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This document is a Statement of Work (SOW) for Polysomnography (sleep study) services at the Quentin N Burdick Memorial Healthcare Facility, a 27-bed Indian Health Service hospital located in Belcourt, North Dakota, serving the Native American population on the Turtle Mountain Indian reservation. The contract requires the contractor to provide comprehensive sleep testing services, including qualified Respiratory Therapists or Polysomnography technicians, multi-channel PSG equipment, and Home Sleep Apnea Testing (HSAT) devices like the WatchPAT ONE, which offers 7-channel diagnostic capabilities with 89% correlation to in-lab studies. The contractor will be responsible for equipment maintenance, supply provision, medical record management, and quality improvement, while ensuring compliance with healthcare industry standards, ethical practices, and Indian Health Service regulations.

The contract stipulates specific requirements including maintaining general liability insurance with $1 million per occurrence and $3 million aggregate coverage, conducting character investigations for personnel with potential child contact, and adhering to privacy act guidelines for medical record management. The fixed-price, non-personal service contract allows the facility to collect both technical and professional components of the sleep study services, with the government retaining the right to evaluate service quality without controlling medical professional judgments. The contract is set to begin January 1, 2026, and includes provisions for inservice training, equipment provision, and collaboration with hospital staff to support the facility's mission of providing high-quality healthcare to the Native American community.

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Section C Statement of Work

Quentin N Burdick Memorial Healthcare Facility

January 1, 2026

C-1 Purpose of Contract

Provide Polysomnography testing or sleep studies along with ancillary equipment that is required for Polysomnography lab testing and analysis that would be provided by the Contractor for Quentin N Burdick Memorial Health Care Facility.

The mission of the Quentin N Burdick Memorial Healthcare Facility in Belcourt, North Dakota is to provide the best possible health care services to the Native American population on the Turtle Mountain Indian reservation. The total 27 bed Inpatient facility is also known as the Belcourt Indian Health Service Hospital, the Belcourt Service Unit, or the IHS hospital.

To meet the mission, the Quentin N Burdick Memorial Health Care Facility requires contractor support to assist the Facility in the provision of Polysomnography (PSG) testing services. The contract effort shall be tailored to provide the equipment and technical support and supplied necessary to perform Polysomnography testing.

The contractor shall comply with all materials aspects of applicable laws and regulations governing the licensing, as applicable and conduct of its personnel” with the ethical standards of the healthcare industry and with the applicable policies, procedures, rules and regulations of Hospital. Contractor shall cooperate with Hospital in satisfying all requirements needed with respect to the sleep lab industry to aid Hospital in maintained its accreditation, licensure, Medicare, Medicaid and other governmental program provider status.

Each contract resulting from this solicitation shall

(a) Provide a fixed-price, non-personal service contract that allows Quentin N Burdick Health Care Facility, to collect both technical and professional components of said contract.

(b) Allow the Government to evaluate the quality of professional and administrative Services provided, but retain no control over the medical, professional aspects of the services rendered (e.g., professional judgements, diagnosis for specific medical treatments.

(c) Require the Contractor to identify the Government for any liability producing act or omission by the Contractor, its employees and agents occurring during the contract performance.

(d) Require the contractors to ensure that its subcontracts for provision of health care services contain the requirements of the clause at FAR 52.237-7 (section I-4), including the maintenance of medical liability insurance.

C-2 Statement of Work

a. Provide certain sleep testing services to satisfy the Hospital needs and the community needs for quality sleep testing.

b. Provide Inservice training for medical and nursing staff of the Hospital upon reasonable request by Hospital.

c. Personnel; Provide qualified personnel to perform the services who are Respiratory Therapists or Polysomnography technicians. Contractor will ensure that personnel provided to perform the service meet the Hospitals and applicable regulatory competency and proficiency standards and will make available documentation of such competency and proficiencies as request by Hospital. Their personal shall conduct sleep studies for Hospital patients (which shall include applying equipment to the patients), Monitor patients undergoing studies during testing, and give technical and other support to Program director. Any personal providing assistance to Program Director hereunder shall be and remain employees of the contractor and may be disciplined, transferred or discharged only the contractor. Contractor shall provide Program Director with opportunities to provide input about the performance of such personnel to appropriate Contractor’s management.

d. Equipment PSG; Contractor shall provide, maintain and make available the equipment reasonable for the providers at Hospital of the Service. The equipment shall include, but not to be limited to, all equipment necessary for a multi-channel Polysomnography sleep study and nasal CPAP equipment. Hospital shall promptly notify the contractor (by in -person or telephone report to Contractor, followed by a written report, if requested) of any defect, malfunction or other deficiency of such equipment of which Hospital becomes aware within ten (10) days of the discovery. New equipment may be recommended by the Hospital, but Contractor shall have sole discretion to determine whether to purchase such recommended equipment. Hospital shall take reasonable measures to ensure that any equipment that remains at the Hospital will be kept secured. The hospital will designate a clean storage area for the equipment to be properly stored. Equipment when stored in this designated area will be cleaned per manufacturer's guidelines. This is to include date it was cleaned, bag over the cleaned items indicating the equipment is ready for the next patient use.

Equipment HST: Contractor will provide WatchPAT ONE, which is a Home sleep Apnea Device (HST) that utilizes the peripheral arterial signal for sleep apnea diagnosis. It measures up to 7 channels (PAT signal, heart rate, oximetry, actigraphy, body position, snoring and chest motion. The device is clinically validated with an 89% correlation to an in-lab PSG. The device is disposable which allows for no risk of Coronavirus infection and can be mailed directly to the patient’s home.

e. Supplies: Contractor shall provide all supplies necessary to provide the services. Hospital shall make reasonable efforts to advise Contractors concerning the supplies needed, provided that, Contractor shall have sole discretion to determine whether to purchase such recommended supplies.

f. Medical Records: Contractor shall be reasonable for the maintenance of all the patients’ records pertaining to the services performed hereunder, in accordance with the Hospitals approved standards and will provide written reports to Program director and interpreting physician. The contractor shall have sole discretion to determine whether to purchase such recommended supplies.

g. Quality Improvement: Contractor shall participate as requested, in Hospital utilization review, Quality improvement, peer review and similar programs and committees with respect to the services. The contractor shall address and correct professional quality issues identify by any such program or committee in an appropriate and timely manner.

h. Reporting: Contractor shall report to Program manager of Hospital who contracting the service. Any complaints relating to the services provided here under received by hospital or contractor shall be forwarded to an appropriate official of the other party for the mutual resolution or for notice resolution.

The Contractor shall comply with all I.H.S facility infection control and safely procedures, practices, and standards.

The contractor and/or sub-contractor shall respect and maintain the basic rights of patients, to include but not be limited to personal dignity.

C-3 GDX Technician Qualifications.

Contractor GDX technician(s) “CNFAT” shall be certified by the certification agency or equivalent.

It is a condition of this contract that all required certifications in this Statement of Work remain current during the life of this contract.

Contractor technician must hold a current, unrestricted Certification from any of the 50 United States of the Commonwealth of Puerto Rico.

The Contractor technician shall speak, understand, read, and write English fluently and communicate with sufficient clarity to be understood by Aberdeen Area Indian Service personnel and patients.

The contractor technician shall not have any work or health restrictions which interfere with the performance of sleep services.

The Contractor shall possess sufficient initiate, interpersonal relationship skills and social sensitivity such that he/she can relate constructively to patients from Native American communities in the Aberdeen Area I.H.S.

The Contractor technician shall maintain standards of personal hygiene and grooming such that his/her image as a health care provider is compatible with expectations of the Aberdeen Area Indian Health Service clinical staff and the Native American community.

C-4 GOVERNMENT FURNISHED PROPERTY, FACILITIES, AND SERVICES

The service unit shall provide administrative and professional ancillary support deemed necessary to support the function(s). Contractor and Hospital shall mutually agree on the scheduling of sleep studies outside of the normal operating hrs.

The service unit shall provide all required blank Government forms applicable to the Indian Health Service. Service Unit personnel will also provide appropriate orientation to the necessity of such forms.

The service unit shall provide an ongoing method of monitoring and evaluation of the quality and appropriates of patient care, and of identifying defiance in the quality of services performed before the level of performance becomes unacceptable.

Transcription service is available at the service unit. Additionally, handwritten documentation of medical records is acceptable.

Program Director. Hospital will provide Respiratory Therapy to assist the contractor as may be required to facilitate the Services provided by the contractor there under including, but not limited to assisting the contractor personnel in maintained adequate reports and providing such reports, as requested by Hospital. Respiratory Therapy/Nursing shall have control of the Sleep Lab and the contractor shall manage and control the technical and administrative duties of the Sleep lab.

Facilities. Hospital shall provide the contractor with adequate physical space for use in performing the Services. The size and location of such space shall be determined by Hospital in consultation with the contractor. At a minimum the space shall contain a private room with a bed and a bathroom and an administrative area for technicians to monitor the sleep testing.

Hospital facilities shall be used only in connection with performance of the duties hereunder involving Hospital operations and Hospital patients.

Personnel and Scheduling. Hospital shall designate an individual employed by Hospital to provide administrative functions to facilitate the Services provided by the contractor hereunder including, but not limited to: (a) schedule all bed reservations for all sleep studies, (b) upon receiving notice of cancellation notify the contractor of such cancellation as soon as practicable thereafter, and (c) submit billing information to Hospital’s accounts receivable department.

C-5 CONTRACTOR FURNISHED PROPERTY

The contractor shall provide all necessary equipment and tech support and supplies required by the technician to perform the sleep study testing.

Employee Performance. The Contractor shall not allow any employee to perform work under this contract who is under the influence of alcohol, drugs, or any other incapacitating agents.

C-6 GENERAL LIABILITY AND PROPERTY DAMAGE INSURANCE:

The contractor or the sub-contractor shall at all times, during the terms of this contract, maintain general liability and property damage insurance. Insuring against liability for death, bodily injury and property damage occurring during the term of this agreement within minimum limits of One Million Dollars (1,000,000.00) per occurrence and Three Million Dollars ($3,000,000.00) aggregate. All policies which the contractor is required to carry under this contract shall contain a covenant that the coverage shall not be cancelled unless at least sixty

(60) days written notice is given to the hospital.

An apparently successful offers upon request by the contracting officer, will furnish prior to contract award evidence of its insurability concerning the insurance required by this contract.

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

A CERTIFICATE OF INSURANCE EVIDENCING THE REQUIRED COVERAGE WILL BE PROVIDED TO

THE CONTRACTING OFFICER PRIOR TO THE COMMENCEMENT OF SERVICES UNDER THIS

CONTRACT. If the insurance is on a claim made basis and evidence of an extended reporting endorsement (tail) is not provided prior to the commencement of services, evidence of such endorsement will be provided to the Contracting Officer prior to the expiration of this contract.

Final payment under this contract will be withheld until evidence of the extended reporting endorsement (tail) is provided to the Contracting Officer.

The policies evidencing required insurance will also contain an endorsement to the effect that any cancellation or material change adversely affecting Government’s interest will not be effective until 60 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 will provide evidence that the Government will be indemnified to the limits specified in this Statement of Work. This will be for the entire period of the contract, either under the new policy, or a combination of old and new policies.

THE CONTRACTOR SHALL INSERT THE SUBSTANCE OF THIS CLAUSE, INCLUDING THIS

PARAGRAPH, IN ALL SUBCONTRACTS UNDER THIS CONTRACT FOR HEALTH CARE SERVICES AND

WILL REQUIRE SUCH SUBCONTRACTORS TO PROVIDE EVIDENCE OF AND MAINTAIN INSURANCE

IN ACCORDANCE WITH THIS CLAUSE. AT LEAST 5 DAYS BEFORE THE COMMENCEMENT OF

WORK BY ANY SUBCONTRACTOR, THE CONTRACTOR WILL FURNISH TO THE CONTRACTING

OFFICER EVIDENCE OF SUCH INSURANCE.

The Government reserves the right to accept or reject services if the level of work is unsatisfactory.

C-7 PRIVACY ACT NOTIFICATION:

(a) This contract requires the Contractor, on behalf of the Indian Health Service (IHS), to provide Health care to American Indians and Alaskan Natives and report selected medical record and financial information to IHS. The Snyder Act (25 U.S.C. 13) and Public Law 83-5658 (42 U.S.C. 2001) authorizes the collection of this information. To be reimbursed by IHS, you must provide the information requested by delivery orders issued under this contract. IHS will use the information for financial, legal, research, and heal care purposes.

(b) Disclosure of this information may be made by IHS to: other providers of health care for treatment of health maintenance of American Indian or Alaskan Native people; the Office of Worker’s Compensation Programs, Department of Labor;

the Department of Justice for their representation of the United States; and for congressional inquiry; quality assessment, medical audit, or utilization review, billing third parties for the payment of care; analytical and evaluation studies; to Federal or State agencies as required by law, research purposes supported by IHS; and identification of handicapped children under 10 U.S.C. 1401 et. Seq.

(c) Disclosure of the appropriate medical record information without prior consent of the subject patient may be made by you to: another provider of health care treating the same patient; a Federal or State agency as required by law such as the reporting of communicable diseases, births, deaths, or the commission of crimes (i.e., gunshot wounds, rape, child abuse or neglect, alcohol or drug abuse, etc.); and billing third parties for the payment of care not reimbursed by IHS.

You must forward all other requests for information contained on this form to the applicable IHS Ordering Official.

C-8 REQUIREMENTS:

Force Majeure. Delay and/or failure to perform by any party to this contract shall be excused and shall not constitute a breach or cause for termination of this contract to the extent that such delay and/or failure to perform is directly or indirectly caused by any condition beyond its control. Including, but not limited to: fires, floods, earthquakes, snow, tornadoes, disasters, other acts of God, accidents, riots, wars, operation of law, strikes, governmental actions or regulations. Including, without limitation actions taken by the FDA, shortages of labor, fuel, power, materials, supplies or transportation, supplier delay; provided, however, that if contractor/sub-contractor failure to perform due to force majeure continues for a period of sixty-(60) days, Hospital shall be free to terminate this contract.

Access to Books and Records: In order to ensure that the Hospital may be reimbursed for payments (if any) made to contractor hereunder as part of its reasonable cost of furnishing services under the Medicare program. It is understood that if contractor/sub-contractor is determined to be a subcontractor under the provisions of subparagraph (I) of Section 1861 of the Social Security Act as added by Section 952 of the Omnibus Budget Reconciliation of Act of 1980, or regulations adopted pursuant. Thereto, contractor/sub-contractor will, until the expiration of four (4) years after the furnishing of services under this contract, make available upon request of the federal officials or their representatives the contract (agreement) and the providers books, documents and records as may be necessary to certify the nature and extent of costs incurred by the Hospital. And, that provider will make a similar requirement of any related organization with which provider subcontracts to perform this contract.

Compliance with local, state and federal laws; The parties intended, and in good faith, believe that the terms of this contract comply with all local, state and federal laws. Expressly including 42 U.S.C. & 1320 (the Fraud and Abuse Statue) and 42 U.S.C. & 1395 (the Stark Bill) and the Internal Revenue Code (collectively “Laws). In the event that either party forms the reasonable belief that his contract violates said Laws, then said party shall provide the other party written notice of its concern and the parties shall make a good faith effort to amend the contract to eliminate the problematic term(s). In the event that the parties are unable, after good faith efforts, to amend the contract, then either party may terminate this contract by providing thirty

(30) days advance written notice of termination.

C-9 CHARACTER INVESTIGATION

Individuals providing services on personal or non-personal services contract, the duties and responsibilities of which involve regular contact with, or control over, Indian children, are subject to a character investigation. IHS personnel offices will conduct these investigations following award of a personal or nonpersonal service contract unless in the judgment of the Contracting Officer, investigation may be waived based on prior investigations on file. Until the character investigation has been completed and the Contracting Officer notified, such individuals shall not have unsupervised contact with Indian children.

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