36C25520Q0112-006.docx

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Cardiology Monitors Services - Columbia VA Medical Center
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36C25520Q0112
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This is a solicitation for cardiac monitoring services at the Harry S Truman Memorial Veterans Hospital in Columbia, Missouri. The Department of Veterans Affairs Network Contracting Office intends to award a firm fixed price requirements contract for wireless cardiac event and holter monitoring services. Interested offerors must submit responses by February 7, 2020. The contract will have a one-year base period and four one-year options, with NAICS code 621610 and a size standard of $16.5 million. Offerors must demonstrate experience providing ambulatory cardiac monitoring devices including wireless holter, event, and real-time remote telemetry monitors to record, transmit, and report 100% of patients' ECG data over 1 to 30 days. The contractor will be responsible for equipment, disposable supplies, and technical support.

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36C25520Q0112

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C25520Q0112 01-27-2020 Thomas, Daniel | daniel.thomas6@va.gov 913-946-1966 02-05-2020 12:00 P.M.

36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth

KS

66048 X 621610 $16.5 Million N/A X Columbia VA Medical Center Harry S. Truman 800 Hospital Drive Columbia

MO

65201 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth

KS

66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin

TX

877-353-9791 512-460-5429 The request for quote is for Wireless Cardiac Event monitor and Wireless Holter monitor services for diagnosing patients located at the Harry S. Truman Memorial Veterans Hospital in Columbia MO.

Contractor must be able to perform in accordance with the Statement of Work and Schedule of Services and Price.

The Governement intends to award a firm fixed price contract as a result of this solicitation for base year and up to four (4) one-year options that mat be exercised at the Contracting Officer's discretion.

This solicitation is Unrestricted.

X X X 1(one) William Webb Contracting Officer Table of Contents

SECTION A1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1
SECTION B - CONTINUATION OF SF 1449 BLOCKS4
B.1 CONTRACT ADMINISTRATION DATA4
B.2 PRICE/COST SCHEDULE5
B.3 STATEMENT OF WORK7
SECTION C - CONTRACT CLAUSES21
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)21
C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)27
C.3 52.216-18 ORDERING (OCT 1995)27
C.4 52.216-19 ORDER LIMITATIONS (OCT 1995)27
C.5 52.216-21 REQUIREMENTS (OCT 1995)28
C.6 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)29
C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)29
C.8 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)29
C.9 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (OCT 2019)29
C.10 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018)30
C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)30
C.12 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008)31
C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (OCT 2019)32
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS40
SECTION E - SOLICITATION PROVISIONS41
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)41
E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)47
E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019)47
E.4 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)48
E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)49
E.6 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (OCT 2019)50
E.7 VAAR 852.215-72 NOTICE OF INTENT TO RE-SOLICIT (OCT 2019)51
E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018)51
E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)51
E.10 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)52
E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (OCT 2018)52

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C255 William Webb Department of Veteran Affairs Network Contracting Office (NCO) 15 3450 S. 4th Street Trafficway Leavenworth, KS 66048

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X]
52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or
[]
52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly[]
b. Semi-Annually[]
c. Other[X] Monthly in arrears

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin, TX

B.2 PRICE/COST SCHEDULE

Wireless Cardiac Event monitor and Wireless Holter monitor services for diagnosing patients located at the Harry S Truman Memorial Veterans Hospital (Truman VA) in Columbia, MO in accordance with Statement of Work (SOW).

Base Year - 12 Months Dates: TBD

CLIN No.
SUB-CLIN
Description
Qty.
Unit
Unit Cost
Total

Annual Cost

0001
None
CARDIAC MONITORING SERVICES
1
YR
$
$
Total for Base Year
$

Option Year I (TBD)

CLIN No.
SUB-CLIN
Description
Qty.
Unit
Unit Cost
Total

Annual Cost

1001
None
CARDIAC MONITORING SERVICES
1
YR
$
$
Total for Option Year I
$

Option Year II I (TBD)

CLIN No.
SUB-CLIN
Description
Qty.
Unit
Unit Cost
Total

Annual Cost

2001
None
CARDIAC MONITORING SERVICES
1
YR
$
$
Total for Option Year II
$

Option Year III I (TBD)

CLIN No.
SUB-CLIN
Description
Qty.
Unit
Unit Cost
Total

Annual Cost

3001
None
CARDIAC MONITORING SERVICES
1
YR
$
$
Total for Option Year III
$

Option Year IV (TBD)

CLIN No.
SUB-CLIN
Description
Qty.
Unit
Unit Cost
Total

Annual Cost

3001
None
CARDIAC MONITORING SERVICES
1
YR
$
$
Total for Option Year IV
$

Six (6) Month Extension

CLIN No.
SUB-CLIN
Description
Qty.
Unit
Unit Cost
Total

Annual Cost

3001
None
CARDIAC MONITORING SERVICES
1
YR
$
$
Total for Six (6) Month Extension
$

Grand Total for Base and Four (4) Option Years: $ Grand Total for Base, Four (4) Option Years & Six (6) Month Extension: $ 36C25520Q0112

Page 1 of Page 1 of

B.3 STATEMENT OF WORK

PART I. GENERAL REQUIREMENTS

The contractor shall provide Wireless Cardiac Event monitor and Wireless Holter monitor services for diagnosing patients located at the Harry S Truman Memorial Veterans Hospital (Truman VA) in Columbia, MO. Holter and Cardiac Telemonitoring Technology: The contractor shall provide Ambulatory monitoring (Holter and Continuous telemetry device(s)) for patients experiencing intermittent symptoms, such as palpitations, syncope, dizziness, and shortness of breath, as well as atrial fibrillation reporting. The device(s) is given to patients to use for up to 30 days. After the evaluation period, the patient returns the device(s) either to the company in an envelope provided or to the facility.

PART II SCOPE

The contractor will provide Ambulatory monitoring devices (Holter and Cardiac Telemetry) for patient care in the Cardiology Section. They will provide the following:

a. The contractor shall furnish, for the life of the contract, the following equipment at no additional costs to the Government:

1) Personal cardiac Holter monitors.

2) Personal Cardiac Telemetry monitors.

3) Current operator’s manual(s) as well as hands on training by local representative.

b. The system shall have an on-board manual to include system operation and troubleshooting. The contractor shall repeat the monitoring study at no additional costs to the Government for the following reasons or other unforeseen issues:

1) Device(s) provides unsatisfactory results.

2) Device(s) fails to transmit or download information.

3) Information is not retrievable through the use of the web-based system.

4) There is an imaging defect or artifact determined by the VA to be substandard.

2. Place of Performance: The selected contractor shall be providing equipment and off site monitoring. No travel fees will apply. All delivery, disposable items, and equipment are included in the item price. Location: Harry S Truman Memorial Veterans Hospital, 800 Hospital Drive, Columbia, MO 65201. Devices shall be provided to patients either directly by VA Facility or by mail directly to the patient by the contractor. Upon completion of wearing the recorder, device(s) shall be mailed directly back to contractor at no expense to patient or VA.

3. Performance Period: Base year with Four (4) Option Years.

Anticipated Start Date: not to exceed 15 days after award.

4. Procedure: The device(s) is given to patients to use for 1 to 30 days depending on the indication for the holter or cardiac telemetry. Upon receipt of order, contractor shall contact patient within 24 hours by phone, and electrocardiography (ECG) technicians will instruct and explain to the patients about what the device(s) is, how to use it, how to hook it up, and how to place leads. This can be done while at the VA facility or while patient is at home. They will then hook up the device(s) to the patient, with specific instruction in order to continue to have the device(s) on for the duration of evaluation. After the evaluation period, the patient returns the device(s) to the contractor in the envelopes provided or to the healthcare facility.

5. General Requirements:

a. Wireless Holter/Telemetry: The contractor will provide monitoring devices that can perform Wireless Cardiac Telemetry, and Wireless Holter for patient care. The monitors will provide the following:

1) Monitors that are ordered for the patients specific needs.

2) Education regarding the set-up and continuous wearing of the devices along with 24/7 technical support that will be offered on the phone.

3) Wireless equipment that is assigned to patients shall require monitoring 24 hours a day, while the devices are in use.

4) Capability of event transmissions being sent via wireless/cell phone technology.

5) Bidirectional communication between our EMR(CPRS) and the contractor is highly desirable

6) Ability to store 100% of the ECG data in the device(s) when patient is in an area of no cellular service; no event can be lost due to memory limitations.

7) ECG real time transmissions and analysis to have a minimum of 3 leads, up to 6 leads (views) with no more than 3 electrodes.

8) Ability for 100% of ECG data to be transmitted in real-time to Receiving Center for entire monitoring period. Transmitted ECG data is reviewed in real-time by qualified cardiac technicians.

9) Ability to post daily Holter reports analyzing all ECG data over the monitoring period. ECG data is sent via wireless in real time and over each 24 hours, and at end of each 24 hour period, ECG data re-analyzed and posted for physician daily review.

10) Ability to immediately transmit, alert and report Patient Activated Events immediately upon Patient pressing “event” button. No further patient interaction needed. When meets physician notification criteria, physician will also be immediately called per facility instructions.

11) Ability to immediately transmit, alert and report Asymptomatic Events meeting the physician’s notification criteria. Physician will also be immediately called per facility instructions.

12) Technical reading of the device(s) along with a comprehensive report that is available online and will be interpreted by the medical staff.

13) Both patients and VA staff shall have unlimited 24/7 telephone access to contractor’s support staff that are knowledgeable and shall supply help in resolving any monitoring problems.

14) Contractor shall electronically post the data, analysis, and interpretation for immediate review by the appropriate Truman VA facility within 24 hours of receipt unless there is a potentially life-threatening arrhythmia and/or event. In the event of a life threatening arrhythmia and/or event, the contractor shall call 911 and dispatch emergency services to ensure the patient receives adequate treatment.

15) Contractor shall post an all-results-data export file encoded as either XML or HL7 within 24 hours of receipt.

16) All events of an emergency or STAT nature shall immediately be phoned to the appropriate Truman VA facility no later than one hour (1) after receipt and recognition of such data.

17) The contractor shall provide detailed reports for all Veteran patients receiving full services to the COR (Contracting Officer Representative) at the end of the current billing period. Full services are defined as patients that have been identified by a VA provider as requiring monitoring services, have been assigned a monitor that has been returned to the contractor for interpretation, the interpretation has been reported back to the appropriate medical center, and the interpretation report is determined to be without technical error.

18) Ability to post an End of Study Remote Telemetry Report compiling all Telemetry and Holter ECG data into one conclusion report.

b. Telemetry: All Events whether symptomatic or asymptomatic will trigger immediately alerts to bring to reviewing technician’s attention. The ECG is automatically transferred to a cardiac monitoring center, where it is immediately reviewed, reported and the cardiologist is informed according to pre-selected notification criteria.

c. Holter Monitoring: All ECG data will be reanalyzed daily as both a quality control and to provide comprehensive reporting to physician. Daily Wireless Holters shall be posted every 24 hours for physician review. Non-Wireless Holter will be posted within 24 hours of download for physician review. Daily Holter reports shall be standard Holter reports shall include:

1) Heart Rate ECG data including: Minimum, Maximum and Average Heart Rates, Total number of Analyzed Beats, total number of Analyzed Minutes, total number of minutes in Sinus Bradycardia /Tachycardia and longest episode of each, total Pauses in excess of 2 seconds and max pause.

2) Total number of VE’s, V-Pairs, V-Runs, Longest V-Run, Maximum and Minimum HR V- Run (if applicable), VE’s per 1000/per Hour ratio, and Ventricular R on T.

3) Total number of SVE’s, SVE-Pairs, SV-Runs, Longest SV-Run, Maximum HR SV-Run (if applicable), SVE’s per 1000/per Hour ratio.

4) Atrial Fibrillation / Flutter: Burden, Total number of minutes in A-Fib, Number of Episodes, A-Fib graph.

5) ST Segment Analysis: Max ST Depression and Elevation, Total number of ST minutes, Max ST Episode, and Max HR in ST Episode.

6) QT Analysis: When applicable, Max QT and QTc.

7) Heart Rate Variability: Time Domain and Spectral Power.

8) Full Disclosure capability.

d. End of Study Reports: All ECG data (exceeding 48 hours) will be compiled into an End of Study to provide comprehensive reporting to physician. End of Study ECG report shall include at minimum:

1) Comprehensive compilation of Heart Rate ECG data over the entire monitoring period including: Minimum, Maximum and Average Heart Rates, Total number of Analyzed Beats, Total number of Analyzed Minutes, Total Pauses in excess of 2 seconds and max pause. Representative strips shall be provided.

2) Total number of VE’s, V-Pairs, V-Runs, Longest V-Run, Maximum HR V-Run (if applicable).

3) Total number of SVE’s, SVE-Pairs, SV-Runs, Longest SV-Run, Maximum HR SV-Run (if applicable).

4) Atrial Fibrillation / Flutter: Burden, Minimum, Maximum and Average HR, and Longest episode.

5) Full Disclosure capability.

6) Description of all events, both patient-triggered and automatic (in response to rhythm and/or Heart rate meeting programmed criteria), including date/time stamp, symptoms reported, tracing, preliminary interpretation.

6. Device Services:

a. Wireless 30 Day ECG Monitoring Devices: Wireless Holter, Wireless Cardiac Event, and Wireless Real-Time Remote Telemetry monitor, recording, transmitting and reporting on 100% of the ECG data.

b. Standard Holter that can be downloaded.

c. Standard Cardiac Event with Holter that does not require cellular reception. Events transmitted via phone lines and reported upon receipt. Must be able to record 100% of ECG data over 30 day monitoring period. Final download capability transferring 100% of ECG data to Holter file for Multi-Day Holter analysis.

7. Data Management: While patient is wearing the device, transmission patient activated report, urgent asymptomatic event report, daily Holter report and end of study report options will be made available online. The VA shall have access to patient reporting 24 hours a day at the physician’s or authorized representative’s convenience through password protection. Registration information will be entered by VA technician on the contractor’s web site, or by transmission of an XML or HL7 encoded data transfer file from VA to contractor to provide an automated registration process.

8. Work Flow: The device(s) is given to patients to use for 1 to 30 days depending on the indication for continuous monitoring. Initially, ECG technicians will instruct and explain to the patients what the device(s) is, how the patient will use it, how to hook it up, and how to place leads. They will then hook up the device(s), and let the patient go home with specific instructions in order to continue to have the device on for the duration of evaluation. Alternatively, the monitor(s) will be sent directly to the patient, and the patient will be hooked up at home with instructions from the vendor. In either of these cases a baseline is always submitted to the monitoring center where trained personnel record and interpret the strip. Physician notification criteria will be established prior to enrollment. When asymptomatic and/or symptomatic ECG events are alerted that meet the criteria, a call is made to the ECG director and an urgent report with the date is prepared and posted for physician evaluation. Each day a daily Holter report will be presented that includes all the data for the prior 24 hours. An end of service summary report shall be available 3-5 days after the service is completed (Access to the data from the website is limited to the physicians and/or any other authorized representative responsible for evaluating the data). Once the ECG data is ready for evaluation, the contractor shall post the End of Study for the department to review.

9. Equipment:

a. All equipment offered shall be U.S. Food and Drug Administration (FDA) approved.

b. All cardiac event and Holter monitors shall be provided by the contractor for VA use and shall be state-of-the-art equipment, lightweight, and simple for patients to use. Patients will use the monitors for one (1) to thirty(30) days, or as specified by the VA provider. Samples shall be provided to each site during the training or orientation process.

c. The contractor and facility COR will determine an equipment inventory level at the time of contract award that shall remain at each facility location at all times. This equipment inventory must be adequately restocked at all times to ensure that the facility can always meet the daily patient demand.

d. All equipment remains the sole property of the contractor including the initial delivery of the units. The contractor is responsible for all service maintenance and repairs of the equipment and hardware.

e. The contractor shall supply a postage-paid return container for all monitors.

10. Instrument Capabilities

a. Lightweight and easy to use design that can be held in one hand.

b. Available instruments should include a wireless waterproof patch recorder.

c. Capability of event transmissions being sent via wireless/cell phone or advanced technology.

d. Bidirectional communication between our EMR(CPRS) and the contractor is highly desirable

e. Telemetry real time monitoring Capability transmitting and recording 100% of ECG data.

f. Customizable monitors.

g. Wireless 24/48 hour Holter / Cardiac Event/ Outpatient Telemetry devices providing all three monitoring functions over the 1 -30 days monitoring period.

h. Pacemaker pulse detection.

i. Instrument/Monitor has a date and time stamp for clinical reports.

j. Instrument/Monitor can correlate between time and symptom and identify/present all rhythm strips associated with all reported symptoms.

k. All monitoring devices must provide a of 1 to 6 diagnostic leads of continuous ECG data over entire monitoring period, 3 lead pacemaker annotations, and the ability to correlate symptoms and activity with ECG changes.

l. All consumable items (batteries, patches) are provided to patient by contractor who returns the item after monitoring period.

m. Contractor equipment shall be capable of storing up to thirty-day (30) of all ECG data, using standard size batteries readily available, and easily changed by the patient.

11. Training: The contractor shall provide comprehensive training to the Truman VA staff. This may require multiple training sessions for numerous staff. The training shall consist of proper use of the monitoring devices, instructions on how to upload patient information into contractor provided software and/or websites, and how to maintain or provide basic quality assurance tests. Contractor shall also provide each participant at each facility copies of manuals, equipment checklists, surveys, and specific contact information in the event that a medical center staff person needed to contact the contractor 24/7.

12. Technical Support: Technical support is required via telephone for troubleshooting of method and/or problems. The response time for telephone technical assistance shall be within one (1) hour from the time of the initial call for technical support. Contractor must also show availability 24/7 for patient support. Contractor must have appropriately trained personnel available by phone throughout the duration of all tests for patient support.

13. Quality

a. Maintenance:

1) All monitors at each location will be kept at OEM specs. All portable ECG monitoring equipment shall be cleaned, disinfected, and decontaminated according to accreditation standards, each time before it is sent back to facility after download by contractor. Unclean equipment should be stored in an area separate from cleaned equipment to prevent cross contamination.

2) Contractor shall demonstrate set procedures for proper inspection and maintenance of the portable monitoring equipment and shall provide each location a copy of the inspection checklist.

3) The contractor shall have a formal procedure to validate the functional integrity of any device before it is provided to a patient, and shall, at a minimum, complete and document such validation procedure whenever a device is returned with non-diagnostic or unsatisfactory results, or when visual inspection suggests the possibility of device damage.

4) Contractor shall report on the failure rate of their equipment and supply maintenance records.

5) When upgrades to the analytical software or hardware are available that are designed to improve the performance of the analytical system, those upgrades shall be made available to the Truman VA at no additional costs.

6) The contractor shall coordinate installation of upgrades with the COR.

7) The contractor shall provide customer notifications and latest operator’s manual within 10 days after their release/publication.

b. Quality Program:

1) The contractor shall maintain a quality system that ensures conformance to contractual requirements and meets the requirements of ISO 9001 and/or CMS requirements for equivalent ECG technical monitoring, or an equivalent quality system during performance of this contract.

2) Contractor must have a clearly defined process by which it collects the required data, performs root cause analysis, and can supply easily understandable reports.

3) Contractor must demonstrate that their information systems are HIPAA compliant and that the raw data can be transferred securely and with accuracy to the VA.

14. Government holidays: The contractor is not required to provide service on the following National holidays, nor shall the contractor be paid for these holidays.

The following national holidays observed by the Federal Government: New Year’s Day1 January
Martin Luther King’s BirthdayThird Monday in January President’s DayThird Monday in February
Memorial DayLast Monday in May
Independence Day4 July
Labor DayFirst Monday in September
Columbus DaySecond Monday in October
Veterans Day11 November
Thanksgiving Day4th Thursday in November
Christmas Day25 December

If a holiday falls on Sunday, the following Monday shall be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government agencies. Also included would be any day specifically declared by the President of the United States.

15. Overtime and holidays: Any overtime or holiday pay that may be entitled to contractor personnel performing under this contract shall be the sole responsibility of the contractor and shall not be billed to nor reimbursed by the Government.

16. Ordering activity: Contractor shall not accept any instructions issued by any person other than the CO or COR acting within the limits of his/her authority.

17. Changes to Contract: Only those services specified herein are authorized. Before performing any service of a non-contractual nature, contractor shall advise the CO of the reason(s) for the additional work and/or service. Prior authorization shall be obtained from the CO before performing the services.

18. Complaints: Contractor shall promptly and courteously respond to complaints within 3 working days. Including complaints brought to contractor’s attention by the CO. Contractor shall maintain a written record of all complaints, both written and oral showing the identity of the individual, the nature of the complaint, and contractor’s response. Contractor shall permit the Government to inspect such records upon reasonable notice.

19. Badges: All contractor personnel shall be required to wear VA provided identification (I.D.) badges above the waist at all times while on the VA grounds. Contractors shall be required to coordinate with COR in order to obtain the VA provided I.D. badges for all staff. All VA provided I.D. badges shall be returned at the end of the contract or upon completion of service. Failure to wear ID badges may result in removal from any of the VA facilities and/or otherwise referred to federal property.

PART III: GENERAL ADMINISTRATION

a. Contract Officer Representative (COR)

(1) Contact TBD | contact number | @va.gov to coordinate this service. The contractor will contact the COR to schedule the work to be completed; upon arrival, the contractor will contact the COR. The COR will escort the contractor to the appropriate area and monitor the work being done. Upon completion of the work, the COR will escort the contractor out of the area.

b. Place of Performance

1) Columbia VA Medical Center Harry S. Truman 800 Hospital Drive Columbia, MO 65201

c. Period of Performance

(1) See Block 3 of SF1449.

d. Contract Administration Data

(1) All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

e. Non-Personal Services

(1) This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

f. Quality Control

(1) CONTRACT PERFORMANCE MONITORING. The POC may perform surveillance of services by any of the methods listed below:

a) Observing actual performance;

b) Inspecting the services to determine whether the performance meets the performance standards; and

c) Review of any other appropriate records.

d) When unacceptable performance occurs, the POC shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the POC shall document the discussion and place it in the POC file. When the POC determines that formal written communication is required, the POC shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor must present this corrective action plan to the POC. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

e) Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a POC to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s).

f) If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

g) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

g. Contract Security The C&A requirements do not apply and a Security Accreditation Package is not required.

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(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.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) [Reserved]

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

(End of Clause) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html (FAR) http://www.va.gov/oal/library/vaar/index.asp (VAAR)

(End of Clause)

FAR Number
Title
Date
52.203-17
CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS AND REQUIREMENT TO INFORM EMPLOYEES OF WHISTLEBLOWER RIGHTS
APR 2014
52.204-4
PRINTED OR COPIED DOUBLE-SIDED ON POSTCONSUMER FIBER CONTENT PAPER
MAY 2011
52.204-13
SYSTEM FOR AWARD MANAGEMENT MAINTENANCE
OCT 2018
52.204-18
COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE
JUL 2016
52.227-14
RIGHTS IN DATA—GENERAL
MAY 2014
52.232-40
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS
DEC 2013
52.237-3
CONTINUITY OF SERVICES
JAN 1991

C.3 52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 03/02/2020 through 03/01/2025.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task order is considered "issued" when the Government deposits the order in…

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