36C26319R0095-001.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER

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 54

36C263-19-R-0095

6. SOLICITATION ISSUE DATE

4-12-2019

Josh Howe (651) 293-3031 05-01-2019

36C263

Department of Veterans Affairs Network Contract Office 23 316 North Robert Street, #522 St. Paul MN 55101-1495

X 100

X

621999

$15 Million

X

N/A

X

Department of Veterans Affairs Iowa City Health Care System 601 Highway 6 West

Iowa City IA 52246-2208

Department of Veterans Affairs Network Contract Office 23 316 North Robert Street, #522 St. Paul MN 55101-1495

Y

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971

Cardiac Monitoring Services for VA ICHCS 38 U.S. Code § 8153

Period of Performance 01 June 2019 to 31 May 2024.

(estimated start date)

See Schedule and Performance Work Statement for details.

This is a 100% set-aside for Women-Owned Small Business.

The Department of Labor wage rates for Johnson County, Iowa are attached. (See attachment E).

Funding will be provided by task/purchase orders issued for each ordering period.

X X

X -one-

Kyle Bauman Contracting Officer

36C263-19-R-0095

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PERFORMANCE WORK STATEMENT

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.216-18 ORDERING (OCT 1995)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.7 VAAR 852.211-70 SERVICE DATA MANUALS (NOV 2018)

C.8 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)

C.9 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.10 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.11 VAAR 852.237-7 INDEMNIFICATION AND MEDICAL LIABILITY INSURANCE

(JAN 2008)

C.12 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2019)

SECTION D - CONTRACT ATTACHMENTS

Attachment A – Pricing Schedule Attachment B – Quality Assurance Surveillance Plan Attachment C – VA Information and Information System Security Attachment D – Business Associate Agreement Attachment E – Department Of Labor Wage Standards - Johnson Cty, IA

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.3 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-

OWNED SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION)

E.4 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(SEP 2018)

E.5 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.6 VAAR 852.270-1 REPRESENTATIVES OF CONTRACTING OFFICERS (JAN 2008) .. 37

E.7 VAAR 852.271-70 NONDISCRIMINATION IN SERVICES PROVIDED TO

BENEFICIARIES (JAN 2008)

E.8 VAAR 852.273-74 AWARD WITHOUT EXCHANGES (JAN 2003)

E.9 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.10 852.273-73 EVALUATION—HEALTH CARE RESOURCES (JAN 2003)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL

ITEMS (OCT 2018)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

CENTRAL CONTRACTOR REGISTRATION IS REQUIRED TO BE ACCOMPLISHED BY

THE CONTRACTOR BEFORE AWARD. https://www.sam.gov/portal/public/SAM

1. ADMINISTRATION DATA

a. Contractor information: List below responsible party that may be contacted during the term of this agreement for matters pertaining to the agreement or resulting orders:

Company Name: _____________________________________________

Address: _____________________________________________

Federal Taxpayer Identification: ______________________________________

Data Universal Numbering System (DUNS) Number: ______________________________________

Contact Person (s): ______________________________________

Telephone: ______________________________________

E-mail: ______________________________________

b. Government: Point of Contact – Kyle Bauman – Contracting Officer Network Contracting Office 23 316 North Robert Street, #529 St. Paul, MN 55101-1495 Phone (651) 293-3012 Contracting Officer Representative – Tracy Kolosik

*If Government Contacts change, notification will be sent to the Contractor by e-mail. Contract modification shall not be required.

2. TERMS OF AGREEMENT: This is a Firm-Fixed-Price, Indefinite Quantity contract, established for a period of five years from the effective date of award, plus an option to extend services for six months beyond the five years.

3. AVAILABILITY OF FUNDS: The Contractor shall perform no service until funding is provided for the applicable ordering period.

4. CONTRACT REMITTANCE ADDRESS: All payments by the Government to the Contractor will be made in accordance with FAR 52.232-33, Payment by Electronic Funds Transfer – System for Award Management, and VAAR 852.232-72, Electronic Submission of Payment Requests.

5. INVOICES: Contractor shall provide a detailed monthly invoice for all patients receiving full services to the COR. This will be provided by the 10th of each following month. The COR is responsible for certifying invoices for payment for only those services received and deemed acceptable by VA. Once certified by the COR, payment can be made via the Tungsten Network.

6. GOVERNMENT INVOICE ADDRESS: As part of compliance with the Prompt Payment Act of 1982, and the Improper Payment Elimination and Recovery Act of 2010, the VA uses a third-party electronic invoicing provider named Tungsten (previously OB10). Refer to the Tungsten Network http://www.tungsten-network.com/customer-campaigns/veterans-affairs-us/ for information on how to register and points of contact for questions and assistance. Be sure to include on your invoices:

• Name and Address of Company

• Your firm’s Tax Payer ID Number (TIN)

• Your firm’s “Remit Address” information

• The VA Purchase Order (PO) number

• Your firm’s contact information: (Personal Name, Email, and Phone)

• Your VA point of contact information: (Personal Name, Email, and Phone)

• The Period of Performance dates (Beginning and Ending)

• List of patients (name and patient ID#) that received cardiac monitoring

• Type of monitoring

• Start and stop date of cardiac monitoring

• Date End of Summary Report uploaded to website

• Unit Price per patient

• Total Price

7. VA INFORMATION AND INFORMATION SYSTEM SECURITY: See Attachment C.

8. ACKNOWLEDGEMENT OF AMENDMENTS: The offeror acknowledges receipt of Amendments to the Solicitation numbered and dated as follows:

Amendment Date 0001 03-08-2019 0002 04-15-2019 http://www.tungsten-network.com/customer-campaigns/veterans-affairs-us/

B.2 PERFORMANCE WORK STATEMENT

Contractor shall provide equipment (including monitoring devices), supplies, labor, secure internet website and management required to perform cardiac arrhythmia monitoring services consistent with the two (2) CLINs specified in Attachment A – (up to) 30-day memory loop monitor (standard event) and (up to) 14-day ambulatory cardiac telemetry monitor (ACT or telemetry) to the ICVAHCS, 601 Highway 6 West, Iowa City, IA 52246 as specified, for patients experiencing infrequent symptomatic cardiac events. Services shall be provided twenty-four (24) hours a day, seven (7) days a week, including federal holidays on an on-demand/as-needed basis. Reports and tracings shall also be available to the ICVAHCS staff 24 hours a day, seven days a week, 365 days a year via the secure internet website, facsimile (fax) or other electronic method.

1. ORDERING/REQUEST FOR SERVICES:

The ICVAHCS Cardiology Department personnel will separately place orders, place monitors and register patients for cardiac arrhythmia monitoring services. Registration via secure internet website is preferable though registration via telephone or secure facsimile (fax) is acceptable. Monitors will by placed by ICVAHCS Cardiology Department personnel and instruction will be provided to patients on the monitoring process. Patients will return the device, when the study is complete, to the Contractor using the prepaid envelopes for return via U.S. mail, supplied by the Contractor.

Contractor shall retain files for each registered patient.

ICVAHCS personnel will provide the contractor with patient and physician-specific information necessary to register the patient for monitoring services. Information should, at a minimum, include the following:

a. Referring/primary physician name and phone number

b. Referring/primary physician’s orders/monitoring and reporting criteria

c. Account ID (referring Station) number (per Exhibits), name, address and phone number

d. Patient name, address, phone number and consult (or equivalent) number

NOTE: The consult number, preceded by zeros to bring total number of digits to nine (9), (or equivalent – e.g., phone number minus the first digit of the area code) shall consist of the same number characters as, and be used instead of, the patient’s social security number.

e. Alternate/supplemental patient contact information and relationship to patient

f. ICVACHS emergency/on-call designate number(s)

g. Account/administrative contact person’s name, title, direct phone number and email address

h. Account secondary phone number

i. Account fax number for reports

j. Type of monitoring required

2. TRACINGS/ NOTIFICATIONS/REPORTS

Contractor shall be staffed with trained clinicians and/or certified cardiac technicians. The contractor will be required to provide two different types of reports – interim and end of study. Upon receipt of recorded data, Contractor personnel shall perform preliminary interpretation of ECG/EKG tracings and compile interim or end of study reports as specified in this section.

Tracings are the raw data that are generated by contractor monitoring devices and are used as backup documentation for reports. Reports (interim and end of study) are the interpretation of the raw data at various intervals as clinically necessary.

Interim reports: Contractor shall provide interim reports only when clinically necessary. Contractor shall immediately notify appropriate ICVAHCS personnel of adverse events in accordance with 3.

IMMEDIATE NOTIFICATIONS, below, followed up with an interim report supported by pertinent tracings

– including tracings showing preceding activity and subsequent activity for said adverse event – within 30 minutes of notification. Additionally, Contractor shall notify ICVAHCS personnel when there are occurrences of “no tracings” for 12 consecutive hours.

End of Study reports: Contractor shall compile an end of study report upon conclusion of each patient’s monitoring service. Contractor shall provide any and all associated recorded data – including tracings cited as “not pertinent” or “unclear” by Contractor clinical personnel – upon request for further assessment by the ICVAHCS personnel. Contractor shall make end of study reports available to ICVAHCS personnel within 24 hours after receipt of recorded data. These reports must be in MS Word or .pdf format and available for electronic download/fax transmission via a secure internet website. End of study reports must contain the following:

a. Minimum and maximum sinus rates;

b. Average heart rate;

c. Basic conduction statement with pause duration;

d. Percent of ventricular and atrial ectopy;

e. Strips of all ventricular tachycardia and representative supraventricular tachycardia events.

f. Percentage of time in tachycardia and bradycardia; and,

g. Comments regarding manual transmissions (i.e., “There were no manual transmissions” or “Manual transmissions are documented”).

Although not mandatory, individual symptom statement with “rhythm at that time” mentioned therein accompanied by the strips is desirable.

Contractor shall send electronic alert to appropriate ICVAHCS personnel within 24 hours of availability when a report is queued or available for download/transmittal.

Authorized medical personnel at the ICVAHCS will review the preliminary interpretation and will enter final diagnostic interpretation into the Computerized Patient Record System (CPRS).

Repeat the Study 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:

i. Device provides unsatisfactory results.

ii. Device fails to transmit or download information.

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

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

3. IMMEDIATE NOTIFICATIONS

If ICVAHCS patients experience an event/recording(s) deemed immediate/emergent during non-business hours or on a federal holiday, Contractor personnel shall follow the notification process outlined below.

Due to differences in organizational structure and staffing, Government contact and emergency instructions may vary. Contractor must be able to follow the criteria specific to the applicable facility and referring physician provided during patient registration. In cases of discrepancies between the referring physician’s instructions/criteria and this contract, the referring physician’s instructions/criteria shall take precedence. The contact information and numbers provided herein represent current standard operating procedure associated with Government notification.

Contractor shall research and incorporate into individual patient records, the contact information for non-VA emergency medical response team (EMT) local to any Government referred patient.

Should Contractor personnel be unsuccessful after three attempts in a fifteen-minute period to reach appropriate Government medical personnel to report an emergent condition, Contractor shall notify the non-VA emergency medical response team (EMT) local to the veteran experiencing the medical emergency.

IOWA CITY VA HCS (636): Office hours: Monday – Friday 8:00 a.m. – 4:30 p.m

During office hours: Cardiology Department @ 319-338-0581 extension 4820 Emergent, after hours, weekends and holidays: Emergency Department @ 319-338-0581 extension 5937 OR the Administrative Officer of the Day (AOD) @ 319-338-0581 extension 6358

NOTIFICATION CRITERIA – IMMEDIATE/EMERGENT

Contractor shall immediately verbally notify the Government of any recordings/events of an emergent nature. Contractor shall follow up with a written interim report, accompanied by the incident recorded data, within thirty (30) minutes. Unless specified to the contrary in the referring physician’s instructions, emergent criteria shall be as indicated below.

a. (Sinus/Supraventricular) Tachycardia – 150 beats per minute (BPM) [or 180 BPM – dependent upon primary/referring physician] with duration of 30 seconds or greater

b. Sustained Wide Complex Tachycardia 120 BPM or greater

c. Sustained Bradycardia (all rhythms with Bradycardic rate including averaged Atrial Fibrillation/ Atrial Flutter) 35 BPM or less (or 40 BPM – dependent upon primary/referring physician).

d. Atrial Fibrillation/Flutter

1) New onset (as documented by contractor with duration of 30 seconds or greater)

2) Ventricular response 180 BPM or greater (or 150 BPM or greater – dependent upon primary/referring physician) with duration of 30 seconds or greater

e. Ventricular fibrillation/flutter

f. Complete AV block

g. Asystole

h. Idioventricular rhythm

i. Junctional rhythm sustained for 30 seconds or more

j. Syncope/disturbance of consciousness with rhythm change

k. Torsade de pointes

l. Sinus pause (3 seconds and greater)

4. CUSTOMER SUPPORT

Contractor shall provide customer support to ICVAHCS personnel including:

Training – Contractor shall provide on-site training at no charge on use of its service, equipment, system, secure internet website and all processes, as requested, to authorized ICVAHCS personnel. Contractor shall provide additional on-site training, if required and at no charge, to address system, software or processing changes/upgrades as they are implemented.

Phone Support - Contractor shall provide direct line phone numbers (bypassing menus, recorded messages, etc.) providing authorized ICVAHCS personnel immediate access to contractor customer service personnel 24/7/365. Voice/live response to customer and patient calls shall not exceed thirty (30) seconds.

Email Support – Non-automated response to customer email or website inquiry. Contactor response time shall not exceed four (4) hours from time of inquiry/email.

Account Representatives – Contractor shall assign an account representative and alternate representative to provide direct and on-site support if needed.

5. CUSTOMER SERVICE

Contractor shall provide customer service support 24/7/365 days per year to ICVAHCS patients under this contract. Contractor cardiac technicians (certified preferred) must be available to discuss patient symptoms and then correlate the symptoms with the ECG/EKG findings. Patients provided with monitoring devices may make an unlimited number of symptomatic calls to contractor service center(s). Contractor shall not, under any circumstances, furnish reports directly to patients.

Contractor shall instruct patients, when applicable, to contact the ICVAHCS personnel and/or physician for all post monitoring follow-up care. Contractor shall, for complications occurring within 48 hours of a completed monitoring service, instruct patients to contact the ICVAHCS personnel and/or physician or the nearest medical facility offering emergency services.

Contractor shall also assist patients (or their authorized designee) with obtaining, understanding and operating contractor monitoring devices.

6. EQUIPMENT/INFORMATION TECHNOLOGY REQUIRED

Equipment – All monitoring devices provided in the performance of this contract must be FDA approved. Contractor shall provide and replace any hardware, software, peripherals, instructions and manuals required to support its data collection/reporting system at no charge. Contractor shall provide at no additional charge any dedicated lines, docking stations, related equipment, electronics and interfaces, as well as any associated labor to integrate contractor-owned equipment and electronics with ICVAHCS equipment if necessary to successfully download and upload of recorded data. This shall include, at a minimum, the following:

a. Up to 30-day memory loop monitors (standard event) which can be used to record, then accurately, easily and clearly transmit to the contractor via land line or cell phone;

b. Accessory patches, wires, batteries, wires, etc. and all other supplemental/peripheral items to operate equipment – i.e., batteries, covers, diodes, electrodes, instructions, cell phone, telephonic hookup and baseline on the device, etc.;

c. Up to 14-day ambulatory cardiac telemetry monitor (ACT or telemetry) Ambulatory Cardiac Telemetry (ACT) equipment provided under this contract shall include:

1) Sensor(s) and cell phone/transmitter;

2) An embedded algorithm and cellular communication technology capable of monitoring in real time/near real time;

3) A telemetry service that provides auto-trigger and auto-send functionality automatically and instantly detecting and transmitting both symptomatic and asymptomatic arrhythmia without the necessity of any patient intervention;

4) An auto-trigger for atrial fibrillation, tachycardia, bradycardia, and pause;

5) A feature permitting patients to manually activate and transmit the ECG data to the contractor monitoring facilities; and,

6) Equipment shall enable contractor to pull ECG/EKG data at any point during the period of service while patient wears the device and provide a full Holter, memory loop/event, or ACT analysis including HR variability, PVC count, AF burden summary and other key metrics.

d. Contractor shall retain title and ownership to all equipment provided to the ICVAHCS during the performance of this contract.

e. 100% of the equipment and availability (denominator) and equipment failures when issued (numerator) will be monitored on a daily basis. Any issues that arise shall be reported immediately to VA. Any monitors with reported problems will be replaced immediately with no additional costs to VA. If equipment fails mid-study, the Contractor shall mail a replacement monitor directly to the patient.

Website/Internet Portal – Contractor’s secure internet website or portal to accept, report or transmit patient data, must meet all requirements described herein and, at a minimum, contain the features listed below.

a. Secure internet website with protection and data accuracy compliant with HIPPA and the ICVAHCS standards.

b. Direct links to the website for both patient and physician information on the service and monitors.

c. Convenient access to patient reports with sorting and printing capabilities (either individually or in a batch mode, as requested).

d. Mandatory unique authentication and identification (logon) access to data.

e. Direct line contact information permitting patients and ICVAHCS personnel to communicate directly with Contractor customer service personnel 24/7/365.

f. Audit/reporting function within contractor electronic system permitting ICVAHCS Information Security personnel, upon request, remote access to contract-related records/data.

7. INVENTORY LEVELS

ICVAHCS Inventory – Contractor shall have in place, equipment and related peripheral supplies at each Cardiology ECG/EKG Department within fifteen (15) days of contract award to establish the inventory levels stated below. These inventory levels will be maintained by Contractor via replacement shipment within 24 hours of patient registration. Tracking information shall be provided to appropriate ICVAHCS contact upon shipment.

Up to 30-day memory loop monitor (standard event) - 10 Up to 14-day ambulatory cardiac telemetry monitor ACT/Telemetry - 5

Contractor Inventory – Contractor shall maintain dedicated inventory levels in sufficient quantities to handle projected workload as specified in Attachment A.

8. MAINTENANCE

a. Contractor shall perform all preventive maintenance, repairs, quality control, cleaning, disinfecting and decontamination according to accreditation standards of all 30-day memory loop monitors (standard event) and 14-day ambulatory cardiac telemetry monitor (ACT or telemetry) equipment used in performance of this contract. Proper documentation of inspection and maintenance results and corrective action taken, as necessary, must be available to ICVAHCS personnel.

b. 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.

c. In the event of an equipment failure of the 30-day memory loop monitors (standard event) or Ambulatory Cardiac Telemetry (ACT or telemetry) equipment, contractor shall ship a replacement monitor to the patient within 24 hours and the defective monitor will be mailed back to the contractor in the prepaid envelope for return via U.S. mail by the patient. In turn, the patient shall ensure cell phone remains charged, batteries for the sensor are changed, if needed, and device is shipped back to the contractor in a timely manner.

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

e. 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 ICVAHCS at no additional cost.

f. Contractor shall provide customer notifications and latest operator’s manual within 10 days after their release/publication.

9. Quality Program

a. The contractor shall maintain a Quality Control Plan 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.

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

c. Contractor shall demonstrate that their information systems are HIPAA compliant and that the raw data can be transferred securely and with accuracy to the ICVAHCS.

d. Contractor must be Joint Commission Certified.

10. Complaints

Contractor shall promptly and courteously respond to complaints within 3 working days.

Including complaints brought to the contractor’s attention by the Contracting Officer.

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 ICVAHCS personnel to inspect such records upon reasonable notice.

[End of PERFORMANCE WORK STATEMENT (PWS)]

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 52.216-18 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 the effective date of the contract through contract completion.

(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 the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule.

(End of Clause)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than $6,600.00, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of $35,000.00;

(2) Any order for a combination of items in excess of $90,000.00; or

(3) A series of orders from the same ordering office within five days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph

(b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within five days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

(End of Clause)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies or services specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum."

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after contract completion.

(End of Clause)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of Clause)

C.6 SUPPLEMENTAL INSURANCE REQUIREMENTS

In accordance with FAR 28.307-2 and FAR 52.228-5, the following minimum coverage shall apply to this contract:

(a) Workers' compensation and employer’s liability: Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 is required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

(b) General Liability: $500,000.00 per occurrences.

(c) Automobile liability: $200,000.00 per person; $500,000.00 per occurrence and $20,000.00 property damage.

(d) The successful bidder must present to the Contracting Officer, prior to award, evidence of general liability insurance without any exclusionary clauses for asbestos that would void the general liability coverage.

(End of Clause)

C.7 VAAR 852.211-70 SERVICE DATA MANUALS (NOV 2018)

The Contractor shall follow standard commercial practices to furnish manual(s), handbook(s) or brochure(s) containing operation, installation, and maintenance instructions, including pictures or illustrations, schematics, and complete repair/test guides, as necessary, for technical medical equipment and devices, and/or other technical and mechanical equipment provided per CLIN(s) listed in the PWS.

The manuals, handbooks or brochures shall be provided in hard copy, soft copy or with electronic access instructions, consistent with standard industry practices for the equipment or device. Where applicable, the manuals, handbooks or brochures will include electrical data and connection diagrams for all utilities.

The documentation shall also contain a complete list of all replaceable parts showing part number, name, and quantity required.

(End of Clause)

C.8 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009)

The offeror agrees, if awarded a contract, to use the service-disabled veteran-owned small businesses or veteran-owned small businesses proposed as subcontractors in accordance with 852.215-70, Service- Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, or to substitute one or more service-disabled veteran-owned small businesses or veteran-owned small businesses for subcontract work of the same or similar value.

C.9 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

(a) This solicitation includes FAR 52.219-30 Notice of Set-Aside for Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business…