2. Statement of Work.pdf

Statement of Work Radiology Ready

Whiteriver Service Unit 8/31/2022

General: This document describes the requirement for the provision of teleradiology interpretation and on-site radiologist services for the Phoenix Area Indian Health Service (PAIHS), Whitriver, Phoenix Area Office Servicing Area.

Background: PAIHS is an agency within the US Department of Health and Human Services, DHHS and is responsible for providing 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 Indian Health Service (IHS) is the principal 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.

The Whitriver Servicing Area is a principal medical provider of comprehensive direct and high priority contract inpatient, ambulatory care, preventive and community health, and environmental health services for members of the surrounding Native American population. The IHS continues to experience difficulties in recruiting and retaining radiologists who can provide radiology services within the IHS medical facilities. Given the current availability of teleradiology/telemedicine technology, the IHS is pursuing contracts to provide these services within the IHS facilities.

DEFINITIONS

Blinded Over-Readings – Second interpretation of imaging study during peer review process to confirm accuracy.

Contracting Officer (CO): A Government employee authorized and warranted to issue contracts, and to make subsequent modification(s). The CO has full authority to make determinations on all changes and disputes regarding the contract.

Contractor: The individual awarded a legal binding contract to provide teleradiology and interpretation services.

Credentialing – The process of verifying provider licensure, certification, training and education through IHS credentialing process.

DICOM – Diagnostic Imaging Communication in Medicine

Federal Acquisition Regulation (FAR): The primary regulation used by all federal executive agencies in the acquisition of supplies and services.

Health Center: A facility, physically separated from a hospital, with a full range of ambulatory services including at least primary care physicians, nursing, laboratory, and x-ray which are available at least 40 hours a week for outpatient care.

HL7 format – The Health Level Seven is one of several American National Standards Institute. (ANSI) – accredited Standards Developing Organizations (SDOs) operating in the healthcare arena. Most SDOs produce standards (sometimes called specifications or protocols) for a particular healthcare domain such as pharmacy, medical devices, imaging or insurance (claims processing) transactions. Health Level Seven’s domain is clinical and administrative data.

SECTION C: (Continued) Description/Specification

Past Performance Information – Relevant information regarding a contractor’s actions under previously awarded contracts. This includes the contractor’s record of conformance to specifications and to standards of good workmanship; the contractor’s record of containing and forecasting costs on any previously performed cost reimbursable contracts; the contractor’s adherence to contract schedules, including the administrative aspect of performance; the contractor’s history for reasonable and cooperative behavior and commitment to customer satisfaction; and generally, the contractor’s business-like concern for the interest of the customer.

Referring Facility Physician – An IHS medical professional who orders diagnostic radiographic and/or other medical imaging services or designee.

Routine/Standard Interpretations of radiographic/medical images - Interpretations of standard radiographic and other medical images (i.e. ultrasound, CT, MRI, mammography) of a non-emergent nature. Written interpretations required within 24 hrs by telefax or electronic mail.

Stat (includes emergent and or critical): Interpretations of radiographic/medical images - Interpretations of radiographic and other medical images done as stat or on emergency basis. Telephonic interpretations to the referring facility physician or designee required within 60 minutes, (following arrival at the radiologists’ destination) with written interpretation to follow.

Teleradiology – The technology used to transmit digital medical images on a network.

Turnaround Time - The maximum allowable time to receive an interpretation from the Contractor once the Contractor’s radiologist has received the medical images. (24 hours for routine, 60 minutes for STAT.

Written – defined as either electronic or telefax or transcribed transmission. Hand written statements of interpretation are not acceptable.

Business Associate Agreement—A requirement issued by the Government in order to ensure the non-disclosure of patient sensitive information to include information protected under the Health Insurance Portability and Accountability Act.

A. The Contractor shall provide routine teleradiology services to the Whitriver Serving Area.

B. Specific to teleradiology services, the Contractor shall be responsible for:

1. Reading all plain radiographs (X-ray), sonograms, fluoroscope studies, computerized tomography (CT) studies, magnetic resonance imaging (MRI) studies, Dual Energy X-ray Absortiometry (DEXA) scans and other diagnostic radiology studies performed at Whiteriver Hospital and Cibecue Health Center. Studies will be designated by the Whiteriver diagnostic imaging department as “routine” or “emergent” (24/7).

Emergent studies will not exceed 20% of the total study volume.

2. Providing a final written interpretation on all routine studies within 24 hours after receipt of the study.

Interpretations on studies received with <24hrs remaining in the business week (Monday – Friday, excluding holidays) will be provided on the first business day of the following week.

3. Providing a preliminary written interpretation on all emergent studies (24/7) within one hour of receipt of the study. Emergent interpretation services will be available 24 hours per day, seven days per week.

4. Contacting the IHS emergency room physician, or Clinical Director, immediately in the event that the interpretation of a study suggests a significant health risk to the patient that was unappreciated by the referring provider or interpreting radiologist on their preliminary impression.

5. Be available 24/7 for questions from providers concerning the Contractor’s study interpretations.

Contractor will define the method for contacting the Radiologist.

6. Providing teleradiology reception capability compatible with the WRSU teleradiology system. Contractor is responsible for expenses outside of IHS network.

7. Providing all transcription services, including an HL-7 bidirectional interface for transcription reception utilizing “Thin-air Teleris” software or other methods deemed acceptable by government. Contractor is responsible for all expenses including, but not limited to, technical support, license fees, software, etc., to provide the interface and transcription services. Providing any supplies, service personnel and transportation required to perform the contractual services obligation. Provide a point of contact for network and technical issues 24 hours a day, 7 days a week. Provide a point of contact for interpretation/clinical issues 24 hours a day, 7 days a week.

C. Specific to on-site services and departmental administrative responsibilities, the Contractor shall be responsible for:

1. Providing technical assistance and feedback to staff technicians/technologists on quality of films taken.

2. Work closely with the department supervisor to solve problems of an administrative nature to assure that departmental resources are optimally utilized.

3. Annually review and sign off on departmental policies and procedures in the capacity of a technical consultant.

4. Traveling to Whiteriver to provide on-site clinics within the following parameters:

a. Clinics will be one day per week and six hours in length for an average of five (5) patients per clinic. Hours of the clinic will be between 8:00am-2:30pm with a 30 minute lunch break.

Contractor may be released early upon approval of the Contracting Officers Representative

(COR).

b. Clinics shall be scheduled in advance, by mutual agreement between the Clinical Director, Chief of Diagnostic Imaging and the Contractor.

c. The contractor will be responsible for all travel costs and arrangements necessary to provide the on-site services.

5. Demonstrate an active involvement in the following departmental programs to assure compliance with The Joint Commission (TJC) requirements:

a. Quality Management programs (X-ray, CT, MRI, DEXA, ultrasound and other services.)

b. Safety programs

c. Infection control programs

d. Health information management programs

6. The contractor must meet all applicable criteria to become a credentialed and privileged member of the Whiteriver medical staff. The contractor shall provide to WRSU a completed credentials file which shall include documentation of:

a. Radiology residency training

b. Board certification radiology

c. Medical school training

d. Tort claims history and liability coverage

e. Experience appropriate to the scope of service

f. Licensure (active unrestricted U.S. medical license)

7. Provide monthly Continuing Medical Education (CME) in-service to medical staff and as needed for diagnostic imaging technical staff.

SECTION C (Continued): Description/Specification

8. Quality management

a. The contractor will have in place a daily proactive monitoring system to ensure that contract interpretation benchmarks are met.

b. Contractor will have a designated coordinator for technical and medical staff issues.

c. Contractor shall have a designated primary technical consultant for computer, network and software issues relative to this contract.

d. Contractor will develop or shall demonstrate a Quality Assurance (QA) program to monitor performance and submit monthly reports to Contracting Officer Representative (COR).

9. Radiology History. Currently there is no known record of anticipated historical reads for the area.

Radiology Statistics by Fiscal Year

YEAR 2017 2018 2019 2020 2021

X-ray 10228 10713 11434 9898 11238

CT 2685 3178 4094 3942 5818

Ultrasound 1618 1580 1727 1536 1728

MRI 692 828 843 750 1045

Average increase over base year

10. Protocol for critical results reporting:

The contractor will call the requesting provider of a radiology exam immediately upon interpretation and determination the results of the interpretation can have a critical impact on the patient care (critical results). Below is a list of the criteria for critical results. This list may be modified through a contract modification. Results will be communicated to the ordering provider. If the provider cannot be reached the results will be called to PAIHS, the Whitriver Servicing designee in the following protocol:

• If the requesting provider cannot be reached contact the emergency room provider and call the results to provider.

• If the Emergency Room provider is unavailable, then give the results to a registered nurse in the emergency room.

The contractor’s report will document the time critical results are called in and the individual receiving the results.

The contractor will also submit a monthly report of all critical results called into PAIHS, Whitriver Hospital to the

COR.

Anatomical Area

• CNS

• ACUTE STROKE

• Cerebral Hemorrhage/Hematoma

• Cervical Spine Fracture

• Depressed Skull Fracture

• Spinal Cord Compression

• Brain Tumor (mass effect)

• Brain Tumor (no mass effect)

• Cerebral Aneurysm

• Orbital Injury

Neck

• Carotid Artery Dissection

• Epiglotitis

• Paratracheal Abscess

• Critical Carotid Stenosis

Chest

• Aortic Dissection

• Tension Pneumothorax

• Pulmonary Embolism

• Ruptured Aneurysm or Impending Rupture

• Hemothorax

• Lung Nodule

• Pericardial Effusion

• Pleura Effusion (massive)

• Pneumothorax (new)

• Pneumonia (new)

• Mediastinal Emphysema

• Evidence of TB (new)

Abdomen

• Appendicitis

• Aortic Aneurysm (leaking)

• Biliary Obstruction

• Bowel Obstruction

• Hemoperitoneum (massive)

• Ischemic Bowel

• Pneumoperitoneum (not post-op)

• Portal Venous Air

• Retroperitoneal Hemorrhage

• Traumatic Visceral Injury

• Volvulus

• Cholecystitis

• Diverticulitis

• Intussusception

• Meckel’s Diverticulum

• Pancreatitis

Uro-Genital

• Ectopic Pregnancy

• Placental Abruption

• Testicular or Ovarian Torsion

• Fetal Demise

• Placental Previa (near term)

Vascular

• Pseudoaneurysm

• DVT or Vascular Occlusion

• Arteriovenous Fistula (new)

Bone

• Spinal Fracture including mechanical or neurological instability (new)

• Spinal Tumor affecting mechanical or neurological stability (new)

• Joint Dislocation (new) New finding suggestive of new fracture (other than those described in Critical

Category)

General

• Misplaced Catheter/Line/Tube

• RETAINED FOREIGN OBJECT

• Unexpected abscess

• New finding highly suggestive of malignancy

11. General

Listed are general requirements and descriptions for the on-site radiologists services which are to be provided weekly.

The department currently uses computed radiography (CR). The department currently uses computed radiography (CR) as the primary means for capturing images. The department operates a Mobile MRI Unit at the site.

Clinics will run from approximately 8:00am- 4:30pm, once a week. Clinic time includes, but is not limited, to radiologist provided services.

The COR may release the contractor earlier if all work is completed. Typically, 5-7 procedures will be scheduled a day. Time will be scheduled once a month for radiologist provided CME to the Medical Staff.

In addition, the radiologist will act as a subject matter expert in reviewing radiology policies and procedures, protocols, and standard of care relative to meeting all regulatory and compliance issues for Government or accrediting agencies. When deemed necessary by the radiology manager or medical staff the radiology will provide in-services and training to the radiology technical staff to improve or enhance their services.

The on-site radiologist will meet the needs of the medical staff by providing on-site consultations for patient cases with the medical staff when needed or requested.

SECTION D: Packaging and Marking

Submission of Information

All postage, fees and electronic commerce transmission, etc. related to the submission of required and general information, including forms, reports, etc., to the Contracting Officer, the COR, or the person(s) designated to receive, shall be the responsibility of the Contractor.

Electronic commerce format shall be submitted either in Microsoft Office Word and Excel or both.

Marking Deliverables

The Contractor shall mark all shipments in accordance with best commercial practices. Additional packing and packaging, and marking requirements shall include the contract award number.

SECTION E: This section left blank

SECTION F: Deliveries or Performance

PERIOD OF PERFORMANCE

The contract period for furnishing services described in the shall be from the date of award for one (1) year, plus four (4) sequential one-year options, which may be exercised in accordance with the terms and conditions hereof.

PLACE OF PERFORMANCE

(a) The services(s) specified in Section C shall be provided to the following address:

Whitriver Servicing Area.

All deliverables shall be in accordance with the attached Statement of Work. The Contractor shall provide the deliverables listed in Section C.

GOVERNMENT HOLIDAYS

Performance is 365 days, 24 hours, 7 days per week including all Government Holidays.

New Year's DAY Martin Luther King Day

President Day Memorial Day

Juneteenth 4th of July Labor Day

Columbus Day Veterans Day

Thnaksgiving Day Christmas Day New Years Day

SECTION G: Contract Administration Data

Contracting Officers Representative (COR)

The Contracting Officer will designate in writing a COR who shall be responsible for:

• Monitoring the Contractor’s technical progress, including surveillance and assessment of performance;

• Interpreting scope of work;

• Performing technical evaluations required;

• Performing technical inspections and acceptances required by this contract;

• Monitoring funds available for obligation under this contract;

• Assisting the Contractor in the resolution of technical problems encountered during performance of this contract;

In no event is the COR empowered to change any of the terms and conditions of the contract. Changes in the scope of work, contract price, quantity, and quality or delivery schedule shall be made only by the Contracting Officer by properly executed modification to the contract. The designation of a COR does not authorize or provide a legal right to change any kind of contractual terms regardless of the Contractor’s apparent difficulties in fulfilling contract requirements.

System for Award Registration

If during the performance of the contract there is any change in the information previously provided for EFT, the Contractor shall revise the information contained in the Central Contractor Registration database at www.sam.gov.

In addition, the Contractor shall notify by email submission of a revised Electronic Funds Transfer in CCR to the Contract Administrator.

Contract Administrator

(a) This contract will be administered by and all written communication to the Contracting Officer shall make reference to the contract number and shall be mailed to the address cited below:

Jonathan Schrader, Contracting Specialist Phoenix Area Indian Health Service (PAIHS) Division of Acquisition Management 40 North Central Avenue, Suite 507 Phoenix, Arizona 85004 Phone: (602) 364-5372 Fax: 602-364-5030 Email: jonathan.schrader@ihs.gov mailto:jonathan.schrader@ihs.gov

SECTION H: Special Contract Requirements

Allied Health Care Professional Credential Policy

Contractor shall have their credentials available for review. Contractor shall be responsible for adherence to all policies and procedures of the Indian Health Service and the Whiteriver Indian Hospital credentialing program.

Security Clearances

All Allied Healthcare Professionals providing services under this award shall undergo IHS mandated security clearance prior to commencement of work.

Prior to the provision of services onsite, the security requirement must be adhered to; the security clearance process includes a Finger Print check, and a screen check of the individual through the Office of Inspector General’s exclusion list at http://exclusions.oig.hhs.gov; documented evidence of the clearances shall be forward to the Contracting Officer at the Phoenix Area Indian Health Service, 40 North Central Avenue Suite 507, Phoenix, Arizona 85004.

Information Technology Security Clearances

All contractors that may have either through remote or direct access and/or interconnected to a federal Information Technology Systems (IT) shall be contractually subject to all Phoenix Area, Indian Health Service (PAIHS) and Federal IT security standards, policies, and reporting requirements. The contractor shall meet and comply with all IHS IT security policies and all applicable standards and guidelines, other Government‐wide laws and regulations for protection and security of all information technology.

Remote or Direct Access to Federal Information Systems

Prior to the contractor’s employees receiving access to the government’s IT systems, IT security awareness training is required.

Information Systems Security Awareness http://www.ihs.gov/ISSA/

Interconnection only to Federal Information Systems:

Referenced are four documents in particular for interconnection, required to be completed:

The following documents are required to be completed and returned to the government before interconnection to the federal system is provided:

• Business Partner Interconnection Security Agreement - (Attachment, see section J – Applicable Document)

• Data Exchange Agreement (DEA) Template (Attachment, see section J – Applicable Document)

• IHS Rules of Behavior for Interconnection Security Agreements

• Business Partner Interconnection Security Agreement Checklist

Collection of Third Party Revenue

The contractor shall provide necessary information for Indian Health Service (IHS) to bill and collect for any third party resources of its patients as a result of services rendered through performance of this contract. Indian Health Service shall be responsible for processing collection of private insurance and/or patient eligible for Medicare and/or Medicaid benefits. Indian Health Services shall have sole right to recover the reasonable costs of services from patients third party resources (also called alternate resources). All third-party billing and collection(s) opportunities derived from this service shall be revenue payable only to the Indian Health Service (IHS). Safeguarding this revenue stream and related assets is vital to IHS health care programs.

SECTION G: (Continued) Contract Administration Data

52.237-7 Indemnification and Medical Liability Insurance (JAN 1997) http://exclusions.oig.hhs.gov/ http://www.ihs.gov/ISSA/

(a) It is expressly agreed and understood that this is a nonpersonal services contract, as defined in Federal Acquisition Regulation (FAR) 37.101, under which the professional services rendered by the Contractor are rendered in its capacity as an independent contractor. The Government may evaluate the quality of professional and administrative services provided, but retains no control over professional aspects of the services rendered, including by example, the Contractor's professional medical judgment, diagnosis, or specific medical treatments. The Contractor shall be solely liable for and expressly agrees to indemnify the Government with respect to any liability producing acts or omissions by it or by its employees or agents. The Contractor shall maintain during the term of this contract liability insurance issued by a responsible insurance carrier of not less than the following amount(s) per specialty per occurrence:__1 (one) million___.

(b) An apparently successful offeror, upon request by the Contracting Officer, shall furnish prior to contract award evidence of its insurability concerning the medical liability insurance required by paragraph (a) of this clause.

(c) Liability insurance may be on either an occurrences basis or on a claims-made basis. If the policy is on a claims-made basis, an extended reporting endorsement (tail) for a period of not less than 3 years after the end of the contract term must also be provided.

(d) Evidence of insurance documenting the required coverage for each health care provider who will perform under this contract shall be provided to the Contracting Officer prior to the commencement of services under this contract.

If the insurance is on a claims-made basis and evidence of an extended reporting endorsement is not provided prior to the commencement of services, evidence of such endorsement shall be provided to the Contracting Officer prior to the expiration of this contract. Final payment under this contract shall be withheld until evidence of the extended reporting endorsement is provided to the Contracting Officer.

(e) The policies evidencing required insurance shall also contain an endorsement to the effect that any cancellation or material change adversely affecting the Government's interest shall not be effective until 30 days after the insurer or the Contractor gives written notice to the Contracting Officer. If during the performance period of the contract the Contractor changes insurance providers, the Contractor must provide evidence that the Government will be indemnified to the limits specified in paragraph (a) of this clause, for the entire period of the contract, either under the new policy, or a combination of old and new policies.

(f) The Contractor shall insert the substance of this clause, including this paragraph (f), in all subcontracts under this contract for health care services and shall require such subcontractors to provide evidence of and maintain insurance in accordance with paragraph (a) of this clause. At least 5 days before the commencement of work by any subcontractor, the Contractor shall furnish to the Contracting Officer evidence of such insurance.

(End of clause)

SECTION J: List of Documents, Exhibits and Other Attachments

• The Joint Commission (TJC). http://ww.jointcommission.org

• Centers for Medicare and Medicaid Services (CMS). http://www.cms.gov

• Health Insurance Portability and Accountability Act (HIPAA) of 1996. http://www.cms.gov

• Privacy Act of 1974. http://www.cms.hhs.gov/PrivacyActof1974

• Food and Drug Administration http://www.fda.gov/AboutFDA/CentersOffices/cdrh/default.htm

• DICOM http://medical.nema.org

• American College of Radiology http://www.acr.org/s_acr/index.asp

• HHS Office of Chief Information Officer (OCIO) Policy on Privacy Impact Assessments http://www.hhs.gov/ocio/policy/index.html

• Information Systems Security Awareness http://www.ihs.gov/ISSA/ http://ww.jointcommission.org/ http://www.cms.gov/ http://www.cms.gov/ http://www.cms.hhs.gov/PrivacyActof1974 http://www.fda.gov/AboutFDA/CentersOffices/cdrh/default.htm http://www.acr.org/s_acr/index.asp http://www.hhs.gov/ocio/policy/index.html http://www.ihs.gov/ISSA/