Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF MAY 08, 2022 SAM #7464
SOLICITATION NOTICE

65 -- Full and Open competition for BF-XT190 Therapeutic bronchoscope, 3.2 mm channel Pittsburgh VA Healthcare System

Notice Date

5/6/2022 8:12:08 AM
 

Notice Type

Presolicitation
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
 

ZIP Code

15215
 

Solicitation Number

36C24422Q0709
 

Response Due

5/13/2022 12:00:00 PM
 

Archive Date

05/16/2022
 

Point of Contact

Mr. LaShawn Knight, Contract Specialist, Phone: 240-215-8892 ext. 2199
 

E-Mail Address

lashawn.knight@va.gov
(lashawn.knight@va.gov)
 

Awardee

null
 

Description

Statement of Work VA Pittsburgh Healthcare System (VAPHS) SCOPE OF WORK AND GENERAL SPECIFICATIONS FOR BF-XT190 : Therapeutic bronchoscope, 3.2 mm channel Program Manager (Requestor): Angelica Howell Biomed Representative: VHAPTHBiomedicalEngineering@va.gov Logistics Representative: VHAPTHLogisticsAST@va.gov Contracting Officer s Representative (COR): Jason C. Tedrow Background VAPHS requires new medical equipment to BF-XT190 : Therapeutic bronchoscope, 3.2 mm channel. The current equipment is experience frequent failures and will not be supported in the future. Project Scope VAPHS requires the purchase of a BF-XT190 : Therapeutic bronchoscope, 3.2 mm channel. This bronchoscope is used to perform specific bronchoscopy procedures at the VHPHS The following requirements are needed: Provide one (1) Laser Cassette Printer which meets the specifications listed in section 3. Provide delivery of printer to VA Pittsburgh Healthcare System, Department of Pathology and Laboratory Medicine. The awarded vendor must install and provide instructions and/or training on the use of instrumentation supplied. Training will be provided at no additional cost. The awarded vendor must clearly indicate the terms of the standard warranty provided with the instrument. Information concerning extended warranty options, if available, may be provided. The warranty period begins on the date of installation. Specifications Rotary Function: Insertion tube rotation of up to 120° left and right may effectively reduce hand rotation* and supports easier insertion and positioning of endoscopic devices.The unit must be able to hold at least 100 cassettes Extra-large 3.2 mm Working Channel: Provide greater suction capability for therapeutic procedures performed by pulmonologists and thoracic surgeons. High-resolution Image: Excellent image quality comparable to our previous generation model of the same size. Electronic Magnification: Close-up observation of bronchial surfaces is readily available with 1.2 x and 1.5 x electronic magnification. Delivery Location Attn: Angelica Howell VA Pittsburgh Healthcare System University Drive C Building 1 Pittsburgh, PA 15240-1001 Prior to delivery, Contracting Officer Representative and/or Business Manager shall receive shipping information from Contractor and forward to Logistics and Biomed using the emails listed above. The Contractor must comply and provide all necessary information to VAPHS. Otherwise, the delivery may be refused and require redelivery at no additional cost to the government. Safety Data Sheet (SDS) Contractor shall provide three (3) copies of each Safety Data Sheet for every product, chemical, etc. used on this project. SDS sheets shall be provided for any material on the same day those materials arrive on VA property. At no time shall the contractor have, or permit subcontractors to have, materials on station without SDS sheets. All instructions for use shall be followed. Products will not be used until SDS's are submitted to the COR. The contractor shall maintain a current, green in color, loose-leaf notebook on the job site at all times, which is readily available for viewing by the COR or VA Safety Officer. Delivery Coordination Normal business hours for acceptance of deliveries are 8:00am-3:30pm, Monday thru Friday excluding Federal Holidays. Deliveries must be coordinated in advance with COR once a ship date is established. The COR, Biomedical Engineering and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. The VA-issued purchase order number must be included in the packing slip. All items included in the requirement shall be shipped and delivered to site at same time. If deliveries must be broken into several shipments due to size, this must be coordinated in advance with the COR. Failure the coordinate shipment with COR, may result in failure to deliver on site and cause re-scheduling of delivery/freight at no charge to the government. The packing slip must include the VA-issued purchase order number Additional Charges There will be no additional charge for time spent at the site during, or after the normal hours of coverage awaiting the arrival of additional FSE and/or delivery of parts or installation. Packaging Waste management Contractor shall remove packaging materials and all shipping debris from site and dispose of at appropriate recycling facilities. Contractor shall collect and separate for disposal all paper, plastic, polystyrene, corrugated cardboard, packaging material in appropriate bins for recycling on site if available. Contract shall fold metal and plastic banding, flatten and place in designated areas for trash. Estimates Vendors will submit one quote. In the quote, vendors will indicate whether their solution has MET, NOT MET or MET WITH QUALIFICATIONS for each line item in this document (MET WITH QUALIFICATIONS will require a detailed listing of non-compliance). In addition, vendors will complete the Instructions to Offertory s (ITO) and respond in detail to each question. Vendors are required to respond to each item individually in both documents. Include the specification/question number and text in your response document to facilitate review. Symplr The vendor will be required to register on the Symplr website https://www.symplr.com/. Symplr will be used to monitor vendor compliance with vaccination and HIPPA requirements listed below. 11. Influenza Vaccination VHA Directive 1192 requires all health care personnel (HCP) to participate in the seasonal influenza prevention program and outlines the key implementation steps. Health care personnel is defined in VHA Directive 1192 as all VA licensed and unlicensed, clinical and administrative, paid and unpaid, full- and part-time employees, intermittent employees, fee basis employees, VA contractors, students, researchers, volunteers, and trainees who work in VHA locations. HCP covered by the policy are expected to receive annual influenza vaccination. This requirement is extended to all Contractor personnel with potential to come into minimal contact (passing in the corridor) with any patients, visitors, or staff members at VAPHS. Those individuals unable or unwilling to be vaccinated are required to wear a face mask throughout the influenza season. Masks are available at entrances throughout the medical center. It is the responsibility of the contractor to ensure that all contract staff is compliant with the requirements outlined in VHA Directive 1192. The contractor shall maintain the following documentation: - Documentation of vaccination, e.g., signed record of immunization from a health care provider or pharmacy, or a copy of medical records documenting the vaccination. - Completed Health Care Personnel Influenza Vaccination Form (Attachment B of VHA Directive 1192) if unwilling or unable to receive the vaccine. The contractor is required to submit annual certification in the form of a memorandum to the Contracting Officer s Representative (COR) that all contract staff performing services at VA facilities is in compliance with VHA Directive 1192. 12. Tuberculosis Prevention Standard Personnel Testing (PPD, etc.): Contractor shall provide proof of the following tests for personnel within five (5) calendar days after contract award and prior to the first duty shift to the COR and Contracting Officer.  Tests shall be current within the past year. TUBERCULOSIS TESTING:  Contractor shall provide proof of a negative reaction to PPD testing for all contract personnel.  A negative chest radiographic report for active tuberculosis shall be provided in cases of positive PPD results.  The PPD test shall be repeated annually. RUBELLA TESTING:  Contractor shall provide proof of immunization for all contract personnel for measles, mumps, rubella or a rubella titer of 1.8 or greater.  If the titer is less than 1.8, a rubella immunization shall be administered with follow-up documentation to the COR. Please provide a signed memo stating that: (number of assigned Key Personnel) assigned to VA Contract #___________ have tested negative for tuberculosis within the past 365 days. (number of assigned Key Personnel) assigned to VA Contract #___________ have been immunized for measles, mumps, rubella or a rubella titer of 1.8 or greater. 13. COVID 19 Contractor shall provide evidence of vaccination records or a negative COVID testing result within 72 hours of planned onsite visitation. This is to include installation, training, maintenance and repairs. Emergency repairs will be evaluated on a case by case situation. 14. HIPAA Training Certificates If Contractor will be working onsite for installation and activation of equipment, all HIPAA training completion documentation must be provided to the COR listed in the awarded contract. 15. Smoking All VA Pittsburgh property is smoke-free. Contractor personnel will comply with VA Pittsburgh smoking policies. Violations will result in a warning and possible citation. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data- General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. 6. SECURITY INCIDENT INVESTIGATION a. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 7. LIQUIDATED DAMAGES FOR DATA BREACH a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $______ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least three (3) relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 9. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors Contractor employees who work in or travel to VHA locations must comply with the following: Documentation requirements: If fully vaccinated, shall show proof of vaccination. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination. If unvaccinated and granted a medical or religious exception, shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor s order or an FDA approved over-the-counter test. Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel. Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.  Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.  Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/3fe98da68d6c4b5196f491e7d2978f2f/view)
 

Place of Performance

Address: Department of Veterans Affairs Pittsburgh VA Healthcare System University Drive C, Pittsburgh 15240-1003, USA

Zip Code: 15240-1003

Country: USA
 

Record

SN06320165-F 20220508/220506230058 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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