PWS 03082021 revision 2.pdf

MRI FULLY EQUIPPED MOBILE TRAILER INCLUSIVE OF MAINTENANCE AND INSTRUMENT

TRAINING, MANNED BY NNMC PERSONNEL

SOLICITATION NUMBER: RFQIHS1419014 ‐ NAVAJO AREA INDIAN HEALTH SERVICE

B‐4 Performance Work Statement:

B‐4.1 Duties

a) The Contractor shall provide all necessary equipment, freestanding unit and all necessary supplies required to provide on‐site MRI fully equipped trailer, inclusive of maintenance and instrument training. The trailer shall be manned for day‐to‐day operations by NNMC personnel.

b) The Contractor shall provide on‐site mobile MRI trailer for services on a daily basis, excluding federally recognized holidays. The on‐site MRI fully equipped trailer, inclusive of maintenance and training shall be provided every workday, Monday to Friday 8am ‐ 4:30pm. Maintenance and training are inclusive in the total price and shall be provided as specified in this PWs.

c) The Contractor shall maintain a documented quality control program which shall be reviewed on an annual basis by the COR.

d) The Contractor shall provide 24/7 maintenance coverage of mobile MRI trailer, MRI scanner and all other components of the system.

e) The Contractor is responsible for providing a power injector for contrasted studies.

f) The Contractor shall provide a lift for patients to enter the Mobile MRI scanner/trailer.

g) The Contractor shall provide staff access to the mobile MRI scanner/trailer.

h) The Contractor shall provide PM and service coverage for the MRI scanner 24/7.

i) The contractor shall provide maintenance technician availability within 12 hours of NNMC maintenance request.

j) The Contractor shall provide equipment training on scanner and trailer components.

k) Contractor shall provide Applications training for 2 weeks to train staff at NNMC on the functions of the MRI scanner and coils used.

B‐4.2 Enhancement Studies:

MRI scans requiring enhancement studies shall be done with the administration of contrast media.

B‐4.3 Films:

All exams shall be stored Vista Rad PACS system. Data connection shall be provided to the facility. Contractor is responsible for connections from the facility to the trailer.

B‐4.4 Government Furnished Equipment and Property:

a) NNMC shall provide the necessary space for the set‐up of the Contractor’s mobile unit. NNMC shall provide electrical power, data line connectivity and a telephone line accessible to NNMC to meet code requirements.

b) NNMC shall provide a tear‐away locking emergency drug box which shall be maintained by NNMC’s pharmacy. NNMC shall provide necessary medical supplies, i.e. syringes, tape, butterflies, gauze and bandages.

c) NNMC’s radiology department shall provide contrast media for enhancement studies performed on IHS patients. The Contractor is responsible for providing the power injector for use with contrasted exams.

d) NNMC’s staff radiologist shall provide interpretations for all MRI studies. NNMC’s radiology shall have the final responsibility for performing 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.

B‐4.4 Maintenance:

a) The Contractor shall at a minimum follow any maintenance schedules recommended by the manufactures of the mobile unit. 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. 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 on a quarterly basis. The Contractor shall not bill the Government for any time the trailer is not accessible during normal operating hours and days.

b) The Contractor may remove the MRI unit from service for a period of up to two (2) consecutive weeks during each twelve (12) month period under this agreement to facilitate manufacturer updates and engineering changes. This shall be coordinated with scheduling of patients in the Radiology Department at NNMC.

B‐4.5 Client Scheduling and Background :

a) NNMC shall be responsible for scheduling all patients.

b) 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 is expected to demonstrate sensitivity to cross‐cultural and language difference and have the ability to work through interpreters as necessary.

B‐4.6 Qualifications:

a) The Contractor shall maintain appropriate certification for the MRI scanner providing services throughout the term of this contract and provide the documentation to the COR.

b) The Qualified Medical Physicist shall be appropriately certified with the

American Board of Radiology. Provide documentation as requested by the COR.

c) The Contractor’s mobile trailer shall be appropriately State licensed and/or possess all necessary permits/accreditation, and meet National Life Safety

Standard Codes.

d) The Contractor shall possess medical liability insurance in accordance with

FAR 52.237‐7: Indemnification and Medical Liability Insurance. The Contractor maintain medical liability insurance throughout the term of the contract and provide updated copies to the Contracting Officer’s Representative upon renewal/s.

B‐4.7 Equipment Specifications for Contractor‐owned Fully Equipment Mobile Trailer:

The MRI equipment specifications and performance shall meet all state and federal requirements, and meet the following minimum capabilities listed below. The MRI scanner should have a minimum of 16 channels with comparable 23x or higher software capabilities of MRCP, and MRA/MRI angiography. Table weight tolerance of

350lbs or greater.

a) Acquisition techniques:

1. Spin Echo

2. Inversion Recovery

3. Partial Saturation

4. Fast Scan Techniques

5. Fat Saturation

6. Field/Gradient Echo

7. Matrices: 256 x 256 and 512 x 512 or greater.

8. Multi‐slice: contiguous slice (interleaved or non‐interleaved).

9. Planes: transverse, sagittal, coronal, axial and arbitrary oblique planes.

10. Gating: the system shall perform cardiac gating.

In addition, the MRI scanner should have capabilities that allow for scan quality and techniques that would permit NNMC to adhere to the MRI monograph or reference document in the 2013 American college of Radiology Standards. The

MRI unit shall be a "state of the art unit”.

b) Reconstruction and display shall be complete in 1 second or less per slice.

c) Matrices: display of 512 x 512 or greater.

d) Resolution: high contrast shall be 0.5mm or better in a 20‐25cm Field of View

(FOV) and 1.0mm or better in a 35‐50cm FOV. Surface coil resolution shall be

0.5mm or better in a 10‐15cm FOV.

e) Image Quality: Spatial linearity: maximum deviation in Cartesian coordinates shall not exceed 1% averaged over a 40cm FOV, using a 30cm +1cm diameter phantom.

f) Artifacts shall be less than 3% (over the uniformity specs) of signal intensity measured in a 25cm and 40cm FOV.

g) Patient alignment: system shall have a patient alignment system such as light beams with scale for checking the scan plane alignment and indexing the patient into the scan plane with an accuracy of +2mm.

h) Autotune: System shall be able to complete tuning in 60 seconds or less.

i) Protocols shall be selectable, controlled by software and displayed.

j) Major components:

1. Table: weight tolerance of 350 lbs. (minimum).

2. Data processing system shall be data linked to all consoles and permit scanning (data acquisition), image reconstruction (data processing), and display functions (data readout) simultaneously, without effecting the speed of any function.

3. MR Angiography Capabilities: a) time of flight techniques; b) phase contrast is preferred but optional and flow analysis; c) phase contrast MRA with user‐selectable velocity sensitivity.

4. Safety/Warning Systems for magnet quenching and emergency shutdown.

k) The MRI unit shall contain a compatible EKG, pulse oximeter, automatic blood pressure and CO2 gas monitoring devices.

l) The MRI unit must have specialized surface coils for imaging the head, chest, spine, abdomen, pelvis and joints.

m) The MRI unit must have the capabilities or MRCP exams.

B‐4.8 Quality Control Requirements:

a) The Contractor shall have a planned, systematic and on‐going process for monitoring, evaluating, and improving the quality of care within the Contractor’s

MRI quality improvement plan which shall be integrated with the clinical services at NNMC.

b) The Contractor shall have documented proof of the following daily quality control tests as listed below:

1. The following quality control tests shall be performed and documented at least annually and after any major change on equipment by a qualified physicist.

a. Review of daily quality control testing records.

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

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

d. Complete review of the system and its functions

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 maintained by the MRI Contractor and available for the COR.

B.5 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.

Performance

Objective

Performance

Standard

Performance Threshold

(This is the maximum error rate. It could possibly be "Zero deviation from standard")

Method of

Surveillance

Incentive Dis‐Incentive

PRS #1. The

Contractor shall provide on‐site MRI scanner and technical support to provide services 5 days per week.

The

Contractor provided on site MRI scanner.

The scanner shall be available for services 98% of the time

Monthly stats.

98% uptime is number of clinical hours performed divided by scheduled Clinical hours in the month.

Payment for work accomplished.

Successful evaluation using the Contractor Performance

Assessment

Non‐payment for work not accomplished.

Unsuccessful evaluation using the Contractor Performance

Assessment

Report (CPAR). Report (CPAR).

PRS #2. The

Contractor shall provide quality customer service.

Validated customer complaints

No more than one validated customer complaint per 6 month time period

*Validated customer complaints from providers and patients.

Successful evaluation using the Contractor Performance

Assessment

Report

(CPAR).

Unsuccessful evaluation using the Contractor Performance

Assessment

Report

(CPAR).

PRS #3. The

Contractor shall provide quality MRI images and 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 low quality study/exam per month

**Validated complaint from

Radiologist or orthopedic surgeon.

Payment for work accomplished.

Successful evaluation using the Contractor Performance

Assessment

Report

(CPAR).

Non‐Payment for work not accomplished.

Unsuccessful evaluation using the Contractor Performance

Assessment

Report

(CPAR).

PRS #4. Adhere to

HIPAA requirements

Within acceptable standards

Zero deviation from standard

Subject to contract termination

Contract shall continue.

Option years may be exercised.

Contract termination.

* 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 orthopedic 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 technologists 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.

B‐6 Period of Performance: The effective date of this contract is from APRIL July 01, 2021 through DECEMBER 31, 2021 for one (1) basic contract period and four (4) twelve month option periods. If the Government exercises its option pursuant to

52.217‐9 Option to Extend the term of the Contract, the period of performance will be extended in accordance with the following schedule.

PERIOD OPTION PERIODS

FIRST OPTION PERIOD: January 01, 2022 through December 31, 2022

SECOND OPTION PERIOD: January 01, 2023 through December 31, 2023

THIRD OPTION PERIOD: January 01, 2024 through December 31, 2024

FOURTH OPTION PERIOD: January 01, 2025 through December 31, 2025

B‐7 Contracting Officer Responsibility:

Authority to negotiate changes in terms, conditions, or amounts cited in this contract is reserved to the Contracting Officer.

B‐8 Contracting Officer’s Representative:

The Contracting Officer will designate in writing by separate letter a Contracting

Officer’s Representative (COR) who will be responsible for:

1. Monitoring the Contractor’s technical progress on individual orders, including surveillance and assessment of performance.

2. Technical inspections and acceptable required by this contract; and

3. Assisting the Contractor in the resolution of technical and administrative problems encountered during the performance of this contract.

B‐9 Contractor's Representative:

Designated Contractor’s Representative, whom we may contact for prompt Contract

Administration:

NAME:____________________________

TITLE:______________________________

ADDRESS:___________________________ TELEPHONE:_________________________

E‐MAIL ADDRESS:_____________________

B‐10 Government Point of Contact:

Gary Williams, RT (R)(CT)

Northern Navajo Medical Center

Shiprock, NM 87420

(505) 368‐7153