36C24818R0186-0006001.docx

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Renovate Pharmacy to Meet USP 800
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36C24818R0186
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36C24818R0186 0006 RFI's Phase 2.1 Answers.docx

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Pharmacy renovation RFIs

1. What is the level of infectious disease control rating for this site?

4D

2. Will the qualified superintendent be able to fill in soles as the SSHO and QCM if required?

No

3. Please explain the number labeling (1-8) on the floor plan provided in amendment 5.

The numbered rooms are administrative functions.

4. In the floor plan provided in amendment 5, are the rooms labeled 1-8 part of the renovated pharmacy?

Yes

5. How much space and what program will the pharmacy need in order to remain operational during construction?

The designer will need to work with the COR and end user to determine.

6. Does the VA have a current hazardous material survey for the area in the scope of work? If so, please provide.

Yes. Provided as attachment

7. Please confirm the number of Hazardous Drug Handling Rooms, Non-hazardous drug handling rooms, storage rooms, ante rooms, offices, workrooms, bathrooms, etc.

Designer is to work with COR for determination.

8. The Vault is highlighted as being renovated, please confirm if this Vault will be replaced, if so can the VA give out a basis of design for a new one?

The VA would like to renovate the interior. No re- design or location changes

9. Is the solicitation released in amendment 5 omits the previous amendments including the last set of RFI answers released in Amendments 2 and 4?

Previous RFIs are obsolete.

10. In order to respond to the Phase II proposal requirements, the D/B team will need more definition around the scope and space program that is to be provided. This information will be used to determine a phasing schedule, estimate of downtime as well as the construction cost.

None will be provided.

11. Does the existing IV Prep area exhaust extend all the way to the tower roof/penthouse?

Exhaust is through the penthouse.

12. Does the VA want the new IV Prep area exhaust to extend all the way to the tower roof/penthouse or can it terminate on the 2nd floor roof area?

Designer is to determine the most cost-effective method.

13. Does the VA want a dedicated AHU for the cleanroom or can it be served from the main Pharmacy AHU?

Designer is to determine the most cost-effective method.

14. Can the 2nd floor roof be used for a new Pharmacy AHU?

Yes

15. Can we use the abandoned dumbwaiter shaft for ductwork and/or utilities access for this project?

Yes

16. Are the design professionals required to be Asbestos trained to do non-destructive above ceiling observations?

Yes

17. Design-Build Statement of Work, p.4, #8 Electrical states, “All panels shall be metered before any planned connection to insure available capacity.” NEC requires a 30-day continuous monitoring. Does the VA require the same time period? If not, what is the VA required duration for monitoring the electrical panels?

Always follow applicable NEC codes. The VA would like all pharmacy equipment on new electrical panels with dedicated circuits if possible.

18. Can the new IV Prep cleanroom be constructed somewhere other than in its current location so that the Pharmacy can operate continuously duration construction?

The new prep cleanroom can be constructed anywhere within the project area outlined in the solicitation. This was annotated in the architectural plan.

19. Does the VA intend to reuse the IV Prep hoods or will they be replaced with new hoods? If new hoods, will the VA specify and/or pre-purchase them or will the design professionals specify them.

The VA would like new prep hoods. The designer should spec the hoods.

20. Please provide existing known Asbestos Containing Material (ACM) report.

Map of hazardous material locations provided as attachment

21. Do the previous RFIs and Responses remain valid from the Original Phase 1 and 2 of this solicitation?

No

22. What non Pharmacy office space needs to remain and/or to be accommodated for in the renovation?

No offices that do not belong to the pharmacy are to remain

23. Does the Pharmacy Department have a standing certification/maintenance contract for the Laminar Hoods/BSC? Is there a particular brand or Model that the pharmacy staff prefers?

No maintenance contract exists. Designer should submit reconditions for model.

24. After the new compounding suite is certified, what is to happen with the existing suite equipment?

If not required, the equipment will be turned over to the VA or disposed of/recycled.

25. Are there any anticipated modifications to the Vault or High-Density Storage System?

The VA would like to redesign the existing storage and provide additional if required.

26. If any work is to be done in the Vault or High-Density Storage System areas will the Pharmacy Staff still need to access these areas or will staff, equipment and pharmacy items be temporarily relocated?

Staff access to existing will be required.

27. In order to abate any area of the pharmacy with a hard ceiling (including the high density storage and vault areas), that area will need to be vacated by all VA staff and the ceiling will have to be demoed in order to properly we abate the area. Will the pharmacy be able to support vacating these areas during a phase of construction?

Yes. However operational capability must be not be impaired.

28. Please provide the Hazardous Material Survey for the area that was completed in 2018.

Provided as attachment.

29. Please confirm if the contractor will be supplying the fume hoods and refrigerators and if so what brand/models are desired.

Contractor to provide new, code compliant vent hoods.

30. Is the end result of the project to have 2 suites of compounding rooms (where each suite contains hazardous and non-hazardous rooms and anti-room)?

Only one compliant suite is required.

31. Please confirm that contractor will be required to have inside and outside air monitoring during asbestos abatement and the VA will not be providing an Air Monitor.

The contractor must follow all asbestos abatement requirements. The VA will not provide air monitoring equipment.

32. Please provide the quantity Hoods, BSCs, and Refrigerators required for each room as the TIL does not specify the number required.

The quantity of hoods will be determined by the designer. one additional refrigerator is necessary for drug storage. Passthrough refrigerators not allowed per USP. Freezers are inadequate. Currently have 3, need 4 total

33. Please confirm that there is no renovation work required in the corridor.

The corridor with in the project space is available for use as space and should be renovated.

34. How much swing space will be available for the Pharmacy to use during each phase of construction?

Space available is within the project area. Additional area may be available however that space is unknown at this time.

35. Where do the dumbwaiter shafts end below the roof? Are they inside or outside of the penthouse?

Dumbwaiter’s mechanical room is in the penthouse.

36. Can the dumbwaiter shaft be completely removed from the pharmacy space? Is it stripped of tracks, carriages and power wiring?

Yes

37. What is the nearest connection to campus chilled water? Note that CRD recommends individual-zone, ceiling-mounted, water-cooled air conditioners to support the hazardous and non-hazardous spaces.

Designer will need to determine.

38. An estimated 60 GPM at a range from 44-55 degrees F is required. Is this available at chilled-water main pressure Yes

39. Up to 3,500 CFM of makeup air will be required to compensate for exhaust, for high-end humidity control and for pressurization and air exchange. A dedicated roof- or penthouse-mounted makeup air handler will be required. Is there a preferred location for this equipment, as near as possible to the dumbwaiter shaft?

Designer will determine the most cost effective and functional solution.

40. This unit, designed to treat ambient air at a maximum of 100 degrees drybulb/80 degrees F wetbulb, will require 65 GPM of chilled water at a maximum of 46 degrees F. Is this flow available?

Yes

41. We would also like to get information on the present use of the adjacent rooms. We noted, during our tour, that 1A-108b houses the Pyxis equipment, and 1A-108a is presently set up with three stations for data entry and that 1A-108 is for general storage and workstations. As other offices are being offered for the expansion, we would like to get information on the present use of the following rooms.

Questions- what is the present use of each of the following rooms?

a. 1A-112a

b. 1A-112b

c. 1A-112c

d. 1A-112d

e. 1A-112e Cannot comment as these are not currently pharmacy owned spaces. As far as I know 112e is the ED director’s office, and 112a might be a breakroom.

42. Where do personnel enter presently?

Primarily through the door in 1A-108d, but also through 1D-104.

43. Should there be a locker room/change room?

Possibly. Current requirements only require chemotherapy compounding staff to change out. Currently these staff members utilize locker rooms on the ground floor and SCI, but this increases potential for contamination to and from. having a small change area might be beneficial, especially if requirements change in the future to require dress out for any staff. I think the space would be more valuable for drug storage and dispensing though.

44. Where do general and non-hazardous supplies enter the facility?

Through the loading dock with the mckesson order, which is delivered to the ground floor pharmacy and then brought up through the door in 1A-108d

45. Where are they unpacked?

G-006 and 1A-108. It would be nice to have a breakdown space.

46. Where do hazardous supplies enter the facility?

Same as #44

47. Where are they unpacked?

1A-108

48. Where are supplies kitted and sent into the compounding rooms?

Kitted? Supplies are taken from storage location 1A-108a and 1A-108d.

49. Where is checking done?

1A-108 for IV products, 1A-108b for unit dose items and overnight ED dispensing.

50. How is hazardous waste disposed of?

EMS takes the trace chemotherapy waste (yellow bins and bags), Safety removes the black buckets (bulk chemo and RCRA waste)

51. How is non-hazardous and bulk waste disposed of?

EMS comes to remove

52. Is the present refrigerated drug storage adequate? What additional refrigeration, including passthrough refrigerators, are required?

No, at least one additional refrigerator is necessary for drug storage. Passthrough refrigerators not allowed per USP. Freezers are inadequate. Currently have 3, need 4 total

53. We would like to get information on the current and future compounding volumes. As this will be a major renovation, the design for the sterile rooms must provide sufficient space and features for both present and anticipated future compounding.

Question: What are the current and planned hazardous compounding volumes?

Current hazardous compounding is appx 30 preps on an average day, this can go up to 40 on a busy day. Chemotherapy is expected to increase.

We see that there are two (2) @ 4’ exhausted biological safety cabinets located in the chemo IV prep room. In larger hospitals, it is usually the preference to utilize 4’ hoods over 6’ hoods. As a larger room is planned, it could be fitted with a third exhausting BSC. This can function for both conventional anti-neoplastics as well as investigational drugs and for research.

Questions:

54. Are three BSCs desirable for the new pharmacy design?

Desired but not required. BCG cannot be made in the same BSC as intravenous chemo without a full clean and circulation, and best practice is for a dedicated hood. With three BSCs we could truly dedicate a hood to BSC preparation and allow for additional chemo compounding capacity during busy times.

55. Is a fourth BSC, or space and mechanical provisions for a fourth BSC of value?

No

56. What volume of in-room hazardous refrigerated storage is required?

25 cu ft refrigerator.

57. What are the current and planned non-hazardous compounding volumes?

Current production volume is appx 500 preps per day.workload is expected to increase when the new bed tower is built. Planned workload depends on number of patients the new bed tower will add.

58. What is the frequency of STAT compounding?

Cannot quantify right now, we are waiting on a report with this data. STAT compounding does occur regularly.

Presently, there are three (3) @ 4’ laminar flow workstations and one (1) disabled aseptic isolator (glovebox).

59. Are three laminar flow workstations sufficient?

Currently yes

60. Would 6’ models enhance efficiency?

One larger model would be beneficial, for training and for use of additional compounding equipment.

61. What volume of in-room non-hazardous refrigerated storage is required?

None inside the buffer area. 5 refrigerators.

62. Aside from the comments and questions above, what features will enhance staff efficiency and comfort in their work?

Floors should be antifatigue and easy maintenance (not require waxing). Large viewing windows and room walls should be continuous without columns or breaks to allow for carts and equipment and to maintain site lines. Intercom system instead of phones. Wall mounted monitors should be low profile and easy to clean.

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