36C77625R0017 0001 Custom Packs Amendment.pdf

5. PROJECT NUMBER (if applicable)

CODE7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER3. 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 CODECODE

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 41

0001 02-21-2025 None

36C776

Department of Veterans Affairs Program Contracting Activity Central Attn: Laura Nabity, Contract Specialist 6100 Oak Tree Blvd, Suite 490 Independence OH 44131

36C776

Department of Veterans Affairs Program Contracting Activity Central Attn: PCAC Supply 1 6100 Oak Tree Blvd, Suite 490 Independence OH 44131

36C77625R0017

01-13-2025

X

X X

** HOUR & DATE for Receipt of Offers is EXTENDED to: 03-31-2025 1:00 pm CDT

See CONTINUATION Page Funding provided at Order by Authorized Ordering Officers

Custom Sterile Procedure Packs for VA Central Region: VISNs5, 9, 10, 12, 15, 16, & 23

Solicitation 36C77625R0017 Amendment 0001

Please reference page 2 and 3 for the Summary of Changes to the Solicitation.

Please reference pages 3-12 for the Questions and Answers.

All Offerors are required to acknowledge and sign Amendment(s).

Contracting Officer

Summary of Changes Solicitation: 36C77625R0017 Custom Sterile Procedure Packs

Amendment 0001

The purpose of this Solicitation Amendment 0001 is to make the following changes:

1. Replace Section B.3 Statement of Work (SOW), pages 6 through 24, with the revised Section B.3 Statement of Work (SOW) Amended. Changes are highlighted in yellow.

2. Uncheck or Remove the following Clauses and Provisions from:

a. Section C.23 FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Products and Commercial Services, page 53, Uncheck

(41) FAR 52.223-9, Estimate of Percentage of Recovered Material Content for EPA- Designated Items.

b. Section C.23 FAR 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Products and Commercial Services page 54, Uncheck

(46) FAR 52.223-3 Sustainable Products and Services.

c. Section E.18 52.252-1 Solicitation Provisions Incorporated by Reference, page 81, Provisions 52.223-4 Recovered Material Certification and VAAR 852.223-70 Instructions to Offerors – Sustainable Acquisition Plan were removed.

3. Change the dates in Section C.6 FAR 52.216-18 Ordering (a), page 33, from “July 1, 2025 through April 30, 2030” to “September 1, 2025 through June 30, 2030”.

4. Remove Paris Everson’s name and email from Section E.12 52.233-2 Service of Protest.

5. Replace the following Section D Attachments, page 59, with the Amended Attachments:

a. Attachment D.2 – Schedule of Items Custom Packs Amended

b. Attachment D.4 – Bills of Materials VISN 5 Amended

c. Attachment D.5 – Bills of Materials VISN 9 Amended

d. Attachment D.6 – Bills of Materials VISN 10 Amended

e. Attachment D.7 – Bills of Materials VISN 12 Amended

f. Attachment D.8 - Bills of Materials VISN 15 Amended

g. Attachment D.9 – Bills of Materials VISN 16 Amended

h. Attachment D.10 – Bills of Materials VISN 23 Amended

i. Attachment D.11 – Three Sample Packs – Bills of Materials Amended (Solicitation Only)

Minor changes to the Attachments include changing a few pack names and spreadsheet column names to be consistent and clear, and correcting the TAA calculation formula.

Major changes to the Attachments include adding a missing pack BOM, deleting two packs, adding the “KIT” components to the applicable packs, and adding column I, Manufacturer’s Business Size (Large or Small), to the BOM Attachments. Column I must be completed when filling out the BOM Attachments. These major changes are highlighted in yellow on the BOM Attachments.

6. Replace Section E.2 Addendum to FAR 52.212-1 Instructions to Offerors, pages 63 through 71, with the revised Section E.2 Addendum to FAR 52.212-1 Instructions to Offerors - Amended.

Changes are highlighted in yellow which include:

a. Solicitation’s Response Due Date is now 1:00 p.m. Central Time, Monday, March 31, 2025.

b. Sample Packs arrival date is now No Sooner than Thursday, March 20, 2025.

7. Answered the questions received by 1:00 pm Central Time, Tuesday, January 28, 2025.

36C77625R0017 – Custom Sterile Procedure Packs

Solicitation: 36C77625R0017 - Questions (Q) & Answers (A)

Q.1. In Reference to Attachment D.11 – Three Sample Packs – Bills of Materials: From the Sample Packs (#1 Basic Pack), component item "BAG BEDSIDE UTILITY LARGE 6 X 12" from Tidi Products, MPN 950251, has been discontinued by the manufacturer and is no longer available for purchase. Can you help clarify the process for submitting substitutions?

A.1. Attachment D.11 – Three Sample Packs – Bills of Materials, has been revised. Please see the amended Attachment D.11 included in this Amendment. Substitutions are allowed. Please fill out column G stating the reason for the substitution and then columns H through J with the substituted/alternate product.

Q.2. In Reference to Attachment D.11 – Three Sample Packs – Bills of Materials: From the Sample Packs (#1 Basic Pack) component item “NDL CNTR 20CT FM MAG” from OR Necessities, MPN NS9102, returns no results online. There is no business I can find entitled OR Necessities. The best I could find is a OR Necessities line of products manufactured by Medline with a 20CT foam, magnetic needle holder under a part number NC20ABR. Is this the desired component? Or would that suffice for substitution?

A.2. Attachment D.11 – Three Sample Packs – Bills of Materials, has been revised. Please see the amended Attachment D.11 included in this Amendment. Substitutions are allowed. Please fill out column G stating the reason for the substitution and then columns H through J with the substituted/alternate product.

Q.3. In Reference to Attachment D.11 – Three Sample Packs – Bills of Materials: From the Sample Packs (#1 Basic Pack) component item “TABLE COVER, 50” x 90”, BULK FOLD” from OR Specialities, MPN PE61024. OR Specialities stated they distribute for conmed and a few specific manufacturers only, but do not have a line of business selling Table Covers.

A.3. Attachment D.11 – Three Sample Packs – Bills of Materials, has been revised. Please see the amended Attachment D.11 included in this Amendment. Substitutions are allowed. Please fill out column G stating the reason for the substitution and then columns H through J with the substituted/alternate product.

Q.4a. The current contract has been successfully performed under a Service-Disabled Veteran- Owned Small Business (SDVOSB) set-aside and there is clear evidence that at least two SDVOSBs are capable of meeting the requirements at fair and reasonable prices. In light of VA’s commitment to supporting SDVOSBs, we believe it would be appropriate to consult OSDBU and reinstate the SDVOSB set-aside for this procurement.

Q.4b. RFQ is unrestricted. The current contract is SDVOSB set-aside. Why is the solicitation not a set-aside award for an SDVOSB, based on it currently being successfully performed under an SDVOSB set-aside award?

A.4. Based on intensive Market Research, the VA did not find small businesses that manufactured the components of at least 50% of the contract value for this requirement even when specific class waivers were taken into account. This requirement is for the acquisition of multiple items, 13 CFR §121.406(d) states that at least 50% of the estimated contract value be composed of items manufactured by small business concerns. Therefore, the analysis of the Non-Manufacturer Rule, 13 CFR §121.406(b), and 13 CFR §121.406(d) confirms that this requirement is not suitable to be set-aside for small business and should go forward as an unrestricted solicitation. Small businesses are not prohibited from submitting offers. Both large and small businesses are encouraged to submit offers.

Q.5. The selection of a Lowest Price Technically Acceptable (LPTA) award criteria for this procurement, with no meaningful consideration of past performance, is not well conceived.

A.5. Past Performance for this procurement is taken into account as a responsibility determination.

Q.6. In Reference to Section 7. Packaging 7.2 states Expiration dating of all custom sterile procedure packs delivered under this program shall have a minimal shelf life of ninety (90) calendar days remaining upon delivery to the Government. However, 10.6 states “The vendor shall have inventory controls in place to track the expiration dates of the custom pack inventory. If at any time active inventory has less than 180 days shelf life, the contractor shall notify the ordering facility electronically.” We recommend changing 10.6 to 90 days.

A.6. The notification requirement at 180 days provides the ordering VA time to order the inventory prior to reaching the minimum shelf-life standard. Notifications at 90 days would not allow the vendor to meet the 90-day delivery shelf-life requirement, therefore, notification at 180 days shall remain a requirement.

Q.7. In reference to Section 10 Inventory Management. 10.2 states “The contractor shall have a minimum of 30 days but no more than 45 days of stock-on-hand for each active line item.” Given the need to keep inventory between 30-45 days, we recommend delivery orders placed do not exceed 30 days otherwise we cannot guarantee a 3 day delivery time.

A.7. The government does not wish to cap order requirements, however, orders of packs exceeding

45 days will be exempt from the 3-day delivery requirement and the 97% order fulfillment metric.

Q.8. In reference to Section 6.3 Unavailability of Component Parts and 6.4 Component Short-term Substitution Process. We recommend having a VA pre-approved auto-sub list for short term component delays to avoid a prolonged approval process which could lead to backorders or stock-outs. Component manufacturers estimated delivery times vary and change without notice causing last minute delays. A pre-approved auto-sub list will expedite the process.

A.8. A pre-approved auto-sub list for all packs and components is not feasible. However, the contractor may work with the local VA facility COR to establish short-term automatic substitutes for components where reoccurring delays are experienced. Establishment of any pre-approved auto-sub is at the sole discretion of the local COR.

Q.9a. We would like to request an extension of 6 weeks on the response date. This is a massive amount of data to compile and to present a thorough and detailed response, we need more time.

Q.9b. Request an extension to the due date of 6 weeks to allow time for answers to questions to be posted that may impact responses and BOM information.

A.9. The solicitation’s closing date will be extended; offers are due no later than 1:00 pm CT, Monday, March 31, 2025.

Q.10. We submit that reliance on TAA sourcing requirements poses challenges in the event of potential tariff changes 6.3 Unavailability of Component Parts and 6.4 Component Short-term Substitution Process. We recommend having a VA pre-approved auto-sub list for short term component delays to avoid a prolonged approval process which could lead to backorders or stock-outs. Component manufacturers estimated delivery times vary and change without notice causing last minute delays. A pre-approved auto-sub list will expedite the process.

A.10. A pre-approved auto-sub list for all packs and components is not feasible. However, the contractor may work with the local COR to establish short-term automatic substitutes for components where re-occurring delays are experienced. Establishment of any pre-approved auto-sub list is at the sole discretion of the local COR. In the event of a substantial and significant tariff that will affect long-term availability of components, the CO may consider a substitution under Section 6.5.2. of the SOW.

Q.11. We submit that reliance on TAA sourcing requirements poses challenges in the event of potential tariff changes that will undermine the sustainability of TAA-based pricing. We recommend incorporating provisions for tariff-based price adjustments or exploring a BAA model to provide greater flexibility and long-term cost management. A set-aside for SDVOSBs would render the BAA applicable instead of the TAA.

A.11. In the event of a substantial and significant tariff that will affect long-term availability of components, the CO may consider a substitution under Section 6.5.2. of the SOW.

As mentioned in Q4, this requirement is not suitable to be set-aside for small business. Only TAA compliant components are acceptable.

Q.12. Offerors with proprietary OEM packs and components may face inherent conflicts of interest in managing the program, particularly when selecting product substitutions. Requiring an OCI mitigation plan would help ensure transparency and fairness in the procurement process and ensure that the clinician’s preference remains the primary basis for building out the procedure packs.

A.12. The contractor does not select the pack components or component substitutions. The VA must approve all recommended substitutions and will consider conflicts of interest at that time.

Q.13. The prior contracts for this program were awarded by VISN 23, which has significant experience in managing its unique challenges. While we have tremendous respect for the PCAC, we are concerned that it may lack awareness of the core product sourcing and management challenges impacting this procurement, or the lessons learned from prior failed contracts. We recommend canceling the procurement and either reassigning it back to VISN 23 or have the PCAC undertake an “industry day” to gain more operational awareness of the program, would best serve the needs of this program.

A.13. The prior contracts for this program were awarded by SAO Central which included subdivision VISN 23. SAO Central has been reorganized and is now part of PCAC. Based on our market research, the VA does not see a need for an “industry day” for this procurement.

Q.14. In reference to page 10, Section 6.1 Sterilization and Assembly, is the Government willing to accept a pack label that includes manufacturer, description of the component, quantity of component, Country of Origin (COO), and lot number of the tray with a supplemental electronic Bill of Materials that includes the above mentioned plus manufacturer item number, sterilization date, and component level lot number?

A.14. The government requires the packing list to include all items described in Section 6.1 of the

SOW.

Q.15. In the sample requirements, one of the components (3300PNS) is not a TAA compliant item, would you like for us to include it, exclude it, or source an alternative if available?

A.15. Please provide a TAA compliant substitute as outlined in the sample pack substitution process.

Please fill out column G stating the reason for the substitution and then columns H through J with the substituted/alternate product.

Q.16. Please clarify the difference in a “packing list” referenced in 6.1 as compared to “the label” in

7.2. Both reference the bill of materials, which is your preference for the bill of materials to be included in the pack?

A.16. The packing list in Section 6.1 shall be included with the shipment. Section 7.2 discusses the label located inside of each pack.

Q.17. Is the component level lot number a requirement for the bill of materials that should be included in the pack, as this is not an industry standard practice?

A.17. Yes, component level lot numbers are a requirement of the government.

Q.18. For US origination / TAA compliance, is the pack or its constituents considered the "item" ? .

A.18. Each manufactured component in each pack is considered the “item” for US origination / TAA compliance.

Q.19. If we assemble, package, and sterilize the trays in the United States, does that designate the tray an item from the US?

A.19. No.

Q.20. If constituents of the tray were the answer to Q18, is there a % threshold for acceptability, or percent dollar amount of the contract, for domestic designation, as some suppliers may not disclose country of origin?

A.20. The constituents are expected to be 100% TAA compliant.

Q.21. Is there a pricing preference for SDVOSB? If an SDVOSB is providing a response, is there a dollar or percentage preference amount considered?

A.21. Because the solicitation is LPTA, there is no preferences for SDVOSBs or other small businesses.

Q.22. FAR 52-219-33 Nonmanufacturer Rule is not checked. Please provide an explanation for not allowing this rule.

A.22. The Nonmanufacturer Rule does not apply to unrestricted acquisitions.

Q.23. Pg. 11 Components - RFQ is TAA per 52.2225-5. But your BOM spreadsheets in D.4-D.10 are set up when BAA compliance is required. Please explain the justification for having to calculate TAA % if the RFQ is TAA required. Until awarded, and contractor works with a facility, the contractor will not be able to determine if the facility wants and the CO approves a non-TAA component. Are you allowing non-TAA compliant components to be considered in the BOMs?

A.23. The BOMs have been updated to capture TAA compliance. All components must be TAA compliant; non-TAA compliant components shall not be provided under this contract. The TAA percentage calculation is a requirement of the government.

Q.24. Pg. 74 E.5 52.204-29 deals with waivers for FASCSA – isn’t this for IT purchases and not items that pertain to the bills of materials listed in D.4-D.10?

A.24. No. Per FAR 4.2306 (b)(1), this provision, 52.204-29 is required in this solicitation.

Q.25. Pg. 17 Inventory Management, Section10.5 Notes quarterly modifications. Due to the length of time required to modify a custom pack, we recommend changing to bi-annual modifications.

A.25. Quarterly modifications will remain as the goal due to changes in Government needs and the availability of component parts.

Q.26. Pg. 18 Transition – 12.1 Transition Plan states full conversion with delivery by Contractor due on the 121st day after the contract award. RFQ 36C77622R0105 provided 240 days after award for almost 500 custom packs. RFQ 36C77625R0017 lists out 463 custom packs for 35 facilities.

We recommend utilizing 240 days in order to provide adequate time to work with facility clinical staff to obtain the correct components to ensure BOMs are designed and built according to Clinical and OR staff’s customized requirements.

A.26. In accordance with RFQ 36C77625R0017, the Government requires full conversion with packs ready for delivery on the 121st calendar day after award. Offerors shall ensure transition plans submitted include all resources needed to ensure the milestone is achieved.

Q.27. Pg. 18 Transition, Section 12.2 RFQ states validation shall occur within 45 calendar days after contract award. In reality, this is just 33 business days. With 35 facilities and 463 unique pack configurations, 45 calendar days doesn’t allow adequate time to work with facility Clinical and/or OR staff to ensure BOMs are complete and accurate for their purpose. Nor does it allow for staff absences/time off. Custom packs require extensive knowledge of components and placement in packs. We recommend validation and signoffs be completed within 90 calendar days after the award.

A.27. The government requires packs are validated within 45 calendar days to ensure packs are available for delivery within the 121st day of contract award.

Q.28. Pg. 32 C4 First Article Testing – RFQ lists multiple requirements for the contractor to supply a sample pack, upon request, and to work with facility staff to ensure it meets facility requirements. Several sections in C4 reference a time frame to paragraph (b). Nowhere in section C4 (b) does it specify what the time frame is. We recommend removing C4 First Article Testing as delays in getting responses from VA staff is common. Putting the burden on contractors to get VA staff to approve/disapprove is an unfair practice. Validation of BOMs is already covered in the Transition section.

A.28. First article testing of packs is at the request of the participating facilities and the requesting facility shall make the vendor aware of the need no later than the 21st day of the validation process. Reference the amended SOW regarding first article testing.

Q.29. Pg. 14 Packaging:

a. 7.1 All latex-free packs shall be labeled on the outside as Totally Latex-Free. We don’t use ‘Totally Latex-Free’ as we are not able to guarantee that any trace latex did not come in contact with components. Would it be sufficient to note on the BOM with a mark for any item containing latex instead? Example: “Note ** Only the components marked with this symbol in the list above contain latex.” See Amended SOW Section 7.1.

b. 7.2 Each pack shall have a label specifying the manufactured date and sterilization date of the pack and the expiration date of any dated products. Labels are put on packs at the time of production. Sterilization date is an unknown at the time of production. Recommend removing ‘sterilization date’. This is a requirement of the government; we recommend changing the internal order of operations to ensure it can be achieved.

c. 7.3 Each pack shall have a separate label on the outside of the pack that includes the ordering station number and station specified pack name and expiration date. Putting the ordering station number on the pack is not common practice. Even though these are custom packs built to specifications by a facility, it is not uncommon for a facility to order and use a pack not assigned to their station number. We recommend removing this requirement. This is a requirement of the government; the station number is used in the internal Quality Control (QC) process.

d. 7.5 A packing slip shall be enclosed with each shipment indicating the contract number, purchase order number, description of items, complete stock/tray number, accurate unit of measure, quantity ordered, quantity shipped, and case price. Industry standard does not include pricing on pack slips. Packing slips are also limited in the character spacing provided. Pricing information is included on the invoice. We recommend removing ‘case price’. Recommendation accepted; case price was removed from Section 7.5 of the SOW. See Amended SOW.

A.29. See above; multiple questions/recommendations with answers shown after in Blue Font.

Q.30. Pg. 23 15 Contractor Reporting Requirements and Invoicing:

a. 15.1.3 Sales Reports – Monthly Sales Report shall include Lot #, Lot expiration date. Lot numbers and expiration dates are provided on each case and pack. This information is kept with RAQA and not supplied through the database. Recommend removing Lot number and expiration date from Sales reports. The Government requires lot numbers and expiration dates on the sales report. This allows management to monitor the 90-day shelf life listed in section 7.2.

b. 15.2 Weekly Reporting – Inventory and Usage. Recommend Tuesday or Wednesday reporting as receivers are clearing from the prior week’s shipments on Monday. If a VA only receives deliveries once/twice a week, a Monday notification would not be optimal for the ordering pattern to be maintained. Weekly reports shall be submitted on Monday by 5 P.M. ET, unless a Federal holiday. VA receives orders same-day.

c. 15.2.1 Inventory and Usage – The Weekly Custom Packs Inventory and Usage Reports shall contain at a minimum quantity in transit. Recommend removing ‘quantity in transit’ as this is internal information between manufacturer and DC, not transit to a facility. The Weekly Custom Packs Inventory and Sales Reports shall contain the quantity in transit. Quantity in transit has been added to the definitions section of the SOW and are defined as packs that are in transit for delivery to the ordering VA Medical Facility. See Amended SOW.

d. 15.2.1 Inventory and Usage – Recommend removing rolling quarterly snapshot of usage by pack. Contractor can only produce records for what has been ordered. Facilities should be managing their own usage files to identify trends and adjust EMUs as needed. Changed usage to Sales. See Amended SOW. Quarterly reports will remain as required.

A.30. See above; multiple questions/recommendations with answers shown after in Blue Font.

Q.31. Pg. 60 52.212-1 Instructions to Offerors lists NAICS code 541519. SF1449 lists 339113.

Please confirm the Instructions to Offerors should be NAICS 339113.

A.31. Page 60, FAR 52.212-1 is the actual FAR Provision as shown in the FAR. The NAICS code for this solicitation is 339113 as shown on page 1, Box 10, of the solicitation.

Q.32. BOMs list EtO indicator dots. EO indicators are chemical indicators that change color when exposed to EO gas. They confirm that the product has been exposed to EO but do not provide a direct measure of sterility. They do not account for all variables that can affect sterilization, such as EO concentration, temperature, humidity, and exposure time. In addition, there are limitations to the EO indicators such as the placement, process variable and interpretation of the color changes. We recommend removing EtO dots from all BOMs and instead provide a Certificate of Conformance with each shipment. This certificate will verify that the sterility of products has been rigorously tested and meets all regulatory standards.

A.32. Section 6.2.1.4 is updated to include “or other indicator demonstrating that packs were sterilized, and the sterilization method used.” See Amended SOW.

Q.33. Attachments for all VISN Bill of Materials do not contain component Manufacture Name or Manufacturer Part Number. Will you provide us the Manufacturer Name and Manufacturer Part Number for all VISN BOMs like the data you provided in Attachment D.11?

A.33. The Government is not asking for brand names and will not provide the brand name information for each component; the offeror shall provide this information with their offer.

Offerors are required to submit the manufacturer, country of origin, and part number (see FAR 52.225-6, FAR 52.225-18 and as mentioned in the instructions Addendum to 52.212-1 and evaluation FAR 52.212-2).

Q.34. Could you please confirm that a Sustainable Acquisition Plan per FAR 852.223-70 is not required if there are no sustainable products listed in the SOW?

A.34. The CO has determined a written Sustainability Plan is not necessary. FAR 52.223-4 and VAAR 852.223-70 Provisions have been removed.

Q.35. The below listed items are custom manufactured Fluid Management kits for Heart Cath and Angio procedures. It is impossible to quote these kits without the component breakout of each kit. Would you provide either the Kit Contents or the applicable Vendor Part Number?

KIT MANIFOLD – Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT MINOR ANGIOGRAPHY - Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT ANGIO CSTM-CATH PACK - Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT ANGIO LEFT HEART CUSTOM - Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT CUSTOM MANIFOLD VAMC - Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT CUSTOM VA MED CENTER - Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT CUSTOM VA ST LOUIS - Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT MANIFOLD - Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT MANIFOLD CUSTOM LHK - BOM Attachment updated. See pack on the Amended BOM.

KIT MEDRAD CHIEF AMMS - Could not find as a BOM component; no response from Questionee regarding which custom pack this was listed.

KIT PSP V.A. HOSPITAL – BOM Attachment updated. See pack on the Amended BOM.

KIT PSP-VA HOSP - BOM Attachment updated. See pack on the Amended BOM.

KIT PSP-VA HOSPITAL 589 - BOM Attachment updated. See pack on the Amended BOM.

KIT RIGHT HEART VA MED CTR - BOM Attachment updated. See pack on Amended BOM.

KIT SPECIALS CSTM – BOM and Custom Pack deleted from solicitation.

A.35. See above; multiple KIT questions with answers shown above after kit name in Blue Font.

The contents of the highlighted kits can be found on the Amended BOM Attachments and are highlighted in yellow. The components in each “kit” are listed below the list of pack components on the specific pack’s BOM/component tab.

End of Questions and Answers

B.3 STATEMENT OF WORK (SOW) Amended

MIDCON CUSTOM STERILE PROCEDURE PACKS

1. Introduction

The U.S. Department of Veterans Affairs (VA), Veteran Integrated Service Networks (VISNs) 5, 9, 10, 12, 15, 16, and 23, has a requirement for an ongoing supply of Custom Sterile Procedure Packs and associated services for an estimated 35 VA Medical Centers and Community Based Outpatient Clinics (CBOCs). The number of participating VA facilities may change based on the Government’s needs. The Contractor shall be responsible for providing all labor, materials, transportation, storage, equipment, supervision, quality assurance, electronic communication, order reporting, and delivery of the packs. The Contractor shall maintain compliance with federal, state, and local regulations to provide custom sterile procedure packs and creation of new packs, as deemed necessary for the participating medical facilities.

2. Period of Performance

The period of performance for this contract is one (1) five-year ordering period with five (5) one-year pricing periods.

Five (5) Year Ordering Period July 1, 2025 through June 30, 2030

Pricing Period Dates Pricing Period 1 July 1, 2025 through June 30, 2026 Pricing Period 2 July 1, 2026 through June 30, 2027 Pricing Period 3 July 1, 2027 through June 30, 2028 Pricing Period 4 July 1, 2028 through June 30, 2029 Pricing Period 5 July 1, 2029 through June 30, 2030

3. Delivery Locations and Delivery Schedule

3.1. Delivery Locations: All components for Custom Sterile Procedure Packs shall be delivered to VA Medical Centers, VA Health Care Systems, or VA Community Base Outreach Clinics identified in Attachment D.1 - Delivery Locations. The number and location of VA facilities located within these VISNs may increase or decrease based on the Government’s need to provide healthcare to Veterans.

3.2. Delivery Schedule: Delivery days and times are Monday through Friday (M-F) between the business hours of 8:00 a.m. - 3:30 p.m. local time, Federal Holidays excluded. Any delivery service performed outside of these delivery hours must be approved in advance by the local VA facility’s Contracting Officer Representative (COR). Attachment D.2, Schedule of Items, lists the types of custom sterile procedure packs along with the estimated annual number of cases for each pack. This is an estimate only, not a guarantee. The types of custom sterile procedure packs and the quantity needed may increase or decrease based on Veterans needs.

3.3. Federal Holidays: The Contractor is not required to provide delivery services on the following Federal Holidays, nor shall the Contractor be paid for delivery on these holidays:

Holiday Date(s) Month and Date:

New Year's Day January 1 Martin Luther King's Birthday Third Monday in January President's Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19 Independence Day July 4 Labor Day First Monday in September Columbus Day Second Monday in October Veterans Day November 11 Thanksgiving Day Fourth Thursday in November Christmas Day December 25

*When a Federal Holiday falls on a Sunday, the following Monday shall be observed as a Federal Holiday. When a Federal Holiday falls on a Saturday, the proceeding Friday is observed as a Federal Holiday by U.S. Government agencies.

**This list will also include any other day specifically declared by the President of the United States of America to be a Federal Holiday.

4. Abbreviations and Definitions

4.1. Abbreviations

AAMI Association for Advancement of Medical Instrumentation AORN Association of Operating Room Nurses ARO After Receipt of Order ASTM American Society for Testing and Materials BOM Bill of Materials (list of items in a pack) CBOC Community Based Outpatient Clinic CEN European Committee for Standardization CFR Code of Federal Regulations CO Contracting Officer COR Contracting Officer Representative(s) CS Contract Specialist DOT Department of Transportation DSOH Days of Stock on Hand EDI Electronic Data Interchange EMU Estimated Monthly Usage EN 46001 European Nations Quality Standards ETA Estimated Time of Arrival ETO Ethylene Oxide FAR Federal Acquisition Regulation FDA Food and Drug Administration FOB Freight on Board FSC Financial Services Center GS1 Global Standards 1 HCS Health Care System

HF High Frequency LIN Line Item Number ISO International Organization for Standardization M-F Monday through Friday MBO Manufacturers Back Order NCPS National Center for Patient Safety OO / OOs Ordering Officer / Ordering Officers PHT/DEHP Phthalates and Di(2-ethylhexyl) phthalate PM Program Manager PO Purchase Order POC Point of Contact RFID Radio Frequency Identification SDS Safety Data Sheet SMDA Safe Medical Device Act SOP Standard Operating Procedures TAA Trade Agreements Act / Trade Agreements UHF Ultra-High Frequency USMCA United States, Mexico, Canada Agreement VA Department of Veterans of Affairs VAAR Veterans Affairs Acquisition Regulation VAMC Veterans Affairs Medical Center VHA Veterans Health Administration VISN Veterans Integrated Service Network

4.2. Definitions

4.2.1. Component: A component is an item or set of items in a pack, used in a procedure for the benefit of the patient or clinician. Components are not defined as material required, while maintaining the integrity of the package.

4.2.2. Contractual Exception: Packs not shipped due to manufacturer’s backorder, manufacturer’s recall, manufacture’s discontinued items. Packs for which delivery is excusable as set forth in FAR 52.212-4(f).

4.2.3. Custom Sterile Procedure Pack Program (Custom Packs): Custom pack programs are designed to develop individualized procedure packs to save on operating room start-up times, cut down on the time between patients, and create standard practices that result in hospital effectiveness, efficiency, and charge/cost capture.

4.2.4. Fill Rate: Rate in which ordered products are delivered within contracted delivery time. The calculation for fill rate will be (Items Delivered/Items Ordered). The fill rate is applicable to all approved full production custom sterile procedure packs.

4.2.5. First Article Pack: FAR Part 9.3 states First Article approval ensures that the Contractor can furnish a product that conforms to all contract requirements for acceptance. First article packs shall be at no cost to the Government.

4.2.6. Manufacturer Back Order (MBO): A physical order placed by the Custom Sterile Procedure Pack contractor to a product supplier, and which is not shipped to the Custom Sterile Procedure Pack Contractor from the product supplier within thirty days.

4.2.7. New Pack: A brand-new pack that is required of the medical facility that is newly configured.

4.2.8. Pack Conversion: A reconfiguration of an existing pack.

4.2.9. Packs Partially Filled: Includes any packs where the quantity delivered is less than quantity ordered.

4.2.10. Packs Totally Filled: Includes an order for which all packs ordered were delivered.

4.2.11. Piggyback: Component part that is affixed to the outside of the custom sterile procedure pack due to the inability to include it inside the pack (i.e., unique sterilization requirements).

4.2.12. Short-Dates/Short=Dated Product: Any product delivered with an expiration date less than twelve months from date of delivery.

4.2.13. Short-term Component Delays: Components that are unavailable for a period of ninety (90) days or less. These items may be substituted during the delay period or removed from the pack at the ordering facilities discretion and as approved by the local COR. If packs are built without a component or acceptable substitute, the contractor shall provide a discount on the price of the pack, greater than or equal to the cost of the component not included.

4.2.14. Long-term Component Delays: Components that are unavailable for a period greater than ninety days shall be removed from the custom pack and the Contractor shall work with the impacted VA to update the BOM, pricing, and submit to contracting for contract modification.

4.2.15. Quantity in transit: Packs that are in transit for delivery to the ordering VA Medical Facility.

5. Ordering Processes

5.1. Ordering Officers: Ordering Officers (OOs) will be authorized to place orders under this contract. The Contracting Officer (CO) will furnish the Contractor with the names of individuals authorized as OOs to place orders against the contract by a separate Ordering Officer Appointment letter upon issuance of the contract. When OO’s are added after award, the CO will furnish the Contractor with the names of individuals authorized as OOs by memorandum upon OO appointment. OOs are responsible for issuing and administering orders placed under this contract. OOs have no authority to modify any term of this basic contract and may not negotiate contract prices or terms and conditions. Any deviation from the terms of the basic contract must be approved in writing by the CO responsible for this contract. The Contractor shall accept orders against this contract only from the CO and/or authorized OOs.

Fulfilling orders from persons other than the CO or OO may result in loss or delay in payment for supplies/services provided under such orders. Orders will be placed via Electronic Data Interchange (EDI). EDI capabilities should be fully operational within 30 days of the contract’s performance period start date. If, during the first 30 days of the period of performance the vendor is not capable of accepting orders via EDI, the vendor may accept orders via email.

5.2. All delivery orders (DOs) are subject to the terms and conditions of this contract. Orders shall be placed against this contract via electronic commerce using the Line-Item Number (LIN) series outlined in the Schedule of Items identified in the awarded contract. The quantities given in the solicitation are estimates only. There is no expressed or implied guarantee that these quantities will be purchased. The actual quantities ordered by the facilities will vary based on the medical needs of each facility. If orders are not placed via EDI, the order form shall contain at a minimum the following information:

5.2.1. Date of Order

5.2.2. Contractor Name

5.2.3. Contract Number and Purchase Order (PO) Number

5.2.4. VA Facility Name

5.2.5. Line-Item Number (LIN), subline item number (if applicable)

5.2.6. Custom Sterile Procedure Pack Description

5.2.7. Quantity Ordered

5.2.8. Unit Price

5.2.9. Total Amount

5.2.10. Place of Delivery or Performance

5.2.11. Obligated Delivery/Purchase Order

5.3. The Contractor shall accept orders until 12:01 p.m. Local VA Facility Time, M-F, to exclude weekends and holidays. Upon receipt of the order(s), the Contractor shall send a confirmation (via electronic commerce methods) of the request within two (2) hours of order placement for non-emergency deliveries

5.4. Upon receiving an order, the Contractor shall deliver within three (3) business days for standard deliveries and within twenty-four (24) hours for emergency deliveries, unless otherwise stated in the delivery order. For orders that are more than the 45 days of stock, the packs exceeding the 45 days shall be excluded from the 3-day delivery requirement and be delivered within 15 business days of order placement.

5.5. The Contractor shall have full-time representation to receive orders and/or to address delivery/customer service issues. The Contractor shall respond with an acknowledgement of any service-related issues or problems within 24 hours.

5.6. The Government shall place delivery orders to the following: (Offeror to complete):

5.6.1. Contact Person:____________________________

5.6.2. Department: ____________________________

5.6.3. Email Address:____________________________

5.7. The Government shall contact the following for any delivery/customer service issues: (Offeror to complete):

5.7.1. Customer Service Number: _______________________

5.7.2. Customer Service Email: _________________________

5.8. The Contractor shall also provide additional flexible ordering options such as scheduled and funded automatic shipments. Under this contract some facilities with reoccurring known needs may require flexibilities to place daily, weekly, monthly, quarterly, annual, or other interval orders upon facility conversion to be delivered at specified dates. Once placed, the ordering frequency may need to change at any time for orders to be delivered within the contractually required periods. The Government requires a supplier that can be flexible in meeting the changing needs of the Government. The scenarios are not all-inclusive of the Government’s needs but are representative of the flexibilities necessary.

6. Contractor Tasks and Responsibilities

6.1. Assembly and Sterilization: The Contractor shall ensure an individual lot number for each custom sterile procedure pack is assigned for clear tracking of all packs. The packing list shall include the manufacturer, manufacturer item number, description of the component, quantity of component, Country of Origin (COO), sterilization date, and, the lot number of the pack and each component in the pack to ensure traceability. The Contractor shall meet the following assembly and sterilization requirements:

6.1.1. The Contractor shall validate the sterilization process with the Association for Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) annually, at a minimum.

6.1.2. All component debris, sterility tests, and residual tests shall be performed by contracted laboratories at Contractor’s expense.

6.1.3. The Contractor shall guarantee prior to sterilization that the products shall be assembled in secure air-controlled rooms, which are accessible only to authorized personnel with proper attire. The contractor shall follow the Healthcare Sterile Processing Association (HSPA) (https://myhspa.org) and/or Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) guidelines for proper attire.

6.1.4. The Contractor shall follow current International Organization for Standardization (ISO) for sterilization of health care products and be ISO 9001:2015 certified (or equivalent).

6.1.5. The Contractor shall guarantee that all aspects of the assembly, packaging and sterilization adhere to the quality control standards set by the FDA. The Contractor (all entities in the production process) shall be registered with the FDA and remain current for the duration of the contract and undergo routine FDA inspections.

6.1.6. In accordance with the Executive Order (EO) 14057 dated December 8, 2021, (https://www.fedcenter.gov/programs/eo14057/) the Contractor shall consider earth-friendly solutions and provide a program that supports green purchasing. The Contractor shall provide a recycling program for re-usable items that are salvageable and recommend green product components when available.

6.1.7. The Contractor shall ensure there is no re-sterilization of any single-use product for resale to the VA. Re-sterilization of any product is prohibited.

6.1.8. The Contractor shall maintain sterilization services at all times. Sterilization services can be in the form of in-house sterilization or contracted sterilization services;

however, the contracted vendor shall have a written contingency plan in place should the primary sterilization service fail, to ensure service is uninterrupted.

6.1.9. The Contractor shall inspect all component products and check for damage and short dates.

6.1.10. The Contractor shall have continual maintenance performed on all sterilizing equipment.

6.1.11. The Contractor shall have a quality assurance program and quality assurance staff who are familiar with operating room procedures, infection control practices, aseptic techniques, and sterilization methods.

6.1.12. The Contractor shall ensure sterilization sub-contractor(s) are ISO (International Organization for Standardization) 9001:2015, or equivalent and Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org) certified. The contractor shall ensure sterilization sub-contractor(s) adhere to sterilization standards set-forth by the Healthcare Sterile Processing Association (HSPA) (https://myhspa.org), and/or Association for the Advancement of Medical Instrumentation (AAMI) (http://www.aami.org). Sterilization sub-contractors shall be registered with the FDA and remain current for the duration of the contract and undergo routine FDA inspections. The Contractor shall provide the sterilization subcontractor’s certifications and FDA registration annually.

6.1.13. The Contractor shall provide copies of the standard operating procedures governing batch control, product tracing, component manufacturing lot numbering and written policies and/or procedures on component recalls when requested.

6.1.14. All custom packs shall be free of debris and particulates.

6.1.15. The Contractor shall comply with the most current and updated version of these codes and standards for the entire term of the contract.

6.2. Components

6.2.1. Component Parts

6.2.1.1. The Contractor shall ensure that all individual components within the pack are

Trade Agreements Act / Trade Agreements (TAA) compliant unless otherwise authorized by the CO to place orders from a non-TAA compliant country.

6.2.1.2. The substitution or changing of these specific items after award would require the changing of instruments or equipment to utilize the alternative item. The Contractor shall highlight the equal/substituted item on the custom pack’s component list/packing label which was approved by the medical center prior to substitution. The Contractor shall assist the facility staff with ordinary questions and information regarding product exchanges and substitutions.

6.2.1.3. All component packaging shall be removed from outer packaging to reduce steps in the operating/procedure room, unless otherwise required by the customer or the component manufacturer.

6.2.1.4. All packs are to use rigid plastic base trays and component parts to reduce ETO (Ethylene Oxide) residue and eliminate possible particulate contamination from Styrofoam. Biodegradable trays that have the same affect are acceptable.

ETO tape/indicator or other indicator demonstrating that packs were sterilized and the method of sterilization used shall be affixed to the outer wrap and tray where applicable. All custom packs shall be sterilized in an approved packaging material with a plastic dust cover. Custom packs material shall allow the sterilization of the contents, maintain sterility, and provide a way to remove the contents without contamination. Plastic dust covers shall be sealed with a method of sealing which results in a complete seal that is tamper evident and allows for ease of aseptic presentation.