Performance Work Statement_Draft.doc

VA HANDBOOK 6500.6

MARCH 12, 2010

APPENDIX C

PERFORMANCE OF WORK

PREVENTIVE & CORRECTIVE MAINTENANCE OF THE

RADIOLOGY MAINTENANCE & REPAIR

VA MEDICAL CENTER, CT

General Information: The VACT Healthcare System maintains an annual service contract for the certification of all diagnostic imaging equipment of NRC, NHPP and TJC as a yearly requirement at the West Haven and Newington campuses.

Type of Contract: Firm-Fixed Price Service Contract.

Contract Performance Period:

Base Yr. 8/19/2023-8/18/2024

Option Yr. 1 8/19/2024-8/18/2025

Option Yr. 2 8/19/2025-8/18/2026

Option Yr. 3 8/19/2026-8/18/2027

Option Yr. 4 8/19/2027-8/18/2028 Objective: This contract is to ensure safe and reliable diagnostic imaging equipment performance while meeting all safety requirements, industry standards and NRC, NHPP and TJC regulations. This shall be completed to ensure maximum uptime with minimal impact on patient care.

Contract Transaction Number: 689-23-4-7441-0228 Scope of Work

1. EQUIPMENT IDENTIFICATION:

VA Connecticut Equipment List for Location –

PCI ID -Make Model Type Modality- Room Fee VA Newington 10197 Canon/Toshiba Aquilion ONE Stationary CT

VA Newington 10350 Hologic Horizon A Stationary Bone Dens

VA Newington 10309 Kavo Nomad Handheld Intraoral

VA Newington 8009 Planmeca Pro-X Stationary Intraoral

VA Newington 8010 Planmeca Pro-X Stationary Intraoral

VA Newington 8011 Planmeca Pro-X Stationary Intraoral

VA Newington 9550 Planmeca Pro-X Stationary Intraoral

VA Newington 7202 Planmeca ProMax Stationary Panoramic

VA Newington 7214 Fuji FCR Go 2 Portable Radiographic

VA Newington 7069 Fuji FCR Go 2 Portable Radiographic

VA Newington 8488 GE Discovery XR 656 HD Stationary Radiographic Rm 213

VA Newington 9297 GE Discovery XR 656 HD Stationary Radiographic Rm 214

VA West Haven 9741 Canon Aquilion Van CT Trailer

VA West Haven 7101 Toshiba Aquilion ONE Stationary CT

VA West Haven 8003 Toshiba Aquilion Stationary CT G-187-F

VA West Haven 10072 Samsung BodyTom Stationary CT NM Dept

VA West Haven 7067 Hologic Horizon A Stationary Bone Dens. ER

VA West Haven 10001 GE OEC Elite Vas MTS Portable C-Arm

VA West Haven 7059 Philips Allura Stationary C-Arm Cath Lab 1

VA West Haven 7061 GE Innova Stationary C-Arm IR

VA West Haven 7066 GE OEC 9900 Elite Portable C-Arm

VA West Haven 7227 GE OEC 9900 Elite Portable C-Arm OR

VA West Haven 7229 GE OEC 9900 Elite Portable C-Arm

VA West Haven 7873 GE OEC 9900 Elite Portable C-Arm FL 5 Bronc

VA West Haven 7874 Hologic Fluoroscan Insight Portable C-Arm OR

VA West Haven 7875 GE OEC 9900 Elite Portable C-Arm FL 3 OR

VA West Haven 8862 Hologic Insight FD Portable C-Arm Mini

VA West Haven 9318 Philips Allura Xper Stationary C-Arm Cath Lab

VA West Haven 9341 GE 9900 Elite Stationary C-Arm FL 2 Pain

VA West Haven 8820 Liebel-Flarsheim Digital Urology Stationary Fluoroscope OR 2

VA West Haven 9031 Siemens Agile MAX Stationary Fluoroscope R/F Rm 1104

VA West Haven 9228 Philips EasyDiagnost Eleva Stationary Fluoroscope R/F Rm 1106

VA West Haven kavo1 Kavo Nomad Handheld Intraoral Old Psych ER

VA West Haven 8822 Planmeca Pro X Stationary Intraoral

VA West Haven 7974 Planmeca ProX Stationary Intraoral

VA West Haven 7975 Planmeca ProX Stationary Intraoral

VA West Haven 7976 Planmeca ProX Stationary Intraoral

VA West Haven 8823 Planmeca Pro Max Stationary Panoramic

VA West Haven 7068 Philips Diagnost wDR Portable Radiographic

VA West Haven 7211 Philips Digital Diagnost Stationary Radiographic ER Rm 1

VA West Haven 7215 Philips Diagnost wDR Portable Radiographic

VA West Haven 9295 GE Discovery XR 656 HD Stationary Radiographic ER Rm 2

VA West Haven 9227 Philips EasyDiagnost Eleva Stationary Radiographic R/F Rm 1106

VA West Haven 9013 Samsung GM 85 Digital Portable Radiographic

VA West Haven 9030 Siemens Agile MAX Stationary Radiographic R/F Rm 1104

VA West Haven 7077 Philips 3T Stationary MRI

VA West Haven 8535 Siemens Magnetom SolaFit Stationary MRI

VA West Haven 7112 Philips Forte Jetstream Stationary Gamma Camera Rm 2

VA West Haven 7102 GE Discovery VCT Stationary PET CT Camera

VA West Haven 7070 GE Discovery VCT Stationary PET CT Non-DX CT

VA West Haven 8889 Siemens Intevo 16 Stationary SPECT CT Camera

VA West Haven 8890 Siemens Intevo 16 Stationary SPECT CT DX CT

3 Dose Calibrators (1 in Nuc. Med/2 in PET CT

Location:

VA CT Health Care System West Haven Campus, 950 Campbell Ave, CT 06516 Newington Campus, 555 Willard Ave, Newington, CT 06111

2. CONFORMANCE STANDARDS:

Initial (Acceptance or Relocation), annual and post repair surveys/inspections of diagnostic radiography equipment including CT, fluoroscopes, potables, C-Arms, dental units, and general diagnostic machines. MRI and image display monitors, Nuc Med cameras, PET/CT and SPECT equipment.

3. SERVICE AND MAINTENANCE:

Major repairs or replacement of a major component (i.e., tube changes, collimator repair, detector replacement or generator repair), post repair surveys of CT and fluoro equipment must be performed within seven (7) days of vendor notification of service need(s). Verbal confirmation that equipment has passed and is safe for use is required at the completion of service/repair. Annual, initial and post repair (i.e., Tube replacement) testing must include measurements of sufficient numbers and types to thoroughly evaluate the safety of the radiation producing equipment and safety of its use for patients and operators. JCAHO, NHPP and CT DEEP (when in effect) testing standards must be followed. In addition, contractor shall be able to provide on-site fluoro safety training for physicians and technologists. Contractor must be able to provide patient skin dose calculations for prolonged fluoroscopy procedures.

4. PARTS EXCHANGE: N/A, Physicist do not provide parts.

5. LABOR & TRAVEL EXPENSES:

All labor and travel conducted during normal business hours: Monday through Friday, 8:00am – 5:00pm relative to customer’s local time, however service calls may exceed normal operating hours to start re-use after a repair.

6. CERTIFIED TRAINED TECHNICIANS AND KEY PERSONNEL:

All medical physicists/personnel providing service to equipment at VACT must meet JCAHO and NHPP requirements for education, training, experience, and all other credentials required by VHA and other governing agencies. This includes the required annual radiation safety training to keep their own occupational doses ALARA.

VACT must have a current resume/cv on file for all physicists who will or may come to either of our campuses to test or otherwise work on our equipment. VACT must see and approve the resume/cv for any new physicists who would be coming to work at VACT campuses prior to their arrival.

subcontractors must account for < 51% of the physicists’ time working at VACT. medical physicists must be educated and experienced in nuclear medicine and pet diagnostic and therapy procedures such that they can answer questions and offer advice on issues in these areas. they must be knowledgeable about lu-177, ra-233 and y-90 therapy to provide advice. they also must be experienced with radiation shielding and performance of dose reconstruction for patient and staff for incidents and in critical situations.

7. HOURS OF COVERAGE:

A. Normal hours of coverage for non-emergencies are Monday through Friday from 08:00 AM to 05:00 PM, excluding federal holidays. All service will be performed during normal hours of coverage unless requested or approved by the Contracting Officer’s Representative (COR) or Designee of the service(s).

NOTE: Emergencies can stop critical patient care, therefore the medical physicist must be able to arrive at VACT within 3 hours from the time of receipt of an emergency call from VACT, such as for urgent CT equipment inspection to allow equipment use to resume.

B. Federal Holidays observed by the VAMC are:

New Years' Day, Martin Luther King Day, Presidents' Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans' Day, Thanksgiving Day, and Christmas Day

8. SCHEDULED SERVICE:

Testing must be scheduled during normal Biomed/Clinical Engineering staff working hours/tours. These days/times must also accommodate the VACT Radiology and all other services that are involved with the management of covered equipment.

Testing must be in compliance with the American college of radiology and any other relevant standards. Tests routinely performed annually and at acceptance will include, but not limited to, mA linearity, timer accuracy, kVp accuracy, HVL, exposure reproducibility, light field/x-ray alignment and equipment output at various settings. Dose rate surveys in the control room and adjacent occupied areas are to be included during acceptance testing or relocation of equipment.

Testing of CT equipment shall also include evaluation of table incrementation and travel accuracy, image uniformity, slice thickness and position accuracy, alignment light accuracy, radiation beam width, image noise, artifact evaluation, spatial resolution, high contrast resolution, low contrast resolution, contrast scale/CT #’s, mA scan time calibration and evaluation of patient dose to reference/recommended doses. The contractor shall be able to make recommendations for patient dose reduction methods, and comment on our use of SureStart and other modes of operation. Annual CT inspections must include a review of our CT protocols, technical factors used as well as Our ALERT and Notification levels. Contractor must be able to offer recommendations to ensure patient dose optimization when compared to national recommendations and good practices.

Fluoroscopy equipment testing shall also include evaluation of equipment output, resolution, and patient doses. Report must include output data to be posted for each fluoro room or portable unit. For Nuclear Medicine cameras, phantoms will be used to assess image/system uniformity, resolution, and artifact evaluation.

The Contractor shall perform Inspection Service to ensure that equipment performs in accordance with Section 3, Conformance Standards. An outline of the PM procedures and schedule shall be provided to the COR or designated representative. The Contractor shall provide and utilize procedures and checklists with worksheet originals indicating work performed and actual values obtained (as applicable). At minimum, the contractor will perform electrical safety testing in accordance with NFPA-00 standards. Services shall include, but need not be limited to, the following:

· Reviewing operating system software diagnostics to ensure that the system is operating in accordance with Section 3, Conformance Standards, or the manufacturer's specifications.

· Testing and Reporting by Physicist.

· Performing remedial maintenance of non-emergent nature.

· Testing and replacing faulty and worn parts and/or parts likely to become faulty, fail or become worn.

· Inspecting and replacing where indicated, electrical wiring and cables for wear and fraying.

· Inspecting, and replacing where indicated, all mechanical components which may include, but is not limited to: X-ray tube mounting hardware, patient restraints and support devices, cables and mounting hardware, chains, belts, bearings and tracks, interlocks, clutches, motors, keyboards, and patient couches for mechanical integrity, safety, and performance.

· Providing documentation of services performed.\

9. DOCUMENTATION/REPORTS:

Signed reports shall be received within two- four weeks of performance of testing. Any equipment that has failed testing will be immediately removed from service and must be immediately reported to the appropriate VACT staff members including THE RADIATION SAFETY OFFICER. The documentation shall include detailed descriptions of the scheduled maintenance (i.e., Emergency repairs inspection, not repairs) procedures performed, including replaced parts no parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with Section 3, Conformance Standards, or the manufacturer's specifications.

Notations must be made in the CT Annual report to document that our CT protocols were reviewed. Medical physicists must review the CT QA program and be able to make recommendations for any enhancements required. Such documentation shall meet the guidelines as set forth in the Conformance Standards section. The Engineering Service Report (ESR) will consist of a separate PM report for the item(s) covered under the "specific" contract. Grouping different equipment from different contracts on "one" ESR is prohibited. Service reports must be sent to the COR or the requesting entity upon completion of each service. In addition, each ESR must, at a minimum, document the following data legibly and in complete detail:

A. Name of contractor and contract number.

B. Name of FSE who performed services.

C. Contractor service ESR number/log number.

D. Date, time (starting and ending), equipment downtime and hours on-site for service call.

E. VA purchase order number(s) covering the call if outside normal working hours.

F. Description of problem reported by the COR or designated representative.

G. Identification of equipment to be serviced:

1) Inventory ID number,

2) Manufacturer's name,

3) Device name, and location

4) Model number,

5) Serial number,

6) Any other manufacturer's identification numbers.

H. Itemized Description of Service Performed (including, if applicable, costs associated with after normal working hour services) including:

1) Labor and Travel,

2) Materials and Circuit Location of problem/corrective action.

I. Total Cost to be billed (if applicable - i.e., part(s) not covered, or service rendered after normal hours of coverage).

J. Signatures:

1) FSE performing services described.

2) Authorized VA Employee who witnessed service described.

NOTE: - Any additional charges claimed must be approved by the COR or designated representative before service is completed.

10. REPORTING REQUIREMENTS:

The Contractor shall be required to report to the Clinical Engineering Department to log in. This check- in is mandatory. When the service is completed, the FSE shall document services rendered on a legible ESR(s). The FSE shall be required to log out with Biomedical Engineering and submit the ESR(s) to the COR or designated representative. ALL ESRs shall be submitted to the equipment user for an "acceptance signature" and to the COR or designated representative for an "authorization signature". If COR or designated representative is unavailable, a signed, authorized copy of the ESR will be left with the user.

11. PAYMENT:

Invoices shall include at a minimum, the following information: Contract Number, Purchase Order/Task Order Number, Contractor Name, Item(s) covered (to include serial #'s) by the PMI and covered period of service. All invoices shall be mailed to the Department of Veterans Affairs Financial Services Center’s address as follows:

FMS-VA-1-650

P.O. Box 149971

Austin, TX 78714

12. ADDITIONAL CHARGES:

There shall be no additional charge for time spent at the site (during, or after the normal hours of coverage) awaiting the arrival of additional FSE and/or delivery of parts.

13. REPORTING REQUIRED SERVICES BEYOND THE CONTRACT SCOPE:

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the COR and/or designated representative (in writing) of the existence or the development of any defects in, or repairs required, to the scheduled equipment which the Contractor considers he/she is not responsible for under the terms of the contract. The Contractor shall furnish to the COR or designated representative a written estimate of the cost to make necessary repairs.

14. CONDITION OF EQUIPMENT:

The Contractor shall accept responsibility for the equipment. Failure to inspect the equipment prior to contract award will not relieve the Contractor from performance of the requirements of this contract.

15. TEST EQUIPMENT:

The contractor’s Test Equipment (including ION Chambers, GM Survey Meters, Phantoms and other test equipment) shall be current state of the art, properly maintained and calibrated and remain in working condition.

16. IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

The Contractor's FSE's shall wear visible identification at all times while on the premises of the VAMC. The Contractor shall park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

17. TRANSPORTATION CHARGES:

All costs associated with transportation, from shipping point to the destination specified above, and all costs of removal after contract completion, shall be paid by the Contractor, and incorporated in the price proposal. The Contractor shall be responsible for all damage in transit including any transportation costs for replacement.

18. COMPLIANCE WITH OSHA BLOODBORNE PATHOGENS STANDARD:

The Contractor shall comply with the Federal/California OSHA Bloodborne Pathogens Standard. The Contractor shall:

A. Have methods by which all employees are educated as to risks associated with bloodborne pathogens.

B. Have policies and procedures which reduce the risk of employee exposure to bloodborne pathogens.

C. Have mechanisms for employee counseling and treatment following exposure to bloodborne pathogens.

D. Provide appropriate personal protective equipment/clothing such as gloves, gowns, masks, protective eyewear, mouthpieces for the employee during performance of the contract.

19. MISCELLANEOUS

Additional equipment may be added and/or removed throughout the life of this contract and shall be considered within scope.

20. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

Security Requirements:

All contractor personnel shall obtain a short-term identification badge issued by the COR or government designated representative. Such badge shall be worn by the individual and prominently displayed at all times while on VA Property. No employee of the contractor shall enter the project site without a valid identification badge issued by the VA. To obtain a short-term identification badge, contractor personnel shall present to the COR a valid (non-expired) photo identification issued by a US federal, state, or local government agency.

1. Citations to pertinent laws, codes, and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

Contactor policies and procedures shall comply with all VA Privacy & Security, the Privacy Act and Health Insurance Portability and Accountability Act (HIPAA).

Escort will be provided as required in sensitive work areas.

The C&A requirements do not apply, and the security accreditation package is not required.

Per the VA handbook 6500.6, no VA sensitive information will be transferred, shared, or stored with said vendor. As such, no additional mechanisms will be needed to ensure the protection of information.

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