PWS.docx

SCOPE OF WORK: The contractor shall provide all labor, personnel, equipment, tools, materials, and any other items services necessary to maintain calibration of telehealth audiology equipment for the Fargo VA Health Care System and all Community Based Outpatient Clinics. This is a firm-fixed contract with a performance period of a base period plus four (4) options.

EQUIPMENT: Prior to the beginning of the award of contract, a list of equipment for the services requested will be provided to the contractor by the Telehealth department. The equipment list shall include the equipment below and other related audiology equipment.

AURICAL PMM

AURICAL HIT

Zodiac Astera

COMMUNITY BASED OUTPAITENT CLINIC LOCATIONS: Equipment may not stay at original locations. Equipment will be placed where needed and serviced at that location. The Community Based Outpatient Clinics locations for audiology services to be performed include:

Dickinson, ND Williston, ND Jamestown, ND Bemidji, MN Fergus Falls, MN Grafton, ND Devils Lake, ND Grand Forks, ND Minot, ND Lisbon Veterans Home, ND Fargo, ND

SERVICES TO BE PROVIDED: Yearly calibration for audiology equipment is essential to ensure accurate testing results for patients. The equipment list for the calibration services to be performed is as follows:

The equipment list for the calibration services to be performed in is as follows:

Zodiac x10 Astera x11 Freefit x11 Aurical PMM x11 Aurical HIT x 11 Noah Link x11 Noah link wires/air link 2 x11 Equipment may be updated during the terms of the contract and reviewed at that time.

· Listed equipment other than audiometers are required to be calibrated in accordance with manufacturer specifications.

· The calibration schedule is as follows and will be completed in January of each contract year.

· The contractor will provide all required services within the normal business hours (8:00 AM to 5:00 PM (EST) M-F), excluding holidays.

PREVENTIVE MAINTENANCE:

0. The Contractor shall perform preventive maintenance (PM) service to ensure that equipment listed performs in accordance industry requirements. Any exceptions to the PM schedule shall be arranged and approved in advance with the POC and provided in writing to the CO.

0. The Contractor shall provide complete and original documentation indicating PM work performed, referencing the procedures followed, actual tests and/or evaluation results obtained to the POC at the completion of the PM service.

0. Parts (including required consumable parts, well as shipment charges), travel, and labor necessary for PM are provided by awarded contractor at no additional customer cost.

0. Any charges for materials such as lubricants, fluids, cleaning supplies, services, manuals, or tools required for the Contractor to successfully complete scheduled PM shall be provided by the Contractor and are included within this contract, and it’s agreed upon price.

0. Preventive maintenance will be provided at a scheduled time and must be scheduled at least one week in advance to minimize the impact to patient scheduling. All exceptions to the preventive maintenance schedule and procedure shall be addressed and approved in advance with the POC. The inspection shall be thorough and shall conform to manufacturer and Industry Standards for the equipment. Sufficient time shall be allowed to permit a thorough inspection and test of each device comprising the overall system. Maintenance work and inspections may be combined at the approval of the POC or Biomedical Engineering or alternate designee if downtime is not considered significant.

0. The Contractor shall immediately, but no later than 24 consecutive hours after discovery, notify the CO and COR, (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 the CO and COR with a written estimate of the cost to make necessary repairs.

Addresses: Each facility address, the contact person’s name and telephone number are provided below:

Dickinson, ND 766 Elks Dr. Suite 6H Dickinson, ND 58601 Amanda Chamness / 701.483.1850

Williston, ND 1542 16th St. W. Suite 300, Williston, ND 58801 Laretha Roberson / 701.572.2470

Jamestown, ND 2420 20th Street SW, Suite 8, Jamestown, ND 58401 Kimberly Andersen / 701.952.4787 x2232

Bemidji, MN 1217 Anne St.

Bemidji, MN 56601 Michelle Hanson / 218.755.6360 x2269

Grafton, ND 1319 11th St. West Grafton, ND 58237 Ashley Bessette / 701.352.4059 x2227

Fergus Falls, MN 1839 N Park St Fergus Falls, MN 56537 Linda Spangler / 218.739.1400 x2224

Devils Lake, ND 1031 7th St NE, Devils Lake, ND 58301 Shelley Kenner / 701.662.5801 x2231

Grand Forks, ND 3221 32nd Ave S Ste 700, Grand Forks, ND 58201 Christina Fiebiger/ 701.335.4380 x2260

Minot, ND Southside Plaza 3400 Broadway St., Minot, ND 58701 Margaret Supernant / 701.418.2600 x2240

Lisbon, ND North Dakota Veterans Home 1600 Veterans Dr Lisbon, ND 58054

Fargo, ND Fargo VA Medical Center 2101 N Elm St.

Fargo, ND 58102 Nicole Gabrielson/ 701.239.3700 x2734

REQUIRED STANDARDS: Audiometers must be calibrated to the American National Standards Institute Specifications for Audiometers:

a. ANSI S3.6-1996

b. ANSI S3.1-1999

c. ANSI S3.39-1987 (R2002)

A final calibration report of the above-mentioned equipment shall accompany the Contractor’s invoice. of work activity. Payment will not be authorized without appropriate detail of charges and/or without the final calibration report for each clinic. Any charges or expenses beyond those identified on the purchase order will be disallowed unless prior authorization was provided by the VA contracting officer placing the order. Ensure the PO# is on ALL invoices.

DOCUMENTATION/REPORTS: The documentation will include equipment down time and detailed descriptions of the scheduled and unscheduled maintenance procedures performed, including replaced parts and prices (for outside normal working hour services) required to maintain the equipment in accordance with conformance standards. Such documentation shall meet the guidelines as set forth in the Conformance Standards. Documentation will be provided to the COR (or a Biomedical Engineering representative if COR is unavailable) within 5 business days of the service. In addition, each ESR must at a minimum document the following data legibly and in complete detail:

1. Name of Contractor

1. Name of FSE who performed services.

1. Contractor Service ESR Number/Log Number.

1. Date, Time (starting and ending), Hours-On-Site for service call.

1. VA Purchase Order Number(s) (if any) covering the call, if outside normal working hours.

1. Description of Problem Reported by COR/User.

1. Identification of Equipment to be serviced to include the following: Equipment ID # or EE# from the bar-code, Manufacturer's Name, Device Name, Model#, Serial #, and any other Manufacturer's identification numbers.

1. Itemized Description of Service(s) Performed (including Costs associated with after normal working hour services), including Labor and Travel, Parts (with part numbers) and Materials and Circuit Location of problem/corrective action.

1. Total Cost to be billed.

1. Signatures from the following:

9. FSE performing services described.

9. VA Employee who witnessed service described.

1. Equipment downtime calculated in accordance with Conformance Standards.

Note: Any additional charges claimed must be approved by the COR before service is started.

CONFORMANCE STANDARDS: Contractor shall provide services and material to ensure that the equipment functions in conformance with the latest requirements of NFPA-99, JC, NEC, OSHA, HIPAA, Federal and VA security specifications and requirements as applicable. The equipment shall be maintained such that it meets or exceeds the performance specifications as established in the OEM’s technical specifications. Additional performance specifications that exceed the OEM specifications shall be specified in writing by the VA.

CONDITION OF EQUIPMENT: The contractor accepts responsibility for the equipment described in this scope of work, in "as is" condition. Failure to inspect the equipment prior to contract award will not relieve the contractor from performance of the requirements of this contract.

DEFINITIONS/ACRONYMS:

1. Biomedical Engineering - Supervisor or designee

1. CO - Contracting Officer.

1. COR - Contracting Officer's Representative.

1. PM - Preventive Maintenance Inspection. Services which are periodic in nature and are required to maintain the equipment in such condition that it may be operated in accordance with its intended design and functional capacity with minimal incidence of malfunction or operative conditions. Service shall consist of calibration and testing in accordance with the manufacturer’s latest established service procedures to ensure operation of equipment within manufacturer’s or VA’s performance specifications, whichever is the most rigorous. PM includes cleaning, inspecting lubricating and testing all equipment. All equipment shall be operated at least one complete operating cycle at the end of each PM.

1. FSE - Field Service Engineer. A person who is authorized by the contractor to perform maintenance (corrective and/or preventive) services on the VA Medical Center premises.

1. ESR - Vendor Engineering Service Report. A documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

1. Acceptance Signature - VAPHS employee who indicates FSE demonstrated service conclusion/status and user has accepted work as complete/pending as stated in ESR.

1. Authorization Signature - COR's signature; indicates COR accepts work status as stated in ESR.

1. NFPA - National Fire Protection Association.

1. CDRH - Center for Devices and Radiological Health.

1. OEM - Original Equipment Manufacturer

1. POC - Point of Contact

NARA Records Management Language for Contracts (July 10, 2019) https://www.archives.gov/records-mgmt/policy/records-mgmt-language

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [FACILITY] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [FACILITY] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [FACILITY] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [FACILITY] policy.

8. The Contractor shall not create or maintain any records containing any non-public [FACILITY] information that are not specifically tied to or authorized by the contract.

9. The 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 from public disclosure by an exemption to the Freedom of Information Act.

10. The [FACILITY] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [FACILITY]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of Requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.