36C25520Q0112-001.docx

Contract Opportunity Sources Sought Notice

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* = Required Field Contract Opportunity Sources Sought Notice Q Cardiology Monitors 66048 36C25520Q0112 N 621610 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 daniel.thomas6@va.gov Harry S. Truman Memorial Veterans' Hospital 800 Hospital Drive Columbia, MO 65201-5272 daniel.thomas6@va.gov daniel.thomas6@va.gov Draft SOW This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter into negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.

The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract on the basis of this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.

The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below.

Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition. Responses to this notice shall include the following: (a) company name (b) address (c) point of contact (d) phone, fax, and email (e) DUNS number (f) Cage Code (g) Tax ID Number (h) Type of small business, e.g. Services Disabled Veteran Owned small Business, Veteran-owned small business, 8(a), HUBZone, Women Owned Small Business, Small disadvantaged business, or Small Business HUBZone business and (i) must provide a capability statement that addresses the organizations qualifications and ability to perform as a contractor for the work described below.

The VA Heartland Network 15, Contracting Office located at 3450 South 4th Street, Leavenworth, KS, 66048-5055 is seeking (SEE DRAFT STATEMENT OF WORK).

NAICS Code: 621610 (Home Health Services) $16.5 Million.

Product and Service Code: Q502 (Medical Services/cardio-Vascular)

Important information: The Government is not obligated to nor will it pay for or reimburse any costs associated with responding to this sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. Currently a total set-aside for Service Disabled Veteran Owned Small Business firms is anticipated based on the Veterans Administration requirement with Public Law 109-461, Section 8127 Veterans Benefit Act. However, if response by Service Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined. No sub-contracting opportunity is anticipated. This contract shall include a base year and four (4) option years.

Notice to potential offerors: All offerors who provide goods or services to the United States Federal Government must be registered in the System for Award Management (SAM located on the web at www.sam.gov). Additionally, all Service Disabled Veteran Owned Businesses or Veteran Owned Businesses who respond to a solicitation on this project must be registered with the Department of Veterans Affairs Center for Veterans Enterprise VetBiz Registry located at http://vip.vetbiz.gov. All interested Offerors should submit information by e-mail: to Daniel.Thomas6@va.gov.

All information submissions should be received by 12:00 P.M. CST on January 08, 2020. After review of the responses to this announcement, the Government intends to proceed with the acquisition and a subsequent solicitation will be published.

STATEMENT OF WORK (Draft)

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

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

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

1) Personal cardiac Holter monitors.

2) Personal Cardiac Telemetry monitors.

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

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

1) Device(s) provides unsatisfactory results.

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

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

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

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

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

Year. Anticipated Start Date:

Base Year:

Option Year 1:

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

6. General Requirements:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

8) Full Disclosure capability.

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

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

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

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

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

5) Full Disclosure capability.

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

7. Device Services:

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

b. Standard Holter that can be downloaded.

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

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

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

10. Equipment:

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

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

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

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

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

11. Instrument Capabilities:

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

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

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

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

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

f. Customizable monitors.

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

h. Pacemaker pulse detection.

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

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

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

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

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

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

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

14. Quality:

a. Maintenance:

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

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

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

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

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

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

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

b. Quality Program:

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

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

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

15. Government holidays: The contractor is not required to provide service on the following National holidays, not shall the contractor be paid for these holidays.

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

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

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

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

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

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

Quality Assurance Surveillance Plan (QASP)

For: Cardiac Monitoring

Contract Number:

Contract Description: The contractor shall provide Cardiac Monitoring for VA patients to include but not limited to all management, supervision, manpower, materials, supplies and equipment in accordance with the requirements of this contract.

Contractor’s name:

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored.

· How monitoring will take place.

· Who will conduct the monitoring.

· How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

a. Contracting Officer (CO) - The CO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO:

Organization or Agency: Department of Veterans Affairs

b. Contracting Officer’s Technical Representative (COTR) - The COTR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COTR shall keep a quality assurance file. The COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf.

Assigned COTR:

c. Other Key Government Personnel – Chief Quality Management

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s program manager for this contract.

a. Program Manager -

b. Other Contractor Personnel -

4. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Access

5. INCENTIVES

The Government shall use Exercise of Option Period and Past Performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.

6. METHODS OF QA SURVEILLANCE

Various methods exist to monitor performance. The COTR shall use the surveillance methods listed below in the administration of this QASP.

a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)

b. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)

d. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.)

g. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.

8. RATINGS

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

Poor, Marginal, Satisfactorily, Very Good & Excellent

9. DOCUMENTING PERFORMANCE

a. ACCEPTABLE PERFORMANCE

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

b. UNACCEPTABLE PERFORMANCE

When unacceptable performance occurs, the COTR shall inform the contractor and contracting officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COTR shall document the discussion and place it in the COTR file.

When the COTR determines formal written communication is required, the COTR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's program manager and contracting officer.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COTR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

10. FREQUENCY OF MEASUREMENT

a. Frequency of Measurement.

During contract performance, the COTR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COTR shall meet with the contractor on an as needed basis to assess performance and shall provide a written assessment.

<After award, both the contractor’s Program Manager and the COTR shall sign this document.>