36C25223Q0892 0002.docx

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) None 36C25223Q0892 Department of Veterans Affairs

GLAC (69D)

115 South 84th Street, Suite 101 Milwaukee

WI

53214-1476 Department of Veterans Affairs

GLAC-MILWAUKEE (69D)

Great Lakes Acquisition Center - HC 115 South 84th Street, Suite 101 Milwaukee

WI

53214-1476 To all Offerors/Bidders

36C25223Q0892 08-22-2023

X X X

August 24, 2023, 3:00 PM CDT X The purpose of this Amendment 0002:

1. Extend the deadline for submitting a quote for SPS Water Testing, Tomah, Wisconsin, to Thursday, August 24, 2023, 3:00 PM.

2. Provide answers to clarification questions submitted by potential offerors.

3. Provide an updated Performance Work Statement based upon questions summitted by potential offerors.

All other items and conditions of the solicitation remain the same.

James R. Hedman Contracting Officer

CONTINUATION PAGES

1. The Heterotrophic Plate Count (HPC) & Total Organic Carbon (TOC) are both done by the lab we do most of our business with. However, the HPC has a turnaround time with them of 3-5 business days. The scope of work states a 4 day turn around time.

Change turnaround time to 3-5 business days.

PWS changed to 3-5 days and included in Amendment posted 8/22/2023.

3. Promptness is something we are committed to. We just need direction of what samples need to be collected, and from where, and we get the results back as soon as humanly possible. There are a lot of moving parts to this process, many of which are out of our control. We deal with the Wisconsin DNR on a daily basis, so know all about deadlines, but if we could be flexible on the deadlines to better set expectations that would be ideal.

Our deadlines are strict because of national VHA requirements and directives. We can’t waiver from them.

5. Table 3.D. of the solicitation PWS does not provide the same sample counts for HPC tests at CLIN 0001. CLIN 0001 indicates 24 SPS samples to be collected monthly for HPC testing. The table 3.D. only provides details on four (4) samples for HPC:

“Heterotrophic Plate Counts (HPC). At Reverse Osmosis (RO) Unit/Tank, and both the beginning and end of waterline that feeds the RO system.

2 utility samples – Reprocessing area” Please provide clarification as to the specific details for the 24 SPS HPC samples to be collected monthly. Is CLIN0001 correct for 24 monthly samples with an annual quantity of 288 OR is Table 3.D correct at 4 HPC samples monthly for an annual quantity of 48?

24 monthly tests and 288 tests annually are required for overall system validation.

6. What is the desired Turnaround Time (TAT) for SPS Hardness/Ionic Contaminants Panel in CLIN003? It is not detailed at PWS 3.A.

7-day turnaround time.

7. For CLINs 0006, 0007, 0008, 0009, and 0010 the VA states “Validation, System Repair, and Interventional Testing - Heterotrophic Plate Counts (HPC) - Not to exceed XXX samples per year. Frequency of testing - XXXXX.” As it currently is structured the contract will be awarded to the contractor who assumes the most risk in recovering cost. This is a risk that could be removed but which could drive adverse outcomes for the government.

VA staff will perform weekly testing for emergency repair validation only.

8. If the vendor is to perform sample collection, the VA should define how many samples will be collected each week as the unit price for the 240 samples per year would need to include test, sample collection, trip fee, and shipping. The other recommendation would be that the VA include a contract line item for “Trip Fee for weekly Validation, System Repair, and Interventional Testing” and define the estimated quantity of trips needed on an annual basis in the bid schedule.

VA staff will perform weekly testing for emergency repair validation only.

9. The PWS states “E.1. Schedule of Supplies: Contractor shall supply all sampling supplies, sample and shipping containers, shipping labels and postage to complete sampling, packing wrap and cold packs to maintain temperatures and sample integrity as well as any required additional emergency sampling, taken by Tomah VAMC staff.” Please confirm what testing samples this refers to where sampling is to be taken by Tomah VAMC staff.

Yes, should be line item 0011.

11. The PWS states at E.2.a.ii “VA requires monthly, quarterly, and annual source water samples for analysis plus 36 emergency samples for Endotoxins and Heterotrophic Plate Counts (HPC) if necessary.” The VA should include separate contract line items for any testing and analysis intended by this statement. The current contract line items do not clearly provide for this requirement. Please clarify.

Yes, should be line item 0012.

12. This does not appear to be a complete statement or sentence E.3.a “Validation Testing. In the event of critical water system repairs, replacement, or modifications, testing intervals”. Please clarify the intent of this incomplete sentence.

VA requires samples be taken to validate the water system when there are system repairs, replacement, or modifications, and for testing intervals established by the TIR 34 standard – Now ANSI-AAMI ST108:2023 Water for Processing of Medical Devices.

*NOTE: AAMI - TIR 34: 2017 is now ANSI/AAMI ST108:2023 Water for Processing of Medical Devices.

PERFORMANCE WORK STATEMENT

SPS WATER TESTING

SERVICES

Provide Laboratory Analysis of water samples for Association for the Advancement of Medical Instrumentation (AAMI) compliance with water quality in accordance with VHA Directive 1116(2) dated March 23, 2016: Reference guidance in current 2017 AAMI TIR34 and various equipment Instructions for Use (IFU) and Steris equipment IFU, at the Tomah VA Medical Center and according to the following statement of work.

1. OBJECTIVE

A. The Tomah VA Medical Center (Tomah VAMC) Sterile Processing Service (SPS) is establishing a contracted water quality testing program on a monthly testing cycle in accordance with AAMI TIR34:2014R17.

2. GENERAL SCOPE

A. Contractor shall provide for the use of secure password protected web-based reporting system by the Tomah VAMC, with history of reports maintained on vendor database and exportable as excel and pdf documents.

B. The Contractor shall make this water testing requirement “turnkey” to the fullest extent possible.

C. The Contractor shall furnish all supplies, labor, materials, and equipment necessary for this service. No Government property shall be provided.

D. Contractor shall provide all safety equipment and personal protective equipment for their employees outside of the Tomah VAMC-SPS areas.

E. Any changes to this PWS shall be authorized and approved only through written modification of this contract from the CO (Contracting Officer) in coordination with the COR (Contracting Officers Representative). Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

F. Notwithstanding, the Contractor shall perform no additional work without the prior written authorization of the Contracting Officer. Any additional work, which may be performed by the Contractor without this approval, will be performed by the Contractor at no additional cost to the Government.

G. Within fourteen (14) days of the award of this contract, the Contractor and the Government shall agree upon a date for work to take place.

3. DETAILED SCOPE

A. Turnaround Time (TAT) for all samples shall be as follows.

1) Endotoxins – 7 days

2) Heterotrophic Plate Counts (HPC) – 3-5 Days

3) Total Organic Carbon – 7 Days B. Vendor will come to the Tomah VAMC SPS location to take water samples in secured areas of the Tomah VAMC SPS area. Utility and Critical water will be tested. Reports will be supplied electronically and hard copy.

C. Contractor shall be required to take and record outlet temperature, Ph levels and conductivity of the water at the time each sample is collected.

D. See table below for samples that are to be collected each for the testing described above:

DESCRIPTION

Heterotrophic Plate Counts (HPC). At Reverse Osmosis (RO) Unit/Tank, and both the beginning and end of waterline that feeds the RO system.

2 utility samples – Reprocessing area

SPS Hardness/Ionic Contaminants Panel – For 1 critical and 2 utility samples

Limulus Amoebocyte Lysate (LAL)/Endotoxin – as needed for 1 critical and 2 utility samples

Steam for Ionic Contaminants, Total Organic Carbon (TOC) and hardness

E. Schedule of Supplies:

1) Contractor shall supply all sampling supplies, sample and shipping containers, shipping labels and postage to complete sampling, packing wrap and cold packs to maintain temperatures and sample integrity as well as any required additional emergency sampling, taken by Tomah VAMC staff.

2) AAMI compliance with water quality Water Testing Requirements:

a) General Procedures for AAMI compliance with water quality:

i. The contractor shall furnish all sample collection bottles and return shipping labels, all transportation costs, and resources necessary to perform for AAMI compliance with water quality testing. Containers must be sterile, appropriate for the analysis, properly preserved, and ready for prompt transportation to the laboratory under strict chain of custody procedures. Contractor shall be required to provide trained staff to perform sample collections.

ii. VA requires monthly, quarterly, and annual source water samples for analysis plus 36 emergency samples for Endotoxins and Heterotrophic Plate Counts (HPC) if necessary.

3) Validation Testing.

a) In the event of critical water system repairs, replacement, or modifications, testing intervals F. Contractor’s Equipment Maintenance and Calibration.

1) Contractor shall maintain all testing equipment per Manufacturer’s specifications and recommendations.

2) All testing equipment used in the performance of this contract shall be calibrated per manufacturer’s recommendations. Calibration of testing equipment shall be traceable back to all applicable National and International standards.

a) Contractor shall provide contract COR with all required calibration and maintenance schedules for all testing equipment used in performance of this contract.

G. Sample/specimen Analysis and Reporting:

a) Endotoxin testing must be in compliance with use of Limulus Amoebocyte Lysate testing as listed in AAMI TIR34R17 (see below).

b) The laboratory must have environmental microbiology accreditation by a nationally recognized accrediting body, such as Environmental Microbiology Laboratory Accreditation Program (EMLAP), National Environmental Laboratory Accreditation Program (NELAP) and American Industrial Hygiene Association (AIHA). Proof of certification must be provided before acceptance of contract.

c) Contractor required to provide all sample analysis reports via e-mail to identified Contracting Officers Representative (COR) and Assistant Contracting Officers Representative (ACOR) and Tomah VAMC Point of Contact. Confirmation of notification from Tomah VAMC COR/ACOR is required to complete notification process.

d) Contractor shall be required to provide water testing services no less than once per month and more frequent if necessary. Successive stops between testing shall not exceed 35 calendar days.

e) Contractor Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations and conditions, including the specific outlet temperature of water at the time the sample was collected, pH, biocide residual levels, method detection limits, and a description of test methodology.

f) Collection of samples will be performed in full compliance with Facility Personal Protective Equipment (PPE) practice and policy. Collection Team will be escorted into SPS restricted access areas.

g) Unscheduled, event related collections, may be required to be collected on weekends and federal holidays.

H. Sampling for Tomah VA Medical Center and Outpatient Clinic water quality of Utility and Critical water:

1) Laboratory and Chemical Analysis:

a) Requirements for testing per AAMI TIR34

TIR34 2014R2017 A.5.3 Quality Characteristics

a) Bacterial content

b) Endotoxin content

c) Total organic carbon

d) Ionic contaminants

b) Routine water monitoring and testing shall occur at the frequencies identified in the table below for each test. All testing shall occur at the Tomah VA Medical Center campus unless otherwise noted.

• Bacteria - Heterotrophic Plate Count (Spread Plate)

• 24 samples

• Tomah VAMC – 54 samples

• Wausau CBOC – 12 samples LAL/Endotoxin

• 17 samples Total Organic Carbon (TOC)

• 17 samples

· Ionic Contaminants – 10 samples each.

· Chloride

· Iron

· Copper

· Manganese

· Ph

· Conductivity

· Hardness/CAC03 (Total)

c) Validation, System Repair, and Interventional Testing.

i. Sampling and testing frequency is identified by occasion per AAMI TIR 34: 2014/(R)2017: On installation, modification, or repair of the critical water treatment system or when persistent increased microbial levels are detected by heterotrophic plate count, Adenosine Triphosphate (ATP), or TOC.

• Bacteria - Heterotrophic Plate Count (Spread Plate)

• Not to exceed 240 samples per year.

• Tomah VAMC – Not to exceed 108 samples per year.

• Wausau CBOC – Not to exceed 24 samples per year.

LAL/Endotoxin

• Not to exceed 50 samples per year.

Total Organic Carbon (TOC)

• Not to exceed 50 samples per year.

· Ionic Contaminants – Not to exceed 50 samples each, per year.

· Chloride

· Iron

· Copper

· Manganese

· Ph

· Conductivity

· Hardness/CAC03 (Total)

d) Requirements and Procedures for Sampling of SPS water lines for Colony Forming Units (CFU) and Endotoxin: The contractor shall utilize the Standard Spread Plate Method 9215B. The contractor will provide an outline of their actual testing procedures. Proof of certification and outline of actual testing procedures must be provided before acceptance of the contract. Sampling results will report the number of colony forming units of heterotrophic water bacteria per milliliter of water (cfu/ml).

e) Utility water with bacteria in water findings of >95 or greater will require immediate (<24 hours) notification by both telephone and email from the Contractor to the contract COR/ACOR.

f) Sampling will be tested for presence of Endotoxin and response of results expected as soon as analysis is complete. Parameters for Limulus Amebocyte Lysate (LAL) testing as listed in AAMI TIR34R17.

I. Contractor takes all responsibility of their staff while on Tomah VAMC property. Contractor staff will be escorted in all restricted areas of SPS. All Contractor staff will be required to wear full PPE supplied by the Tomah VAMC SPS, no exceptions. The Contractor’s field service employee will wear visible identification issued by the VA Police Service.

a) Upon request, retesting after remediation, or other non-routine testing, will be performed at the request of the contract COR/ACOR or POC. Should the quantity listed in the price schedule be exceeded, additional tests shall be provided and shall be performed on a separate purchase order.

4. SERVICE HOURS AND FEDERAL HOLIDAYS

A. Normal hours of coverage are Monday through Friday from 7:30 am to 4:30 pm, excluding holidays. All work shall be performed during normal hours of coverage unless otherwise requested or approved by the COR or their designee.

B. All contract work shall be on a date and time mutually agreed upon between the Contractor and the COR.

C. Federal Holidays observed by the VAMC are:

5. GENERAL INFORMATION

A. Compliance with General Safety Regulations:

1) The Contractor shall coordinate all dates for service and testing with contract COR.

2) The contractor’s FST (Field Service Technician) shall contact the COR/POC prior to performing service at this location and shall communicate to the COR of their presence on the Tomah VA Medical Center campus.

3) Contractor is responsible to replace any items damaged by the contractor, sub-contractor, their employees, or equipment at no extra charge to the Government.

4) Contractor personnel must conduct their work in a manner that does not interfere with the normal functions of the facility and will stop work if asked by the CO/COR as required if interruptions do occur.

6. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

A. Scheduling of work shall be arranged with at least one, or all the Point of Contacts below and in the following order: contract COR (Contracting Officers Representative) or contract ACOR (Alternate Contracting Officers Representative).

7. COMPETENCIES AND QUALIFICATIONS OF PERSONNEL AND COMPANY SERVICING EQUIPMENT IN THIS CONTRACT:

A. The Contractor services shall be performed by trained and qualified personnel and performed in accordance with manufacturer’s guidelines.

B. The laboratory must have environmental microbiology accreditation by a nationally recognized accrediting body (i.e., Environmental Microbiology Laboratory Accreditation Program (EMLAP), National Environmental Laboratory Accreditation Program (NELAP) and the AIHA or equivalent national accrediting body.

8. ORIENTATION FOR CONTRACTOR EMPLOYEES:

A. Contractor will attend an orientation meeting as arranged by the Contracting Officer's Representative (COR). The VA will schedule this meeting and it will include discussion of the following topics: (VA will provide information to the contractor regarding these topics and will document the meeting)

· Fire and Safety

· Infection control

· Disaster procedures - Other B. The Contractor will be responsible to ensure that Contractor employees coming to the work site will receive the information required above.

9. SECURITY REQUIREMENTS

A. All Contractor FST’s (Field Service Technician(s)) shall obtain contractor ID badges from the COR. Identification shall be worn visible always by the Contractor and all FST’s while on premises. Contractor shall coordinate with COR to acquire said identification badges.

B. During normal working hours of operation, Monday through Friday, the contractor shall check in with the COR/Tomah VAMC (Veterans Affairs Medical Center) POC (Point of Contact) when arriving to perform work and check out with the COR/Tomah VAMC POC when work/workday is complete.

C. During other than normal hours of operation, the contractor shall sign in and out with the Fire Department located on the east end of B36.

D. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VAMC will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

E. Effective October 1, 2019, smoking is prohibited both inside and outside (entire campus) at the VAMC.

F. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

10. RISK CONTROL

A. The Contractor shall take all necessary precautions to protect government property and shall repair any damage caused by their efforts.

B. All work affecting patients shall be coordinated in advance by the Government and the Contractor to have minimal impact on the patients.

11. PLACE OF PERFORMANCE

Tomah VA Medical Center, 500 E. Veterans St., Tomah, WI. 54660.

END

AMENDMENT

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