KR question and VA replies to anesthesia RFP.pdf

RFP #36C24125R0116-Anesthesia -Questions received from interested parties and VHA replies:

1. NAICS CODE AND SIZE STANDARD CONFLICT

The Combined Synopsis and the SF 1449 (Block 10) identify the acquisition as NAICS 339112 with a size standard of 1,000 employees. Provision 52.219-1 at Section E.8(b) instead states NAICS 339113 with a size standard of 800 employees. These are different industries and thresholds, and the difference affects small-business size determinations and eligibility under the Veterans Preference factor.

REQUEST: Please confirm the controlling NAICS code and size standard, and amend the conflicting reference.

NAICS 339112 with a size standard of 1000 employees are applicable to this

RFP.

At FAR Provision 52.219-1, remove NAICS 339113 and small business size standard of 800 employees and replace with NAICS 339112 and small business size standard of 1,000 employees.

2. CONTRACTING OFFICER EMAIL ADDRESS CONFLICT

The submission instructions in Section E.5 (A.1) and Additional Instructions #13 and #14 direct proposals and questions to sarah.scott@va.gov. Section B.1 and the Past Performance Questionnaire (Attachment 7) list sarah.scott1@va.gov.

REQUEST: Please confirm the correct email address for the Contracting Officer for both questions and proposal submission, to avoid non-delivery.

Confirm Contracting Officer’s correct email address is sarah.scott1@va.gov.

Confirm Contract Specialist’s email address is: melanie.stockman@va.gov

3. POINT-OF-CONTACT TELEPHONE CONFLICT

The Combined Synopsis lists 320-255-6309 for the Contract Specialist; the SF 1449 (Block 7b) lists 320-420-8478.

REQUEST: Please confirm the correct telephone number.

Confirm Contract Specialist’s correct phone number is: 320-420-8478 Confirm Contract Specialist’s email address: melanie.stockman@va.gov mailto:sarah.scott@va.gov mailto:sarah.scott1@va.gov mailto:sarah.scott1@va.gov mailto:melanie.stockman@va.gov mailto:melanie.stockman@va.gov

4. ADMINISTERING OFFICE / ADDRESS CONFLICT

The Combined Synopsis identifies the office as VHA Regional Procurement Office East, Building 32, Pittsburgh, PA 15215. The SF 1449 (Blocks 9 and 16) identifies NCO 1, 1 VA Center, Augusta, ME 04330.

REQUEST: Please confirm the office administering this action.

Confirm correct administering office as:

Veterans Health Administration Regional Procurement Office East Building 32 Suite 1A1111 1010 Delafield Road Pittsburgh PA 15215-1802

5. PAST PERFORMANCE - NUMBER OF REFERENCES (THREE vs. FIVE) Section E.5 (Volume II), the Section E.6 evaluation approach, and Attachment 4 (three reference blocks) all indicate three references. The Past Performance Questionnaire (Attachment 7) states "Maximum of Five References from Past Three Years."

REQUEST: Please confirm the number of past performance references the Government will accept and evaluate.

Clarification of Attachment 7:-offerors to submit a maximum of THREE (3) references from Past Three Years

6. CONSUMABLES SCOPE (CLIN 0019 SERIES)

The SOW (Sections 1.0 and 9.0) includes "consumables" within scope, and Attachment 5 provides a Consumables CLIN each year (0019/1019/2019/3019/4019, etc.) described narrowly as "Startup kits, filters/tubing/hosing." Section E.5 Additional Instruction 5(c) requests a "Complete list of consumables and supplies required for startup and operation (see also CLINS-tailorable)," and Instruction #11 requests all support items needed for the systems to be fully operational.

REQUEST: Please clarify (a) whether the Government expects offerors to load their full recurring consumable line under the Consumables CLIN, or only startup consumables necessary to make the system operational at acceptance; and (b) whether consumables not included on the awarded schedule would require a bilateral product-add/refresh modification under SOW Section 15.0 before they could be ordered.

ONLY STARTUP SUPPLIES ARE BEING REQUESTED.

SECTION 15 IS ONLY APPLICABLE TO THE EQUIPMENT AND IF THERE ARE

MODIFICATION, REMOVAL, OR RECALLS APPLICABLE TO THE STARTUP

SUPPLIES ON CONTRACT

7. ATTACHMENT 5 - YEAR STRUCTURE vs. PERIOD OF PERFORMANCE Attachment 5 enumerates ten separate "Contract Year" blocks (CY1-CY10) and provides both a "Price/Base Period" column and a "Price for Option Period" column for every year. The period of performance is described elsewhere (Section B.1, SOW 9.1) as a five-year base period plus one five-year option period.

REQUEST: Please clarify how offerors should populate the schedule - i.e., whether a single unit price per CLIN per year is expected across all ten years, or base-period and option-period pricing keyed to the 5+5 structure. Confirm which columns apply to CY1-CY5 versus CY6-CY10.

ATTACHMENT 5 WAS PROVIDED AS A SAMPLE PRICING STRUCTURE.

OFFERORS TO SUBMIT PRICING/QUOTE SHEET FOR EACH YEAR OF THE BASE

PERIOD. OPEN TO PROPOSALS FOR YEARS 6-10, THIRTY (30) DAYS PRIOR TO

EXERCISING THE OPTION PERIOD.

8. Could you provide clarification as to why this pricing structure was selected over a 5+5 structure with an Economic Price Adjustment?

THIS PRICING STRUCTURE WAS SELECTED FOR THIS PROCUREMENT BASED

ON THE GOVERNMENT’S NEEDS.

9. ATTACHMENT 5 – CLINs There seems to be a disconnect between the documents’ requirements for consumable supplies: SOW §9.0, when describing what VAMCs buy through the vehicle, lists “instruments, accessories, training, and maintenance services” but omits “consumables” — even though §1.0/§9.0 scope and Attachment 5 include them.

REQUEST: Please clarify if consumable supplies are included in this request.

YES CONSUMABLE SUPPLIES ARE INCLUDED IN THIS REQUEST

10. FDA "APPROVED" vs. "CLEARED" / 510(k)

SOW Section 1.0 and the SF 1449 refer to units that are "FDA approved," while MTR 1, SOW Section 7.0, and Additional Instruction #3 refer to FDA clearance and the 510(k) process. Anesthesia units are typically Class II devices cleared via 510(k) rather than PMA-approved.

REQUEST: Please confirm that evidence of FDA 510(k) clearance satisfies the FDA requirement.

THE FDA 510(K) CLEARANCE SATISFIES THIS REQUIREMENT.

11. SECTION 508 / ICT ACCESSIBILITY CHECKLISTS

Section E.15 (VAAR 852.239-75) requires offerors to submit "appropriate VA Section 508 Checklists ... in accordance with the checklist completion instructions," but no checklist template or instructions are included in the solicitation package.

REQUEST: Please provide (or link to) the specific VA Section 508/ICT checklist(s) and completion instructions required for this procurement.

REFERENCE SECTION E.15/VAAR CLAUSE 852.239-75 (a), which references http://www.section508.va.gov which includes the link for checklists.

12. RULES OF BEHAVIOR AND CSCA APPENDICES

Section B.3 (Item 9) requires covered personnel to sign the Contractor Rules of Behavior referenced as "Appendix E," and SOW Section 8.0 requires a Contractor Security Control Assessment (CSCA) per "Appendix B" of VA Handbook 6500.6. Neither appendix is attached.

REQUEST: Please provide or link to the referenced Rules of Behavior and the CSCA template/instructions.

CONTRACTOR RULES OF BEHAVIOR INCLUDED WITH AMENDMENT.

CONTRACTOR SECURITY CONTROL ASSESSMENT (CSCA) INCLUDED WITH

AMENDMENT.

http://www.section508.va.gov/

13. FAR 52.212-4 VERSION

Section E incorporates 52.212-1 as "(DEVIATION OCT 2025)" and 52.212-2 as "(DEVIATION AUG 2025)," but the Section C.1 addendum incorporates 52.212-4 in its NOV 2023 (pre-deviation) form.

REQUEST: Please confirm whether 52.212-4 is intended in the NOV 2023 version or the corresponding deviation version consistent with 52.212-1 and 52.212-2.

IN SECTION C.1-ADDENDUM-CORRECT FAR 52.212-4/CONTRACT TERMS

& CONDITIONS-COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

TO LIST DEVIATION DATE OF JUN 2026 (NOT NOV 2023)

14. ORCA REFERENCE

Section E.5 (cover-letter and Volume V instructions) directs offerors to provide an "ORCA document in SAM." The Online Representations and Certifications Application (ORCA) has been retired and consolidated into SAM.gov.

REQUEST: Please confirm that current SAM representations and certifications (FAR 52.204-7 / 52.204-8) satisfy this requirement.

Confirmation that evidence of current/active/valid SAM representations and certifications satisfies this requirement.

15. LEGACY IT SECURITY REFERENCES

Several IT security requirements cite superseded baselines and terminology: the Federal Desktop Core Configuration (FDCC) and "Internet Explorer 7 ... Windows XP and Vista" (Section B.3, Item 4.b); "Certification and Accreditation (C&A)" (Section B.3, Item 5) in lieu of current RMF Assessment & Authorization; and the "July 1, 2003" version of the 36 CFR Part 1194 accessibility standards (SOW Section 3.0.e), which conflicts with the current ICT standards referenced at Section E.15.

REQUEST: Please confirm that the currently applicable VA configuration baselines, RMF authorization process, and revised Section 508/ICT standards govern, and consider updating the cited references.

‘CERTIFICATION AND ACCREDITATION’-THIS TERM HAS BEEN RETIRED AND

SHOULD BE REPLACED WITH ‘ASSESSMENT & AUTHORIZATION’.

REFERENCED IN THE CURRENT 6500 IN THE ISSO SECTION (PG 13).

BASELINES: RELEVANT GUIDANCE FROM VA NOTICE 24-12 (ATTACHED)

MAKES CLEAR THAT VA SYSTEMS MUST ADHERE TO VA APPROVED

BASELINE CONFIGURATIONS AND UPDATES, PATCHING, INSTALLATION,

http://sam.gov/

AND OPERATION MUST NOT DEVIATE FROM CURRENT BASELINE

SETTINGS.

508 COMPLIANCE: SECTION 508 APPLIES TO ELECTRONIC AND

INFORMATION TECHNOLOGY (EIT) THAT IS: DEVELOPED, MAINTAINED,

PROCURED, OR USED BY FEDERAL AGENCIES AND INTENDED FOR USE BY

FEDERAL EMPLOYEES OR THE PUBLIC.

IF A MEDICAL DEVICE’S USER INTERFACE IS: ONLY ACCESSED BY TRAINED

CLINICIANS, NOT USED BY PATIENTS, NOT USED BY MEMBERS OF THE

PUBLIC, THEN IT IS GENERALLY NOT CONSIDERED COVERED EIT FOR

SECTION 508 COMPLIANCE PURPOSES.

16. May a non-OEM prime contractor submit a proposal using an identified anesthesia OEM as its authorized supplier/subcontractor, provided the OEM supplies the equipment and performs or supports the required installation, training, warranty, maintenance, cybersecurity, and nationwide service obligations?

YES, HOWEVER AN AUTHORIZED DISTRIBUTOR LETTER (ADL)

WILL BE REQUIRED TO CLARIFY AUTHORITY OF NON-OEM. A

NON-OEM WILL STILL NEED TO MEET ALL OF THE SOW

REQUIREMENTS AS IF THEY WERE THE MANUFACTURER.

17. Must an offeror propose the complete range of equipment/services contemplated by the RFP, or may an offeror propose one OEM anesthesia platform/family together with its associated accessories, monitoring, integration, installation, training, warranty, maintenance, consumables, and other supported options?

AN OFFEROR MUST PROPOSE THE COMPLETE RANGE OF

EQUIPMENT/SERVICES LISTED IN THE RFP PER ONE OEM. WE

ARE ONLY ACCEPTING FULL PROPOSALS PER OUR REQUEST.

NO PARTIAL PROPOSALS WILL BE ACCEPTED.

18. Is there a stated minimum guarantee, maximum contract ceiling, or estimated ordering volume/value for each resulting IDIQ award? If not stated elsewhere in the solicitation, can VA provide a planning estimate for anticipated equipment ordering volume over the base and option periods?

REFERENCE SECTION B FOR MINIMUM/MAXIMUM INFORMATION

19. For OEM-supported maintenance, installation, training, trade-in and integration services, may the prime incorporate its OEM/subcontractor’s published or negotiated pricing into the prime’s proposal and remain responsible to VA for overall performance and invoicing?

Yes, The awardee is responsible for meeting the SOW and the instructions in the proposal. See answer to question #17 above.

20. The solicitation establishes CLIN 0001 as an anesthesia machine and provides for evaluation of proposed unit prices based on the estimated quantities identified in Attachment 5. We respectfully request clarification regarding how offerors are to identify the specific configuration of the anesthesia machine proposed under CLIN 0001. Anesthesia machines are highly configurable medical devices. A base model may be offered with numerous manufacturer-specific options, accessories, software configurations, monitoring capabilities, ventilation features, mounting configurations, and other components. These items may each have a distinct OEM Part number and associated price. Accordingly, the description “anesthesia machine” alone may not uniquely identify the specific configuration being offered, including the options and components included in the proposed unit price.

We propose that the existing CLIN structure and price evaluation methodology remain unchanged. The OEM part numbers would simply be added to Attachment 5 as an additional product identification/reference field.

THE INTENT OF CLIN 001 IS TO ACCOMMODATE MULTIPLE ANESTHESIA MACHINE

CONFIGURATIONS OR BUILD SPECIFICATIONS, IN AS MANY VARIATIONS AS THE

VENDOR DETERMINES NECESSARY. VENDORS MAY PROPOSE AND PRICE COMPLETE

CONFIGURATIONS UNDER CLIN 001 AND 002 TO SUPPORT ANY APPLICABLE

CONFIGURATION OPTIONS. WHEN INDIVIDUAL COMPONENTS ARE PROPOSED, THE

VENDOR SHALL CLEARLY IDENTIFY WHICH COMPONENTS ARE COMPATIBLE AND

MUST BE ORDERED TOGETHER TO ENSURE ACCURATE, EFFICIENT ORDERING AND

ASSEMBLY.

21.In Section 0018 titled “Service Maintenance”-it states that service contracts (full coverage, first look, parts only, PM only, etc), corrective maintenance, preventative maintenance, emergency repair, service kits, software upgrades, parts, on-site support etc has a Unit of Measure is determined to be each hour. Can you confirm that UOM is in fact each hour?

THE UOM CAN BE HOUR, EACH OR WHATEVER MAKES SENSE FOR THIS SPECIFIC

OFFERING. AS AN EXAMPLE TIME AND MATERIALS PRICING SHOULD BE HOURLY BUT

A FULL SERVICE CONTRACT SHOULD BE EACH.

22. 12.3 states “VA requirements set forth in SOW”. Please identify where the additional testing and certification requirements are in the SOW.

REMOVE ‘VA REQUIREMENTS SET FORTH IN SOW’ FROM SECTION 12.3.

23.Section 12.4 states “The Contractor shall provide final acceptance test results and a summary signature page indicating completion by the Contractor. Will an email commissioning service order from a Field Service Engineer showing acceptance testing results satisfy this requirement?

YES

24. The 14.3 Response section mentions “OCONUS sites are considered Alaska, Hawaii and Puerto Rico. What is the response expectation for onsite service in OCONUS locations?

ALL SERVICE REQUIREMENTS ARE THE SAME REGARDLESS OF CONUS OR OCONUS.

UPDATE SECTION 14.3 DEFINITION OF OCONUS TO INCLUDE THE LOCATIONS OF

ALASKA, HAWAII, PUERTO RICO, VIRGIN ISLANDS, GUAM, PHILIPPINES, AMERCIAN

SAMOA, AND NORTHERN MARIANA ISLANDS.

25. Each CLIN will be evaluated using the estimated quantities provided in Attachment 5, Price Cost Schedule of the solicitation. Please identify where the estimated quantities are provided in the Price Cost Schedule so we have an estimate volume off which to base volume discounts.

OFFERORS SHOULD SUBMIT THEIR BEST PRICING AVAILABLE TO THE GOVERNMENT.

QUANTITIES ARE UNKNOWN-SEE MINIMUM GUARANTEES AND CEILING AS LISTED IN

RFP.

26. Regarding “PRICE EVALUATION APPROACH”, it mentions “The Government will evaluate price in accordance with FAR 15.404-1(b) to determine whether it is considered fair and reasonable’. What method will the Government use to determine what is ‘fair and reasonable’ ?

We will utilize numerous sources to review the pricing provided to determine whether or not it is considered fair and reasonable to the Government. Such sources include but are not limited to: VA historical data, contract pricing from FSS/GSA contracts and other available Government contract data.

LIST OF ATTACHMENTS FOR THIS AMENDMENT:

-CSCA CONTRACTOR SECURITY CONTROL ASSESSMENT

-CONTRACTOR RULES OF BEHAVIOR

-HANDBOOK 6500

-VA NOTICE 24-12 UPDATE TO HANDBOOK