36C24921Q0003 0001.docx

36C24921Q0003 - 0001

5. PROJECT NUMBER (if applicable)

CODE

7.

ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. 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 CODE

CODE

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 NUMBERE

D 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 amendmen t, 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) 08-28-2020 None 90C Department of Veterans Affairs Network Contracting Office 9 (90C)

NCO 9

1639 Medical Center Parkway, Suite 400 Murfreesboro TN 37129 90C Network Contracting Office 9 Department of Veterans Affairs Network Contracting Office (90C) 1639 Medical Center Parkway Suite 400 Murfreesboro TN 37129 To all Offerors/Bidders

36C24921Q0003 08-06-2020

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 9/17/2020 @ 14:00 CST X The purpose of this amendment is to extend the quote due date, provide answers to RFI's recieved, and open an aditional period for aceptance of RFI's as a result of answers provided.

1. The new quote due date is now September 17, 2020 @ 14:00 CST, no late quotes will be accepted.

2. Final acceptance of additional RFI are due on August 31, 2020 @ 14:00 CST, no late RFI's will be accepted.

3. Ansers to previously received Request for Information is attached. See: S05-RFI Answer to RFQ 36C24921Q0003

------------------------------------------END OF AMENDMENT 0001---------------------------------------------------------

Shawn M. Hendricks Contracting Officer

NCO915L2-4043

RFI Answer to RFQ 36C24921Q0003

1. Review Operators Logbook There’s a RO/DI Water System Maintenance Log that appears to be a weekly log. However, on top of the RO cabinet, there is a request for a daily check for anti-scalant level, chlorine residual, and DI monitor.

0. Question: Where is this information kept and is this part of the “Operator Log” the hospital is requesting to be checked monthly? The operator log is being recorded by SPS staff weekly and posted on the door to the room with the RODI system. This is to be reviewed monthly by the technician.

0. Question: What is defined as the DI monitor? The DI monitor currently in place is the indicator light between the two DI tanks. If the indicator is green/passing from the first tank, then the water is considered to have met the requirement for DI monitoring. SPS is obtaining a handheld ultrameter to measure conductivity/resistivity of the water at the point of use.

1. There is an 1 MΩ-cm Water Quality/Resistivity Indicator Light after the worker DI tank, but no monitor to record the actual water’s resistivity and no monitor/indicator light after the polisher DI tank, which is the true water quality that the SPS is using.

0. Are water hardness, pH level, pressure drops across filters, RO product and reject flow rates and calculated recovery being logged daily in an Operators Logbook and expected to be reviewed? Currently, the temperature, product flow, pump PSI, filter pressure drop, hour meter reading value, free chlorine level, product water quality (less than 50 US), water conductivity, verification of light on DI polisher are recorded weekly and are expected to be reviewed whenever the technician is on site.

2. AAMI TIR34 recommends there should be daily and shift checks of this information. If this information is being logged, we’d like to be provided access to this as part of the review of the Operator Logbook. See attached log - S06-Completed Operator Log

1. Inspect & Replace Pyrogen/Filter

1. Question: What is the make and P/N of the pyrogen filters currently used? 5-micron filters are currently used for the pyrogens.

1. Inspect & Replace Vent Filters

2. Company X follow-up: Confirm vent filter make and P/N used on MWST’s and see if interchangeable with water filter housing. Are water filters interchangeable for air filters? An air filter is preferred for this setup.

2. Question: What is the make and P/N of the air filter currently used? The current filter placed on the system is that of a water filter, when it should have been an air filter for the vent in question. This was completed upon installation of the RODI system between late 2018 – early 2019. It is my understanding that these are not interchangeable. No P/N available due to it not being what is preferred.

1. AAMI Test RO Product (every 6 months)

3. Question: Does the hospital want to increase the frequency of water testing to meet AAMI TIR34 recommendations, per Table 1, Section 4, “Categories and recommended levels of water quality for medical device reprocessing” and Table 6, Section 7, “Overview of water quality monitoring”? The facility is actively obtaining a device to test all of the below values with the exception of TOC. SPS staff will test the water at point of use using a facility owned device at the frequency outlined in AAMI TIR34.

0. Total Organic Carbon (“TOC”) – Monthly or quarterly

0. pH – Monthly

0. Resistivity – Monthly (AAMI recommends daily)

0. Water hardness – Monthly (AAMI recommends daily)

0. Chlorides – Monthly (AAMI has no frequency recommendation but states Table 6 is “not exhaustive.”)

1. LAL Water Test

4. Question: Where are the three (3) locations desired for LAL sampling?

0. There are 4 potential sampling ports:

0. After RO membranes (“Product Water”) Yes

0. After DI polisher tank

0. After 0.2µ filter Yes

0. Return Loop (“RL”) Yes

4. To clarify, LAL samples are incubated for 60 minutes, not 48 hours. The facility requires that results be provided in a timely manner as to minimize the quantity of instrumentation that may be affected by critical water that is out of range, and ultimately to minimize the number of Veterans affected. If there is an acceptable LAL incubation test that only requires 60 minutes, then that will be sufficient to the facility.

4. Question: Is it acceptable to regularly test for TOC rather than LAL? A regular TOC test would be acceptable based on the TIR 34, however, if elevated microbial levels are detected via the TOC, expectation of the service would be that the contractor disinfect the system as outlined in the solicitation. A LAL test is also recommended should a TOC test result in high microbial levels based on the TIR34.

2. AAMI TIR34 doesn’t require monthly LAL testing of Critical Water. LAL endotoxin testing per AAMI guidance is to perform at installation, modification, repair, or persistent elevated HPC levels. If microbial levels in water are monitored by viable count, ATP assessment, TOC, or other applicable tests, endotoxin levels only need to be determined when the system is installed, modified, or repaired.

1. Bacteria Water Test (Contractor to Pull) 48-hour incubation

5. Question: Where are the three (3) locations desired for LAL sampling?

0. There are 4 potential sampling ports:

0. After RO membranes ("Product Water") Yes

0. After DI polisher tank

0. After 0.2µ filter Yes

0. Return Loop ("RL") Yes

5. Question: Does the hospital want to add any point-of-use locations inside the SPS (e.g. purified water faucets) No, Lexington VA is actively obtaining a device to routinely test the water at point-of-use.

1. Question: The water spray guns are listed as using purified water. Is this correct? If so, do you want the spray guns added to the point-of-use sampling? The spray guns do utilize the critical water provided by the RODI system. After discussion with – SPS & Endoscopy Nurse Manager, and if possible, adding an additional sampling at the point of use would be beneficial.

1. Sterilant for Central System, Low pH Cleaner

6. Question: Is there a difference between the “sterilant,” and low pH cleaners? Are these the same? There is a difference. Minncare cold sterilant is used as a sterilant and Liquiclean 103 low pH cleaner is used as the low pH cleaner.

1. High pH Cleaner

7. Question: What high pH cleaner is desired? What is the desired procedure for using this cleaner in conjunction with the low pH cleaner? Americlean B solution is recommended by the manufacturer; however, comparable alternatives are acceptable. Please follow the procedure for cleaning in place outlined in the Ameriwater system operation manual 98-0106 Revision J, page 40-41, using pH cleaners provided by the contractor.

1. Scheduling of monthly disinfecting

8. Question: Confirm the hospital wants weekday working hours downtime to perform monthly disinfecting. Yes, Preferred hours of work are 7:30 AM to 4 PM Eastern time, Monday – Friday. The earlier hours of that timeframe are preferred, but not required. Should the facility be unable to cease operations during the 7:30 AM to 4 PM timeframe due to need of short turnaround items, the contractor could be requested to disinfect at a later time.

1. Hospital supplied water

9. Question: What is the water quality of the supply water from the hospital to the SPS water treatment equipment? Response from Engineering at this time - The report from the water testing company only includes some of the information requested. Some information is not relevant, but the Ph and chlorine are included. Station engineers monitor the hardness daily for the boiler operations but generally the averages are less than 1 and close to zero. The testing is a third-party test company that primarily test for legionaries.

0. Water hardness - averages are less than 1 and close to zero.

0. Conductivity / resistivity - 337 us/cm

0. pH - 7.00

0. Chlorides - 1.9ppm

0. Bacteria (HPC) – not in test

1. Existing RO system’s performance

10. Question: What is the existing performance of the current RO system? (i.e. conductivity of product water? Percent of rejection?) Conductivity of an average of 7.25us the past 4 weeks. Rejectivity is measured at 99% at this time.

0. This information will help understand what the current state of the RO system after a year of use.

1. New system

11. Question: The solicitation mentions consumables such as UV light, however there’s no UV irradiation system at the Troy campus. Will a UV system be installed in the Frank campus installation? At this present time this facility is still under construction. The current design has listed items that will be put into place. Please utilize the items identified in the RFQ- Section B.2 Statement of Work, Item 1.2 Background. In this section you will find a list of items that are to be placed in the RO/DI design for building 28.

11. Question: What will be the differences (equipment, materials, or layout configuration) between the current and new systems? There is no current system as this is a new build, this project layout configuration cannot be provided as a result of its current phase “under construction”. This RO/DI (Frank Campus) will differ based on it being a smaller scale system in relation to the one in place at SPS (Troy Campus). This SOW relates to the maintenance of a RO/DI system and shall be quoted based on this only. Please reference contents as outlined per Section B.2 SOW, Item 1.2 Background, “Building 28 consist of” to establish your quote in relation to Section B.2 SOW, Item 1.6 Services Performed Under Maintenance Plan.

1. Blue Filter Housing, what is in that filter? Example, is it a 5-micron, Code F filter Cartridge? Yes, it is a 5-micron filter.

1. White Filter Housings (the 3 on the loop), what is in those housings? Are they Ultrafilters, 0.2-micron, etc.? There are probably 3 different types of filter cartridges in there. These filters are all 0.5-micron filters.

1. Remote Alarm, is there a remote alarm on the system? This is part of the new TIR34 recommendations. To keep things simple and for the purpose of evaluating this, I suggest we discuss the TIR34 recommendations at a later date. There is no remote alarm system at this time. This is something that can be discussed at a later time.

1. In the body of the solicitation, I see the equipment in question. Could you provide an equipment list complete with serial numbers so I can get some ideas for how we can be of service? RODI- Model-HCR02 Serial # 50176; Pumping System-Model-MLE808 2-56C-HA Serial # 98362237

See attached document: S06-Completed Operator Log.

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