36C25021Q0555 0001.docx

36C25021Q0555 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 NUMBERED 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 amendment, 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) 04-12-2021 None Department of Veterans Affairs Network Contracting Office 10 (NCO 10) 24 Frank Lloyd Wright Drive Lobby M, Suite M2200 Ann Arbor MI 48105 Y Department of Veterans Affair Network Contracting Office 10 (NCO10) 24 Frank Lloyd Wright Drive Lobby M, Suite M2200 Ann Arbor MI 48105 To all Offerors/Bidders

36C25021Q0555

X X X

X One (1) The purpose of this Amendment is to answer questions received by offerors regarding the referenced solicitation.

This amendment replaces B.2 Price Schedule and B.3 Statement of Work in their entirety.

Kristina L. Peart Contracting Officer

CONTINUATION PAGE

Questions and Answers from all offerors:

Question: Past Performance is an evaluation factor. How is a new company that does not have government past performance rated? Would commercial past performance be an acceptable substitute? If not, would we be considered “not responsive” or would we be given a past performance rating of neutral?

Answer: Commercial Past Performance can be considered. If the Contractor does not have any relevant past performance (at a hospital of the same magnitude), they would be neutral.

Question: The pricing table on pages 4-7 only has enough pricing spots for the base year and optional years 1 and 2. The contract mentioned that there will be 4 optional years. Should there be more pricing spots for optional years 3 and 4?

Answer: The resulting contract will be a base with two (2) option years.

Question: Does the facility already have a Legionella Prevention Plan in place?

Answer: Yes – The VA’s plan will be provided to the Contractor after award. The Contractor will certify the VA plan once Contract is in place.

Question: Regarding the Heterotrophic Plate Counts are you looking for only Total Coliform or another sub analysis?

Answer: 3.2.2 Microbial level in water The water used at each stage of reprocessing should not increase the bioburden of the devices being processed. Water entering the facility from the public utility is usually chlorinated to prevent microbial replication. Even in chlorinated water, however, the level of microorganisms depends on the effectiveness of the municipal treatment process and on the state of the distribution system. (For example, cleaning of the city distribution system often leads to “brown water” as a result of dislodging biofilm within the system. The microbial levels in tap water at such times can be considerably higher than when cleaning is not being performed.) In addition, chlorinated water might contain other inorganic components that will damage medical devices during reprocessing, thereby necessitating water treatment, such as DI, to remove these components. Such treatment will also remove the chlorine; consequently, any microorganisms present will have a significantly greater ability to replicate. Alternative water treatment processes, such as RO, will remove microorganisms as well as inorganic components, thereby reducing the microbial load in the water. However, the RO distribution network could become contaminated with microorganisms and subsequently develop biofilm on the inner surfaces of the piping; in this case, the water will still have unacceptable microbial levels when it is used in medical device reprocessing despite having been properly treated initially. Because of these considerations, it is necessary to assess the microbial level of water used for device reprocessing in the facility to ensure that it is acceptable. It is necessary to monitor bacterial levels in tap water, softened water, and deionized water only when systems are installed, modified, or repaired or if problems are identified (see Table 1 and Table 6). Once the microbial level is at an acceptable level (i.e., the level is < 100 colony-forming units per milliliter [cfus/mL]), then monitoring is no longer required. However, it is necessary to monitor microbial levels in “Critical Water” (see 4.2) at intervals that should conform to the recommendations of Table 1 and Table 6. Rapidly addressing unacceptable microbial levels in the water distribution system is critical to keeping biofilm to a minimum. The risk of adverse patient events associated with the number of microorganisms in the water depends on the type of device and its intended use. The risk is low for devices that will contact only intact tissue. The risk is higher for devices that contact the patient’s bloodstream or other sterile body sites. A report documented Pseudomonas aeruginosa infections associated with the use of transrectal, ultrasound-guided transducer assemblies (CDC, 2006). As a result of this report, FDA issued a public health notification stating that these medical devices are critical and should be sterilized unless there are parts that cannot withstand the rigors of sterilization, in which case high-level disinfection may be used (FDA, 2006a). In addition, FDA recommended that sterile water—not tap water—should always be used to rinse such devices after high-level disinfection. Microbial level is measured as the number of cfus per mL of water.

Above is the standard for bacteria and acceptable levels per the AAMI TIR34 guidance.

Question: Can you please clarify the requirement for the Legionella Point of Use Filters? Are we expected to sample from these locations upon a positive legionella test or are we required to change these filters upon a positive legionella test?

Answer: 30 filters are required per year. Upon a positive legionella, the outlet will be flushed by VAMC staff, a retest will be completed by the contractor, and the POU filter, provided by the contractor, will be installed by VAMC staff.

Question: Can you please confirm the following interpretation of sample requirements?

Legionella Tests at West 10th street facility = 10 samples with results each quarter?

Legionella Tests at Vet House facility = 5 samples with results each quarter?

Total organic carbon with results = 5 samples with results each month?

Heterotrophic Plate Count with results = 5 samples with results each month?

Answer:

Question: Is the expected scope of work going to include the sampling of the water systems AND the laboratory testing of the samples?

Answer: Please see RFQ 36C25021Q0555, Scope of work to include laboratory testing of the samples.

Question: Is there an updated release date for the RFQ?

Question: Since it was not released on 4/8 (not that I can tell), will the response date be extended out from the current date of 4/15?

Answer: RFQ 36C25021Q0555 was issued on 4/8/21 and solicitation will not be extended.

Question: Is there an incumbent contractor or is this a new requirement?

Who is the incumbent contractor?

Answer: There is not an incumbent. This is a new requirement.

Question: CLINs indicate 120 samples per year for Legionella but SOW indicates 60 samples per quarter which is 240 samples annually, can the government clarify these numbers? Will the government provide updated B.2 if needed?

Answer: 20 quarterly at the main facility and 20 quarterly at cold springs + 40 annually retests for a total of 200 annually. B.2 and B.3 have been correct in this amendment.

Question: Will the contractor be USING the Myron 750II to make measurements for conductivity, TDS, resistivity, and pH or just performing the calibration?

Answer: The Contact will only be providing calibration and may use any equipment to properly do the calibration.

Question: Statement of Work 2. Scope states “Services shall be for the period of 2/1/2021 through 1/31/2022 with four (4) pre-priced one (1)-year options for renewal.” Please clarify the dates of service as these dates are different than B.2?

Answer: The period of performance is reflected in the Price Schedule and SOW as 5/1/2021 through 4/30/2022 with two (2) option years.

Question: Statement of Work 3. Specific Tasks -Deliverable Product Table a. Please provide requirements of “Certification of facility Legionella Prevention Plan.”

Is this a plan that is already in place?

Is the contractor expected to develop a plan and then certify it each year?

What is meant by “certification.”

Answer: The VA’s Plan is already in place. Contractor will review to provide recommended updates and /or changes to ensure Legionella prevention plan is accurate.

Question: Statement of Work 3. Specific Tasks -Deliverable Product Table a. Regarding Certification of facility Legionella Prevention Plan – Will the government consider removing this requirement from the water testing requirements as it appears it could be a conflict of interest?

Answer: The VA will not remove this requirement as the Contractor is only Certifying the existing VA plan is accurate and does not have any major deficiencies.

Question: Statement of Work 3. Specific Tasks -Deliverable Product Table b. SPS AAMI TIR 34 Testing – Total Organic Carbon with results and Heterotrophic Plate Count with results show frequency as monthly but B.2 shows annual quantity as 120. Please clarify frequency and total annual quantities? Will the government provide updated B.2 if needed?

Answer: 5 HPC tests per month, with 5 retests in event of out-of-range results = 120 samples Question: Statement of Work 5. Security Requirements refer to “contractor’s repairman,” is the contractor expected to provide repairs on this contract? If so, please provide details.

Answer: There are no repairs required – see revised B.3 SOW

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

0.00

Contractor shall provide complete testing on multiple water systems in meeting the criteria of VHA DIR- 1061 Prevention of Healthcare-Associated Legionella Disease and Scald Injury From Potable Water Distribution Systems and AAMI TIR 31 at the Richard L Roudebush VA Medical Center, located at 1481 W. 10th Street, Indianapolis, IN 46202 and Vet House located at 2669 Cold Springs Rd., Indianapolis, IN 46222, for the period of April 1, 2021 through March 31, 2022 with four (4) one (1) year options to be exercised at the Government’s discretion.

Contract Period: Base POP Begin: 05-01-2021 POP End: 04-30-2022

0001AA

Legionella analysis culture (potable, nonpotable or swab)

0001AB

Annual Certification of Legionella prevention plan

0001AC

Legionella point of use filters

0001AD

Total Organic Carbon

0001AE

Heterotrophic Plate Count

0001AF

Endotoxin

0001AG

Hardness

0001AH

Ionic Contaminent

0001AI

Calibration of Myron 750II Conductivity/TDS

0001AJ

Calibration of Myron 750II Resistivity

0001AK

Calibration of Myron 750II pH

0.00

Complete testing on multiple water systems in meeting the criteria of VHA DIR- 1061 Prevention of Healthcare-Associated Legionella Disease and Scald Injury From Potable Water Distribution Systems and AAMI TIR 31.

Contract Period: Option 1 POP Begin: 05-01-2022 POP End: 04-30-2023

1001AA

Legionella analysis culture (potable, nonpotable or swab)

1001AB

Annual Certification of Legionella prevention plan

1001AC

Legionella point of use filters

1001AD

Total Organic Carbon

1001AE

Heterotrophic Plate Count

1001AF

Endotoxin

1001AG

Hardness

1001AH

Ionic Contaminent

1001AI

Calibration of Myron 750II Conductivity/TDS

1001AJ

Calibration of Myron 750II Resistivity

1001AK

Calibration of Myron 750II pH

0.00

Complete testing on multiple water systems in meeting the criteria of VHA DIR- 1061 Prevention of Healthcare-Associated Legionella Disease and Scald Injury From Potable Water Distribution Systems and AAMI TIR 31.

Contract Period: Option 2 POP Begin: 05-01-2023 POP End: 04-30-2024

2001AA

Legionella analysis culture (potable, nonpotable or swab)

2001AB

Annual Certification of Legionella prevention plan

2001AC

Legionella point of use filters

2001AD

Total Organic Carbon

2001AE

Heterotrophic Plate Count

2001AF

Endotoxin

2001AG

Hardness

2001AH

Ionic Contaminent

2001AI

Calibration of Myron 750II Conductivity/TDS

2001AJ

Calibration of Myron 750II Resistivity

2001AK

Calibration of Myron 750II pH

B.3 STATEMENT OF WORK (SOW)-WATER QUALITY TESTING

1. Background.

The medical center is required to complete testing on multiple water systems. The facility must test water to ensure there is no growth of legionella per VHA Directive 1061. The facility must also test pure water supplied to Sterile Processing is adequate to sterilize surgical instruments per AAMI TIR 31.

2. Scope.

The Veterans Affairs, VA Medical Center, Indianapolis, intends to solicit and award a contract to provide assistance in meeting the criteria of VHA DIR- 1061 Prevention of Healthcare-Associated Legionella Disease and Scald Injury From Potable Water Distribution Systems and AAMI TIR 31 at the Richard L Roudebush VA Medical Center, located at 1481 W. 10th Street, Indianapolis, IN 46202 and Vet House located at 2669 Cold Springs Rd., Indianapolis, IN 46222. Services shall be in accordance with the terms, conditions, provisions and schedule of the contract. Services shall be for the period of 5/1/2021 through 4/30/2022 with two (2) pre-priced one (1)-year options for renewal.

3. Specific Tasks-Deliverable Product.

Contractor shall provide all labor, materials, equipment, transportation, lodging and supervision necessary to collect appropriate samples and deliver to a lab meeting CDC Elite requirements.

a. Legionella Testing Service Performed Under Maintenance Plan

b. SPS AAMI TIR 34 Testing

4. Hours of Operation All work for this contract is to be done during normal business hours.

5. Performance Monitoring Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the performance monitoring of this contract.

a) Direct Observation-(Can be performed periodically or through 100% surveillance.)

b) Periodic Inspection-(Evaluates outcomes on a periodic basis. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.)

5.1 Acceptable Performance

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action.

5.2 Unacceptable Performance

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR) and present it to the contractor's program manager.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

6. Security Requirements Vendor will not have access to VA Sensitive Information, patient records, or data. For services performed during normal work hours, 7:00 a.m. to 4:40 p.m. at the Richard L Roudebush VA Medical Center, contractor’s repairman shall report to the Plumbing Shop, Building 1, Rm A-B117. After all work is complete, the contractor’s employee shall again report in person to the room listed above, submit a written service report outlining the services performed and completed to include location and parts used.

For services performed outside normal working hours, the contractor’s employee should report to the Chiller Plant at Richard L Roudebush VA Medical Center. After all work is complete the contractor’s repairman shall again report to the Chiller Plant where the contractor’s employee shall submit the report required above.

7. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

Solicitation to provide all labor, material, equipment, transportation, lodging and supervision necessary to perform all testing and delivery of samples to CDC Elite approved laboratory for results.

The Richard L Roudebush VA Medical Center will not furnish parts and/or test equipment for the performance of this contract. It is the responsibility of the contractor to bring the appropriate equipment; and/or supplies necessary to complete the work as required within.

8. Other Pertinent Information or Special Considerations.

All work shall be performed by personnel qualified to work on the specific equipment. All work performed shall compliant with AAMI and VHA Directive 1061 guidelines and shall be designed to assure that the Richard L Roudebush VA Medical Center is providing the best possible water to the patients, staff, and services.

9. Place of Performance.

The Richard L Roudebush Department of Veterans Affairs Medical Center located at 1481 W. 10th Street, Indianapolis, IN 46202 and 2669 Cold Springs Road, Indianapolis, IN 46222. Legionella testing will take place facility wide. AAMI TIR 34 testing will take place in Sterile Processing department and Reverse Osmosis mechanical room.