36C24522Q0576.docx

SUBJECT*

Neuro-Surgical Drills & Attachments

GENERAL INFORMATION

VA Maryland Health Care System Contracting Officer (90C) P.O. Box 1000, Bldg. 101b, Room 8 Perry Point MD 21902

POINT OF CONTACT*

Rebecca Gobble

PLACE OF PERFORMANCE

10 North Green Street

Baltimore, Maryland

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

EMAIL DESCRIPTION

DESCRIPTION

Please see attached RFQ 36C24522Q0576.

Service-Disabled Veteran Owned Small Business Set Aside

Responses are due by 05/20/2022 at 5:00 P.M. EST.

Please send email responses to Rebecca.Gobble@va.gov

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as an RFQ. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2021-05.

Note to CO: Obtain the most recent Federal Acquisition Circular (FAC) from ACQUISITION.GOV Federal Acquisition Regulation

This solicitation is set-aside for Service-Disabled Veteran Owned Small Business Set-Aside.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112.

The FSC/PSC is 6515.

The Baltimore VA Medical Center is seeking to procure the CORE 2 console powered instrument driver and its associated drills and attachments. This system increases the ability to efficiently and more effectively be utilized within numerous surgical specialties without surgeons needing to reach for different systems for bone sawing and drilling. The CORE 2 console powered instrument driver and its associated drills and attachments provides a wide range of surgical applications including specialties like NSE high speed drills, ENT shavers, Joint shavers and bone mills. This system utilizes smart programming that auto-activates the screen on the CORE 2 device to allow the system to display its presets based on the instrument itself or the surgeon profile that it is attached to. The Baltimore VA Medical Center is looking to procure the CORE 2 console powered instrument driver and its associated drills and attachments

All interested companies shall provide quotations for the following:

Supplies/Services

PI Drive 2 Plus Motor (Product # 5407-350-000)

Core Saber Handswitch (Product # 5400-121-000)

Straight Attachment (Product # 5407-120-450)

Elite 7CM Angled Attachment (Product # 5407-120-452)

Elite 12CM Straight Attachment (Product # 5407-120-470)

Elite 12CM Angled Attachment (Product # 5407-120-472)

Elite 14CM Straight Attachment (Product # 5407-120-480)

Elite 14CM Angled Attachment (Product # 5407-120-482)

Elite 20CM Angled Attachment (Product # 5407-120-492)

HD 14CM Angled Attachment (Product # 5407-120-072)

HUB (Product # 5407-120-300)

Footed Attachment 16MM (Product # 5407-FA2-000)

Footed Attachment 25MM (Product # 5407-FA3-000)

Maestro Perforator Chuck (Product # 5400-210-060)

Signature Sterilization Tray-large (Product # 5407-478-000)

Signature Sterilization Tray-small (Product # 5407-476-000)

CORE 2 Console (Product # 5400-052-000US)

CORE Footswitch (Product # 5402-007-000)

EA

EA

Statement of Work

1. PURPOSE:

0. The overall purpose of this requirement is to procure a Neuro Surgical Drill System replacement to be deployed at the VA Maryland Health Care System (VAMHCS). These specific Neuro Surgical Drill Systems will be utilized within the operating suites located at the Baltimore VA Medical Center. The requirement will account for the procurement of the Neuro Surgical Drills, Neuro Surgical drill motors, hand switched, various hand attachments (angled and straight), various foot attachments, a chuck, sterilization trays, powered instrument drivers, accessories, assembly, and validation.

1. SCOPE:

1. The contractor shall deliver and install the system with all specified salient characteristics. Only new equipment will be accepted.

1. The contractor shall provide shipping, transport, installation, and all equipment necessary to meet the requirements and capabilities listed within the scope.

1. The assembly and validation of the system must be performed by a vendor service trained representative.

1. The contractor is responsible for identifying any missing parts or components not included in the order for the Neuro Surgical Drill Systems to be successfully installed and validated to their full potential.

1. The contractor shall include accessories and consumables for initial deployment of the Neuro Surgical Drill Systems. Contractor shall include accessories and consumables the Neuro Surgical Drill Systems.

1. SALIENT CHARACTERISTICS:

5. Five (5) Drill Electric Motors that are technically equivalent to:

0. Manufacturer: Stryker

0. Model: PI Drive + Motor

1. Maximum speed of 75K RMP

1. Detachable Hand switch

5. Five (5) Hand switches that are technically equivalent to:

1. Manufacturer: Stryker

1. Model: CORE Saber Handpiece

5. Five (5) 7cm Straight Attachments and Five (5) 7cm Angled Attachments that are technically equivalent to:

2. Manufacturer: Stryker

2. Model: Elite Straight Attachment

2. Model: Elite 7cm Angled Attachment

5. Five (5) 12cm Straight Attachments and Five (5) 12cm Angled Attachments that are technically equivalent to:

3. Manufacturer: Stryker

3. Model: Elite 12cm Straight Attachment

3. Model: Elite 12cm Angled Attachment

5. Five (5) 14cm Straight Attachments and Five (5) 14cm Angled Attachments that are technically equivalent to:

4. Manufacturer: Stryker

4. Model: Elite 14cm Straight Attachment

4. Model: Elite 14cm Angled Attachment

5. Five (5) 20cm Angled Attachments that are technically equivalent to:

5. Manufacturer: Stryker

5. Model: Elite 20cm Straight Attachment

5. Five (5) HD 14cm Angled Attachments that are technically equivalent to:

6. Manufacturer: Stryker

6. Model: HD 14cm Straight Attachment

5. Five (5) HUBs that are technically equivalent to:

7. Manufacturer: Stryker

7. Model: HUB

5. Five (5) 16mm Footed Attachments that are technically equivalent to:

8. Manufacturer: Stryker

8. Model: Footed Attachment 16mm

5. Five (5) 25mm Footed Attachments that are technically equivalent to:

9. Manufacturer: Stryker

9. Model: Footed Attachment 25mm

5. Five (5) Large Sterilization Trays that are technically equivalent to:

10. Manufacturer: Stryker

10. Model: Signature Sterilization Tray-Large, Full

5. Three (3) Small Sterilization Trays that are technically equivalent to:

11. Manufacturer: Stryker

11. Model: Signature Sterilization Tray-Small, ½

5. Four (4) Powered Instrument Driver that are technically equivalent to:

12. Manufacturer: Stryker

12. Model: CORE 2 Console

5. Four (4) Foot Switches that are technically equivalent to:

13. Manufacturer: Stryker

13. Model: CORE Footswitch

5. Five (5) chucks that are technically equivalent to:

14. Manufacturer: Stryker

14. Model: Maestro Perforator Chuck

5. All Manuals (Service/Maintenance and Operation Manuals)

5. Disposables for implementation

1. IMPLEMENTATION AND INSTALLATION

6. Installation and validation shall be included in the procurement cost and shall include but not limited to:

0. Programming of the Neuro Surgical Drill Systems.

0. All materials required to assembly the Neuro Surgical Drill Systems shall be provided by the contractor.

1. TRAINING

7. The contractor shall provide onsite training for the VAMHCS operating suite staff on the operation of the medical equipment.

7. Biomedical Engineering training for the Baltimore VA Medical Centers Biomedical Equipment Support Specialists (BESS) on maintenance and operating procedures.

1. DELIVERY

8. The contractor shall deliver necessary equipment to the Baltimore VA Medical Center located at the following address below with at least a two week notice to the Biomedical Engineering team at the Baltimore VA Medical Center or the COR of this procurement.

Baltimore VA Medical Center ATTN: Biomedical Engineering (5B-183) Brian Ogle 10 North Greene Street Baltimore, Maryland 21201

8. The contractor shall deliver equipment and all items required for installation only when the site is ready for installation to proceed. This includes a two week notice from the vendor to the site detailing the delivery information of the equipment detailed in this procurement.

8. The contractor shall coordinate all deliveries, installation, and parking arrangements with the COR.

8. Delivered materials will arrive in manufacturer’s original sealed containers with the associated purchase order number listed on the outside of the box.

8. The contractor shall conduct a joint inspection with the COR upon delivery of the equipment and shall provide the COR a list of missing or damaged items found upon inspection. This inspection will need to be scheduled prior to the vendor representative arrives to the Baltimore VA Medical Center.

8. The contractor shall remove all related shipping debris and packing from the VAMHCS facilities.

1. SITE CONDITIONS

9. There shall be no smoking on hospital property at any time.

1. INSPECTION AND ACCEPTANCE

2. The contractor shall conduct a joint inspection with the COR upon delivery equipment.

2. The contractor shall provide the VA COR a list of missing and /or damaged items found upon inspection and have those items replaced at no cost to the Government.

2. The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the VA Contracting Officer.

1. DELIVERABLES

3. Operation and Maintenance Manuals

0. Deliver compilation of all manufacturer recommended maintenance schedules and operation materials packaged upon delivery. Manuals shall be made available in an electronic format.

1. OPERATOR TRAINING

4. Onsite education and training by a vendor service trained representative will be provided to VAMHCS clinical staff. The scheduling of operator training shall be coordinated with the VAMHCS clinical staff after delivery and installation.

4. Onsite education and training by a vendor service trained representative shall be provided to the VAMHCS Biomedical Engineer Shop, including the Biomedical Equipment Support Specialists (BESS). The scheduling of service training shall be coordinated with the COR or Lead BESS located at the Baltimore VA Medical Center after delivery and installation.

1. PROTECTION OF PROPERTY

5. The contractor shall protect all items from damage. The contractor shall take precaution against damage to the building(s), grounds and furnishings. The contractor shall repair or replace any items related to building(s) or grounds damaged accidentally or on purpose due to actions by the Contractor.

1. SECURITY REQUIREMENTS

6. The contractor must have a photo ID available when performing work at the VA Medical Center and be willing to present it to VA staff.

6. The contractor is responsible for providing any personal protective equipment (PPE) that is deemed necessary to complete tasks stated in this requirement.

6. The contractor must follow the VA Maryland Health Care Systems current COVID-19 guidance for entry to any medical center or Community Based Outpatient Clinic (CBOC).

1. WARRANTY

7. At a minimum, Neuro Surgical Drill Systems, accessories and handpieces must include a 1-year warranty on all parts and labor at no cost to the Government.

7. The warranty shall begin upon completion of validation testing.

7. Warranty shall include onsite repairs and over the phone support.

7. Contractor shall provide routine maintenance service program during warranty period.

7. All repairs shall be performed by a vendor or contractor which has been certified by the vendor to perform the repairs.

7. The warranty shall include all travel and shipping costs associated with any warranty repair.

Place of Performance/Place of Delivery

10 North Greene Street Baltimore, MD

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items”

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items”

3. FAR 52.211-6, “Brand Name Or Equal”

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” 03/11/2021

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” 03/11/2021

· FAR 52.211-6 “Brand Name Or Equal”

VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, shall show proof of vaccination.

i. 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.

2) 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.

3) 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.

4) 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.

2. 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.

a. 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.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

The following subparagraphs of FAR 52.212-5 are applicable:

All quoters shall submit the following: Please see below information in accordance to FAR 52.212-1(b).

Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

At the very least the device should have the following characteristics as shown below.

The following are the decision factors:

· All items provided should match or be equivalent to the salient characteristics as listed above under the statement of work section.

· Vendor must provide On Site Education and Training for the Equipment Supplied.

· The drills and attachments provided should offer a wide range of surgical applications that can easily be interchangeable between the sets.

· The equipment and system should be easily interchangeable and have the ability to be swapped to meet the surgeons’ preferred settings.

The award will be made to the response most advantageous to the Government.

Responses should contain your best terms, conditions and shipping costs.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show—

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender’s request and expense, unless they are destroyed during pre-award testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with subpart 4.10 of the Federal Acquisition Regulation), or alternative commercial items for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoters shall list exception(s) and rationale for the exception(s), if any.

Submission of your response shall be received no later than 05/20/2022 at 5:00 P.M. EST. to Rebecca.Gobble@va.gov

Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

(f) Late submissions, modifications, revisions, and withdrawals of offers.

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers, or revisions are due.

Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below.

Point of Contact Rebecca Gobble, Contracting Officer, 410-642-2411 x26534, Rebecca.Gobble@va.gov

VHAPM Part 813.106 SAP: Soliciting Competition & Evaluation of Quotations SOP Original Date: 10/12/17 Revision 04 Date: 06/10/20