleradiology.

r. References shall be made available upon request.

s. All radiologists providing interpretations under this contract shall be English speaking.

t. License: All radiologist(s) shall possess a current, valid unrestricted license in a state, the District of Columbia, the Commonwealth of Puerto Rico, or a Territory of the United States, throughout the term of this contract.

u. Board Eligibility: All radiologists shall be Board Eligible or Certified by the American College of Radiology (ACR) throughout the term of this contract. All radiologists shall be eligible to participate in the Medicare or Medicaid programs.

v. Credentialing and Privileging: The contractor shall be independently accredited by The Joint Commission or employ radiologists who are credentialed and privileged by The Joint Commission or equivalent institution to perform teleradiological interpretations.

w. All radiologists shall meet the "Qualifications and Responsibilities of Personnel" in the American College of Radiology Technical Specification for Teleradiology Section III, A, Physician.

x. The Contractor shall perform quarterly Quality Control peer review on interpretations from electronic images specific to each facility location covered under this contract. This Quality Control (QC) peer review shall occur as part of the Contractor's Joint Commission-Compliance Quality Control program. Discordant interpretations shall be graded as to their clinical significance (agree, disagree-insignificant, disagree-significant).

y. In addition, a log quantifying discrepancy rates between preliminary vs. final interpretations shall be maintained and reported as part of the quarterly quality control report. This log should likewise assess discordant interpretations as to their clinical significance (agree, disagree-insignificant, disagree-significant).

B.7 PRICE/COST SCHEDULE

The quantities in the Schedule are for pricing purposes and basis for evaluation for award and do not represent what the Government will order. The Government is using the Indefinite-Delivery, Requirements type contract because exact quantities cannot be pre-determined. The Government will issue orders in accordance with the Ordering and Requirements Clauses as needs arise and the contractor will be reimbursed for exact quantities performed at the prices quoted. The Government will Order during the life of this contract a minimum of $1,000,000 and a maximum of $3,000,000.

SECTION – B 75H70521R00005 – Radiology Interpretation

Total Base Year: $___________________

Total Option Year 1: $___________________

Total Option Year 2: $___________________

Total Option Year 3: $___________________

Total Option Year 4: $___________________

B.8 METHOD OF PAYMENT

a) The IHS Bemidji Division of Finance is designated for payment processing. Payment shall be made by electronic funds transfer (EFT). Payment shall be made in arrears.

b) The Contractor’s rate identified for services described herein is considered as an all-inclusive rate. All-inclusive is defined to include but is not limited to services, travel, lodging, liability insurance, fringe benefits, federal, state and local taxes, and all other costs pertinent to the performance of this contract.

c) Billing: The Contractor shall provide information concerning Contractor radiologists such that billing for radiology interpretation services can be successfully conducted by the sending IHS facilities. This information may include, but is not limited to, radiologist NPI and other Medicare / Medicaid billing identification numbers and identifiers. The Contractor shall work with the IHS facilities to facilitate billing for services by IHS facilities. At the time of award, billing addresses will be determined for each facility.

CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The COR will be appointed in writing by the CO after the contract is awarded. The CO will provide a copy of this designation and COR contact information to the Contractor. The role of program and technical personnel in monitoring the contract is to assist and advise the Contracting Officer, and act as the COR when so designated by the Contracting Officer. The COR does not have the authority to change or alter the order amount, terms and conditions.

COR activities include—

1. Providing technical monitoring during contract performance and advising the Contracting Officer relating to delivery, acceptance, or rejection of deliverables in accordance with the terms of the contract;

2. Assessing contractor performance;

3. Recommending necessary changes to the schedule of work and period of performance to accomplish the objectives of the contract (The COR shall provide the Contracting Officer a written request along with an appropriate justification and a funding document, if additional funds are needed.);

4. Reviewing invoices/vouchers and recommending approval/disapproval by the Contracting Officer, including providing comments regarding anything unusual discovered in the review;

5. Reviewing and recommending approval or disapproval of technical submissions, subcontractors, overtime, travel, and key personnel changes;

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

7. Participating, as necessary, in various phases of the contract closeout process;

8. Provide receiving authorization within two days of services/items received or invoiced

SECTION C- CONTRACT CLAUSES

FEDERAL ACQUISITION REGULATIONS

C.1. 52.252-2 CLAUSES INCORPORATED BY REFERENCE. This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this address: www.acqusition.gov

C.2. 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (JAN 2021)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 ( 19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of…