Amend_1_Attachment_E_-_SOW_Temp_Mobile_CT_Trailer.pdf

Amend-1 Attachment E – Scope of Work Temporary Mobile CT Trailer

Performance Work Statement

The Phoenix Indian Medical Center (PIMC) is in need of a Lease for Temporary Mobile CT Trailer with the following minimum requirements.

A. Description of Service:

The contractor shall provide all supervision, labor (see staffing paragraph), parts, materials, tools, supplies (with the exception of Government furnished supplies listed), maintenance, and equipment necessary to provide Computer Tomography (CT) units and qualified technical staff to operate the CT scanner and equipment. The contractor shall be responsible for performing a variety of CT examinations for government beneficiaries in the PIMC. 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.

Contractor shall maintain all Federal and State licenses required for possession and operation of equipment. The scanner and trailer offered may either be brand new, or in like new condition.

Like new condition is defined as brand new within the last 3 years and up to date to OEM specifications with OEM certification.

A minimum 16-slice Computer Tomography unit to be placed on-site and in a mobile trailer, with the most updated/current version hardware and software available from the manufacturer. System must include 3D reconstruction package and be capable of performing the highest quality CT scans possible. The system must include a Vascular scanning for CT Angiography. Software and hardware shall be upgraded in concurrence with newest OEM factory releases no later than 3 months post release from OEM.

B. Contractor Furnished Equipment:

16 Slice Computer Tomography Scanner and Injector:

Contactor to include all hardware and service requirements for Temporary Mobile CT Trailer for one 16 Slice Computer Tomography Scanner and trailer for the Phoenix Indian Medical Center, (PIMC). The System shall be Food and Drug Administration (FDA) approved and be on the VistA Imaging Approved Digital Imaging and Communications in Medicine (DICOM) Modality Interfaces list dated February 28, 2019 (Attachment C - VistA Imaging DICOM Modality Interfaces 2.28.19). It must interface with VistA Imaging and VistA Rad which is supported by the Veteran’s Administration. Descriptions herein describe the minimum system requirements to be provided by the Contractor, which if properly configured and installed, shall utilize the source of ionized radiation to expose and process diagnostic images in the medical treatment of PIMC patients. These systems shall be utilized by Registered Computer Tomography Radiologic Technologist and Radiologist. The contractor shall provide connectivity with VistA Rad and VistA Imaging and the digital radiographic system. The contractor shall demonstrative with the Contracting Officer and COR that the system has connectivity and is functioning.

System Minimum Requirements:

1. EQUIPMENT:

A. Computer Tomography Scanner

a. 16 Slice Computer Tomography Scanner

b. Dose Reduction software.

c. Metal Reduction software.

d. NEMA (National Electrical Manufactures Association’s) Medical Imaging and

Technology Alliance (MITA) standards XR 25, XR 26 and XR 29.

e. 550 lb. patient capacity table (minimum).

f. 47 cm table width (minimum).

g. Storage capacity of raw data 2 Terabytes (minimum).

h. X-ray tube heat capacity 7.0 MHU (minimum).

i. Ease of use automated features (Milli Amps MA and Multi Planner Reconstructions

(MPR’s))

j. Spatial resolution.

k. DICOM – VA Vista Rad and Vista Imaging compatible

l. Windows 7, Windows 10 or Unix

m. Hard copy and digital copy, if available, of the original OEM System manuals, software CD/DVDs, schematic drawings, and any additional OEM documents for both Computer Tomography Scanner and Injector;

C. Injector:

a. Contrast injector to remotely inject during contrast enhanced CT exams.

c. Hard copy and digital copy, if available, of the original OEM System manuals, software CD/DVDs, schematic drawings, and any additional OEM documents for both Computer Tomography Scanner and Injector;

d. Windows 7 or Unix; if applicable.

e. DICOM – VA Vista Rad and Vista Imaging compatible; if applicable

Additional Requirements:

a. The semi-trailer that houses the CT scanner must have sufficient space to provide for patient wheelchair access as well as service access. This is typically provided with 2 slide-out extensions within the CT scan room. In addition, a lead shielded operator control room with a door and an additional room for an office or storage. The control room shall have lockable storage cabinets. A dual syringe injector shall be positioned on a wheel stand in the scan room with operator controls integrated into the CT scanner console. The injector shall have adequate length power cables to reach to either side of the CT table as needed.

b. Contractor will need to install protocols from existing current GE 16 Slice Scanner to the lease scanner.

c. Two height adjustable office chairs with wheels, to fit the space constraints, will be provided by the vendor.

d. The CT trailer must meet both Federal and Arizona State codes for Radiation safety and lead shielding.

e. The CT trailer must have an ADA patient lift with guardrails for wheelchair & stretcher patient access with an outside remote switch hand control. Heavy duty non-slip stairs with dual handrails must also be provided for safe staff and patient access. Stairs must meet approval from the PIMC Safety manager. Vendor will provide accessories and positioning devices including CT slicker, pad, chin & body straps, head holder, knee bolster and blanket warmer for patient comfort.

f. The CT unit shall have the ability to perform CT exams of the head, neck, body and extremities, with the capability to perform 3D CT angiography, with a minimum table capacity of 550 lbs and gantry bore of 70 cm.

g. Vendor must provide full service maintenance service and OEM parts & labor, including preventative maintenance (PM) as recommended by the original equipment manufacturer (OEM) specifications for all systems and devices provided (CT and Injector). Vendor must schedule PM’s with the Contracting Officer’s Representative (COR) with at least 1-month advance notice. Technical Phone Support must be available within 1 hour from initial call for service Sunday through Saturday, 24 hours per day 7 days a week, 365 days per year. OEM service (including emergency repair) Sunday through Saturday, 24 hours per day 7 days a week, 365 days per year must be available within 4 hours from initial call for service and all repairs must be completed within 48 hours from initial call. Contractor shall provide a phone number to call for technical/repair services.

h. Vendor must provide full service maintenance and parts (all parts) on the CT trailer, including heating, electrical and air conditioning. In addition, monthly and annual safety inspections in accordance with local/national regulations such as National Fire Protection Association (NFPA) 10, 101, 110 and Joint Commission EC standards must be performed.

This includes, but is not limited to: fire alarm, fire extinguishers and emergency lighting.

Monthly emergency generator testing will also be required. These reports will be provided to the COR. Contractor shall provide a phone number to call for technical/repair services.

i. Performance shall be according to the Performance Work Statement (PWS) and supporting documents and shall also conform with:

1.1 The Accreditation Association for Ambulatory Health Care (AAAHC);

1.2 Infection Control, National Fire Protection Association (NFPA);

1.3 Health Service Inspection (HSI);

1.4 Centers for Medicaid and Medicare Services (CMS);

1.5 The Joint Commission;

1.6 Indian Health Service (IHS) standards and,

1.7 The American College of Radiology (ACR).

j. Service tickets indicating work being done on the trailer, injector, CT system will be provided to the COR as the work is done.

k. Staffing: PIMC CT Technologists will staff and operate the unit.

l. The contractor shall provide 1 day of clinical applications training for two (2) PIMC CT Radiologic Technologists, on site by an American Registry of Radiologic Technologists (AART) CT certified Technologist. A minimum of 24 hours Category A, CE credits pre-approved by American Society of Radiologic Technologists (ASRT) will be provided at the time of training with a certificate approved by the ASRT for each Technologist receiving training.

m. CT unit must send images via DICOM to our PIMC Vista PACS archiving system and must be an already approved Veteran Admiration (VA) DICOM interface verified by the Contractor. Contractors responding to this solicitation will provide compliance with VA and

DICOM standards. Contactor shall assist the PIMC Vista PACS administrator and PIMC IT Department to set up the CT unit and demonstrate that the images are transmitting to the PIMC Vista PACS system.

n. Adequate length electrical & data cables must be provided to reach our connections on the outside of the building and shall be compatible with PIMC current outside connectors.

o. The PIMC will provide an estimated 24-foot-wide by 48-foot-deep pad with power and data outlets. Vendor will validate that existing utilities and pad will be sufficient for their system.

A site visit is recommended to survey the location of the CT trailer, electrical and data connections prior to submitting an offer.

p. CT scanner must be certified/calibrated to OEM specifications and must be maintained with original OEM parts, including the CT x-ray tube.

q. Injector must be certified/calibrated to OEM specifications and must be maintained with original OEM parts.

r. Mobile unit must have air conditioning and heating.

s. At the end of the lease the CT hard disk drive must be removed by the vendor and turned over to the COR for destruction at no cost to the PIMC.

t. Any removable media used for diagnostic purposes will be required to be scanned by PIMC prior to use. Coordinate with the COR.

u. Contractor will deliver, set-up and test unit.

v. The contractor will be required to pay for a PIMC approved Licensed Radiation Physicist to inspect the CT Scanner upon delivery (if required by ACR/Joint Commission) and to inspect the operation any time maintenance or repair on the system would impact radiation output to ensure proper operation (i.e. tube changes). Mandatory annual testing is included in this requirement. The Vendor will make sure a copy of the Physicist report is provided to the COR each time the system is inspected.

w. The CT Unit is required to be operational 98% of the time. The 98% monthly uptime is calculated by the number of hours the system can see patients monthly by the number of hours that the clinic is available to see patients. Downtime is not counted for lack of facility staff, patient no shows or other situations, such as weather closures, where it was not the fault of the CT system. Failure of the contractor to perform in accordance with this requirement may constitute a sufficient basis for termination of the contract. The following criteria apply for determining appropriate action:

I. Notifications: The COR shall notify the contract holder of failure to meet the uptime standard through electronic mail within 1 hour of occurrence of downtime.

II. Deductions: The Government has the right to withhold a portion of monthly payment based on failure to meet the stated uptime. This negative incentive is calculated by the number of cancelled patients that occur beyond a 3-business day grace period.

For example, if the CT is down for 5 days, the first three (3) days there would be no deduction. However, each patient that was scheduled for the other 2 days would incur a $1,000.00 (one thousand dollar) per study per patient. If there were 15 patients with one study each then the cost of the deduction would be $15,000.00 (fifteen thousand dollars). This negative incentive shall not exceed the monthly total payment for the month.

III. Termination: If the Contracting Officer (CO) determines the contract has failed to perform to the extent that a termination is justified, the CO shall issue a notice of termination in accordance with Agency procedures.

x. GOVERNMENT-FURNISHED PROPERTYAND SERVICES

a. GENERAL: The government will provide all direct patient care medical supplies. These include, but are not limited to, contrast materials, syringes, IV tubing, oxygen masks and tubing, needles, emesis basins, gowns, and other similar direct patient care items.

b. EQUIPMENT: The government will provide a telephone line, utilities (power supply), internet connectivity, network connection to hospital or clinic network, CT pad.

c. See Attachment G – CT Mobile Trailer Location for site of CT Trailer.

y. CONTRACTOR FURNISHED EQUIPMENT:

Mobile CT scanner shall include a ramp and/or a lifting device for non-walking patients. Services shall include equipment maintenance, (scheduled and unscheduled) and required supplies necessary to perform services detailed herein. Contractor shall also be responsible for the control of waste management and proper disposal of all waste materials.

Equipment shall include, but not be limited to, a fully equipped CT. Contractor shall submit an equipment specification list of all equipment by location, including the CT unit(s) with contractor’s signed quote. Contractor should already have the CT unit certified by Physicist prior to delivering unit or on site at time of commissioning unit.

Contractor shall provide all equipment service records upon request.

Include name of manufacturer, model number, manufacturer’s brochures cut sheets, equipment specifications and all pertinent data with offer. All equipment to be used will be FDA approved imaging equipment placed at a location designated by the

COR.

1. CT pads and restraints

2. CT compatible nonferrous wheelchair and stretcher with IV pole (gurney)

3. Nonferrous oxygen cylinder

4. Capability to provide patient exam on CD

5. Dressing and storage areas

6. CT license for PACS

7. Interface between CT scanner and PACS, Dicom print, store and work list

8. Optical disk archival device compatible with PACS

9. Code kit and code call button

10. CT compatible 02 saturation monitor

11. Contrast media and warmer

12. CT compatible power injector

x. Blank

aa. TYPE OF CT SCANS (MINIMUM)

1. ABDOMEN WITHOUT CONTRAST

2. ABDOMEN WITH CONTRAST

3. ABDOMEN WITH AND WITHOUT CONTRAST

4. CERVICAL SPINE WITHOUT CONTRAST CERVICAL

5. SPINE WITH CONTRAST

6. CERVICAL SPINE WITH AND WITHOUT CONTRAST

7. HEAD/BRAIN WITHOUT CONTRAST

8. HEAD/BRAIN WITH CONTRAST

9. HEAD/BRAIN WITH AND WITHOUT CONTRAST

10. LDCT LUNG CANCER SCREENING

11. LOWER EXTREMITY WITHOUT CONTRAST LOWER

12. EXTREMITY WITH CONTRAST

13. LOWER EXTREMITY W/ AND W/O CONTRAST

14. LUMBAR SPINE WITHOUT CONTRAST

15. LUMBAR SPINE WITH CONTRAST

16. LUMBAR SPINE WITH AND WITHOUT CONTRAST

17. NECK SOFT TISSUE WITHOUT CONTRAST

18. NECK SOFT TISSUE WITH CONTRAST

19. NECK SOFT TISSUE WITH AND WITHOUT CONTRAST

20. ORBIT/IAC WITHOUT CONTRAST

21. ORBIT/IAC WITH CONTRAST

22. ORBIT/IAC WITH AND WITHOUT CONTRAST

23. PELVIS WITHOUT CONTRAST

24. PELVIS WITH CONTRAST

25. PELVIS WITH AND WITHOUT CONTRAST

26. SINUSES/MAXILLOFACIAL WITHOUT CONTRAST

27. SINUSES/MAXILLOFACIAL WITH CONTRAST

28. SINUSES/MAXILLOFACIAL WITH AND WITHOUT CONTRAST

29. THORACIC SPINE WITHOUT CONTRAST

30. THORACIC SPINE WITH CONTRAST

31. THORACIC SPINE WITH AND WITHOUT CONTRAST

32. THORAX (CHEST) WITHOUT CONTRAST

33. THORAX (CHEST) WITH CONTRAST

34. THORAX (CHEST) WITH / WITHOUT CONTRAST

35. UPPER EXTREMITY WITHOUT CONTRAST

36. UPPER EXTREMITY WITH CONTRAST

37. UPPER EXTREMITY WITH & WITHOUT CONTRAST

38. ABDOMEN/PELVIS WITHOUT CONTRAST

39. ABDOMEN/PELVIS WITH CONTRAST

40. ABDOMEN/PELVIS WITH AND WITHOUT CONTRAST

ab Scheduling:

The Government shall provide scheduling for the patient exams. In many cases, the Emergency Department will send patients as needed 24 hours per day.

Ab. Period of Performance:

Contractor shall provide services for three (3) months (90 days). The dates are to be determined at a later time. In addition the contract will contain two options at 2 months (60 days) each.

Item Description Unit Quantity

1 Base Year - Temporary CT Trailer Services MO 3

2 Option Year I - Temporary CT Trailer Services MO 2

3 Option Year II - Temporary CT Trailer Services MO 2

ac. SITE LOCATIONS:

Phoenix Indian Medical Center Radiology Department 4212 N. 16th Street Phoenix, AZ 85016

Ad. HOURS OF OPERATION:

CT unit will be in operational usage 24 hours per day, 7 days a week, 365 days per year. Installation shall take place between the hours of 8:00 am to 4:30 pm Monday through Friday, excluding Federal Holidays.

Ae. MINIMUM QUALIFICATIONS:

Contractor shall have 5 years of installation mobile CT trailer set-up, configuration, Vista Rad and Vista Imaging experience.

Af. QUALITY CONTROL PROGRAM (QCP): The contractor shall develop and maintain an effective 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 be in compliance with the contract requirements. This QCP is part of the evaluation of proposals.

Ag. QUALITY ASSURANCE (QA):

The government shall 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).

Ah. CONFIDENTIALITY OF INFORMATION:

Unless otherwise specified, all financial, statistical, personnel, and/or technical data which is furnished, produced or otherwise available to the contractor or health care worker during the performance of this contract are considered Government confidential business information and shall not be used for purposes other than performance of work under this contract. The contractor and/or the health care worker shall not release any of the above information without prior written consent of the Contracting Officer. All medical records, scans, and reports remain the property of the Government.

a. PATIENT LISTS: No matter how developed, patient lists shall be treated as confidential information in accordance with the Privacy Act and the Health Insurance Portability and Accountability Act (HIPAA). Lists and/or names of patients shall not be disclosed to or revealed in any way for any use outside the PAIHS, except through PAIHS specified processes.

b. HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA) of 1996: All individuals performing services are required to complete initial and annual refresher HIPAA Privacy and Security training and will be held accountable for complying with health information privacy and security policies and procedures.

c. Contractor is required to maintain the confidentiality of patient records IAW the Privacy Act, Title 5, U.S.C. 552a, Title 38 U.S.C. 5701, 5705, and 7362.

Ai. REPORTING REQUIREMENTS:

Report

Description # of

Copies Recipient Due Date

1 Quality Control 1 COR 1st day then, Quarterly 2 Equipment Maintenance Log 1 COR 1st day then, Quarterly 3 Required Accreditations 1 COR 1st day then, Annually

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D. PRICING: Pricing shall be for an all-inclusive monthly rate. Detailed pricing schedule shall be included with offer Base Year and Options.

E. CT STUDY INTERPRETATION: The PIMC will be responsible for CT Technologist, reading/interpreting all CT studies and dictation of all required study reports.

F. CT DATA OWNERSHIP: The PIMC will own solely the data of the studies performed on the mobile CT under the contract

G. LIABILITY INSURANCE: The Contractor shall provide and maintain adequate liability coverage consistent with the risks associated with the performance of all services required by this PWS. A certificate of insurance evidencing the required coverage shall be provided to the Contracting Officer prior to the commencement of services under this contract. Minimum liability insurance will be one million per occurrence, three million aggregate.

H. DISRUPTION OF CT SERVICES: The CT mobile provider will communicate to the COR any possible and actual disruptions of CT services. Upon becoming aware of possible or actual disruption of CT service, the provider will communicate such service-disruption information to the COR as soon as possible (ASAP). Provider will 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. Contractor will reimburse the Government for downtime per month at the PIMC locations prorated based on scheduled clinic hours divided by actual clinic hours equals percent of performance.

I. PRE-OPERATION PROVIDER/PAIHS TEST OF CT OPERATION: Provider and Government personnel will conduct a test of the CT system and the links to PIMC equipment one week before the date of the first scheduled patients. The test will be performed to insure that the system is working properly and to insure that it is functioning to provide services as, when, and how required per the PWS and supporting documents.

Aj. PERFORMANCE WORK OBJECTIVES/STANDARDS

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

(The Service required -usually a shall statement)

Performance Standard Performance Threshold

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

Method of Surveillance

PRS #1. The contractor shall provide on-site CT scanner and technical support.

The contractor provided on site CT scanner.

The scanner and will be available for services 98% of the time

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

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PRS #3. The contractor shall provide on-site Trailer services.

The contractor provided on site trailer services.

The trailer will be available for usage 99% of the time.

Validated complaint from CT Technologist inspected each day.

AK. PROTOCOLS:

Contractor shall preinstall CT protocalls based off of the existing PIMC GE Bright Speed unit. Contractor may recommend new and updated protocols to PIMC. Contractor shall provide phone support for protocol issues, updates and troubleshooting. Protocols are to be submitted with quote for review.

Ah.

52.237-1 SITE VISIT

52.237-3 Continuity of Services

52.217-8 Option to Extend Services

52.246-20 Warranty of Services

No Advertisement

The Contractor shall not make reference in its commercial advertising to Department of Health and Human Services, Phoenix Indian Medical Center contracts in a manner that states or implies the Phoenix Indian Medical Center approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

Licenses/Permits

The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employees fault or negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of Arizona. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with the regard to any claims, loss, damage, injury, and liability resulting there from.

Performance Work Statement