SOURCES SOUGHT
65 -- PureClear Digital Inspection Scopes Brand Name This is not a Request for Quote
- Notice Date
- 4/12/2022 11:54:51 AM
- Notice Type
- Sources Sought
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- 244-NETWORK CONTRACT OFFICE 4 (36C244) PITTSBURGH PA 15215 USA
- ZIP Code
- 15215
- Solicitation Number
- 36C24422Q0608
- Response Due
- 4/19/2022 1:00:00 PM
- Archive Date
- 04/29/2022
- Point of Contact
- Andrew Taylor, Contracting Officer, Phone: 724-841-7191
- E-Mail Address
-
andrew.taylor3@va.gov
(andrew.taylor3@va.gov)
- Awardee
- null
- Description
- THIS IS NOT A SOLICITATION ANNOUNCEMENT. THIS IS A REQUEST FOR INFORMATION ONLY. This Request for Information (RFI) is intended for information and planning purposes only at this time; and shall not be construed as a solicitation or as an obligation on the part of the Department of Veterans Affairs. Because this is a Request for Information announcement, no evaluation letters and/or results will be issued to the respondents. No solicitation exists. Therefore, do not request a copy of a solicitation. STATEMENT OF WORK VA Pittsburgh Healthcare System University Drive C Pittsburgh, PA 15240l General Specification for: Pure Clear Digital Inspection Scopes Requestor and Sterile Processing Service Chief: Charlene.Haynesworth@va.gov Program Manager: Tonya D. Johnson Tonya.Johnson3@va.gov Biomed Representative: VHAPTHBiomedicalEngineering@va.gov Facilities Representative: vhapthfmsmgrs-supvrs@med.va.gov Logistics Representative: VHAPTHLogisticsAST@va.gov Background/Scope: Sterile Processing Services at the VA Pittsburgh Healthcare System has a requirement for the purchase of brand name Pure Clear Inspection Scopes to improve clinical outcomes providing Sterile Processing staff the ability to perform additional diagnostics on surgical instruments to ensure bioburden and debris is completely removed. Pure Clear Inspection Scopes are needed to thoroughly check for debris and damage inside lumens which we currently do not have a means to check, as well as create a photo & video documented visual inspection protocol. Channels, connection ports, distal tips, and spaces behind elevator channels on any reusable device can be inspected. Justification: VA Pittsburgh Health System (VAPHS/646) surgical staff discovered bioburden on a surgical instrument. In the ensuing Issue Brief it was recommended by The National Program Office Of Sterile Processing (NPOSP) that borescopes be purchased as an inspection tool for SPS. The approval to purchase the borescope will ensure all debris is effectively and completely removed by providing a method to visually verify quality assurance inside of these reprocessed devices. Period of Performance: Pure Clear Borescope shall be delivered as soon as possible OR within 30 days After Receipt of Order Product Description: PureClear Inspection Scopes allow technicians and nurses to access and visually inspect tight internal channel surfaces of new, refurbished, loaned and repaired scopes and other minimally invasive surgical and diagnostic instruments. These hard-to-reach areas can be inspected to confirm functional integrity, ensure removal of all debris, and document the process, which helps meet device IFU and national guidelines. Multiple scope lengths and fiber and digital optics ensure that channels, connection points, distal tips, spaces behind elevator channels, and any small channels can be accessed, illuminated, inspected and documented with video and high-resolution photography. Documentation includes date, device ID, and time stamps for thorough microbiologic surveillance. PureClear Inspection Scopes help reduce the patient safety risks of cross-contamination from exposure to residual bioburden, and the potential added consequences of a healthcare-associated infection. They also reduce the number of reprocessing recalls and related surgical and procedural delays. Units are waterproof and our fiber optic version offers the smallest lumen size on the market (.86mm). 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 POCs once a ship date is established. The POC, Biomedical Engineering, Faculties and/or Logistics Representative shall be the only VA entity signing for freight received on this requirement. 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 POC. Failure the coordinate shipment with POC 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. Delivery Location: Delivery Location is as follows: at the VA Pittsburgh Healthcare System, University Drive C, Pittsburgh, PA 15240. Attn: Charlene Haynesworth (412-360-6615) or Tonya D. Johnson (412-360-6077 OR 412-822-1832) VA Pittsburgh Healthcare System, University Drive C, Pittsburgh, PA 15240 Final Location Sterile Processing AA122 and AA117 Bldg. 1 University Drive. UD Loading Dock address: 4100 Aliquippa Street Pittsburgh, PA 15219 BIOMED: Needs to Be Inspected by Biomed (AN315C) LOGISTICS: EE Tags would need to be assigned FMS: Perform installation of the following on eleven SPS clean side workstations and one Decon workstation: Install NUC Mini PC brackets to pegboards (4 screws with bolts to peg board)Install Ergotron arm (to pegboards 2 screws (2 screws and bolts.) VENDOR: Perform installation of the following on eleven SPS clean side workstations and one Decon workstation: Hook up and install borescopes and NUC Mini PC Kit. Perform in-service training of staff. 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. Contractor requirements prior to notice to proceed meeting Have VA approved form of identification Will need to wear a mask while on the premises and be screened on the way in each day. Contractor Personnel Security Requirements Contractor may not have access to the VA network or any VA sensitive information under this contract. Contractor owned computer equipment including laptops are not permitted to be connected to the VA network. Any removable storage device used in medical equipment must be scanned by Biomed or OIT. The following language from VA Handbook 6500.6 is required in this contract: Appendix C: Paragraphs #3a, #5h, #6a, #7a, #7d, #9(all) All Contractors must receive Privacy training annually using one of the following methods: 1. 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. 2. 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. Clinical Vendors (entering patient care areas/direct patient involvement): Vendor access to the VA Pittsburgh Healthcare System is generally by appointment only and requires credentialing through our vendor credentialing partner, Symplr at https://www.symplr.com/. Symplr registration is at cost to the vendor. Each vendor must complete all requirements of VAPHS in the Symplr system and be in a green light status to be on premises. In the event a vendor is red lighted, a replacement vendor must be substituted and in a green light status or the appointment will be cancelled. All vendors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite. Vendors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone once appointment has ended. Current cost $249/year (standard plan) Service (Non-Clinical) Vendors: Vendor access to the VA Pittsburgh Healthcare System requires credentialing through our vendor credentialing partner, Symplr at https://www.symplr.com/. Symplr registration is at cost to the vendor. Each vendor must complete all requirements of VAPHS in the Symplr system and be in a green light status to be on premises. In the event a vendor is red lighted, a replacement vendor must be substituted and in a green light status or the appointment will be cancelled. All vendors are required to check in at the Symplr kiosk using their smart phone (University Drive) or desktop check-in with Symplr login (Heinz) and obtain a day badge which will include date, time, and location of approved appointment. Company badge with photo ID is also always required to be worn while onsite. Vendors are only permitted to visit the location identified on their badge and must exit the facility promptly, checking out via their smart phone once appointment has ended. Current cost: $99/year. 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. 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. Negative COVID-19 viral test: The facility is recommending a negative COVID-19 viral test not more than 72 hours prior to presenting onsite for vendors who are required to be onsite. Request for Information Instructions The information identified above is intended to be descriptive, not restrictive and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112 (size standard of 1000 employees). Please answer the following questions: (1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? (2) Is your company considered small under the NAICS code identified under this RFI? (3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If not, Can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; Obtained an individual or class waiver? (4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). (5) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? (6) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to sub contracted work and completion of job. (7) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. (8) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? (9) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. (10) Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? (11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. (12) Please provide your DUNS number. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to no later andrew.taylor3@va.gov than, 4 PM Eastern Standard Time (EST) on April 19, 2021 with 36C24422Q0616 in the subject line. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Andrew Taylor. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. If a solicitation is issued, information will be posted on the beta.sam web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information or Questions will only be accepted in writing by e-mail to Contracting Specialist at andrew.taylor3@va.gov DISCLAIMER 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. 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. End of Document
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/4ca4941c6da3442fa4d745fd5edaab05/view)
- Place of Performance
- Address: VA Pittsburgh Healthcare System University Drive C, Pittsburgh 15214
- Zip Code: 15214
- Zip Code: 15214
- Record
- SN06296412-F 20220414/220412230107 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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