RFP 36C10G25R0041 - Amendment 0001 OFFICIAL.pdf

5. PROJECT NUMBER (if applicable)

CODE 7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER 3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO. 1. CONTRACT ID CODE

FACILITY CODE CODE

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 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 is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

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).

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.

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

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30 PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243

(Type or print) (Type or print)

(Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code)

(If other than Item 6)

(Specify type of modification and authority)

(such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

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)

1 5

36C10G

U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

36C10G

U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

To all Offerors/Bidders

36C10G25R0041

X

X X

1. The Purpose of this Amendment is to:

• Correct wording under Section C.6.3.1, change identified is represented by red bold, and

• Provide a revised Attachment 1 - Technical Exhibit A

2. Answers to questions received by offerors are included in this amendment.

3. See Continuation page for details.

RODNEY BURGOS CABASSA

Contracting Officer

Warrant# VA-OPAL-SAC2021-233741

CONTINUATION PAGE 36C10G25R0041 AMENDMENT 0001 Page 2 of 5

Question # Section Page # Question / Clarification Answer / Clarification

1 Attachment 1 - Technical Exhibit A

Will VHA update the VHA laboratory spreadsheet to include the following information: Annual Test Volume (ATV), specialties performed at each site, and VA hospital complexity level (1a, 1b, 1c, 2, 3)? This information is critical in providing an accurate cost.

Added current specialties and Volume for pricing estimates, but subject to change based on VA needs.

Hospital complexity level is an internal VA classification based on factors outside of laboratory activity, and is not appropriate for this need. See Attachment 1 – Technical Exhibit A Revised

2 Section B.4 – Price Cost Schedules

45-49 For each tab (base, options 1,2,3,4) for CLINs 0002, 1002, 2002, 3002, 4002, is the “quantity” column expected to reflect the number of VHA laboratories due for survey in the corresponding year, based on the Accreditation end date (Column D in the Technical Exhibit A)?

No, only use the quantities on Attachment 4 for the calculation of a grand total, regardless of date.

3 Attachment 4 – Sample B.4 Price Cost Schedule

Tab:

BOE_Grand Total

For the row labeled “Disclosures,” is this essentially a list of references listing the sources of individual cost items contained in the spreadsheets that we will submit?

Yes

4 Section B – Scope of Work

9 It is clear that the selected Accrediting Organization (AO) is not to review Proficiency Testing (PT) during the on-site audits. Is the selected AO required to monitor PT between the biennial on-site audits? In

The AO would have no responsibility for PT. All aspects of the PT process including failure notification and corrective action evaluation are

CONTINUATION PAGE 36C10G25R0041 AMENDMENT 0001 Page 3 of 5 other words, will the AO be expected to send notification of PT failures between audits, and monitor the labs’ corrective actions for PT failures between on-site audits?

managed by the VA per agreement with the Centers for Medicare and Medicaid Services

(CMS)

5 ALL ALL We are only able to locate specific IT Security requirements in the BAA.

Are there other IT Security requirements required of this solicitation?

Any vendor portal used for management of AO process must be accessible from VA government owned equipment.

Vendor may not require software installation or have direct access to VA owned equipment or software.

Vendor cannot store

VA PHI/PII

information.

6 C.6.3.1. New Location

25 Under C.6.3.1. New Location – When a new location is added to an already accredited organization, resetting the parent accreditation cycle with each new location would require a full accreditation survey of the entire organization, resulting in increased costs and survey frequency. Such a requirement would impose operational challenges for VA facilities.

Would the VA be agreeable to the process of a one-day, one-surveyor extension survey for new locations?

This focused survey evaluates only the new site, Error in PWS wording – should read under C.6.3.1

“This visit may coincide with a parent location accreditation cycle, but if it falls outside that time frame this audit does not reset the parent accreditation cycle.”

CONTINUATION PAGE 36C10G25R0041 AMENDMENT 0001 Page 4 of 5 and the effective accreditation date is aligned with the parent organization's existing accreditation cycle. This approach ensures continuity, minimizes disruption to services, and avoids unnecessary financial and administrative burdens. This method maintains the integrity of the accreditation process while ensuring practical and cost-effective oversight.

7 C.6.3 Out-of- Cycle Audit/C7, Activity 6

25 Occasionally, laboratories may require a special survey due to a complaint or other survey-related finding. We understand this action is included in the solicitation but considered part of continuous monitoring, C.7 Activity 6.

However, we note that the activity is not considered billable. These type events are not predictable in nature and do incur survey costs above and beyond our normal continuous monitoring activities. To price as accurately as possible (without spreading out the estimated costs across the normal continuous monitoring), would the VA be willing to reclassify these type events as part of the Out-Of-Cycle audit activities (C.6.3) and allow them to be billable as needed? We estimate approximately 8-10 such events during the life of a 5-year period.

No, due to the variable frequency of the need, the administrative burden to obtain funding and issue a task order for complaint related surveys would undermine the intent and timeline of this action. The estimate of 2 per year is accurate considering historical activity and costs should be incorporated into continuous monitoring services

CLIN.

CONTINUATION PAGE 36C10G25R0041 AMENDMENT 0001 Page 5 of 5

Modify RFP 36C10G25R0041, as follows:

C.6.3.1. New Location Occasionally, the VA will have new moderate or high complexity testing locations and these new locations shall follow 42 CFR 493 requirements and be audited by the contractor 4-12 months after testing initiation. This visit may coincide with a parent location accreditation cycle, but if it falls outside that time frame this audit does not reset the parent accreditation cycle.

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

Attachment 1: Technical Exhibit A revised - VHA Accreditation Facilities List

//////////////////////////////////////////////////LAST LINE / END OF DOCUMENT/////////////////////////////////////////////////

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS