36C25220Q0274-001.docx

36C25220Q0274

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

36C25220Q0274 03-16-2020 Prudence Holland, Contract Specialist (414 ) 844-4801 04-03-2020 Noon local time 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 X X 621999 $16.5 Million N/A X 36C252 Great Lakes Acquisition Center (GLAC) Department of Veterans Affairs 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476 36C252 Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101 Milwaukee WI 53214-1476

Department of Veterans Affairs Financial Services Center PO Box 149971 Austin TX 78714-9971 877-353-9791 512-460-5540 Cardiac Arrhythmia Monitoring Services for VISN 12 medical facilities including: Jesse Brown VAMC, Danville VAMC, Captain James A. Lovell Federal Health Care Center, Edward Hines, Jr. VA Hospital, Oscar G. Johnson VAMC, William S.

Middleton Memorial VA Hospital, Tomah VAMC, Milwaukee VAMC, Milo C. Huempfner Health Care Center in accordance with the specifications, pricing, terms and conditions contained herein.

This procurement is a 100% Small Business Set-aside.

X X

ONE

Patrice R. Bond

NCO1215L3-0050

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract administration matters will be handled by:

1. CONTRACTOR’S NAME/ADDRESS/CITY-STATE-ZIP (please print or type):

Contractor Performance Assessment Reporting System (CPARS) past performance point of contact:

Name/Title: email: _____________________

1. GOVERNMENT:

Patrice R. Bond, Contracting Officer Prudence Holland, Contract Specialist Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S. 84th Street, Suite 101 Milwaukee, WI 53214-1476

(414) 844-4806 / (414) 844-4801 Fax (414) 844-4891

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the Contractor will be made in accordance with Federal Acquisition Regulation (FAR) Clause 52.232-33, Payment by Electronic Funds Transfer – System for Award Management (31 U.S.C. 3332).

INVOICES: In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with Tungsten Corporation e-Invoicing network, for submissions of all electronic invoices to VA. Tungsten Network electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with Tungsten Network by submitting an email to Tungsten Network VA.Registration@tungsten-network.com or calling 877-752-0900 option 2 for Enrollment.

Contractor shall submit an electronic invoice by the tenth (10th) of the following month services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at https://authentication.tungsten-network.com/login. For questions regarding the submission of VA electronic invoices, Tungsten Network customer service may be contacted at 877-489-6135.

The invoice sent to Tungsten Network shall reference the vendor name and address, customer name, contract number, appropriate obligation/funding order number, contract - line item number (CLIN)/type of monitoring provided, date of service (DOS); unit price and total invoice cost. Invoices shall also include any payment discount terms.

Contractor shall upload a copy of the invoice with backup data (described below) onto its website portal only if the portal is compliant with Federal Information Processing Standard (FIPS) 140-2. That data shall then be available for, review and download. (Tungsten is still required for certification).

Invoice backup data shall include, as a minimum, facility/station name, invoice number/date being billed, obligation/funding/order number, patient name, date of service (DOS)/end DOS, CLIN/type of monitoring requested, name of requesting physician, number of hours analyzed, unit price of CLIN, and total invoice cost.

The Government will make payment only for the duration period monitored. Contractor shall invoice at CLIN rate for the actual duration monitored. EXAMPLE: If the ordering physician requests 30-day telemetry (CLIN X004) and patient removes monitor after fourteen (14) days, the applicable billing rate would be that for CLIN X003 as listed in the PRICE SCHEDULE.

For questions regarding invoice receipt or payment, please call VAFSC directly at 877-353-9791. Payments shall be made monthly in arrears upon receipt of a properly prepared invoice.

3. POST AWARD ORIENTATION: The Contracting Officer will schedule a post award orientation for contract orientation purposes as required by Procurement Policy Memorandum (PPM) 2019- 01. https://www.va.gov/oal/docs/business/pps/ppm201901.pdf.

[End of CONTRACT ADMINISTRATION DATA]

B.2 SCHEDULE OF SERVICES AND PRICE

Authority: This procurement is being conducted under the authority of 38 U.S.C. 513, Contracts and Personal Services. The Great Lakes Acquisition Center is contracting for services in support of VISN 12 medical facilities and in accordance with FAR 13.5 - Simplified Procedures for Certain Commercial Items. Therefore, VA will utilize simplified procedures for soliciting competition, evaluation, award documentation, and notification.

Purpose: To provide wireless Cardiac Arrhythmia Monitoring Services in support of the Jesse Brown VA Medical Center (VAMC), the VA Illiana Health Care System (Danville, VAMC), the Captain James A. Lovell Federal Health Care Center (FHCC), the Edward Hines, Jr. VA Hospital (VAH), the Oscar G. Johnson (Iron Mountain) VAMC, the William S. Middleton Memorial Veterans Hospital (Madison) VAH, the Tomah VAMC, the Clement J. Zablocki (Milwaukee) VAMC and the Milo C. Huempfner Health Care Center (HCC). Addresses are contained on Exhibits 1 – 9.

Contract/Ordering Period: The resultant contract will be a five (5) year ordering period, Indefinite Delivery, Indefinite Quantity contract with an anticipated start date of July 24, 2020. The quantities listed in Exhibits 1 through 9 – identified by facility station number and contained under Section D, CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS – are the Government’s estimated annual volumes. The Government does not guarantee to order these quantities.

General Ordering Authority & Process: An order is deemed placed when complete patient registration data has been placed by authorized Government personnel into Contractor’s ordering system.

Pricing: Firm-fixed (unit) pricing with estimated annual volumes of Contract Line Item Numbers (CLINs) are contained on Exhibits 1-9. Cumulative annual totals are listed below. The CLIN unit prices will apply to the quantities actually ordered by each facility. Offerors must complete and submit both the Price Schedule below and all Exhibits for consideration of contract award.

PRICE SCHEDULE

Estimated Grand Total (Years 1 – 5) $_________________ The Government’s guaranteed minimum to be ordered during the contract is $9,000.00. The Government’s contract ceiling amount is $5,500,000.00.

BASIS FOR AWARD

One award will be made to the offeror whose quote represents the best value to the Government considering price and non-price factors as listed in clause 52.212-2 Evaluation-Commercial Items. Contract will be firm-fixed (unit) price by CLIN.

The Government may award a contract on the basis of initial quotes received, without exchanges. Therefore, each initial quote should contain the Offeror's best terms from a price and technical standpoint. Instructions to Offerors on price and technical quote submissions are found under clause 52.212-1, ADDENDUM TO FAR 52.212-1 - INSTRUCTIONS TO OFFERORS – COMMERCIAL ITEMS.

[End of SCHEDULE OF SERVICES AND PRICE]

B.3 PERFORMANCE WORK STATEMENT (PWS)

Contractor shall provide wireless equipment (including monitoring devices), supplies, labor, and management required to perform cardiac arrhythmia monitoring services consistent with the CLINs specified on Exhibits 1 through 9 – (up to) 48-hour (Holter); (up to) 30-day memory loop (event) monitor; (up to) 15-day ambulatory (mobile) cardiac telemetry (ACT/MCT) and 15-day to 30-day ACT/MCT to VISN 12 VA medical facilities and FHCC 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. Tracings and reports shall be processed and available to VA/FHCC staff 24 hours per day, seven days per week, 365 days per year via the internet, facsimile (fax) or other electronic method.

1. ORDERING/REQUEST FOR SERVICES:

Each facility’s cardiac unit personnel are authorized to separately place orders by registering patients for cardiac arrhythmia monitoring services. Registration shall be primarily via Contractor’s secure website. Registration via secure facsimile (fax) or via telephone is acceptable in the event primary methodology is temporarily unavailable to the requesting facility. Contractor shall retain separate files for each facility’s registered patients.

Government personnel will provide the contractor with patient and physician-specific information necessary to register the individual for monitoring services. It is imperative that sufficient information be provided to create pertinent cardiac monitoring data for accurate diagnoses while protecting patient privacy.

Other pertinent data for effective monitoring and diagnosis typically provided at registration includes the following:

a. Study details – e.g., type, hookup, start date, duration (days);

b. Physician details – location, ordering, referring;

c. Patient general medical profile – e.g., diagnosis code(s), pacemaker, ICD implanted, current medications, etc.

Patients will be registered by Government personnel who will dispense monitors and hook up the majority of patients. Upon request, contractor shall mail the appropriate monitor to the patient’s residence or desired location specified on the registration form. Contractor will then contact the patient on the day of registration to confirm address and phone number prior to shipment.

Contractor shall notify Government personnel if no successful contact has been made with patient or patient’s caregiver within 48 hours. Upon patient’s receipt of the cardiac monitor, the Contractor shall discuss the device, prep/hook-up, monitoring instructions, and complete a baseline with the patient. If deemed urgent by VA staff, contractor will ship a monitor “overnight.”

Packaging, marking, and shipping of devices shall be in accordance with industry standards. Shipping containers shall include legibly printed packing slips bearing, as a minimum –

· Name and address of originating organization

· Name and address of receiving organization/individual

· Instructions for additional internal handling – e.g., department/internal destination, Government point of contact (POC) name and phone/extension to notify of receipt

· A list of all items in the box/shipping container and applicable obligation (funding order) number against which each should be applied.

Individual labels should be affixed to the exterior of each kit container/box. Labels should contain pertinent information including, as a minimum, kit identification (ID) by name, description and kit serial number, as well as the device inside and its serial number. Latest dates of device calibration, battery charge and inspection may also be indicated along with expiration date(s) of any components contained therein.

2. TRACINGS & REPORTS

Tracings are the raw data that are generated by contractor monitoring devices and are used as backup documentation for reports – interim and summary. These reports are the interpretation of the raw data at various intervals as clinically necessary.

When initial hook-up is at the VA, the technician is required to obtain an acceptable baseline prior to the patient leaving the VA facility. To do this, the contractor shall ensure that tracings are available to review via the website within 10 minutes of patient hookup. The patient will also be instructed to send another baseline (trigger) upon arrival at home. The contractor shall notify the VA technician if a poor signal is received from the patient’s home. The contractor shall, also call the veteran and troubleshoot the poor signal with the patient.

Contractor shall attempt to contact patient and, if needed, notify Government personnel at the originating station when there are occurrences of “no tracings” for six (6) or more consecutive hours. Contractor shall also call the patient when significant artifact is seen for an extended period – e.g., four (4) or more normal daylight or “waking hours.” Contractor shall then troubleshoot the poor signal with the patient.

NOTE: Contractor personnel are expected to use common sense and courtesy regarding time of day/night used to contact patients.

The contractor will be required to provide two different types of reports – interim and summary (end of service). Upon receipt of recorded data, contractor personnel shall perform preliminary interpretation of ECG tracings and compile interim and/or summary reports as specified in this section, below.

Interim reports: Contractor shall provide interim reports when clinically necessary and/or upon request of authorized Government personnel. Contractor shall immediately notify appropriate Government personnel of adverse events in accordance with Article 5. NOTIFICATION – Immediate/Emergent Criteria, below, followed up with an interim report supported by pertinent tracings – including tracings showing 30 seconds before and after said adverse event – within 30 minutes of notification.

Summary (aka: End of Study) Reports: Contractor shall compile a summary report upon conclusion of each patient’s monitoring service. Contractor shall provide any and all associated recorded data upon request – including tracings cited as “not pertinent” or “unclear” by Contractor clinical personnel – for further assessment by the Government. Contractor shall make summary reports available to VA/FHCC personnel within 24 hours after receipt of recorded data by the contractor. These reports must be in MSWord or .pdf format and available for electronic download via a secure site/portal and, if requested by VA/FHCC clinical personnel, transmitted via secure facsimile/line. End of Study Reports shall be error free and must, as a minimum, contain all of the elements identified below.

a. PATIENT NAME & Identifier

b. MONITORING

a. Date registered; type and duration of monitoring requested

b. Actual length of time worn by patient

c. Number of hours of recorded vs. number of hours of analyzed data

d. Explanation for discrepancy(ies) – i.e., artifact, early removal of device by patient, etc.

c. SYMPTOMS/Triggered Events: Yes/No List symptoms / symptomatic events with “rhythm at that time. Include time of day – e.g., 3:00 a.m.

d. BASELINE – At hookup (if at facility) AND at home

a. Rhythm

b. Rate

e. ATRIAL ARRHYTHMIA

a. Premature Atrial Contractions (PACs %) NOTE: Must state a value even if 0%.

b. Supraventricular tachycardia (SVT) runs:

i. Number of runs – e.g., 32 episodes

ii. Longest one was _____ seconds.

c. Atrial Fibrillation: Yes/No

d. Atrial Fibrillation burden (%) NOTE: Must state a value even if 0%.

e. Average A-Fib Heart Rate (HR) – include maximum and minimum.

f. VENTRICULAR ARRHYTHMIA:

a. Premature Ventricular Contractions (PVC %) NOTE: Must state a value even if 0%.

b. Ventricular Tachycardia (VTACH) runs

i. Number of runs – e.g., 32 episodes

ii. Longest one was _____ seconds.

g. INCLUDE STRIPS OF EVENTS: (in the body of the report, not in the summary)

a. All ventricular tachycardia

b. Representative supraventricular tachycardia

h. BRADYARRHYTHYMIA

a. Malignant Bradycardia or AV block: Yes/No NOTE: Include description of type of block.

b. Longest R-R interval – e.g., slowest heart rate in seconds (not beats)

i. HEART RATE (HR) TRENDS:

a. Maximum sinus HR

b. Minimum sinus HR

c. Average sinus HR

d. Duration >= 101 bpm (%)

e. Duration <= 59 bpm (%)

j. PHYSICIAN NOTIFICATIONS:

a. List all episodes requiring physician notification

b. Provide date/time of each notification Contractor shall send an electronic alert to appropriate Government personnel within 24 hours of a report being queued or available for download/transmittal.

Contractor reports shall attain a ninety-five percent (95%) accuracy rate.

Authorized medical personnel at the respective Government facilities will review the preliminary interpretation and final summary report and will enter final diagnostic interpretation into the Computerized Patient Record System (CPRS). Contractor will be notified if Summary Reports fail to achieve predetermined accuracy rates based on data interpretation and completeness of the report. The contractor shall provide the respective Government facility with a corrective action plan within 14 calendar days of notification.

3. NOTIFICATION

If VA/FHCC patients experience an event/recording(s) deemed emergent, 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 procedures associated with Government notification.

Contractor shall research and incorporate into individual patient records, the contact information for the non-VA emergency medical response team (EMT) local to any Government referred patient. Should contractor personnel be unsuccessful after three (3) 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.

JESSE BROWN VAMC (537): Office hours: Monday – Friday 8:00 a.m. – 4:30 p.m.

During office hours: Jesse Brown VAMC (JBVAMC) Heart Station @ 312-569-6616 Emergent, after hours, weekends and holidays: Cardio-Care Unit (CCU) fellow pager @ 312-839-4259 AND the Administrative Officer of the Day (AOD) @ 312-569-8387 DANVILLE VAMC (550): Office hours: Monday – Friday 7:30 a.m. – 4:30 p.m.

During office hours: Danville VAMC Cardiology Department @ 217-554-5286 Emergent, after hours, weekends and holidays: Call veteran’s local EMT FHCC (556): Office hours: Monday – Friday 7:30 a.m. – 4:00 p.m.

During office hours: Cardiology Department @ 224-610-8206 or 224-610-8207 Emergent, after hours, weekends and holidays: AOD @ 224-610-3747 who will page the cardiology fellow on-call.

HINES VAH (578): Office hours: Monday – Friday 8:00 a.m. – 4:30 p.m.

During Office hours: TBD @ time of registration per referring/primary physician After hours, weekends and holidays: TBD @ time of registration per referring/primary physician Emergent - Primary/referring physician and the alternate contact TBD per patient registration.

IRON MOUNTAIN VAMC (585): Office hours: Monday – Friday 7:30 a.m. – 3:30 p.m.

During office hours: Iron Mountain Urgent Care @ 906-774-3300 ext. 34780 Emergent, after hours, weekends and holidays: contact main number @ 906-774-3300 ext. 32636 and request Iron Mountain AOD who will page the Emergency Department.

NOTE: Iron Mountain main number forwards to Madison VAH after hours.

MADISON VAH (607): Office hours: Monday – Friday 7:00 a.m. – 4:00 p.m.

During office hours: VAH Cardiology Department @ 608-256-1901 ext. 17003 Emergent, after hours, weekends and holidays: Contact the facility Emergency Department ED @ 608-256-1901 ext. 17012 and request the ED Charge Nurse and the Medical Officer of the Day (MOD).

TOMAH VAMC (676): Office hours: Monday – Friday 8:00 a.m. – 4:30 p.m.

During Office hours: Respiratory Therapy @ 608-372-3971 Emergent, after hours, weekends and holidays: Contact the Madison VAH Emergency Department (ED) @ 608-256-1901 ext. 17012 and request the AOD. Comment by Wendt, Mary B.: This is different than Madison’s directions.

MILWAUKEE VAMC (695): Office hours: Monday – Friday 8:00 a.m. – 4:30 p.m.

Contact VA Cardiology Department @ 414-384-2000 and page the Cardiology Fellow On-call.

Emergent, Contact the ordering physician by page via the VA operator @ 414-384-2000. If no response in 15 minutes, then contact the VA Cardiology fellow on-call.

GREEN BAY HCC (695GB): Office hours: Monday - Friday 8:00 a.m. - 4:30 p.m.

During office hours: Green Bay HCC Cardiology Department @ 920-431-2500 ext. 72538 Emergent, after hours, weekend and holidays: Contact the Nurse Advice Line @ 888-469-6614 ext. 46345 - Facsimile (fax) 920-431-2975 Immediate/Emergent Criteria 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. This interim report should also include details of the date, time, and Government personnel who confirmed receipt of the notification. Unless specified to the contrary in the referring physician’s instructions, emergent criteria shall include patient arrhythmias that meet any of the criteria outlined below. Comment by Wendt, Mary B.: Reversed Consistency?

a. (Sinus/Superventricular) 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. P–R intervals reflecting one or more of the “patterns” below.

1) Meeting or exceeding 0.2 seconds

2) Steadily “elongating” or other second-degree heart block

e. 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

f. Ventricular fibrillation/flutter

g. Complete AV block

h. Asystole

i. Idioventricular rhythm

j. Junctional rhythm sustained for 30 seconds or more

k. Syncope/disturbance of consciousness with rhythm change

l. Torsade de pointes

6. CUSTOMER SUPPORT

Contractor shall provide customer support to Government personnel including:

Training – Contractor shall provide on-site training at no charge on use of its service, equipment, system and processes, within 30 days of contract award and as requested, to authorized Government 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, as well as to accommodate new Government staff members and annual on-site refresher courses as needed.

Phone Support – Contractor shall provide direct line phone numbers (bypassing menus, recorded messages, etc.) providing authorized Government personnel immediate access to contractor customer service personnel 24/7/365. Wait time for 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.

Local Area Account Representatives – Contractor shall assign a local area account representative and alternate representative to provide direct and on-site support for each of the Government facilities.

7. CUSTOMER SERVICE

Contractor shall provide customer service 24/7/365 days per year to VA/FHCC patients under this contract. Contractor cardiac technicians (certified preferred) must be available to discuss patient symptoms and then correlate the symptoms with the ECG 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 referring Government 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 their Government 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. Contractor shall, if required (due to remoteness or inaccessibility of patient to Government medical facilities), instruct/educate patients on use, care and return of monitoring devices.

8. EQUIPMENT/INFORMATION TECHNOLOGY REQUIRED

General – Contractor’s system shall include Federal Information Processing Standard (FIPS) 140-2 compliant platform(s) ensuring secure storage and encryption of all veteran data. Additionally, contractor must demonstrate it possesses systemic safeguards minimizing negative impact to veteran care resulting from natural and man-made disasters such as severe weather patterns, earthquakes, etc. Such safeguards may include one or more of the following criteria:

a. Multiple service centers certified as Independent Diagnostic Testing Facilities (IDTFs) and/or

b. Equipment – e.g., servers, phones, monitoring devices, etc. – and qualified staff “co-located” in different states [/ “environmental zones” to ensure uninterrupted monitoring services for at-risk veterans.

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 labor required to “tailor” contractor-owned equipment, electronics and reports to Government-unique and/or station-specific clinical standards necessary to optimize download, analysis and reporting of recorded data. This shall include, at a minimum, the following:

a. All monitoring devices must transmit data wirelessly. This includes 24-48 hour holter monitors, up to 30-day event monitors, and up to 30-day telemetry monitors. A docking station is neither acceptable nor approved by the VA/FHCC ISSO.

b. Monitoring devices are lightweight, and simple for patients to use;

c. Contractor utilizes two or more cellular services (i.e., Verizon and AT&T). Each Government facility will individually select their preferred cellular provider. In the occasion a patient resides in an area with poor coverage of the facility’s preferred cellular provider, the contractor will convert/exchange the monitor to use an alternative cellular provider and continue to troubleshoot with the patient as needed;

d. Monitoring devices encompass an all-in-one, multi-mode device. The monitoring device is capable of functioning as a 24-48 hour Holter monitor, up to 30-day event monitor, and/or up to 30-day telemetry unit based upon the patient’s registration;

e. Monitoring device allows the patient to wirelessly transmit his/her symptom and activity level associated with the patient-activated event to the vendor in real-time;

f. Monitoring devices powered by a battery with a history of consistently holding its charge maintaining continuous recording for a minimum of 48-hours even in the absence of cell or wireless service – longer is preferable – before a recharge is necessary;

g. Complete kits that include pre-paid “mailers” – postage paid return envelopes suitable for return of devices upon completion of monitoring period, packaged and marked in accordance with industry standards and as detailed herein;

h. Devices received by the Government in optimum condition “out of the box”;

i. Devices capable of “beat-by-beat” monitoring of cardiac arrhythmias over the entire monitoring period;

j. Devices and/or protocols that ensure patient is alerted within 24 hours of nonfunctioning equipment in Holter or telemetry mode -- e.g., due to disconnected lead, low battery, full or nearly full storage, etc.– consistent with industry standards. Contractor personnel shall remain courteous and sensitive to time of day/night when contacting patients.

k. Holter, event/memory loop and ACT/MCT (mobile telemetry) recorders that accurately, easily and clearly transmit to the contractor wirelessly or via cell phone;

l. Accessory patches, wires, batteries, etc. and all other supplemental/peripheral items, required to operate equipment – i.e., diodes, electrodes, instructions, etc.

m. Cardiac monitors that will undergo a baseline with the vendor during patient hookup to ensure contractor receives a clear tracing and confirm that patient’s registration/account is accurate and activated.

n. ACT/MCT equipment provided under this contract shall include:

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

2) An embedded algorithm and/or 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 detects and transmits 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 data at any point during the period of service while patient wears the device and provide a full Holter, memory loop/event, or ACT/MCT analysis including HR variability, PVC count, AF burden summary and other key metrics.

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

p. Contractor shall, when requested by the applicable Government facility, ship the equipment “kit” directly to remote patients unable to access their medical facility. Additionally, contractor Customer Service personnel shall follow up with the patient to confirm receipt of equipment.

Website/Internet Portal – Contractor’s website or internet 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 HIPAA and the Government standards (FIPS 140-2).

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 both individually and in a batch mode, as requested).

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

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

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

INVENTORY LEVELS

Government Inventory – Contractor shall place equipment and related peripheral supplies at each facility’s Cardiology ECG Department within 30 days of contract award to establish the minimum inventory levels stated below. These minimum inventory levels shall be auto-replenished, and maintained by contractor via replacement shipment within 24 hours of patient registration. Tracking information shall be provided to appropriate Government personnel upon shipment.

Contractor Inventory – Contractor shall maintain dedicated inventory levels in sufficient quantities to handle projected workload as specified in Exhibits 1 through 9.

10. MAINTENANCE

a. Contractor will perform all sanitizing, preventive maintenance, and quality control of all Holter, memory loop/event and ACT/MCT equipment used in performance of this contract to ensure and maintain maximum accuracy prior to packaging and shipment to the Government. Proper documentation of maintenance results and corrective action taken, as necessary, must be made available to the Government upon request.

b. In the event of an equipment failure of any monitor, contractor shall ship a replacement monitor to the patient upon notification to be received by the patient the next day, and the defective monitor will be mailed back by the patient in the prepaid envelope for return via U.S. mail.

[End of PERFORMANCE WORK STATEMENT]

B.4 SPECIAL CONTRACT REQUIREMENTS

1. SERVICES

1. The services specified herein may be changed by written modification to this contract. The Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, 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.

1. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather contractor personnel perform their duties in accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare providers who furnish services under this contract are subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance.

1. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

1. Contractor is required to maintain medical liability insurance for the duration of this contract. Medical liability insurance must cover the providers for services in all states where services are rendered by the providers and updated certification, shall be submitted to CO upon renewal.

1. The services to be performed by the contractor will be performed in accordance with VA policies, procedures, regulations, and the medical staff bylaws of the VA facility (copies and/or links will be provided upon request). In all cases, dignity of the patient shall be given the highest regard and the precepts of the American Hospital Association’s “Bill of Rights for Patients” shall be observed.

1. Contractor shall provide the required services listed herein throughout the contract period. Other necessary personnel for the operation of the services contracted for at the VA will be provided by the contractor at levels mutually agreed upon which are compatible with the safety of the patient and personnel and with quality medical care programming.

1. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

1. Contractor shall not, under any circumstances, furnish reports directly to patients.

2. TERM OF CONTRACT

This contract is effective for a period of five (5) years from the effective date of award. The contractor shall perform no services after conclusion of each actively funded year (performance period) until the Contracting Officer authorizes such services in writing.

1. WORK SCHEDULE

Contractor shall perform cardiac monitoring services – twenty-four (24) hours per day, seven (7) days per week, 365 (366 days during Leap Year) – including weekends and federal holidays, in accordance with all requirements under Section B.3, PERFORMANCE WORK STATEMENT and consistent with industry standards.

1. FEDERAL HOLIDAYS

Contractor will be required to provide services on federal holidays, as scheduled by patient registration data.

The 10 holidays observed by the Federal Government are: New Year’s Day (January 1st), Martin Luther King’s Birthday (3rd Monday in January), Presidents’ Day (3rd Monday in February), Memorial Day (last Monday in May), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

1. QUALIFICATIONS OF CONTRACTOR/CONTRACTOR PERSONNEL

Contractor service center(s) shall be adequately staffed with trained and appropriately licensed medical personnel – e.g., board certified or board eligible physicians; licensed registered nurses (RNs); and Cardiovascular Credentialing International (CCI)/Certified Cardiovascular Technicians (CCTs). Personnel assigned by the contractor to perform the services covered by this contract must meet basic minimum criteria/qualifications of contractor and:

a. Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

b. Contractor personnel will be required to complete annual Privacy/HIPAA training, which may be provided by their organization. Successful completion of such training shall be validated annually by contractor written statement submitted to the Contracting Officer or provision of certificates from VA/FHCC’s TMS training system.

c. Any new requirements for mandatory education and/or competency reassessment that occur during the contract period must be completed by the individual contractor employee(s) within established timeframes.

d. Successful completion of applicable ANSI/ISO/IEC 17024 or equivalent semi-annual certification for contractor medical personnel assigned to monitor, interpret ECG/EKG data, compile interim/preliminary reports, and/or provide direct customer service to Government staff and patient is preferred, but not required.

e. Favorable adjudication of background checks as pre-requisite to employment

f. Current liability insurance

g. FIPS 140-2 compliance, including links of FIPS-certified modules for

1) Data encryption at rest

2) Data encryption during transfer

3) Key management

4) Info on FEDRAMP including risk level

h. Joint Commission Certification preferred, but not required

3. CONTRACTOR’S FACILITY(IES)

A change in contractor’s location, website access, customer service/support, registration or bill to/pay to address(es) or other elements affecting performance under this contract shall be promptly reported to the Contracting Officer and is subject to Government approval.

4. HHS/OIG

To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (https://exclusions.oig.hhs.gov/) for each person providing services under this contract. The parties and entities assigned by contractor to perform under this contract may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the contractor certifies that all persons or entities identified by contractor to work under this contract have been compared against the OIG list and are NOT listed as of the date the offer was signed.

5. JOINT COMMISSION STANDARDS

Joint Commission accreditation is preferred, but not required. The contractor shall perform the required work in compliance with Joint Commission Standards. A copy of these standards may be obtained from Joint Commission, One Renaissance Blvd., Oakbrook Terrace, IL 60181.

The contractor will be responsible to ensure the contractor employees or subcontractors providing work on this contract are fully trained and completely competent to perform the required work. Contractor will gather all credentialing documents requested by the VA/FHCC as well as any other documentation that the carrying out of this contract may require. However, the contractor is not able to nor is the contractor required to make clinical competence determinations on behalf of the VA/FHCC.

6. PERSONNEL POLICY

a. Contractor shall be responsible for protecting its personnel furnishing services under this contract. To carry out this responsibility, to the extent required by law, the contractor shall provide the following for its employees:

· Workers compensation

· Professional liability insurance

· Health examinations

· Income tax withholding, and

1. Social security payments.

b. The parties agree that the contractor, its employees, agents and subcontractors shall not be considered Government employees for any purpose.

7. RECORD KEEPING – CONTRACTOR

Contractor must establish a record keeping system of Government patients by referring facility (customer account number); type/duration of monitoring, accurate diagnoses and billing/payment. These records shall not be comingled with other customer records and must be available to the Contracting Officer (CO) or the Contracting Officer Representative (COR) of any facility covered by this contract upon request within three (3) business days.

8. MEDICAL RECORDS

Medical records of Government patients monitored by contractor under this contract belong to the Government and contractor personnel will not have access to those records. Contractor shall retain all patient monitoring documentation in a secure electronic format as required and provide copies of patient monitoring documentation, if requested by authorized VA/FHCC personnel upon request. That data will be retained for no less than ten (10) years and will be made available to VA/FHCC authorized personnel within three (3) business days at no charge.

These records will be mailed to the VA/FHCC at no additional cost. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information.