C03 36C24526Q0297 0002 CRANIAL PROS AMEND - VENDOR QUESTIONS.pdf

5. PROJECT NUMBER (if applicable)

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

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is required to sign this document and return ___________ copies to the issuing office. is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER 16A. NAME AND TITLE OF CONTRACTING OFFICER

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IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer)

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0002 03-12-2026

19ACQ

Department of Veterans Affairs Perry Point VA Medical Center Contracting Office (19ACQ) 1 Boiler House Road, Bldg. 101C, Room 4 Perry Point MD 21902 Aria Melville, Contracting Officer

19ACQ

Department of Veterans Affairs Perry Point VA Medical Center Contracting Office (19ACQ) 1 Boiler House Road, Bldg. 101C, Room 4 Perry Point MD 21902

To all Offerors/Bidders 36C24526Q0297

03-12-2026 X

X X offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified. ** HOUR & DATE for Receipt of Offers is EXTENDED to: 03-20-2026 16:00 EDT x one (1)

The purpose of this amendment is to extend the solicitation response due date to March 20th, 2026 at 4pm ET.

The contractor is required to submit a copy of this amendment to the Contracting Officer signed as part of their final submission.

In addition, the Contracting Officer is addressing questions submitted by vendors in the pages following this SF-30.

The answers to these questions are final and no additional questions will be accepted nor will any additional extensions be granted.

Aria Melville Contracting Officer

Solicitation: 36C24526Q0297 Amendment: 0002 – Vendor Questions

Question 1 – Cosmetologist-Ownership / Oral Presentations The solicitation requires that oral presentations "must be delivered primarily by the key clinical personnel (e.g., licensed Cosmetologist(s))." However, under DC, Maryland, and Virginia cosmetology licensing laws, licensed cosmetologists who are employees (non-owners) cannot legally represent a business they do not own in official business proceedings.

The combined effect of this requirement is that only cosmetologist-owned businesses can comply. Is this the intended result? If not, will the VA amend the oral presentation requirement to allow company ownership/management to lead presentations, with clinical personnel available to demonstrate fitting techniques?

VA Response to Question 1:

VA requires key clinical personnel to lead oral presentations so it can directly assess the people who will actually measure, fit, customize, and style cranial prostheses, and this is not intended to limit awards to cosmetologist-owned businesses. Presentations may be jointly delivered, with clinical staff leading the clinical demonstration and fitting/styling discussion, while ownership/management covers business and administrative topics. The solicitation does not require any specific ownership structure or that licensed cosmetologists be owners. Offerors must still comply with DC/MD/VA licensing laws on how licensed practitioners may represent a business, and if they believe state law restricts employee-cosmetologists in “official business proceedings,” they may have ownership/management handle formal representation while clinical staff lead the clinical content.

Question 2 – Basis for Cosmetology / Trichology Requirements We have consulted with a DC/MD/VA-licensed cosmetologist who has declined to serve as key personnel because she does not believe her cosmetology license provides legal authority or liability protection for cranial prosthesis fitting. State cosmetology statutes define the practice as services on natural hair; veterans receiving cranial prostheses have no natural hair.

Please clarify the legal or regulatory basis for requiring cosmetology licensure for fitting manufactured medical devices on patients without natural hair.

VA Response to Question 2:

The PWS requires anyone who measures, fits, customizes, or styles cranial prostheses to hold a DC/MD/VA cosmetology license or IAT trichology certification, plus cranial prosthesis and scalp-health training, as a patient-safety and quality-of-care measure. VA is not redefining state cosmetology scope of practice but using these credentials as minimum qualification benchmarks to ensure training in infection control, appropriate scalp assessment within professional scope, and safe product selection. Contractors are responsible for ensuring their staff practice within state-law limits and carry any insurance or professional coverage they deem necessary; if one cosmetologist declines to participate, the contractor may propose other personnel who meet the same requirements.

We want to clarify that these are minimum contractor standards for safety and quality assurance and do not alter or expand any state scope-of-practice definitions.

Question 3 – Trichologist Alternative

The solicitation references IAT-certified Trichologists as acceptable practitioners. Please confirm: Does IAT (International Association of Trichologists) certification fully satisfy the licensure requirements under this solicitation, without the need for state cosmetology licensure?

VA Response to Question 3:

Yes. The solicitation expressly recognizes a “Certified verifiable Trichologist with a certification from the International Association of Trichologist (IAT) and at least 2 years of experience with cranial prosthesis measurement, fitting, customization, and initial styling for patients with medical hair loss” as an “Equivalent Acceptable” alternative to the highly preferred licensed cosmetologist profile. It further states that “any individual who measures, fits, customizes, or styles cranial prosthesis for Veterans under this contract shall hold an active Washington, D.C., Maryland, or Virginia license in cosmetology or certification from the IAT for a Trichologist.”

Accordingly, IAT trichologist certification, when accompanied by the required experience and other mandatory elements in the PWS (e.g., Basic Life Support certification, training in scalp health and infection control, and compliance with facility and insurance requirements), satisfies the professional qualification requirement without the need for state cosmetology licensure.

Question 4 – Timing of Credentials

Section E.3(h) requires personnel to be "credentialed and ready to work at the start of the contract." State license reciprocity requires 30-60 days to process, but the period between proposal deadline (March 9) and performance start (April 1) is only 23 days.

Will the VA accept proposals demonstrating a credible plan to have credentialed personnel in place by April 1, 2026, rather than requiring credentials at the time of proposal submission?

VA Response to Question 4:

Section E.3(i) requires that credentials and supporting documentation be submitted with the proposal at the time offers are due. Any offeror that cannot both (1) provide the required credentialing documents with its submission and (2) ensure that proposed personnel will be properly credentialed and ready to work by the contract start date risks being found unacceptable for failure to meet the solicitation’s minimum qualification and readiness requirements. Section E.3(h) further clarifies that there must be no gaps or lapses in required credentialing prior to the start of the contract, so personnel must remain fully credentialed through the transition into performance.

To accommodate vendors’ need to finalize their key personnel, the VA will extend the proposal due date one additional time; however, all required credentials and documentation for proposed personnel shall be due no later than the new closing date of the solicitation. Proposals that do not include the required credentialing documentation by the close of the solicitation will not be considered acceptable.

Question 5 – Commitment Letter for Facility

Will the VA accept a commitment letter demonstrating the offeror's plan to establish a DMV-area facility prior to the April 1, 2026 performance start date, supported by evidence of current operational facilities in other markets?

VA Response to Question 5:

No commitment letters will be accepted.

Question 6: Key Personnel Designation

The solicitation requires "all individuals providing supplies and services to VA Beneficiaries" to be designated as key personnel. This is broader than the typical application of FAR 52.237-75 and VAAR 852.237-75, which contemplate individuals with unique, irreplaceable qualifications.

Will the VA narrow the key personnel designation to management or clinical supervisors rather than all fitting staff?

VA Response to Question 6:

The VA does not plan to narrow the Key Personnel designation to management or clinical supervisors only. All fitting staff who will provide direct cranial prosthesis services to Veterans are expected to be identified as Key Personnel and to meet the solicitation’s requirements for credentials, training, and participation in the technical presentation and evaluation, as applicable. For example, Key Personnel does not include individuals such as support staff, secretaries etc.

Question 7: DME Provider Path

The solicitation references a "DME Provider" path requiring "DME related accreditations (e.g. DMEPOS, if applicable)." However, cranial prostheses are not covered by Medicare, and therefore no DMEPOS or other DME accreditation exists for cranial prosthesis providers.

Please clarify: If no DME accreditation is applicable to cranial prostheses, what is the purpose of this pathway? And why would DME providers—who routinely fit and deliver medical devices requiring patient contact—require cosmetology or trichology credentials when no such requirement exists for other DME categories?

VA Response to Question 7:

The PWS states that offerors may be DME suppliers, prosthetic fabricators, or personal services providers and refers to “Durable Medical Equipment supplier that employ qualified staff.” Factor 1 then mentions a “DME Provider” path and “DME related accreditations (e.g., DMEPOS, if applicable).”

Our intent is to recognize that some vendors may already operate as DME suppliers and hold relevant DME accreditations for their broader business lines. The solicitation is not meant to require DMEPOS or similar accreditation where no such accreditation exists for cranial prostheses. Where no DME accreditation applies to cranial prostheses, an offeror would not be downgraded solely for lacking DME specific accreditation.

However, for this particular requirement, any individual who “measures, fits, customizes, or styles cranial prosthesis” for Veterans must still meet the same professional qualification standards as other providers: a DC/MD/VA cosmetology license or IAT trichology certification, plus the training and BLS requirements in the PWS. VA’s rationale is that cranial prosthesis services involve direct, hands on work on the Veteran’s scalp and hair bearing regions, and VA has determined that this subset of services requires the specified cosmetology/trichology type preparation and oversight, regardless of whether the contractor is otherwise a DME supplier.

We wish to clarify and emphasize the following:

• DME related accreditation is only relevant “if applicable to the offeror’s existing operations and product lines; no DMEPOS accreditation is required where no recognized DME accreditation applies specifically to cranial prostheses.”

• All providers, including DME suppliers, must still ensure that personnel performing hands on cranial prosthesis services meet the cosmetology/trichology qualification requirements in the PWS.

Question 8: SAM/UEI

Is an active SAM registration and UEI required at the time of quote submission, or only prior to award?

VA Response to Question 8:

Yes

Question 9: Buy American (FAR 52.225-2)

Are foreign-made cranial prostheses acceptable if we disclose country of origin in the certificate? Is there a maximum allowable foreign content, or is it strictly domestic vs.

foreign end product per FAR definitions? Is the signed certificate sufficient at quote time, or do you require country-of-origin documentation with the quote?

VA Response to Question 9:

This solicitation incorporates FAR provision 52.225-2, Buy American Certificate (OCT 2022), and requires offerors to submit a completed Buy American Certificate with their quotation identifying whether the cranial prostheses offered are domestic end products and listing any foreign end products, if applicable. Under the Buy American statute and implementing FAR/VAAR provisions, acceptability and evaluation of foreign-made cranial prostheses will be determined based on the domestic vs. foreign end-product definitions and any applicable exceptions or evaluation preferences; there is no separate “maximum foreign content” threshold in this solicitation beyond those regulatory definitions.

Accordingly, foreign-made cranial prostheses may be proposed, but they must be accurately disclosed on the Buy American Certificate, and the Government will evaluate them in accordance with FAR 52.225-1/-2 and applicable VAAR guidance. The signed and properly completed Buy American Certificate submitted with the quote is generally sufficient at quote time; however, as stated in Section E.9, the Government reserves the right to verify any information in the certificate and to request additional country-of-origin documentation if needed during evaluation or performance.

Question 10: Pricing/Cost Schedule

How should pricing be structured on the cost schedule—priced per prosthesis as a fully loaded unit price, or broken out by service/type (ex: consultation/measurement, fitting, initial cut/style, adjustments)? Should unit pricing include post-delivery adjustments and/or warranty remakes/repairs? For option years, are annual price increases allowed? If yes, is there a preferred method or cap?

VA Response to Question 10:

The solicitation’s price schedule is intended to be structured on a per-unit, fully loaded price basis for cranial prostheses and associated services, consistent with the CLIN structure in Section B; offerors should not create separate CLINs but may internally allocate costs for consultation/measurement, fitting, initial cut/style, and routine adjustments within their proposed unit prices as appropriate. Unit pricing should account for all standard services reasonably associated with delivery and initial adjustment of the cranial prosthesis; any separate charges (e.g., warranty remakes or non-routine repairs) should be clearly identified and explained in the pricing narrative if proposed. For option years, annual price increases are permitted only as allowed by the solicitation and applicable regulations; offerors may propose a reasonable escalation method (such as a fixed percentage or index-based adjustment) subject to the Government’s evaluation and negotiation, but there is no separate escalation cap beyond what is ultimately agreed to and reflected in the awarded contract.

Question 11: - Non-SDVOSBS

Will you consider proposals that are not service-disabled veteran owned?

VA Response to Question 11:

No. This a total set aside for SDVOSBs

Question 12: Facility Accommodation

My location has stairs and the buildings elevator is out and has been grandfathered. So, I am diligently working to obtain an office space for clients that are wheel chair bound and have walkers. At this current time I’ve had one wheelchair client and I went to her home to service her. So my question is, will I no longer be allowed to go to veterans homes? Also am I allowed to sublease a space to service veterans with walkers and wheelchairs?

VA Response to Question 12:

Home visits are not authorized. The solicitation requires all measuring, fitting, and delivery at approved contractor facilities that meet ADA accessibility standards.

Your current location (stairs only, non-working elevator) does not comply with ADA/Approved Facilities requirements.

Subleasing is permitted if facility is licensed, ADA-accessible (incl. restrooms), insured, and pre-approved via D.2 Proposed Contracted Facilities form.