S06 Revised Response to RFIs -Revised (002).pdf

Correct Safety and FCA Issues

Project #517-19-301

Pre-Bid RFIs

1. Is the contractor required to install fencing around temporary SPF units at loading doc with protective fencing or signage? How many linear feet is expected? Theres no drawing to signify requirements of fencing. Answer: Fencing is not needed around temporary SPS trailers, but barricades will be needed to provide protection from vehicles.

2. Can the contractor take the site photos to fulfill the Photo documentation Specification listed in 01

00 00 1.19 PHOTOGRAPHIC DOCUMENTATION? Answer: Provide As indicated or specified.

3. Is Microsoft project professional an acceptable scheduling program approved by the VA? Answer:

See Scheduling Specifications.

4. Is Covid task force procedures included in this solicitation? Answer: VHA Supplemental Contract Requirements for Combatting COVID-19 apply to this solicitation

5. Is exterior project name and Safety signage required? Answer: A sign with exterior project name is not needed; safety signs are required per contract documents, VA policies, and national and local codes/regulations.

6. Drawing AB 100 appears to be missing. Please provide abatement plan. Answer: This sheet has been deleted from the project.

7. What equipment should be included to the Mobil sterile unit. Answer: See performance criteria.

8. Please clarify if the Mobile Sterile Processing System is to be included in this response. If so, what are the specifications/requirements for the mobile unit? Answer: Information provided in contract documents.

9. Is the Mobile Sterile Processing System to be procured by the construction service contractor (page

13 of 80) or is it to be provided by others (A.3 Price/Cost Schedule CLIN #0003)? Answer:

General Contractor to provide.

10. If it is not to be provided within this solicitation, will there be another independent solicitation released to procure the Mobile Sterile Processing System directly with the Mobile Sterile Processing

System vendor? Answer: N/A

11. Is the facility to provide hot water to the SPS trailer? Answer: Trailer To Produce Hot Water

12. Do the boilers that feed the sterilizers need to be fed with RO or DI treated water, per AAMI TIR34:

2014 guideline? Answer: RO

13. Does the MSPS feed water need to comply with AAMI TIR34 guidelines? Answer: Provided as specified.

14. Are both the permanent and temporary facilities required to meet plumbing best practices as described in AAMI TIR34? Answer: Provided as specified.

15. Will the temporary and permanent facility systems have to be validated to AAMI TIR34 and ST79 guidelines? Answer: Provided as specified.

16. Is it a requirement to maintain access to one loading dock? Answer: Yes

17. What is the minimum tray throughput required per cycle per sterilizer? Answer: Current sterilizers run up to 3 large trays (10.5” x 10.5” x 22.5”) per cycle per sterilizer

18. Will the facility need to process any Davinci Si or Xi robotic instrumentation? Answer: No

19. Can a detailed statement of work for the provision of the Mobile Sterile Processing System be provided? Answer: Provided In Documents

20. What utility hook ups to the Mobile Sterile unit will the VA be installing? Answer: Provided per documents.

21. Will the following utility hook ups be available supplied by the VA?

• Steam Answer: Provided per documents

• Domestic water Answer: Provided per documents

• Electrical Answer: Provided per documents

• Access to Sewer Drain lines Answer: Provided per documents

• TAB, Domestic water testing, Answer: Provided per documents

• Sprinkler system wet pipe suppression Answer: Provided per documents

• Fire alarm wired alarm. Answer: Provided per documents

• Will personnel access card readers be required to be temporarily installed on the temporary

SPS? Answer: Yes

22. Drawing AB100 is listed on Index of Drawings but is not included in drawing set.

a. Question: Can this drawing be provided? Answer: Not Required.

23. Drawing MI603 is listed on Index of Drawings but is not included in drawing set.

a. Question: Can this drawing be provided? Answer: Sheet is Deleted from Project and not required.

24. Bid Item 0002 deletes work 'associated with purchase, installation, and start-up of items in the Operating Suite'. The drawings don't define the area of Bid Item 0002.

a. Question: Should bidders assume Bid Item 002 deletes all work associated with Rooms 5A-110, 5A-112, 5A-113/114, 5A-126, 5B-Corr and new mechanical room 5A-117A? Answer: The contractor will remain responsible (should include cost) for the installation of the door to alcove 5A-124, the installation/start-up of DH-1 in 5A-112 and 5A-113/114, and all scope associated with the endoscopy suite.

25. Specification Section 22 31 11 11 40 11 - Water Softeners (See Volume III) We don't see a specification Volume III.

a. Question: Can this specification section be provided? Answer: This project does not have this specification as a part of this design and does not reference Volume

III.

26. Specification Section 22 67 19.16 Reverse Osmosis Water Equipment (See Volume III).

We don't see a Specification Volume III.

a. Question: Can this specification section be provided? Answer: This project does not have this specification as a part of this design and does not reference Volume

III.

27. Is the facility to provide hot water to the SPS trailer? Answer: No.

28. Will this project be performed in accordance with the Department of Veterans Affairs Memorandum date 08/28/2020 (see attachment “A” for reference)?

29. Will this memorandum be applied to both the temporary and permanent facility systems?

Answer: Yes

30. Will the facility need to process any Davinci Si or Xi robotic instrumentation? Answer: No

31. What is the minimum tray throughput required per cycle per sterilizer (on the temporary system)? Answer: Current sterilizers run up to 3 large trays (10.5” x 10.5” x 22.5”) per cycle per sterilizer

32. The basis of design vendor for the mobile sterile processing system utilizes a “statement of work” type document to determine what is needed / desired by the end user. Upon reviewing the drawings and specifications it is not clearly identified as to what is needed / desired for this facility. We feel more information is needed to ensure the facility's requirements are met. (Issue is unclear – No response Provided)

a. Question: Is there a “statement of work” for the mobile sterilization processing system (see attachment “B” example from another VAMC project)? Answer: Documents Define Requirements.

33. Drawing AS100 has a Note #2 under the heading Site Plan for Temporary SPS Mobile Trailers and Components that states: At least one lane of truck access must always be maintained to loading dock.

The same drawing (AS100) shows an emergency exit on the “True West” side of the trailer. The temporary trailer vendor has informed us that due to the size of the trailer that this exit is not required. Can this exit be eliminated to allow for the needed clearance as required in note #2 that states one lane of truck access must always be maintained?

Answer: Documents Define Requirement

34. Drawing G002 has a note labeled Abatement Report Note that states the following:

Abatement is not anticipated for work on this project. Sampling and testing report is available from the VA COR. Completed by Durbin Environmental dated 06/10/2019.

Contractor may sample at their own cost if suspect material is found.

a. Question: Can this report be provided? Answer: Not Required.

35. Drawing AD102 General note number 2 states: Contractor shall refer to sheet AB100 Hazardous Material Abatement Plan prior to performing renovation or demolition work.

Abatement contractor shall remove all hazardous materials prior to general renovation and demolition work. As stated in question #1 the referenced drawing (AB100) was not provided. Answer: Note to be deleted.

Drawing AD102A Reflecting Ceiling Demolition General Notes #2 states: Contractor shall refer to hazardous material abatement plan prior to performing architectural or mechanical renovation or demolition work to determine if asbestos, lead, PCBs, batteries, or mercury in fluorescent bulbs will be disturbed. Abatement contractor shall remove all hazardous materials prior to general architectural and mechanical renovation and demolition work. Answer: Note to be deleted.

Spec section 02-82-13.19-1.1.2 states: Removal, clean-up and disposal of ACM flooring in an appropriate regulated area in the following approximate quantities: (200) square feet of multi-layer floor covering and associated mastics, glues, adhesives and floor leveling compound. (25) each of Transite-Type Radiator Heat Shields (Approximately 10-15 S.F. Each) Answer: Note to be deleted.

Drawing G002 has a note labeled Abatement Report Note that states the following:

Abatement is not anticipated for work on this project.

a. Question: There is a conflict concerning whether hazardous material is present on this project. Can clarification be provided for this issue? Answer: No abatement work in project

36. Drawing A001 Phasing note 5: Infrastructure beyond those indicated on the site drawings are the responsibility of the selected vendor and the contractor. Bid must contain complete, usable, and operable facilities.

a. Question: What infrastructure beyond those indicated on the drawing would be expected if the Basis of Design (Mobile Medical International Corp.) was utilized for the bid? Answer: No further specifics known.

37. Drawing AS100 Note 4 states Provide crash resistant barriers around temporary trailers.

a. Question: What type of crash resistant barriers are required (i.e., water filled plastic, concrete, bollards, etc.)? Answer: Acceptable Protection From Vehicles

38. Drawing A001 Phasing Note 2 states: "All trailer work except final connection are part of base bid indicated utility extensions is work of Bid alternate 1."

a. Question: This note as written is confusing, who is responsible for the final connections in the base bid? Answer: "All trailer work except final connection are part of base bid, indicated utility extensions is work in Bid alternate 1."

39. If moisture remediation is required for the new floor installation, will it be addressed as a change order or should this cost be included in the base bid? Answer: To Our knowledge it is EPDM

40. Drawing A103 General Roof Plan Note 1(Referencing the 1st floor roof) states existing roof membrane appears to be EPDM. Please verify.

a. Question: For bidding purposes, can it be confirmed that the existing roof is EPDM?

Answer: Yes

b. Question: Is there an existing warranty on this roof? Answer: No

41. Drawing A103 Detail 6 shows the roof on the 4th floor to be TPO.

a. Question: Is there an existing warranty on this roof? Answer: No

42. Drawing A103 Detail 4 shows the infill steel plate to be 8” thick.

a. Question: Is this a typo, if so, how thick should the steel plate be? Answer: 1/8”

Thick

43. Spec section 01-33-23-1.6.D & E state: E-mail electronic submittal documents smaller than 5MB in size to e-mail addresses as directed by the Contracting Officer. E. Provide electronic documents over 5MB through an electronic FTP file sharing system. Confirm that the electronic FTP file sharing system can be accessed from the VA computer network. The Contractor is responsible for setting up, providing, and maintaining the electronic FTP file sharing system for the construction contract period of performance.

a. Question: Is a platform such as ProCore acceptable for both small and large submittals? Answer: Yes

44. Drawing A102 shows a note 4 at Door 5A-124. This note states to install gasketed seals and interlocking gasketed threshold. At the site visit it was determined there is no door at this present location.

a. Question: Can you please advise on how to proceed? Answer: See new door in door schedule

45. Question: May grooved fittings by Gruvlok or Victaulic be used on steel hydronic piping in lieu of weld fittings? Answer: Provide Fittings / Connections as Specified.

Department of Veterans Affairs Memorandum Date: August 28, 2020

From: Assistant Under Secretary for Health for Operations (10N)

Subj: Required critical water systems testing and reporting for Sterile Processing Services

(SPS)

To: Veterans Integrated Service Network (VISN) Directors (10N1-23)

VISN Chief Medical Officers (10N1-23)

VISN Quality Management Officers (10N1-23)

VISN Sterile Processing Services Leads (10N1-23)

1. This notice is provided by 10N in collaboration with the National Program Office for

Sterile Processing Service (NPOSP) and the Office of Healthcare Environment and Facilities Program (HEFP) to provide awareness and reinforce the mandatory requirement for a multidisciplinary team approach to ensure testing, routine preventative maintenance, and reporting requirements are performed for Sterile

Processing Service (SPS) critical and utility water systems per VHA Directive 1116(2). There has been an increase in critical water issue briefs recently that are impacting patient care and are attributed to reduced water usage. Appropriate water testing must occur per schedule, with flushing as necessary regardless of whether SPS is operating at full capacity.

2. Water quality requirements within SPS are defined in the Association for the

Advancement of Medical Instrumentation (AAMI) Technical Information Report (TIR)34: 2014/(r)2017, “Water for the Reprocessing of Medical Devices” which is referenced in AAMI ST79:2017, “Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities”. These documents not only define the parameters to be monitored but also outline the frequency of quality testing and limits for the noted contaminants in utility water and critical water.

The following AAMI TIR34 Table 1 provides the contaminants and the limits to be tested for. All VA Medical Centers must comply with this guidance for water quality limits.

Table 1—Categories and recommended levels of water quality for medical device reprocessing

Type of Water Utility Water Critical

Water

Water Use Flushing/Washing/Rin sing

Final Rinse/Steam

Specifications:

Units

Attachment A

Subj: Required critical water systems testing and reporting for Sterile Processing

Services

Hardness mg/L < 150³) < 1

Conductivity (mg/L = ppm) μS/cm < 500 < 10 pH4) 6 – 9 5 – 7

Chlorides mg/L < 250 < 1

Bacteria cfu/mL n/a < 10⁵ < 10 Endotoxin EU/mL n/a < 20⁵ < 10

The following is an abbreviated AAMI TIR34, Table 6 for water quality testing frequency that all Medical Centers must comply with as part of their critical water program for SPS.

Bacteria Monthly

Endotoxins On installation, modification, or repair of the critical water treatment system or when persistent increased microbial levels are detected by heterotrophic plate count

Total organic carbon (TOC)

Monthly or quarterly pH Monthly

Water Hardness Annually

Resistivity Meter Daily

Ionic Contaminants

Annually

Color or Turbidity Daily

Temperature Daily

Filters Daily

3. All critical water testing results for reprocessing activities must be reported to the

VISN SPS Management Board, through the Facility RME Committee.

4. The VISN SPS Management Board is responsible for ensuring all facilities:

a) Perform the required critical and utility water testing as defined in AAMI

TIR34.

b) Have a program in place for testing and performing routine preventative maintenance on the critical water system.

c) Institute a flushing program for both critical and utility/potable water during times of low water usage in SPS.

5. The VISN SPS Management Board will provide an attestation of these requirements to NPOSP by October 1, 2020. Any abnormalities will require

Subj: Required critical water systems testing and reporting for Sterile Processing Services corrective actions and must be reported through the VISN SPS Management

Board to NPOSP until complete. NPOSP contact: mailto:vhaspshss@va.gov.

6. For questions pertaining to this memorandum, please contact:

Marissa Lewis, Acting Director, NPOSP/10NC6 at Marissa.Lewis@va.gov or

Vince Rizzo, Compliance Engineer, HEFP/10NA5E at Vincent.Rizzo@va.gov.

for Renee Oshins mailto:vhaspshss@va.gov mailto:Marissa.Lewis@va.gov mailto:Vincent.Rizzo@va.gov