Questions_and_Answers_-_16-223-SOL-00016.doc

Questions and Answers Solicitation - 16-223-SOL-00016

1. If the services pursuant to this Solicitation are subject to the Service Contract Act, could the DHHS/FDA provide bidder with the applicable wage determinations?

Answer: This requirement is not subject to the Service Contract Act.

2. If the services pursuant to this Solicitation are subject to the Service Contract Act, which occupational listing(s) under the wage determinations is(are) expected to be applicable to the services covered by this Solicitation?

Answer: See answer # 1.

3. Will you please confirm the submittal method? Can we email submittals?

Answer: Per section IV: Proposal Instructions, #26: Your proposal must be mailed or hand delivered.

4. Will you please confirm the small business size standard (annual revenue, number of employees, etc.) for acceptable subcontractors for the Small Business Subcontracting Plan?

Answer: The North American Industry Classification System (NAICS) code number for this contract is 562112 and the size standard for small business under this code is less than $38.5 million.

5. Can you confirm which FDA sites autoclave their RMW material before it is shipped offsite, and is it then shipped as RMW, or non-regulated waste?

Answer: This should be MPW as stated in statement of work section I.4.2. 90% + waste is autoclaved prior to disposal and is shipped as MPW. Note less than 10% of our waste is not inactivated and is shipped as infectious waste.

6. For the listed supplies in the Pricing Schedule, specifically for the non-consumable items already owned by the FDA (e.g. FDA item 25S58- pallet truck/jack), is this equipment already owned by the FDA and available for the Contractor’s use, or is this pricing for replacements, or will it all need to be purchased at start of contract?

Answer: For item 25S58, FDA may already own this equipment and it would be available for the vendor to use. However, there are some locations that do not have this equipment and the vendor will need to provide if required. Offerors should propose as if the Government does not provide this equipment nor have it available for use.

7. Could you please provide a copy of the contract that the incumbent (Clean Venture Cycle Chem) is operating under at the White Oak campus?

Answer: Various locations have been serviced by various contractors over the years. This action is an FDA-wide effort. Thus, it is a new requirement.

8. Which of the other locations, outside of metropolitan DC, for the FDA are utilizing the GSA 899-5 Waste Disposal Contract? Please be specific.

Answer:

CDER – St. Louis, MO

CFSAN – Dauphin Island, AL and Chicago, IL

ORA/WEAC – Winchester, MA ORA – Atlanta, GA/Lenexa, Kansas

9. Can you provide more detail as to the requirements for items 26G and 26H on the Pricing Schedule?

Answer: FDA may require the transportation of equipment from one location to another utilizing a 53 foot Trailer. 26G has been updated and 26H have been deleted.

10. Please detail what is included in item 25S66, Fleet Maintenance Tool Set.

Answer: This is a standard 20 piece truck Maintenance Tool Set.

11. For the waste profile summaries, provided at the pre-bid conference, can you please correspond each waste stream to an item number on the Attachment 2 – Pricing Schedule

Answer: The Information provided in the attached waste streams are the best information the Government has available at this time.

12. Can you please provide waste profile summaries for all other locations, other than the metropolitan DC locations?

Answer: Waste Profiles for all locations that were previously serviced are attached. Those locations include, DC Metro Laboratories, CDER – St. Louis, MO, CFSAN – Dauphin Island, AL and Chicago, IL, ORA/WEAC – Winchester, MA, and ORA – Atlanta, GA/Lenexa, Kansas

13. Please detail what is included in the Protective Gear required in item 25J1

Answer: Level D protection for routine day to day work.

14. For item 25L, what size drum liners are required?

Answer: 55 gallon drum liners.

15. On p13 of the Statement of Work, Section I.2, second paragraph, “The Contractor shall own, or lease, a treatment and/or disposal facility(ies) capable of receiving FDA wastes to supplement any storage-only facilities.” Is it acceptable to have long-term contracts with TSDFs that are capable of receiving the majority of the FDA’s waste to fulfill this requirement?

Answer: The Statement of Work, Section I.2 has been updated to read as follows: the contractor shall have access to a treatment, storage and disposal facility (TSDRF). Yes it is acceptable to have long term contracts with TSDFs facilities, however, these facilities will have to be approved by the FDA.

16. What is the Emergency Response time required for all sites other than those in the Metropolitan DC area?

Answer: Section I.1.9.1 Hazardous Material Emergency Response The Contractor shall provide emergency spill response and cleanup services to the FDA facilities nationwide to mitigate any radioactive spills or releases. The Contractor shall respond to any situation where there is a release or spill of radioactive materials within four (4) hours of telephone notice by the COR

17. Does the FDA segregate pathological waste from other Regulated Medical Waste for shipment?

Answer: No. All MPW (Medical Pathological Waste) is shipped out together in separate waste containers.

18. Will you please confirm for which “Key Personnel” resumes are required?

Answer: Resumes are required for the following Key Personnel:

Radioactive Waste Specialist/Health Physicist Radioactive Waste Technician/Health Physics Technician Health Physics Technician II Senior Health Physicist Project Manager

Waste Chemist

Waste Technician Laborer

Industrial Hygienist

Bar Code Chemist

19. Please provide the name of the current software program that the FDA uses for inventory?

Answer: The Current software program is Health Rx.

20. Please confirm which sites have contractor staff for maintaining inventory system?

Answer: All CFSAN and CVM sites nationwide and WO campus are in the system. This requirement is for all FDA (lab) sites nationwide and will be rolled out incrementally.

21. Please confirm that the Pricing Schedule will be amended to include personnel travel under Item 20 to all sites outside of Metropolitan DC.

Answer: Pricing schedule was amended to include all sites outside of the Metropolitan DC area. Those include line item 20, 29 and 43 highlighted in yellow.

22. Item 25F20 IATA Dangerous Goods Initial Training – is there a minimum number of students that would be required to attend before the training is scheduled?

Answer: No.

23. Could you please provide pictures of Item 25S7 - Biohazard Sharp Object Pouch, and Item.

Answer:

24. Please detail what is included in the Item 25S16 - Chemical Spill Control Cart, and Item 25S18 – the refill.

Answer: Cart supply refill.

25. Please confirm, for RMW, which containers are reusable and which are disposal throughout the locations.

Answer: RMW should be MPW as stated in section I.4.2 of the statement of work. Cubic yard carts are reusable. Sharps containers and all MPW box waste containers are disposable.

26. Item 25S97- can you confirm the size of the refrigeration container that is required? And is a diesel refrigeration unit acceptable?

Answer: The size of the refrigeration containers has been adjusted on the pricing schedule to reflect 25S97A – 48 foot and 25S97B 53 foot.

Yes, diesel refrigeration unit is acceptable.

27. Please provide more information for what is required for Item 25S102 – Annual Emergency Radio Air time.

Answer: This is an emergency radio FCC licensed that will need to be renewed annually by the contractor.

28. Item 28G – Please clarify what types of drums are required.

Answer: 1A2 DOT 55 gallon open head steel drum.

29. Item 31 and 31a – please confirm the size and type of vehicles required for that transport.

Answer: This has been updated on the pricing schedule as follows:

Line Item 31: Standard 26 foot box truck

Line Item 31A: Standard Pickup truck

30. Item 34 – please clarify what is to be included in this emergency response hourly rate.

Answer:

1. Standard rates for regular hour work

2. After hour and Saturday time and a half

3. Sunday and Holidays Over time

31. Will you please extend the bid submittal to August 3rd?

Answer: Yes, this will be extended to August 3rd.

32. Do we need to submit Letters of Commitment with bid submittals (referenced on page 51 of the RFP)? If yes, who needs to complete them (Key Personnel from SOW p29, section I.3.11 only)?

Answer: Yes, letters of commitment are needed for the following Key Personnel’s:

Radioactive Waste Specialist/Health Physicist

Radioactive Waste Technician/Health Physics Technician

Health Physics Technician II

Senior Health Physicist

Project Manager

Waste Chemist

Bar Code Chemist

33. Will you please clarify if resumes or CVs are required for Key Personnel? CVs are listed in the RFP on page 53, and resumes are listed in the RFP page 51.

Answer: Either is acceptable.

34. Please confirm that a list of proposed TSDFs does not need to be submitted until after award of contract (page 23 of SOW)?

Answer:

All proposed TSDFs facilities to be used for this solicitation will need to be submitted with your proposal and address items 1-4 below:

1) copies of all regulatory permits and licenses (Permits for facilities used for chemical wastes must list all EPA and state hazardous waste numbers the facility is permitted to accept and processes as described in 40 CFR 261, subparts C and D.);

2) copies of environment impairment insurance binders;

3) copies of the last two regulatory inspections; and

4) a summary of the facility's regulatory compliance status including notices of violations, fines, RCRA corrective actions, compliance agreements, and permit modifications.

35. Which specific locations require IATA shipping?

Answer: White Oak, Wiley Bldg. and Muirkirk Road Complex.

A. Wiley Building (CPK1), 5100 Paint Branch Pkwy., College Park MD 20740

B. Muirkirk Road Complex (MOD1, MOD2, BRF), 8301, 8401 & 8501 Muirkirk Rd., Laurel MD 20705

C. Federal Research Center – White Oak (FRC) Life Sciences Laboratory - Building 64 Engineering and Physics Laboratory – Building 62 & Animal Research Facility – Building 10, and Buildings 52, 72 and 71 at 10903 New Hampshire Ave., Silver Spring, MD 20993

36. Is the contracted team based in MD required to travel to out of state locations to execute the SOW or is it acceptable to use local out of state labor for those sites (meaning – can we use our California based Chemist for CA work, as opposed to having the MD base team fly to CA)

Answer: No, the contract team based in Maryland is not required to travel to the out of state locations. However, any labor that is utilized has to be cross trained for all services as identified in the following section of the statement of work. They will also have to conform with the personnel qualifications.

Section I.1.7 Integration of Services

The Contractor shall integrate the chemical, radioactive and medical pathological waste services, Dangerous Goods Shipping and Multi-Hazardous Material Inventory Management Services where possible to maximize effective use of personnel, equipment and supplies.

37. PAGE 11 - Please specify agencies and regulatory titles referred to in the Medical Pathological / Regulatory Compliance section.

Answer: See Section I.1.6 he Contractor shall comply with all applicable sections of the laws and regulations listed below and any other applicable laws and regulations that are not listed:

1. U.S. Environmental Protection Agency (EPA): Title 40 CFR.

2. U.S. Department of Transportation (DOT): Title 49 CFR.

3. U.S. Department of Labor (DOL): Title 29 CFR.

4. U.S. Nuclear Regulatory Commission (NRC): Title 10 CFR 19 and 20, 30, 40 and 70.

5. U.S. Drug Enforcement Administration (DEA): Title 21 CFR.

6. U.S. Public Health Service (PHS): Title 45 CFR.

7. Applicable State Environmental Regulations: MD, IL, AL, MA, MO, AR, PA, MI, OH, NY, KS, WA, CA, GA, CO and Puerto Rico.

8. Hazardous waste receiving states: The Contractor shall, when shipping hazardous wastes to another state for disposal, comply with all receiving state requirements regarding the shipping, receiving, storage, treatment, and disposal of such waste.

9. Recycling, treatment, disposal, and storage facilities: The Contractor shall comply with all requirements for waste packaging, etc. imposed by TSDFs that accept FDA wastes and surplus chemicals.

7. Maryland Department of the Environment: Title 26 COMAR.

8. Treatment and disposal facilities: The Contractor shall comply with all requirements for waste packaging, etc. imposed by the treatment and disposal facilities that accept FDA wastes

9. Title 42 Code of Federal Regulations, Public Health

10. IATA, Dangerous Goods Regulations

11. ICAO, Technical Instructions for the Safe Transport of Dangerous Goods by Air

12. Carrier specific rules and instructions (FEDEX, DHL, UPS, USPS, Commercial Airlines, etc.)

Secondary Company References

13. The Contractor shall meet the Department of Transportation Emergency Response Communication Standards (49 CFR 171 and 172.604) applicable to the shipment of hazardous waste. This regulation requires that a comprehensive emergency response service be in place with a 24-hour emergency telephone number, DOT Emergency Response Guide information, and the provision of two technical names for generic N.O.S. descriptions on all hazardous waste shipping papers.

14. The Contractor shall comply with all existing FDA permits, licenses, and decrees listed below, any revisions thereto, and any other future permits and licenses which become effective during the term of the contract.

38. PAGE 12 – I.1.9.1 - Requirement for 4-hour response to radioactive spills nationwide (including Dauphin Island, LA). What level of effort constitutes “response” in terms of meeting the 4-hour requirement?

Answer: Note this section references radioactive when it should be Hazardous Material. Statement of work has been updated.

Contractor or sub-contractor staff needs to be on site within 4 hours to organize and manage spill cleanup.

Section I.1.9 Emergency Response and Remediation of Spills

The Contractor shall ensure that all contractual personnel fully understand and comply with the contingency and spill prevention control and countermeasures plans of each FDA facility.

39. PAGE 12 – I.1.9.2 – Please specify meaning of UNMC acronym.

Answer: There is no meaning to UNMC acronym. UNMC has been replaced with FDA. Statement of work has been updated.

40. PAGE 19 – I.2.5 – Paragraph 2 – Please specify categories of material for segregation

Answer: The categories of material for segregation can be found under Section I.2.2 of the statement of work.

41. PAGE 26 – I.2.13 5 – Please specify meaning of BSC acronym

Answer: Biosafety Cabinet

42. Page 26 – 1.2.13 6e. Please provide specific specifications for the chemical inventory management system and what specific hardware upgrades are required?

Answer: The FDA provides a Safety Inventory and Protocol System (SIPS) hardware and software support for the chemical inventory management system via our Health Rx contract for contractor use.

43. PAGE 31 – I.4.4 – Please specify meaning of SMW acronym

Answer: Special Medical Waste

44. PAGE 37 – I.6 – Please specify meaning of the ESO acronym

Answer: Environmental Safety Officer

45. Attachment 2 – Pricing Schedule

Item 27, 27A, 27B, & 27C – Line item descriptions do not match the personnel qualifications description provided in section I.3.11 of the SOW. Please clarify how the SOW relates to the Pricing Schedule.

Answer: Statement of work, section I.3.11, has been updated to reflect the personnel qualification listed in the pricing schedule.

46. Item 24a – Project Manager – Based on the hours this appears to be 2 man years (2080 ea) – is the intent to have 2 Project Managers or should one of the man hours be moved to the Chemist role? If 2 Project Managers are required please outline respective roles and responsibilities.

Answer: Yes, the intent is to have 2 Project Managers, and the Project Managers should be Chemist, one for the White Oak Campus and the other for the College Park and Muirkirk Campuses.

See section I.2.11 of the statement of work for the roles and responsibilities.

47. Item 25F20 – IATA training – Is this price line for training our employees or FDA/government employees?

Answer: Price would be for training contract staff.

48. Item 25o – Please provide specification of the glass box, or what exactly this is.

Answer: This is a broken glass box that fits into to SMW burn box (16 x 16 x 26) for disposal.

49. Item 25s6 - Please provide specification of the Pan Sterilizing PP, or what exactly this is.

Answer: This is a Nalgene autoclavable pan or tote

50. Item 25s53 – 73-3/8 in trailer – Please clarify what this is. Can we have specifications on this item?

Answer: This is a flatbed cart.

51. Item 25s66 – what exactly is needed in this tool set?

Answer: See answer # 10.

52. Item 25s102 – What are the requirements for this line?

Answer: See answer # 27.

53. Item 26G/H – please clarify what this equipment is? Specifically, we would like to understand

Answer: See answer # 9.

54. Item 28G – It is not clear from the description what is sought. Is this item listed as “drums” for supplies of new containers, disposal of empty containers or disposal of some other category of radioactive material? Please provide additional detail for the line item description.

Answer: See answer # 28.

55. Item 30A24 – Please provided additional description and/or examples for the words “structure” and “analysis” in this line item.

Answer: Concrete boring sampling for decommissioning surveys.

56. Item 33 et. Al. – What information does the FDA seek as input to the pricing schedule for lines listed as Cost Plus?

Answer: All items listed for cost plus are not applicable for pricing. This is a negotiated line item when services or supplies are needed

57. RFQ Doc Page 55 – States 41% of total subcontract is small business while attachment 7 states 33% - which is correct?

Answer: The small business goal is 40% and has been updated in the RFP, section IV, #30 and attachment 7.

58. Item 20: Personnel Travel…should travel to the other locations not in the DC area be added under this line item (i.e San Juan, Lenexa, Denver, Irvine, CA, etc)?

Answer: Yes, all sites should be added. Many sites depending on vendor capabilities can be scheduled for combined pickups. Travel allowance per non DC metro facilities can also be proposed.

59. Who is the incumbent and how long have they had the current contract?

Answer: See answer # 7.

60. Can we please get a copy of the current contract and pricing?

Answer: Because this is a new FDA-wide requirement, contract pricing is not available.

61. What is the annual contract amount/total billings?

Answer: See answer # 60.

62. Can we please get waste profiles for bulk waste streams?

Answer: See attachments for FDA Profiled Waste Streams that are currently available.

63. What is the balanced bid clause for this bid?

Answer: Proposals must be balanced. For instance, proposals should not price something as $10.00 in year one and $150.00 in years two thru five, or the reverse scenario. That is unbalanced.

1. Can we list $0 as the price for a line item?

Answer: No. We need to have your pricing for all line items for comparison, review and analysis of proposals.

64. On p52 of the RFQ, Section IV.28.Factor 2.1 – It states that bidders shall demonstrate, “Offeror(s)’s technical and functional understanding of the FDA and its mission

1. The FDA is a very diverse and large organization, could you please provide a few examples of this?

Answer: See Section I.1

The Food and Drug Administration (FDA) is responsible for arranging for proper disposal of chemical, medical pathological, radioactive and mixed wastes generated by the research laboratory activities within FDA facilities nationwide, including Puerto Rico. Our laboratory operations include the use and generation of diversified chemical, radioactive, and medical pathological wastes of varying toxicities and quantities.

Examples:

CFSAN generates all types of waste in large quantities and includes an animal facility. Whereas, many ORA labs generate only two types of waste in small quantities.

Section I.1.7 Integration of Services

The Contractor shall integrate the chemical, radioactive and medical pathological waste services, Dangerous Goods Shipping and Multi-Hazardous Material Inventory Management Services where possible to maximize effective use of personnel, equipment and supplies. Extreme care shall be taken to minimize the potential for cross contamination of radioactive, biological and chemical wastes by use of separate containment within collection vehicles, carts and or/trucks. Management of daily activities must be coordinated between the Contractor's operational supervisors. Incorporation of the Dangerous Goods Shipping and Multi-Hazardous Material Inventory Management for FDA Nationwide. MGW

2. Can you please provide the response from the incumbent from the last submission as an example?

Answer: No. There has been no FDA-Wide previous contract.

65. On p52 of the RFQ, Section IV.28.Factor 2.2 – It states that bidders shall demonstrate “Offeror(s)’s approach for developing an adequate strategy to accomplish the project’s objectives.”

1. Are the objectives of the project stated in the bid package? If not, could you please explain?

Answer: This is listed in the statement of work, attachment 1.

Specifically found in the following sections.

Section I.1.3

General Requirement and

Section I.2

Chemical Waste Scope of Work

Section I.3

Radioactive Waste Scope of Work

Section I.4

Medical Pathological Waste Scope of Work

Section I.5

Dangerous Goods Shipping Scope of Work

Section I.6 Multi-Hazardous Material Inventory Management Scope of Work

2. Can you please provide the response from the incumbent from the last submission as an example?

Answer: See answer # 64.