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W065--Intent to Sole Source notice. V.A.C. Ulta™ Therapy Wound Vac rental services (new 5-year). Pittsburgh VA Medical Center. This is NOT a request for quotes.

Awarded
36C24421Q0165Federal

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This contract involves the rental of a negative pressure wound therapy system, specifically the V.A.C. Ulta Therapy Unit, for the Department of Veterans Affairs Pittsburgh Healthcare System (VAPHS) at two locations in Pittsburgh, PA. The contractor is required to provide daily rental services of the wound therapy devices under a firm fixed-price contract for a period aligned with the delivery schedule. The scope includes supplying eight spare devices for backup—a total of six at the University Drive campus and two at the H.J. Heinz campus—at no additional charge until the devices are actually used on patients. Devices must maintain specific operational standards, including monitoring and maintaining target pressure between -75 to -200 mmHg, with continuous and intermittent modes and alarm notifications for malfunctions. The contractor must ensure 24/7 availability, delivering and picking up equipment within strict timeframes and providing training to clinical staff annually or as needed. Additional contract requirements include compliance with VA privacy training and background checks for contractor personnel, adherence to stringent invoice procedures via the Tungsten electronic system, and strict billing guidelines prohibiting charges to veterans or their insurers beyond VA payments. The contractual terms emphasize the importance of records management in accordance with federal laws, ensuring all records created or handled during the contract are properly maintained and secured. The contract also incorporates COVID-19 safety protocols for entry to VA facilities, and the contractor is responsible for handling lost or unreturned devices with pro-rated replacement costs. Overall, this contract focuses on reliable, timely delivery and maintenance of wound therapy equipment, comprehensive training, regulatory compliance, and safeguarding of veteran interests and data security.

General Info

Rental of V.A.C. Ulta wound therapy units with backups, maintenance, training, and strict VA compliance.

Contract Value

$442,576.77

NAICS

339113 - Surgical Appliance and Supplies Manufacturing

Place of Performance

PA, USA

Set-Aside

NONE

Award Issued Date

Documents

1

36C24421Q0165 - V.A.C. Ulta Therapy Wound Vac Rental Services

DOCX, High priority: read this first8 pages · special-notice
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Organization & Contact Information

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AgencyDepartment Of Veterans Affairs → 244-NETWORK Contract Office 4 (36C244)
Contacts1 person available
OfficePITTSBURGH, PA, 15215, USA
Office AddressPITTSBURGH, PA, 15215, USA
Contacts
David M. SantiagoContracting Officer

Full Description

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Send a capability statement, no more than one page in length; to include Company Name Duns Number, Socioeconomic Category, brief description of your business entities capability to handle this particular project in the Pittsburgh PA area, website and GSA Contract number if applicable & contract number/information. Email to contact@example.gov with 36C24421Q0165 in the email Subject line, no later than 4:00 pm EST on Friday December 18, 2020. DRAFT STATEMENT OF WORK TITLE Rental of a negative pressure wound therapy system. LOCATION The Department of Veterans Affairs, VA Pittsburgh Healthcare System (VAPHS) - University Drive C, Pittsburgh, PA 15240 and H.J. Heinz 1010 Delafield Road, Pittsburgh, PA 15215. PERIOD of PERFORMANCE See delivery schedule TYPE of CONTRACT Firm fixed price SCOPE The contractor shall provide daily rental of negative pressure wound therapy device equipment for the VAPHS. The Contractor shall provide eight (8) spare negative pressure wound vacuum therapy devices at VAPHS location for backup six (6) spares at University Drive campus, two (2) in the Patient Care Coordinator (PCC) office and four (4) in the Operating Room) and H.J. Heinz campus is to have two (2) spares (at the nursing office), all at no charge. Charges begin once negative pressure wound therapy device is used on a patient. The negative pressure wound therapy device must monitor and maintain target pressure. DEVICE REQUIREMENTS V.A.C. Ulta Therapy Unit Negative pressure: -75 to -200mmHG With both continuous and intermittent operation Able to monitor pressure Alarm notification if equipment malfunctions DAYS AND HOURS OF OPERATION: The hours of operation will be 24 hours per day, 365 days per year to include weekends and holidays. DELIVERY, SET UP AND PICK UP Contractor must be able to deliver seven (7) days per week, 24 hours per day. The contractor shall provide eight (8) total at the two VAPHS location - stock negative pressure wound therapy devices to the VAPHS six (6) spares at University Drive C, Pittsburgh, PA 15240 and two (2) at H.J. Heinz 1010 Delafield Road, Pittsburgh, PA 15215. Once stock negative pressure wound therapy device is placed on a patient, the Contractor shall replace the stock within 24 hours. When additional multiple negative pressure wound therapy devices are needed, the Contractor shall deliver the device for the appropriate patient within four (4) hours of the rental order being placed by the Enterostomal Therapy Nurse, PCC or nursing unit management teams at the VAPHS University Drive and H.J. Heinz Campuses. The Contractor must pick up negative pressure wound therapy devices that are discontinued for an individual patient within 24 hours of being contacted by the Enterostomal Therapy Nurse, Patient Care Coordinator or nursing unit management teams at the VAPHS- University Drive and H.J. Heinz Campuses. EDUCATIONAL PROGRAM The Contractor shall be responsible for in-servicing/providing training to all clinical staff members on each of the contracted products. The goal of the training will be to understand the ordering procedure and protocols, clinical and therapeutic features, benefits of each product, and the appropriate utilization. The Contractor shall provide training to all clinical staff on annual basis or as needed. FIELD SERVICE PROGRAM Service will be provided by the Contractor s distribution center closest to VAPHS University Drive and H.J. Heinz Campuses. The estimated inpatient delivery response time is four (4) hours or less after receipt of order. An updated, estimated delivery time will be provided at the time of the order. The estimated inpatient pick-up response time is approximately 24 hours or less from receipt of discontinuation order. An updated, estimated delivery time will be provided at the time of the notification. CONTRACTOR TRAINING Complete VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information training by using VA s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain. Complete the hard copy version of VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information . Signed training documents must be submitted to the COR or designee. Training must be completed prior to the performance of the contract and annually thereafter. Proof of training completion must be verified and tracked by the COR or designee. CONTRACTOR BADGES A compliant ID badge must always be worn by Contractors while on VA premises. Of-306 AND SF86 must be completed for your background check (see attached OPM requirement) INVOICE Payment will be made upon receipt of a properly prepared, itemized invoice, validated by the technical point of contact. All invoices will be submitted by the fifth workday of the month. A properly prepared invoice will contain: Invoice Number and Date Contractor s Name and Address Accurate Obligation Order Number Itemized report of maintenance requests Itemized report of dates service performed Itemized report of supplies provided Patient s abbreviated name Building & Room # VAC serial # Start and End Dates Partial (P) Cost per daily rental Total number of rental days per unit Total amount due Vendor Electronic Invoice Submission Methods Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is +1 (555) 000-0000 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Taxpayer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review How to Create an Invoice within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official. The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements. For additional information, please contact: Tungsten Support Phone: +1 (555) 000-0000 Website: http://www.tungsten-network.com/uk/en/ Department of Veterans Affairs Financial Service Center Phone: +1 (555) 000-0000 Email: contact@example.gov Payment Adjustments: Invoices will be adjusted when the wound vac rental is discontinued and/or patient is discharged, ending the equipment rental charges. The contractor shall be paid only for actual use of the wound vac, not for storage of the wound vac. ****Lost wound Vacs: If a wound vac is lost or not returned to the vendor, the wound vac will be placed in the vendor s system as missing per the date after discharge of the patient or the date it is discovered missing. The price to replace the wound vac will be pro-rated according to manufactured date and replacement cost of the wound vac. Payments in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract. To the extent that the Veteran desires services which are not a VA benefit or covered under the terms of this contract, the Contractor must notify the Veteran that there will be a charge for such service and that the VA will not be responsible for payment. The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third- party insurance sources (including Medicare) for services rendered to Veteran enrollees under this contract. COVID-19 The VA has implemented an aggressive public health response to protect and care for Veterans, their families, health care providers, and staff in the face of this emerging health risk. We are working directly with the CDC and other federal partners to monitor the outbreak of the virus. Our Medical Center and Community Based Outpatient Clinics (CBOC) have made changes to promote safety in our facilities. We continue to implement and practice enhanced safety measures. Any person entering our facilities will be met by a staff member who will be greeted and asked screening questions along with temperature screening. Depending on the answers, a VA health care professional will assist on the next steps of your visit. Physical distancing, face covering or masking, and limiting the number of visitors is mandatory. Records Management Language for Contracts When Federal agencies acquire goods or services, they need to determine what Federal records management requirements should be included in the contract. Federal contractors often create, send, or receive Federal records. Federal contracts should provide clear legal obligations describing how the contract employees must handle Federal records. Agency records officers, procurement counsel, and acquisitions officers must discuss how to integrate records management obligations into their existing procurement processes. NARA has developed the following language to be included as an agency-specific term and condition in Federal contracts for a variety of services and products. The majority of contracts should include language on records management obligations, but each contract should be evaluated individually. For example, the data-rights paragraph (Paragraph 10 below) may not be appropriate for all contracts. Instead, agencies may be better served by one of the established data-rights clauses in the Federal Acquisition Regulations. This language should not replace specific records management requirements included within Federal information system contracts. RECORDS MANAGEMENT OBLIGATIONS A. - Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. - B. - Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. - The term Federal record: includes [Agency] records. does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract. may include deliverables and documentation associated with deliverables. C. - Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. [Agency] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [Agency] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of - any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [Agency] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [Agency] policy. The Contractor shall not create or maintain any records containing any non-public [Agency] information that are not specifically tied to or authorized by the contract. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. The [Agency] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [Agency] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. Training. - All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

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