Questions and Answers - DEA Hazardous Drug Waste.docx

Questions and Answers

1. Please provide 12–24 months of historical DEA hazardous drug waste volumes (kg or lb.) by site and container location, plus average number of containers filled per month.

2. Is weekly pickup at RMRVAMC a hard requirement for all 47 containers, or will pickups be on an as-needed call-off basis per site?

a. Yes. The contractor is required to service all containers at RMRVAMC on a weekly basis.

3. If actual volumes or pickup frequency vary significantly from the estimates, will the VA allow price adjustments (e.g., per-pickup or per-kg pricing) rather than requiring all changes at no additional cost?

a. No. There are no guaranteed minimums or maximums.

4. How should pricing be structured—per container supplied, per container change-out, per kg/lb. of waste, per pickup, or firm-fixed monthly system price per site?

a. Fixed Monthly Pricing.

5. May we price separate rates for (a) standard business-hours pickups and (b) urgent/off-hours pickups (nights/weekends/holidays) if requested?

a. Urgent/Off-hours pick-up hours are not expected. Previous year’s show Wednesday at 5:00 am was the typical day of the week when pick-ups were scheduled and accomplished since there was less chance of conflicts with patient care and treatment. Please see revised Statement of Work.

6. May we include a minimum charge per pickup per site, and if so, how would VA like that shown on the price schedule?

a. There will be no minimum charge per pickup per site.

7. Are the salient characteristics intended to be brand-specific, or will functionally equivalent DEA drug deactivation systems be accepted if they meet or exceed the listed dimensions and performance?

a. Functionally equivalent will be acceptable. Referencing the SOW, please note issues here are fit and installation of any new systems. Quality must match adjacent surfaces and not interfere with patient care.

8. Will containers remain the property of the contractor throughout the term (rental model), or do you expect them to become Government property?

a. DEA container security hardware becomes property of the government upon installation and inspection by the VA POC. DEA drug neutralization containers typically contain toxic substances; therefore, they become government property upon designation and use under this contract. However, even with Government ownership, disposal is prescribed by the Resource Conservation and Recovery Act (RCRA) as part of the "cradle-to-grave" process, which involves shared legal responsibility for compliance. This means that while the Government takes ownership, the proper, legally compliant disposal procedures for hazardous waste must still be followed by those involved in the process as per the hazardous waste manifest.

9. Should pricing assume a one-for-one swap (full for empty) at each pickup, or does VA expect a surplus inventory of spare containers on each unit?

a. The VA expects a one-for-one swap and a surplus inventory of spare containers to be maintained.

10. Will the VA act as the DEA registrant/generator with us as a service provider, or does VA expect the contractor to hold and use our own DEA registration as a reverse distributor for these wastes?

a. The VA Medical Center will not act as the registrant. The contractor must hold and use their own registrations.

11. The SOW requires an annual report summarizing shipments by type/classification/weight—does VA have a preferred template or will contractor-standard reporting be acceptable?

a. The VA does not have a preferred template; however, the Contractor’s version shall be submitted for review by the VA POC prior to issuance.

12. May contractors include separate line items for manifesting/e-Manifest fees and certificates of destruction, or should those costs be built into the base unit pricing?

a. These costs shall be built into the base unit pricing.

13. For releases occurring through no fault of VA, the SOW makes the contractor responsible for all remediation costs. Will VA consider a reasonable cap or require proof of specific pollution liability limits in insurance instead?

a. No. For releases occurring through no fault of VA, the SOW makes the contractor responsible for all remediation costs. The Contractor must immediately have and provide the correct spill kit to do this. Remediation must be immediately executed at the time of a spill.

14. If VA issues a safety-based ‘stop work’ order, will the contractor be compensated for demobilization/remobilization costs when the stop is not due to contractor fault?

a. While this is not expected, occurrences shall be decided on a case-by-case basis by the Contracting Officer to assess whether, or not, a compensable condition exists. Also, due to the critical nature of the contract, the government’s expectation is close partnering to avoid these situations so the work will occur without interruption.

15. The SOW states PIV processing time/costs are to be included in the proposal. Does VA have standard onboarding timelines so we can estimate labor carry costs while staff wait for access?

a. No. However, consider 6 weeks as a typical timeline; however, this shall not delay service since it must start as soon as contract award is made.

16. Is there a specific training/qualification format (e.g., OSHA, DOT, DEA certifications) you want submitted with the offer, or only upon request after award?”

a. Offeror must demonstrate the ability to perform services in compliance with all Federal and Colorado Department of Public Health and Environment (CDPHE) laws and regulations. Any applicable certifications should be included in your technical submission.

17. Is the solicitation a new requirement set by the government or is this a contract currently being performed that the government is renewing. If this is a renewal, do you have the contract number associated with the old contract?

a. This is a follow-on requirement to Contract 36C25925P0129.

18. The SOW lists 54 locations. Is that accurate and all that is needed?

a. Yes. Please see revised Statement of Work.

19. The SOW states “Secure and locking wall bracket for container storage which can only be installed to behind the wall structural supports.” Does the VA have an issue with wire wall brackets or does it intend on fully enclosing wall cabinets?

a. There is no issue with wire wall brackets as long as they can be secured and fit in the existing area with no additional construction needed.

20. The SOW section 8 only lists 47 locations and containers not 54 as table APPENDIX A suggests.

a. Please see revised Statement of Work. Section 8 updated to reflect 54 containers.

21. The SOW states accumulation in the central storage location for hazardous waste. Currently the Hazardous waste contractor is providing all disposal of these containers. Will that remain the same or does disposal all need to be included in the cost here?

a. The current hazardous waste contractor is not providing all disposal for these containers. Since this is not the condition, disposal should be included in the cost here.

22. The SOW does not define a pickup schedule for these containers. What is the VA facility expectation of the contractor for pickups at each location?

a. RMRVAMC is weekly. Please see revised Statement of Work for estimated pickup frequencies.

23. What will be the changeover if a new contractor is chosen for this?

a. A transition will be coordinated with the Contracting Officer and VA POC.

24. Who is the incumbent contractor and what is the obligation contract number?

a. 36C25925P0129 and Stericycle Inc

25. This waste once neutralized and made deactivated are normally managed as RCRA pharmaceuticals die to the deactivation agent, is this the VA’s current disposal method for these items?

a. Yes.

26. The CLIN pricing on the solicitation document states UM of MO. Can this be adjusted to EA since not all units may be serviced monthly?

a. You will need to provide per month pricing for the required services.

27. The CLIN pricing shows a quality of 12 months, does the VA expect only once a month service on these units at all locations?

a. You will need to provide per month pricing for the required services. RMR VAMC pickups are typically once per week as stated in the revised Statement of Work.

28. If the contractor arrives at a location and the unit does not need to be serviced does the VA want the unit serviced regardless of accumulation on a monthly basis?

a. Yes. The date of the check is entered on the side of the container. If it is full, then it is removed and replaced by an unused one. This will need to occur on a weekly basis for RMR VAMC and as stated for the other sites in the revised Statement of Work.

29. “For each disposal brand to be considered, the Contractor shall submit a functioning example to the Contracting Officer, or their designated representative, for review and approval before the work.” Is the VA expecting the contractor to send them a physical unit for review or a specification sheet for review?

a. Specification sheet.