PWS No. CSU-24-01 On-Site Mobile MRI dated May 1, 2024.pdf

PWS No. CSU-24-01 ON-SITE MOBILE MRI 01 MAY 2024

Chinle Comprehensive Health Care Facility (CCHCF)

Performance Work Statement (PWS) for Non-Personal Services

ON-SITE MOBILE MAGNETIC RESONANCE IMAGING

(MRI) SERVICES

SECTION TABLE OF CONTENTS PAGE

A. General 1

B. Scope 1

C. Definitions 2

D. Government Furnished Information, Property, Services, and Materials 2-3

E. Contractor Furnished Information, Property, and Materials 3-4

F. Performance-Based Requirements 4-6

G. Contractor Qualifications, Certifications, and Staffing Requirements 6-7

H. Equipment Specifications 7-8

I. General Requirements 8

J. Quality Control and Performance Requirements 8-9

K. 52.212-4 Contract Terms and Conditions-Commercial Items (MAY 2015) (m) 9

L. Performance-Based Matrix 9-10

M. Attachment 10

Attachment Site Plan Location 11

Chinle Comprehensive Health Care Facility

Performance Work Statement for Non-Personal Services

ON-SITE MOBILE MAGNETIC RESONANCE IMAGING

(MRI) SERVICES

A. General: This performance work statement describes the requirements for a Non-Personal Service contract for On-site

Mobile Magnetic Resonance Imaging (MRI) services provided in a Contractor-owned mobile unit. The mobile unit shall be brought on-site to CCHCF in Chinle, AZ for services (Five [5] days/week) for the term of the contract.

The Indian Health Service (IHS), an agency within the Department of Health and Human Services, is responsible for providing federal healthcare services to American Indians and Alaska Natives. The provision of healthcare 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 and its goal is to raise their health status to the highest possible level. The IHS provides a comprehensive health service delivery system for approximately 2.6 million American Indians and Alaska Natives who belong to 573 federally recognized tribes in 37 states.

The Chinle Comprehensive Health Care Facility (CCHCF) is a NAIHS facility. CCHCF provides medical care for approximately

35,000 Navajo. Serving a rural area, many of our patients travel 100 miles round trip to receive care and do not have electricity or running water in their homes. In addition, most of our elderly patients speak only Navajo, and live according to traditional

Navajo cultural practices. The CCHCF and Ambulatory Care Center is a 60-bed inpatient hospital and outpatient facility.

Services offered are:

• Adult Inpatient • Integrated Behavioral Health • Optometry • Respiratory Therapy

• Adult Intensive Care • Lab • Outpatient Primary Care • School Health

• Anesthesiology • Labor & Delivery • Pediatric Inpatient • Speech Pathology

• Audiology • Mental Health • Pharmacy • Social Services

• Clinical & Community Nutrition • Native Medicine • Physical Therapy • Urgent Care

• Dental • Nurse Phone Triage Services* • Podiatry • Women’s Health

• Emergency Medicine • OB/GYN & Midwifery • Public Health

*Available after hours. • General Surgery • Occupational Therapy • Radiology

The CCHCF lacks Magnetic Resonance Imaging (MRI) service, prompting frequent referrals outside the service unit. For emergent indications, such as suspected stroke or spinal compression, the lack of MRI necessitates referrals via air transportation (fly outs). Over the last several years, MRI has become more accessible to rural and community hospitals utilizing on-site mobile MRI services. Physician and Surgeons are historically reluctant to refer for MRI service due to concerns over travel burden for patients and the cost to the service unit. Despite these concerns, in prior years, CCHCF referred out

406 MRI studies. Rather than referring out, CCHCF will be able to offer on-site mobile MRI services.

Client Background: Many of the IHS patients receiving services under this contract may only speak a Native language and/or reside on a federally recognized Indian reservation. The Contractor shall demonstrate sensitivity to cross-cultural and language difference and have the ability to work through interpreters as necessary for non-English speaking patients.

Formal interpretation will be provided by CCHCF staff as necessary.

B. Scope: The contractor shall provide On-site Mobile MRI services in accordance with the Performance-Based

Requirements.

1. Duties and responsibilities: The Contractor shall provide On-site Mobile Magnetic Resonance Imaging (MRI) services with diagnostic MRI services to inpatient and outpatient beneficiaries of Chinle Service Unit.

2. Place of Performance: Services are to be performed at the CCHCF. CCHCF will be responsible for providing adequate site for placement, including the requisite power and data connections per the mobile MRI units’ specifications.

Refer to Site Plan identifying the area where the mobile unit will be stationed.

3. Period of Performance: The contractor shall provide coverage five (5) days a week, Monday through Friday, starting at 8:00 am to 5:00 pm, for twelve (12) months and services will start at contract award.

C. Definitions

1. Acceptance: An authorized representative of the Government has inspected and agreed that the work meets all requirements of this contract, to include documentation requirements.

2. Acquisition term for MRI Scans: The process of measuring and storing image data.

3. Approval: The Government has reviewed submittals, deliverables, or administrative documents (e.g., insurance certificates, installation schedules, planned utility interruptions, etc.) and has determined the documents conform to contract or contract requirements. Government Approval shall not relieve the Contractor from responsibility for complying with contract requirements.

4. Authorized Ordering Official: A Government employee with the authority to order/issue and sign individual task orders for MRI services for the CCHCF medical facility.

5. Contracting Officer (CO): A Government employee with warranted delegated authority to enter into, administer, and/or terminate contracts.

6. Contracting Officer’s Representative (COR): A Government individual responsible for administration of this contract.

The COR closely monitors the contract for contractor compliance and provides feed back to the Contracting Officer.

7. Contractor: The individual or firm awarded a legal binding contract to provide supplies and/or services.

8. Customer Input: A criticism against the Contractor submitted to the Contracting Officer. This is one of the criteria used to monitor the Contractor’s performance.

9. Cultural Awareness: The realization and respect for American Indian and Alaskan Native practices.

10. DICOM: Acronym for Diagnostic Imaging Communication in Medicine

11. Enhancement Studies: The use of contrast media to improve the visibility of internal body structures in magnetic resonance imaging (MRI).

12. Federal Acquisition Regulations (FAR): The FAR is the primary set of regulations for use by all Federal Executive agencies in their acquisition of supplies and services with appropriated funds.

13. Holiday: A day marked by the government for general suspension of work in commemoration of an event.

14. MRI Scan: Magnetic resonance imaging (MRI) is a technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within a body.

15. Ordering Activity: An authorized user of IHS that may issue a task or delivery order to obtain required services under this contract.

16. Past Performance Information: Relevant information regarding a contractor’s actions under previously awarded contracts. It includes the contractor’s record of conforming 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 aspects 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.

17. Quality Assurance Surveillance Plan (QASP): An organized written document prepared and used by the Government for Quality Assurance surveillance of the contractor’s performance.

18. Root Cause: A situation where performance does not meet expectations. Cause suggests responsibility or a factor to blame for a problem.

19. Task Order: An order issued by the government in accordance with the terms of the contract that details an ordering activity’s specific requirements. An authorized ordering official’s written order to obtain service, at a minimum will include the following where applicable: description of services, skill categories, hours, price period of performance, contract number, and the ordering activity’s task order number.

20. Service Unit (SU): A facility that houses Service Unit administrative staff and is responsible for the administration, coordination, and implementation of the Indian Health program/s in a designated geographic portion of the Area.

The Navajo Area IHS covers approximately 25,000 square miles across North Arizona, Southern Utah, Western New

Mexico and Colorado. The IHS medical facilities range from small ambulatory care clinics (health centers) to full service hospitals. Most of the medical facilities are located on Indian reservations.

D. Government Furnished Information, Property, Services, and Materials

1. Information: Government unique information related to this requirement, which is necessary for Contractor performance, will be made available to the Contractor. The Contracting Officer or designee will be the point of contact for identification of any required information to be supplied by the Government.

a. CCHCF will be responsible for scheduling patients for exams.

b. CCHCF staff can be contacted as necessary to provide linguistic services when interpretation is necessary for non-English speaking IHS patients.

c. CCHCF staff radiologist will be responsible for reading/interpreting all MRI studies and dictation of all required study reports. CCHCF radiology will have the final responsibility for all aspects of the study including but not limited to: reviewing all indications for the scan, specifying the pulse sequences to be performed, specifying the use and dosage of the contract agents, interpreting the images and generating reports.

2. Joint Use by the Government and the Contractor: Except for the property and service listed in D3. and 4.0, the

Government will provide, for joint use by the Government and the Contractor, all necessary equipment, supplies, and clinic space to perform the services under this contract.

a. CCHCF will provide the necessary space for the weekly set-up of the Contractor’s mobile unit.

b. CCHCF will provide electrical power, data line connectivity, and a telephone line accessible to CCHCF to meet code requirements.

c. Contractor Exclusive Use: The Government will provide facility specific contractor identification badges for each contractor. A minimum fee of $10.00 will be charged for lost or destroyed badges.

3. Inspection: All services rendered in will be inspected, reviewed, and monitored by Raquel Collins, MD, Assistant

Clinical Director or designee for this contract.

a. Contracting Officer’s Responsibility: Authority to negotiate changes in terms, conditions, or amounts cited in this contract is reserved to the Contracting Officer.

b. Contracting Officer’s Representative (COR): The Contracting Officer's Representative (COR): Georgina Nez, Health System Specialist, who shall be responsible for:

b1. Monitoring the Contractor's technical progress on individual task orders, including surveillance and assessment of performance and issuing technical changes to individual task orders;

b2. Interpreting the Scope of Work on Individual Task Orders, with the assistance of the SU medical staff;

b3. Technical inspections and acceptance required by this contract; and b4. Assisting the Contractor in the resolution of technical and administrative problems encountered during the performance of this contract.

c. Point of Contact: Raquel Collins, MD, Assistant Clinical Director, (928) 674-7198, Gilbert Singer, (928) 674-7331, and Georgina Nez, (928) 674-7450 are the points of contact for this requirement.

E. Contractor Furnished Information, Property, and Materials

1. Except for those specified in Section F as government furnished, the contractor shall provide subject to the following:

a. Films/Data: The Contractor shall store all exams on Optical Compact Disc (CD) discs, which will be provided by

CCHCF. The discs will be stored in the Radiology Department at CCHCF. CCHCF will own all data studies performed.

b. Billing: The Contractor shall sign authorization giving CCHCF permission to bill for all patient and 3rd party billing.

CCHCF reserves the right to bill for and collect all applicable reimbursement monies associated with the contracted service from all third-party resources. The Contractor shall provide CCHCF with the National

Practitioner Identification (NPI) number of the contracted providers. The Contractor shall be responsible to ensure their MRI technologist meet the qualifications to obtain and maintain credentials and privileges.

2. Physical Security: The Contractor shall be responsible for safeguarding all Government equipment, information, and property provided for Contractor use. At the close of each work period, Government facilities, equipment, and materials shall be secured.

a. KEY CONTROL: The Contractor shall establish and implement methods of ensuring all keys/key cards issued to the Contractor by the Government are not lost or misplaced and are not used by unauthorized person (note: all references to keys includes key cards).

b. No keys issued to the Contractor by the Government shall be duplicated.

c. The Contractor shall develop procedures covering key control that shall be included in the QCP. Such procedures shall include turn-in of any issued keys by personnel who no longer require access to locked areas.

d. The Contractor shall immediately report any occurrences of lost or duplicate keys to the Government

COR/Project Manager (PM), and Contracting Officer (CO).

e. In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the

Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor.

f. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the

Government and the total cost deducted from the monthly payment due the Contractor.

g. The Contractor shall prohibit the use of Government issued keys by any persons other than the Contractor’s employees. The Contractor shall prohibit the opening of locked areas by Contractor’s employees to permit entrance of persons other than Contractor’s employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

h. Lock Combinations: The Contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The Contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the Contractor’s QCP.

3. Contractor’s Point of Contact: Designated Contractor’s Point of Contact (POC), whom we may contact for prompt

Contract Administration:

Name & Title:

Address:

Telephone No.:

Email Address:

The Contractor shall provide updated Point of Contact information within 30 days of newly appointed Point/s of

Contact for the term of this contract. POC shall be available via the telephone Monday through Friday, 7:00 am to

5:00 pm, including Federal Recognized Holidays and scheduled down days. The POC shall have full authority to act for the Contractor on all matters relating to daily operations. An alternate may be designated, but the Contractor shall identify those times when the alternate will be the primary point of contact.

F. Performance-Based Requirements: The Contractor shall provide uninterrupted On-site Mobile Magnetic Resonance

Imaging (MRI) services with diagnostic MRI services to inpatient and outpatient beneficiaries of Chinle Service Unit during the performance period of the contract.

1. The Contractor shall provide all supervision, personnel, labor, parts, materials, tools, supplies, equipment, and free-standing unit necessary to provide On-site Mobile Magnetic Resonance Imaging (MRI) services to include qualified technical staff to operate the MRI scanners and equipment 2 days per week. CCHCF will be responsible for providing adequate site for placement, including the requisite power and data connections per the mobile MRI units’ specifications. The Contractor shall be responsible for performing a variety of MRI examinations for IHS beneficiaries seeking care at CCHCF or who have been referred to CCHCF.

2. The Contractor shall obtain and maintain all required Federal, State, and Local licenses associated with the operation/transportation of the equipment and performance of the services being requested. The Contractor shall maintain all Federal and State licenses required for possession and operation of equipment for the term of the contract.

3. The Contractor shall provide on-site mobile MRI services five (5) days per week, Monday through Friday, for eight

(8) hours per days Contractor is on site. If a scheduled day falls on a federally recognized holiday, then CCHCF will not pay, rather the Contractor may opt to make up the day or credit the monthly invoice.

4. The Contractor shall maintain a patient exam register which includes the patient’s chart number, type of exam, date of birth and length of time for each exam.

5. The Contractor shall provide on-site diagnostic MRI services in both inpatient and outpatient settings as follows:

a. Outpatient: Patient scheduled for MRI scan services will report to the mobile unit. For emergency scans, CCHCF medical staff will escort the patient to the mobile unit for MRI scans.

b. Inpatient: The patient will be escorted to the mobile unit by a member of the CCHCF nursing or medical staff.

CCHCF will be responsible for determining which patients need to be monitored. The MRI technician shall immediately notify the covering radiologist of any emergency or changes in a previously stable patient. CCHCF will be responsible for managing all patient related emergencies.

6. MRI services will not be available for emergency purposes, except on the days when the mobile MRI unit is scheduled to be on-site.

7. The Contractor shall assume liability of all I.H.S. patients while in the MRI mobile unit.

8. The Contractor shall store all records of MRI studies on a magnetic disc or equivalent device. CCHCF will provide the storage media and storage space.

9. The MRI technologist shall be responsible for ensuring completion of MRI safety screening forms, which will be provided by CCHCF prior to each patient’s exam.

10. Disruption of MRI Services: The Contractor shall communicate to the COR any possible and actual disruptions of MRI services. Upon becoming aware of possible or actual disruption of MRI service, the Contractor shall communicate such service-disruption information to the COR as soon as possible (ASAP). The Contractor shall inform the COR in a timely manner so the patient and service schedule can be appropriately modified with as little inconvenience as possible to patients and services.

11. The Contractor shall perform Preventative Maintenance (PM) as recommended by the original equipment manufacturer (OEM) and repairs for both the MRI System and the Mobile Unit. The Mobile Unit includes, but is not limited to, generator, MRI contrast injector, air conditioning/heating systems, and patient lift. The service contract shall be maintained by an OEM and be comprehensive. Records of all maintenance activities shall be maintained for the life of the MRI equipment and these records shall be available to COR for review. Any unscheduled repairs and maintenance shall be done in a prompt fashion and to the extent possible, during hours when service is not scheduled in order to minimize the amount of time the mobile unit is unavailable for service.

a. The Contractor shall provide a service Point of Contact (POC) and phone number for hospital/clinic employees to call in the event of equipment failures.

b. The Contractor shall have phone response within 1 hour and onsite service within 24 hours for the MRI System and 24 hours for Mobile Unit.

c. The Contractor shall perform initial set-up and annual Physicist review as required per TJC and the ACR and provide copies of the review to the Government including, but not limited to:

c1. Image uniformity for all coils c2. Signal-to-noise for all coils c3. Slice thickness accuracy c4. Slice position accuracy c5. Alignment light accuracy c6. High-contrast resolution. Contrast-to-noise ratio c7. Geometric accuracy c8. Magnetic field homogeneity, c9. Artifact evaluation.

c10. Proper function/performance of display monitors (luminance max/min, uniformity, resolution and spatial accuracy.) Service should be maintained by an OEM and comprehensive.

12. The Contractor shall be solely responsible for all driver-staffing issues related to set-up and operation of the systems.

a. The Contractor shall perform arrival, set-up, take-down, and departure of mobile systems in a manner that causes limited or no disruption to normal CCHCF operations. The Contractor shall perform arrival and departure such that the MRI unit operates full days on days schedule. Appropriate arrival and departure schedules shall be developed such that the MRI unit is fairly accommodated regarding its operation.

13. The Contractor shall provide the following Reporting Requirements:

Report

No.

Description No. of

Copies

Recipient Due Date

1 Quality Control 1 COR Quarterly

2 Equipment Maintenance Log 1 COR Quarterly

3 Personnel Licensure 1 COR

10 days prior to start date of Contractor’s new employee

4 Required Accreditations 1 COR Annually

5 Liability Insurance 1 COR Annually

14. The Contractor shall be responsible for the overall housekeeping inside of the unit including, but not limited to, removal and proper disposal of all debris on a daily basis or as often as necessary to maintain a sanitized and neat environment. Contractor will dispose of waste in appropriate Hospital receptacles.

G. Contractor Qualifications, Certifications, and Staffing Requirements

1. Services shall conform with and, if applicable, certified by:

a. The Accreditation Association for Ambulatory Health Care (AAAHC)

b. Health Insurance Portability and Accountability Act (HIPPA)

c. Infection Control, National Fire Protection Association (NFPA)

d. Health Service Inspection (HSI)

e. Centers for Medicaid and Medicare Services (CMS)

f. The Joint Commission (TJC)

g. Indian Health Service (IHS) Standards

h. The American College of Radiology (ACR)

2. The Contractor’s mobile unit shall be appropriately State licensed and/or possess all necessary permits/accreditation, OSHA standards and meet National Life Safety Standard Codes.

3. The Contractor shall maintain appropriate certification for each MRI technologist and qualified medical physicist providing services throughout the term of this contract and provide the documentation to the COR.

4. The Contractor shall be solely responsible for all MRI technologist staffing responsibilities, except patient scheduling related to operation of the mobile systems. The MRI technologist shall:

a. Be certified by the American Registry of Radiologic Technologist (ARRT).

b. Possess a current, valid, unrestricted appropriate license in any state, the District of Columbia, the

Commonwealth of Puerto Rico, or a Territory of the United States, throughout the term of this contract plus six

(6) months of supervised clinical MRI scanning experience or American Registry of Magnetic Resonance Imaging

Technologist (ARMRIT).

c. Maintain a valid and current Cardiopulmonary Resuscitation (CPR) certification and Basic Life Support (BLS)

Certifications and copies shall be kept on file.

d. Have training, experience, and competent in administering IV injections.

e. Be required to attend Government mandatory orientation before providing direct patient care.

f. The Contractor shall comply with the provision of Public Law 101-630: Occupational/Classification – Indian

Children Protection and Family Violence Protection Act.

g. Language Requirements and Cultural Awareness: The contractor shall read, understand, speak, and write

English to effectively communicate with patients and other health care workers, and shall be respectful of the local, American Indian and Alaska Native culture.

5. The Qualified Medical Physicist shall be appropriately certified with the American Board of Radiology (ACR).

6. The Contractor personnel performing work under this contract must be fingerprinted, background checked, and cleared before performing on-site direct patient care.

7. The Contractor shall maintain all immunizations required of health care provider and before start of work, the health care provider shall provide proof of immunizations for the following disease according the CDC guidelines: Hepatitis

B, measles, mumps, rubella, varicella, and influenza including proof of a negative TB skin test within 12 months (if positive, proof of negative chest X-ray within 12 months).

8. The Contractor personnel shall work in a professional manner at all times by presenting in a clean, neat appearance, and be easily recognized as contractor employees.

9. The Contractor shall possess medical liability insurance in accordance with FAR 52.237-7: Indemnification and

Medical Liability Insurance. The Contractor shall maintain medical liability insurance throughout the term of the contract and provide updated copies to the Contracting Officer’s Representative upon renewal/s.

10. The Contractor shall not employ any person who is an employee of the United States Government if the employment of that person would create a conflict of interest.

11. The Contractor and all personnel are not considered Government employees.

12. The Contractor is required to check the Health and Human Services-Office of Inspector General (HHS/OIG), list of

Excluded Individuals/Entities on the OIG website: www.hhs.gov/oig for each person providing services under this contract to ensure that individuals providing services under the contract have not engaged in fraud or abuse of

Section 1128/A of the Social Security Act regarding Federal health care programs. Contractor shall certify that persons listed in Contractor’s proposal have been checked against the HHS/OIG list and are not on the list. During the performance of this contract the contractor shall not use any individual or business listed on the list of Excluded

Individuals/Entities.

13. The Contractor is required to maintain applicable insurance policies commensurate with normal business practices and as required by Federal/State/Local laws.

H. Equipment Specifications

1. The Mobile MRI Trailer should be at least/minimum twelve (12) feet wide and sixty (60) feet. CCHCF has a high inpatient volume of studies and gurney patients need to be loaded in and out of the trailer. The narrower trailers do not have the room and flexibility of the twelve (12) foot trailers. Mobile MRI scanner shall include a ramp and/or a lifting device for non-walking patients. The unit should be set up for 3 phase, 480volt/200 amperes service. The unit shall have a separate area included within the trailer for a patient changing area.

2. Equipment shall include, but not be limited to, a fully equipped MRI per minimum equipment requirements below.

The MRI unit shall be Joint Commissioned certified and FDA approved:

3. Minimum equipment requirements:

a. GE 1.5 HDxt – with 23 level software (or equal)

b. Wide Open Short Bore Magnet with Dual Flared Enclosures

c. 10.3 Wide patient opening – 60 cm.

d. Patient Bore is (LxWxH) 70 cm x 60 cm x 60 cm

e. Patient table accommodates patient weight to a maximum 350 lbs.

f. High performance Gradient Subsystem

g. Gradient strength is 33 mT/m

h. Slew rate is 120 T/M/s

i. Variable FOV from 2 cm to 48 cm

j. Dicom 3.0 Compliant

k. 2D Spin Echo (SE), 2D Inversion Recovery (IR), Double IR, Triple IR, 2D and 3D Gradient Echo (GRE), Fast Recovery

Fast Spin Echo (FRFSE), Single Shot Fast Spin Echo (SSFSE), 3D Fast Recovery Fast Spin Echo (3DFRFSE), 2D/3D

Spoiled Gradient Recalled (SPGR), 2D/3D Fast Spin Echo, Fast Spin Echo XL, 2D/3D Fast Gradient Echo (FGRE), 2D/3D Fast spoiled Gradient Echo (FSPGR), Cine, Fast Flair, EPI, IVI, 3D Surface Rendering and ClairView, T1 Flair, T2 Flair

l. 2D/3D Time of Flight Angiography (TOF)

m. 2D/3D Phase Contrast MR Angiography

n. MRCP – SSFSE, Single Shot Fast Spin Echo Cholangiopancreatography

o. MRCP3 – Spin Echo Cholangiopancreatography

p. SmartPrep

q. Fluoro-triggered MRA

r. Single Shot Diffusion Weighted Imaging - EchoPlus

s. Perfusion Analysis (Imaging)

t. The following additional equipment should be included:

t1. MRI pads and restraints t2. MRI compatible nonferrous wheelchair and stretcher with IV pole (gurney) t3. Wrist Coil - 16 channel coil for high-resolution hand and wrist imaging t4. Nonferrous oxygen cylinder t5. Capability to provide patient exam on CD t6. MRI license for PACS t7. Interface between MRI scanner and PACS, Dicom print, store and worklist t8. Optical disk archival device compatible with PACS t9. Code kit and code call button t10. MRI compatible 02 saturation monitor t11. Contrast media and warmer t12. MRI compatible power injector t13. Standard Head Coil, 8 Channel Brain Array coil, 4 Channel NV Array t14. 8 Channel CTL Array by GE, HD 12 Channel Body Array, T/R Knee/Foot Coil t15. HD Knee Array, 4 Channel Small Long Boane Flex Array, 4 Channel Should Array (Large) t16. 4-channel Should Array (Medium/Small), HD Wrist Array t17. Vibrant Software for breast imaging or equal.

I. General Requirements

1. Non-Discrimination in Services, Benefits and Facilities

a. The Contractor shall make no distinction among patients under this contract on the basis of race, color, creed, or national origin, including, but not limited to the following: denying a patient any service or benefit or availability of a facility; providing any service or benefit to a patient which is different, or is provided in a different manner or at a different time from that provided to other patients under this contract; subjecting a patient to segregation or separate treatment in any manner related to his/her receipt of any service, restricting a patient in any way in the enjoyment of any advantage or privilege enjoyed by others in determining whether he/she satisfies any admission, enrollment quota, eligibility, membership or other requirement or condition, which an individual must meet in order to be provided any service or benefits; and the assignment of times or places for the provisions of services on the basis of the race, color, creed, or national origin of the patients served.

b. The Government reserves the right to terminate this contract in whole or in part whenever the Contractor fails to comply with the requirements of this clause.

2. Quality of Patient Care: As appropriate, the Contractor shall provide IHS patients under the terms of this contract, proper and adequate general health care services, which are the same or equal to those provided to non-IHS patients.

a. Proper and adequate general health care shall include compliance with The Joint Commission Standards or

Medicare Certification. All patients hospitalized shall be in the facilities utilization and review program.

Reason(s) for admission and length of stay determinations shall be documented and reviewed by appropriate members of the hospital's utilization review committee or local designated Peer Review Organization (PRO).

b. MRI Scan services shall be provided within accepted professional standards.

c. The Government may evaluate the quality of professional and administrative services provided, but retain no control over the medical, professional, and administrative services rendered (e.g., professional judgments, diagnosis for specific medical treatment).

3. Health Insurance Portability and Accountability Act (HIPAA): The IHS is required to comply with the HIPAA in the provision of health care to IHS patients. HIPAA was implemented by the U.S. Department of Health and Human

Services, Office of Civil Rights, under the Code of Federal Regulations, Part 160 and164. Accordingly, all health care providers, including contracted health care providers are required to comply with HIPAA requirements. (Full text will be furnished upon request.)

J. Quality Control and Performance Requirements: The Contractor shall develop and maintain an effective Quality Control

Plan (QCP) to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s QCP is the means by which it assures that work will comply with the contract requirements. This QCP is part of the evaluation of proposals.

1. The Contractor shall have documented proof of the following Quality Control tests as listed below:

a. The following Quality Control tests shall be performed quarterly:

a1. Measurement of central frequency.

a2. Measurement of system signal-to-noise ratio on a standard head or body coil.

a3. Assessment of image quality and image artifacts.

b. The following Quality Control tests shall be performed and documented semi-annually and after any major change on equipment by a qualified physicist.

b1. Review of daily quality control testing records.

b2. Measurement of image uniformity; spatial linearity, and high contrast spatial resolution.

b3. Measurement of slice thickness, location, and separation.

c. All Quality Control testing shall be carried out in accordance with written procedures and methods. Preventive maintenance shall be scheduled, performed, and documented by a qualified service engineer on a regular basis.

Service performed to correct system deficiencies shall also be documented and service records shall be maintained by the MRI contractor and available for the COR.

2. The Government will evaluate the Contractor’s performance under this contract in accordance with the Quality

Assurance Surveillance Plan (QASP). This plan is primarily focused on what the Government must do to ensure that the contractor performs in accordance with the contract performance standards. The QASP defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

3. The Contractor shall provide written emergency plans addressing emergencies such as patient coded, personal injury, fire and disruptive behavior. CCHCF will prove a crash cart for emergency use.

Additionally:

Performance Requirements Summary: The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

K. 52.212-4 Contract Terms and Conditions-Commercial Items (MAY 2015) (m): Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the contractor, or if the contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the contractor for any amount for supplies or services not accepted, and the contractor shall be liable to the

Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

1. Any contractor demonstrating impaired judgment shall not be allowed to continue working on the contract. The

Government reserves the right to remove from the facility any contractor who in the judgment of a licensed healthcare practitioner is impaired.

L. Performance-Based Matrix

Performance-

Based Task Indicator Standard Quality Assurance Incentives

The Contractor shall provide On-site MRI scanner and technical support services in the delivery of patient care to the Chinle

Comprehensive

Health Care

Facility.

Performance The scanner and technologist will be available for services 100% of the time. Monthly stats. % uptime is number of clinical hours performed divided by scheduled

Clinical hours in the month.

Surveillance systems will include:

1. Random Sampling of

Patient Test Management

Audits by Radiology

Supervisor and/or COR.

2. Validated Complaints received based on incident report received by

Radiology Supervisor and/or

COR.

Payment for

Satisfactory service.

No payment for incomplete work.

Contractor performance will be evaluated using the

Contractor

Performance

Assessment Report

(CPAR).

The evaluation will be considered when future IHS contract selections are made.

Customer Service No more than one *Validated

Customer Complaint per 6-month time period.

Quality of Exams All MRI study/exams shall be high quality excluding factors not under technical control i.e.

patient was noncompliant. No more than one **Validated

Complaint from Radiologist or

Surgeon.

HIPPA

Requirements

Adhere to HIPPA requirements.

Within acceptable standards. Zero deviation from standard

Completion of

Scans

Complete scheduled daily scans at a rate > 100%

* Validated Customer Complaint: Complaints must be validated. Complaints are validated if found to be reasonable and true after an administrative investigation.

**Validated Complaint from Radiologist or Surgeon: Complaints are validated if found to be reasonable and true after an administrative investigation. Defective or low-quality MRI scans are limited to image quality issues under the technologist’s control such as proper sequencing protocols, positioning and demonstration of attempts to resolve poor quality studies.

Complaints are validated if found to be reasonable and true after an administrative investigation.

M. Attachment

1. Site Plan Location: Site Plan of Chinle Comprehensive Health Care Facility identifying the area where the mobile unit will be located.

Attachment – M.1. Site Plan Location