W065--668-21-3-1069-0006 Cardiac Event Monitoring Products and Services
VETERANS AFFAIRS, DEPARTMENT OF.VETERANS AFFAIRS, DEPARTMENT OF.260-NETWORK CONTRACT OFFICE 20 (36C260) has announced on 02 Mar 2021
that is accepting bids for the following project: W065--668-21-3-1069-0006 Cardiac Event Monitoring Products and Services.
The tender will take place in United States
and will cover the Pharmaceutical & Medical industry.
The value of this project has not been disclosed by the donor and you can apply until Deadline date
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Location: United States
VETERANS AFFAIRS, DEPARTMENT OF.VETERANS AFFAIRS, DEPARTMENT OF.260-NETWORK CONTRACT OFFICE 20 (36C260)
Pharmaceutical & Medical
THIS IS A SOURCES SOUGHT NOTICE ONLY. This is not a solicitation for bids, proposals, proposal abstracts, or quotations. The purpose of this Sources Sought Notice is to obtain information regarding the availability and capability of all qualified sources to perform a potential requirement. The responses received from interested contractors will assist the Government in determining the appropriate acquisition method.
The intended contract period is a one-year base period plus (4) four one-year option periods.
The Department of Veterans Affairs (VA), Network Contracting Office (NCO) 20, is conducting market research to identify potential sources which can provide the following service (see draft PWS below)
Potential sources having the capabilities necessary to provide the services required are invited to respond to this Sources Sought Notice via e-mail to Shawn Fernandez at firstname.lastname@example.org no later than March 8, 2021 3pm Pacific. No telephone inquiries will be accepted.
A SOURCES SOUGHT QUESTIONNAIRE is below. Responses to the Questionnaire are encouraged from all interested parties. You are advised that providing responses to the questions will not automatically include you in the acquisition process for this solicitation. Please provide any additional feedback in your response that you feel is relevant.
Source Sought Questionnaire:
Company Name ___________________________________________
Phone Number ____________________________________________
Email Address ____________________________________________
* Proof of Systems for Award Management Registration (SAM) is mandatory*
1. Is your firm eligible for participation in one of the following small business programs? If so, please indicate the program. The North American Industry Classification System (NAICS) code is tentatively 621999 All other miscellaneous Ambulatory Healthcare Services; the small business size standard for this NAICS is $16.5 Million.
A size standard, which is usually stated in number of employees or average annual receipts, represents the largest size that a business (including its subsidiaries and affiliates) may be to remain classified as a small business for Small Business Administration and federal contracting programs. The definition of "small" varies by industry.
[ ] yes [ ] no Small Business (SB)
[ ] yes [ ] no HUBZone
[ ] yes [ ] no Small Business 8(a)
[ ] yes [ ] no Small Disadvantaged Business (SDB)
[ ] yes [ ] no Economically Disadvantaged Women-Owned Small Business (EDWOSB)
[ ] yes [ ] no Women-Owned (WO) Small Business
[ ] yes [ ] no Service-Disabled Veteran Owned Small Business (SDVOSB)
[ ] yes [ ] no Other (please specify)
2. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services under the same or a related NAICS codes.
3. Identify any other companies owned (wholly or in-part) by the owners of this business who provide goods or services that are registered under the same or a related NAICS code with the Center for Veterans Enterprise (CVE); Provide the certification type (SDVOSB/VOSB), Federal Identification Number, and state of incorporation for each.
4. Do you plan on responding to a solicitation for this requirement with a Joint Venture utilizing multiple owned companies as majority or non-majority owner?
Yes ___No ___ If yes, please identify which companies are considering a Joint Venture and the ownership of each company.
5. If your company were selected, how many calendar days would your company need after the contract award date before completing providing services?
_____ 15 days _____ 30 days _____45 days _____other (please list)
6. In your opinion, what are the risks associated with this effort? Comment on any current or potential technical, cost, schedule, or performance risks that you would like to make the Government aware of that concerns Readjustment Counseling Services.
7. Provide any additional feedback that you feel is relevant (i.e., problems or any other issues experienced with similar contracts).
Note: Do not include Proprietary, classified, confidential, or sensitive information in responses.
PERFORMANCE STATEMENT OF WORK (PWS)
CARDIAC EVENT MONITORING
The purpose of this contract is to provide cardiac monitoring services to patients serviced by the Mann-Grandstaff VAMC Healthcare System.
The Contractor shall provide all equipment needed for 30 day wireless and looping event monitor testing, either by hospital delivery or direct mail out to patients. The contracted company will provide continuous twenty four hour physical observation of rhythm strips and immediately inform a representative from the vascular lab, AOD, or on call physician/department to any significant changes as specified by a doctor.
2. Contract Title
The contractor agrees in accordance with the terms and conditions stated herein, to furnish to the Department of Veterans Affairs, herein after called Mann-Grandstaff VAMC located at 4815 North Assembly Street, Spokane, Washington 99205, Cardiac Event Monitoring services as specified and at the prices specified in the schedule of services.
The Spokane VAMC requires approximately (15) wireless, (9) looping 30-day, and (30) patch-style event monitors in office at all times to be used by our veteran population. Monitors shall comply with industry standards for 2 channel wireless event monitoring and single 2 channel looping event monitoring. They shall be of such weight and size as to be user-friendly for our predominantly geriatric population. The monitor shall use batteries that are readily available, easily changed, and supplied by the contractor. They shall be capable of monitoring heart rates between 0-500 BPM and recording at least (1.5) minutes, including both pre and post symptoms.
At the beginning of the contract, and any time there is a change in the equipment, the contractor shall provide on-site training for VA personnel.
Contractor shall provide the monitors, which shall be kept on site at the Mann-Grandstaff VAMC, Coeur d Alene, Wenatchee, and our other rural health clinic and will be issued by Diagnostic Imaging Services (Vascular). The Point Of Contact for the Mann-Grandstaff VAMC is Stephany Slocum, or Michael Ricks, Health Technicians (509) 434-7339. Patients will use the event monitor for approximately 30 days before returning them to the Contractor, or Mann-Grandstaff VAMC using a postage-paid return container supplied by the Contractor.
Additional monitors may be needed during the contract period at times of high usage. In such situations, the Spokane VA will contact the contractor by phone, fax, or email to request additional monitors. The contractor will provide the requested monitors to the Mann-Grandstaff VAMC within 2-3 business days.
Both the patients and Mann-Grandstaff VAMC staff shall have toll-free 24 hour/7 day per week telephone access to the contractor s support staff who will supply help in resolving any monitoring problems.
The patient will call the staffed toll free 24 hour phone number to transmit recordings. Upon receipt of a recording, the contractor will review the ECG data and assess the patient s status using patient assessment techniques appropriate for the phone to determine the urgency of the situation. If it is determined to be potentially life-threatening (e.g. sustained tachycardia, significant bradycardia or pauses,) then the contractor will call the Mann-Grandstaff VAMC Officer of the Day at 509-434-7010. In such situations, the ECG rhythm is to be faxed to the VA within 10 minutes (509-434-7105 AND to 509-434-7131). In the event of life threatening dysrhythmias (such as sustained ventricular tachycardia) the vendor is expected to follow their standard policies in terms of instructing patients to go to the nearest medical facility or immediately calling 911).
All other transmissions determined to be routine (i.e. not potentially life threatening) are to be faxed within 24 hours of receipt to the Mann-Grandstaff VAMC Diagnostic Imaging department at 509-434-7105.
At the end of the 30 day monitoring period the patient will return the monitor to the Contractor or Mann-Grandstaff VAMC who in turn will return it to the contractor. Upon receipt of the monitor or notification of termination of the study the Contractor will then issue a replacement monitor within 2-3 business days. All patient supplies shall be included in the contract (e.g. monitor, holder, ECG electrodes, batteries, pre-postage paid shipping container).
Although the documentation and interpretation is completely through Spokane VA Medical Center, this contract will also cover Coeur d Alene, Wenatchee and our other rural health clinic VA patients. The main point of contact is the personnel within the vascular lab who, in turn, coordinates with Coeur d Alene, Wenatchee; rural health clinic s to ensure quality care and follow-up.
5. Specific Tasks
5.1 Process and Policy Management Control
5.1.1 - Integration Management Control Planning- Provide Cardiac event monitors for the vascular lab. Ability to keep floor stock up to par levels. The QASP (Quality assurance surveillance plan) will be utilized for quality assurance. Training will be provided by the contractor for any new software, event monitor, or new process being implemented by the contractor.
5.1.2 - Contract Management- Contractor will Provide a bi-monthly status, or as requested, to assist with monitoring the quality assurance, progress/status reporting and program reviews applied to this contract to the COR (Contracting officers representative) .
5.2 Patient Enrollment
5.2.1 Online Enrollment The Contractor shall provide means of online/fax patient enrollment for 30 day Event Monitor patient services for approximately 110 studies annually, with an approximate of 10% growth each year.
5.2.2 Online Access - Online access to database for Primary care providers, Mann-Grandstaff VAMC cardiologists, and vascular lab. Contractor will have 99% uptime of website.
5.2.3 Transmission Responsiveness/Timeliness Contractor shall provide live customer service to download transmissions within one minute.
5.2.4 Patient Service Contractor will have (24) twenty-four hour continuous live patient service availability to answer questions or help with proper monitor usage.
5.3.1 Patient Instructions - Complete and clear written instructions included with every monitor.
5.3.2 Equipment Distribution Contractor will supply a minimum of 10 event monitors for inventory to be applied in vascular Lab. Monitors will also be distributed to the outlying clinics, as well as ability for monitors to be mailed directly to the patient.
5.3.3 Equipment Supplies All necessary supplies, cleaned, reset monitors, and accessories in monitor package including, but not limited to, instructions, electrodes, batteries and diaries.
5.3.4 Equipment Condition Equipment shall be maintained in good working order. Equipment shall arrive in vascular lab/patients address that meets QA standards for cleanliness.
5.3.5 Equipment Inventory Contractor will supply inventory of monitors and needed supplies at all sites listed for distribution.
5.3.6 EKG tracings All wireless tracings are acquired in two simultaneous leads.
5.3.7 Monitor device configuration 30 day wireless and looping event recorders.
5.4 Report Management
5.4.1 Rhythm monitoring Contractor shall insure that tracings are monitored by trained personnel and overseen by a Cardiologist specialized in rhythm monitoring.
5.4.2 Quality Transmission of Tracing If indicated Contractor will provide verbal education to patient producing the highest quality tracing possible, with little or no artifact.
5.4.3 Report Information Contractor shall provide precise information, graphs and analysis as agreed upon between Company and Mann-Grandstaff VAMC Vascular Lab section and Cardiologist to fit need of studies.
5.4.4 Report Information Delivery - Prompt delivery of accurate reports either by fax, or On-Line acquisition as prearranged criteria 24 hours a day, 7 days a week, 365 calendar days of the year.
5.4.5 Equipment Compliance Review Contractor shall contact patients or vascular lab if no events are transmitted in the first week to ensure compliance, understanding, and quality.
5.4.6 Online Access/Event Monitor - Contractor shall provide 24 hours online access to full event monitor recording.
5.4.7 Urgent vs. Routine Notifications Contractor shall provide prompt and accurate notification for any urgent finding. Notification shall be by fax, e-mail and/or phone call to AOD (administrative officer of the day) or the Vascular Lab.
5.5.1 Invoice Billing - Invoices will be provided to Mann-Grandstaff VAMC monthly for Quality assurance, with all information required by COR for certifying invoices in Austin TX.
5.5.2 Pricing and Reimbursement Rates - Company will provide and adhere to agree upon reimbursement rates.
5.6 Customer Service
5.6.1 Help Desk/Phone Line Contractor shall provide live customer service phone lines that will be available for both patients and hospital employees 24 hours a day, 7 days a week, and 365 days of the year.
5.6.2 Urgent Notifications - In the event of any unexpected findings, key individuals will be alerted, vascular lab during business days M-F 0730-1630 PST, or the AOD after hours at the Mann-Grandstaff VAMC by the contractor.
6. Performance Monitoring
The Government is required to monitor contractor performance and certify the work was done in accordance with the contract. This monitoring is done by the COR.
6.1 Equipment Oversight
COR will randomly select one monitor every two weeks to audit for supplies, cleanliness and performance. Any deficiencies will be documented and immediately reported to Supervisor and Contracted Company. There will be no more than three deficiency reports in a rating period of six months.
6.2 Notification Oversight
Notification failures will require written documentation from the contracted company stating reason for failure and an outline of the process implemented to eliminate issue in the future.
6.3 Rhythm Strip Oversight
COR will randomly select three monitor reports per month to ensure proper process are being followed for rhythm interpretation. The results of these reports will be sent to the vascular lab supervisor. Any deficiencies will be reported to contract Company for follow-up, and documentation outlining the process adjustment to eliminate this issue
7. Security Requirements
7.1 Patient Information Mail out Material
The COR shall develop and implement procedure to insure that no sensitive patient identifying information is sent out in the mail. Any breaches will be immediately reported and remedied. There will be no more than one breach per rating period (six months).
7.2 Patient Information Secure online program
Contractor shall provide an online system that adheres to all standards and policies set by Mann-Grandstaff VAMC Information Security Officer. Any breaches shall be immediately reported and remedied. There shall be no more than one breach per rating period (six months).
7.3 Patient Information Online access of VA and contract company employees
Only Mann-Grandstaff VAMC and contract company employees with a need to know shall have access to the online reporting system. All standards and policies set by VA Information Security Office regarding online system usage shall be strictly adhered to. Any breaches shall be immediately reported and remedied. There will be no more than one breach per rating period (six months).
7.4 Patient Information Faxing and phone usage -patient information
Contractor shall establish strict standards and procedures for contractor employees, which will be set and followed to ensure patient confidentiality. Any breaches shall be immediately reported and remedied. There shall be no more than one breach per rating period (six months).
7.5 Patient Information Patient reports
Contractor shall establish strict standards and procedures in regards to patient reports to ensure patient confidentiality. Any breaches shall be immediately reported and remedied. There shall be no more than one breach per rating period (six months).
7.6 Secure Patient Information Unescorted access to Spokane VAMC facilities
Strict standards to professionalism and patient confidentiality will be adhered to when visiting any Spokane VAMC facilities.
8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI)
There will be no government furnished equipment with this contract.
9. Other Pertinent Information or Special Considerations
9.1 Identification of Non-Disclosure Requirements
The contractor will have access to a significant amount of personal patient information, including full names, birthdates, diagnoses, addresses.
9.2 Packaging, Packing and Shipping Instructions
The contractor shall provide a consistent inventory, whether it is by personal drop off or mail. The contractor shall provide a postage paid process to return monitors for cleaning and interpretation.
9.3 Inspection and Acceptance Criteria
The COR will be responsible for periodically inspecting and certifying that the contracted company is performing to pre-arrange upon standards in regards to timeliness, quality and performance.
10. Risk Control
The Contractor shall be responsible for the proper cleaning and disinfection of equipment prior to each patient use, or as mandated by RME (reusable medical equipment) standards.
11. Place of Performance.
The contractor will only be providing equipment and off site monitoring. No travel fees will apply. All delivery, disposable items, and equipment are included in the item price.
12. Period of Performance -Base year plus (4) four additional option years.
QUALITY ASSURANCE SURVEILLANCE PLAN
For: Medical Services
Contract Number: < Upon award, Government will enter contract number>
Contract Description: CARDIAC EVENT MONITORING
Contractor s name: Upon award, Government will enter
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.
Organization or Agency: Department of Veterans Affairs, Office of Acquisition and Materiel Management
b. Contracting Officer s Technical Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor s performance. The COR shall keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government s behalf.
c. Other Key Government Personnel -
3. CONTRACTOR REPRESENTATIVES
The following employees of the contractor serve as the contractor s program manager for this contract.
a. Program Manager Jessica Ihnen COR
b. Other Contractor Personnel William Pochis, MD Cardiology Supervisor; Paul Phelps Vascular Technician; Michael Ricks Vascular Technician
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 Performance Requirements Summary Matrix, paragraph 4, in the Performance Work Statement (PWS), includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).
Acceptable Quality Level
Method of Surveillance
All request for additional monitors shall be provided within 48 hours of the requested desired date
100% of the of the Cardiac monitors requests will be monitored
Observation and random inspection. (auditing)
Continued contract performance
System dependability also impacts access to requested services. Therefore the contractor shall provide system with an overall minimum uptime of 98%
100% of the equipment and availability (denominator) and equipment failures when issued (Numerator) will be monitored on a monthly basis. The uptime data report shall be provided to the COR quarterly. The report shall be submitted within 10 business days after the end of each quarter.
Observation and random inspection (auditing)
Continued contract performance
100% of exams shall have a verified report within 24 hours. Reports with abnormal assessments based established parameters shall be communicated within 30 minutes.
100% of exams will be monitored on a monthly basis (denominator). The event/transmission date and reported date will be utilized to determine non-compliance (Numerator). The data will be aggregated for all exams each month and reported to the COR quarterly and submitted within 10 business days after the end of each quarter.
Observation and random inspection (auditing)
Notified by staff that physician did not respond to department in a timely manner
Continued contract performance
Patient complaints about the quality of care are reported to Patient Advocate, the COR, and the Contractor Patient for resolution.
All patient complaints are reported immediately (within 24 hours.)
User survey, observation investigation and contacting patient
Continued contract performance
The Government shall use continued contract 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 COR shall use the surveillance methods listed below in the administration of this QASP.
1, 2, 3, 4, 5, 6
a. DIRECT OBSERVATION. (Can be performed periodically or through 100% surveillance.)
1, 2, 3, 4
b. PERIODIC INSPECTION. (Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)
1, 2, 3, 4
c. USER SURVEY. (Combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction. May also generate inspections and sampling.)
d. VALIDATED USER/CUSTOMER COMPLAINTS. (Relies on the patient to identify deficiencies. Complaints are then investigated and validated.)
e. 100% INSPECTION. (Evaluates all outcomes.)
f. PERIODIC SAMPLING. (Variation of random sampling. However, sample is only taken when a problem/deficiency is suspected. Sample results are applicable only for the specific work inspected. Since sample is not entirely random, it cannot be applied to total activity performance.)
1, 2, 3
g. RANDOM SAMPLING. (Designed to evaluate performance by randomly selecting and inspecting a sample of cases.
1, 2, 3
h. Analysis of contractor's progress reports. (Evaluate cost, schedule, etc.)
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:
Observation and random inspection (auditing). User survey, observation, investigation.
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 COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.
When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's program manager.
The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. 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 COR will periodically analyze whether the negotiated frequency of surveillance is appropriate for the work being performed.
b. Frequency of Performance Assessment Meetings.
The COR shall contact/meet with the contractor at least monthly to assess performance and shall provide a written assessment.
Signature Contractor Program Manager
Signature Contracting Officer s Representative
This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.