36C25024R0102 0001.docx

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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

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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

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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

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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

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C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

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Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

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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.

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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.)

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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) 36C250 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105 Y Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105 To all Offerors/Bidders

36C25024R0102 04-03-2024

X X X 4:00pm EST, April 17, 2024 X This amendment to the solicitation is being issued for the following:

1. Extend the time and date of for turn in of quotes to 4:00pm EST, April 17, 2024.

2. Provide answers to questions submitted to the contracting officer. See paragraph A.1.

3. Provid e updated Statement of Work (SOW) and replaces paragraph B.2 SOW of the solicitation.

4. See attached updated Price/Cost Schedule. This price schedule replaces the original price cost schedule and must be turned in to the contracting officer.

5. Section B.1 paragraph 3.c, is updated from "Month ly in the arrears after VA approval" to "Upon completion of quarterly o r re testing".

Christopher D. Gundy Contracting Officer A.1 ANSWERS TO QUESTIONS Question 1: Page 8 of 10 refers to Exhibit B. There is no Exhibit B in the Solicitation or attachments. Can the government provide Exhibit B and provide quantities needed for each location?

Answer: The mention of Exhibit B was intended to be removed. Each VA VISN 10 facility COR will provide the Contractor the list of buildings where samples are to be taken prior to the commencement of work. Each medical facility will have a point of contact and developed their individual needs. Specific locations at each facility will be provided upon award. Price schedule is updated to reflect annual testing anticipated for each facility.

Question 2: Page 12 of 60 1st paragraph – Can the government clarify if this information is to be submitted at contract award?

Answer: Yes, credential/qualifications must be provided with the quote.

Question 3: Can the government provide the addresses of all the facilities where collection services are required so Offerors can determine costs for collection?

Answer: Yes, and this will be updated in the SOW.

Battle Creek – Battle Creek VA Medical Center, 5500 Armstrong Rd, Battle Creek, MI 49037 Ann Arbor – LTC Charles S. Kettles VA Medical Center, 2215 Fuller Rd, Ann Arbor, MI 48105 Detroit – John D. Dingell VA Medical Center, 4646 John R St, Detroit, MI 48201 VANIHCS Marion – 1700 E 38th St, Marion, IN 46953 VANIHCS Fort Wayne – 2121 Lake Ave, Fort Wayne, IN 46805 Saginaw – Aleda E. Lutz VA Medical center, 1500 Weiss St, Saginaw, MI 48602

Question 4: Verifying that according to page 7 the COR will be determining sampling locations for each quarter and transmitting to the contractor.

Answer: Before each collection, the COR will communicate with the Contractor of any specific sampling locations based on deliberations of the facility and their validation needs. If there are no specifics communicated, the location of the samples must be varied during each sampling cycle, as should the types of water samples taken (hot, cold, and mixed). (Appendix C of VHA Directive 1061)

Question 5: According to the pricing sheet, there is only space for sample costs and no labor or hours. Are the labor and hours to be included within the sample costs.

Answer: Yes, labor must be included with each cost.

Question 6: This may be answered if an exhibit B is provided but looking only at the routine sampling of the 6 facilities per year, the pricing sheet indicates 1372 samples. This would indicate that there would be 373 samples per quarter (1372 / 4). Further, as there are 6 facilities there would be roughly 57 samples per facility (373 / 6). As the guidance in the RFQ and VA 1061 indicate a minimum of 20 samples per quarter, there seems to be a discrepancy. Should the labor hours be spread out across 20 samples per facility or 53 samples per facility.

Answer: Labor must be included in the pricing for per sample. See updated price cost schedule breaking down number of tests per medical center.

Question 7: Waivers for buildings with less than 20 samples will require a waiver. Will the consultant or the COR produce these waivers?

Answer: This will be the responsibility of the facility, not the contractor. The VA VISN 10 facility COR will be responsible to communicate to you if this is applicable at their site.

Question 8: The RFQ indicates that additional testing requested will be invoiced separately. Is this to be billed at the same rates to the facility directly or to the base contract?

Answer: This to be billed to the base contract, as this will be a part of the projected “Non-Routine” samples on the pricing schedule. Routine sampling can be invoiced upon completion. Non-routine sampling cannot be on the same invoice as the routine quarterly sampling.

Question 9: Further, non-routine testing mentions copper-silver testing at the Saginaw VA but it is not listed in the pricing schedule or anywhere else that I noticed?

Answer: This is now removed from the Statement of Work.

Question 10: Verifying that the facility will conduct the sampling in the dental facilities. Contractor will only receive samples and have them analyzed?

Answer: Yes, that is correct.

Question 11: Neither the solicitation nor the Directive 1601 talk about water towers, but in the Price Schedule, there is a line item for sampling them. Are water towers going to be sampled?

Answer: Water towers is now removed from the pricing schedule.

Question 12: In the solicitation there is mention that the Dental Centers and Cooling Towers might opt into sampling for Heterotrophic Plate Count analysis. Is that the analysis for the routine and non-routine dental and cooling tower sample line items in the Price Schedule?

Answer: Yes, both routine and non-routine dental and cooling towers are sampled for heterotrophic plate counts.

Question 13: In the solicitation it is stated that chillers will be sampled per the 1601 Directive and has a separate document for them. Are the chiller samples as part of sampling of the cooling tower systems and just documented in a separate location? Because the directive doesn’t state to sample the chillers themselves, just the water that is going from the cooling tower to the chiller’s condenser and from the chiller’s condenser back to the cooling tower as part of sampling the cooling tower systems.

1601 Appendix D 4(1) “The number of water samples is dependent on the size and configuration of the cooling tower. At a minimum, samples must be collected from each basin/sump, and the supply to and return from the chiller(s).”

Answer: Locally, the medical centers are required to have the sampling results in a particular layout. There is a provided excel spreadsheet for chillers and cooling towers that VA oversight requires. The spreadsheet for the chiller has two options for the contractor to document the sample source: supply to chiller or return from chiller. The spreadsheet for the Cooling Towers has one sample source and that’s from a basin or a sump. Each VA VISN 10 facility COR should escort or communicate their site’s specific cooling tower/chiller configuration in order for the Contractor to determine which spreadsheet is applicable.

Question 14: Is this a new requirement? Who is the incumbent and what contract number?

Answer: This requirement has been contracted before. See contract number 36C25019F0018. Information can be looked up on www.fpds.gov.

A.2 STATEMENT OF WORK

VA VISN 10 WATER TESTING

SCOPE: The Department of Veterans Affairs has a requirement for legionella sample collection, analysis, and results management for government-owned buildings in which patients, residents, or visitors stay overnight located in Ann Arbor, Battle Creek, Saginaw, and Detroit, Michigan; Fort Wayne and Marion, Indiana. The facilities mentioned may have other sampling needs that may need to be facilitated as well such as Heterotrophic Plate Count analysis for Dental Clinics and Cooling Towers. The Contractor shall perform sampling and analysis following best practices to meet the requirements set forth in VHA Directive 1061, PREVENTION OF HEALTHCARE-ASSOCIATED LEGIONELLA DISEASE AND SCALD INJURY FROM POTABLE WATER DISTRIBUTION SYSTEMS. Address of each medical center is as follows:

Battle Creek – Battle Creek VA Medical Center, 5500 Armstrong Rd, Battle Creek, MI 49037 Ann Arbor – LTC Charles S. Kettles VA Medical Center, 2215 Fuller Rd, Ann Arbor, MI 48105 Detroit – John D. Dingell VA Medical Center, 4646 John R St, Detroit, MI 48201 VANIHCS Marion – 1700 E 38th St, Marion, IN 46953 VANIHCS Fort Wayne – 2121 Lake Ave, Fort Wayne, IN 46805 Saginaw – Aleda E. Lutz VA Medical center, 1500 Weiss St, Saginaw, MI 48602

The Contractor shall be responsible for:

· On site sample collection (Including all sample containers and testing equipment).

· On site physical and chemical testing - pH, temperature, residual biocide. Residual biocide is chlorine/ monochloramine/ chlorine dioxide depending on what is utilized at the facility. Refer to table below. Legionella testing by culture method.

· Heterotrophic Plate Count testing for Dental Clinics and Cooling Towers (if facility opts in to this arrangement)

· Reporting and managing results data (Electronically)

· Sampling will be conducted the first month of the quarter.

· Testing is required for both the primary and the secondary disinfectant.

· Biocide testing is required for each sample, both hot and cold sample for every sample point.

· Sampling reports shall be issued within 30 calendar days of sample date.

· Current biocides utilized by facilities in the scope of this SOW can be found in the following table:

LEGIONELLA SAMPLE COLLECTION: The Contractor shall provide sampling containers and shall be responsible for physical collection of all samples at each facility. Facility staff will assist and ensure access to all identified sample locations. These locations should alter/change each quarter to maximize testing throughout the system over time. The Contractor shall be responsible for sampling, testing, analysis, and the transportation of all samples to the laboratories actively certified by the Centers for Disease Control and Prevention (CDC) to the Environmental Legionella Isolation Techniques Evaluation (ELITE) laboratory. The Contractor shall furnish all sample collection equipment. Bottles must be sterile, appropriate for the analysis, properly preserved and promptly transported to the laboratory under strict chain of custody procedures.

Contractor will provide a Quality Control and Assurance Plan and Health and Safety Plan for water sample collection and testing.

Contractor will collect samples (Building, Tower, and Chiller per VA Directive 1061) in accordance with all local, state and federal regulations. Different volume size of container is required to facilitate resampling efforts per the 1061 Directive.

Before collecting any samples, all samplers should receive thorough training in proper sampling protocol. This training should include segments on proper procedures for storage and filling of sample containers, handling of preservatives, safety protocols, cleaning of sampling and field equipment, disposal of excess preservatives, and packaging and shipping requirements. Training may be offered by state drinking water programs or another source.

Measuring devices, such as pH or conductivity meters, used for field monitoring must be maintained and calibrated following the EPA-approved analytical methods and the manufacturers’ instructions. The calibration standards used must be within their expiration dates and free of suspended matter. Probes must be washed with deionized water after each use and stored according to instructions. Other equipment items used to collect samples also must be rinsed with deionized water and kept clean between sampling events to prevent contamination of the samples. Contractor should be able to demonstrate that equipment is properly calibrated while onsite if requested by facility point of contact.

Field blanks, made by transferring deionized water to a sample container at the sampling site may be used, to test for contamination due to the introduction through the sampling procedure and sampling environment.

The Contracting Officer's Representative (COR) will assist contractor personnel in obtaining required identification badges to enter the facilities and collect samples. Contractor personnel shall comply with all VA procedures governing building access and security. The Contractor shall collect quarterly samples under this contract the first month of each quarter. Specific distal points sampled will vary per quarter, so communication with the COR will be required before the round of sampling each quarter. Contractor will provide sampling procedure that meets water safety directive.

ENVIRONMENTAL VALIDATION: Environmental validation is the process of testing the building’s potable water distribution system(s) to determine if the engineering controls are successfully inhibiting the growth of Legionella. Testing of the building's hot and cold-water distribution system(s) for L. pneumophila must be performed quarterly (once per Federal Fiscal Year quarter). Additional testing may be required following positive test results.

Water samples shall be collected and analyzed at a minimum of 10 outlets on the hot water distribution system and 10 outlets on the cold-water distribution system for each building occupied by overnight stays in accordance with latest version of VHA Directive 1061 (1). A minimum of (20) samples shall be collected and analyzed for each quarterly testing cycle. Some buildings may have less than 10 hot and cold outlets. (Waiver requests must be submitted for applicable sites). Each medical center will have a representative that will provide a list of buildings where samples are to be taken prior to the commencement of work.

VA VISN 10 facilities may request additional testing at outlets or areas (e.g., water tanks, distribution piping). Additional testing shall be determined by the VAMC COR, VISN 10 Technical Monitor or suggested by the contractor based on local conditions (e.g., size of building, patient population risk factors, known history of healthcare-associated Legionella Disease [HCA LD], suspicion for recent or current HCA LD occurrence, previous environmental testing results, and/or ability to implement engineering controls to prevent Legionella growth in the building water distribution systems). Additional testing will be invoiced separately.

Non-routine testing (outside of the quarterly sampling) may be conducted as needed. For non-routine testing, the contractor shall sample within 3 business days following receipt of notice to proceed by the COR. Swab sampling may be conducted in conjunction with the water collection sampling for non-routine sampling. Swab sampling will be done in accordance with VHA direction and in accordance with direction from the laboratory where the samples will be analyzed. This will be invoiced separately. Examples of nonroutine testing include but are not limited to testing after eradication. Contractor is to provide pricing information on the Price Schedule. Non-routine sampling shall include onsite physical and chemical testing.

Quantify /. pneumophila and identify the presence or absence of other legionella species. VISN 10 also requires quantification of /. pneumophilia isolates (serogroups 1 through 14) using serological testing and/or identify species of non-pneumophilia legionella. e.g., L. Anisa, L. Bozernanii, L. durnojji, L. Gorrnanii, L. Jordanis, L. Longbeachae, L. rnic_dadei, etc..

All samples shall be evaluated and tested by a CDC certified Elite Laboratory. The specific sampling points within identified buildings, and the type of sample (e.g., hot water or cold water) will be specified by the Contracting Officers Representative (COR) for each medical center in consultation with the contractor.

Each sample taken shall be tested to determine the following: water temperature, level of residual biocide, and pH. These tests shall be performed by the contractor, on site, during sample collection. Once collected on site, contractor shall transport samples in accordance with laboratory recommendations and in such a manner as to ensure the integrity of the specimen. Samples shall be evaluated by a testing laboratory with experience in microbial testing of potable water. The laboratory shall be accredited for Legionella isolation by culture isolation as a field of testing. Laboratories must also be able to determine if the Legionella detected in environmental samples is the species Legionella pneumophila and whether it is serogroup 1. NOTE: Rapid testing method, such as polymerase chain reaction (PCR) and direct fluorescent antibody (DFA) are not permitted only culture method is accepted.

The laboratory shall be actively certified or accredited by the: Centers for Disease Control and Prevention (CDC) Environmental Legionella Isolation Techniques Evaluation (ELITE) program and participate in an external quality assessment/proficiency testing program for Legionella isolation. In addition to the requirement for current CDC ELITE certification, the laboratory must have an environmental microbiology accreditation by a recognized accrediting program, accredited to test for legionella, such as: American Accreditation for Laboratory Accreditation (A2LA) or American Industrial Hygiene Association-Environmental Microbiology Laboratory Accreditation Program (AIHA-EMLAP).

· Information about CDC ELITE certified laboratories can be found at:

https://wwwn.cdc.gov/elite/Public/MemberList.aspx

· Information about American Association for Laboratory Accreditation (A2La) can be found at:

https://www.a2la.org/

· Information about American Industrial Hygiene Association (AIHA) laboratories can be found at:

https://www.aihaaccreditedlabs.org/LabAccreditationPrograms/Pages/default.aspx

In addition to the CDC ELITE certification, the laboratory will be accredited to the most recent version of the ISO 11731 standard, Water Quality- Detection and Enumeration of Legionella, and accredited by a recognized an environmental laboratory accrediting agency, for example, Environmental Laboratory Approval Program (ELAP) for environmental analyses of potable water.

Laboratory must be able to report results to at least 1 CFU/ ml for potable domestic water and will report up to 3000 CFU/ml without conducting additional sampling or charges.

RESULTS DATA MANAGEMENT: The Contractor shall outline a plan to facilitate the management of Environmental Validation data. The Contractor's plan shall include procedures for:

· Providing all sample analysis reports via email to each facility's COR. Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations, analytical results and method detection limits and description of test methodology.

· Providing the VHA VISN 10 POC & VAMC COR with progress reports on sampling completion dates and supplemental actions to be taken.

· Testing shall be in accordance with the requirements of VHA Directive 1061.

· Developing a chain of custody to identify the contractor's responsibility for; collecting environmental water samples, ensuring that the water samples are transferred to the environmental testing laboratory, receiving the results, and reporting the results to the COR.

· Providing the VISN 10 POC & VAMC COR with annual reports of the water system monitoring and all Legionella sampling issues.

· All results will be in the VA/VHA format so that data can be uploaded easily. A sample document will be provided with the statement of work. Contractor will also provide the results in a PDF document. Current compatible spreadsheets for data provided can be found as attachments and listed in section D (labeled for building, chiller, and cooling tower):

· If temperature is >110 degrees Fahrenheit, if readily apparent, contractor will indicate in the Notes section of the spreadsheet if a mixing valve is installed. If contractor is not sure, they will ask facility POC. In addition, if temperature is >110 degrees Fahrenheit, contractor will discuss with facility guide and indicate in the Notes section of the spreadsheet if it is a patient care area or not.

· Laboratory results must be reported to 1 CFU/ ml for potable domestic water and up to 3000 CFU/ml.

· Reports must be issued within 30 calendar days from initial receipt of water samples but prior to the end of the quarter (Dec, March, June, Sept).

SAMPLING FOR SAFE DRINKING WATER COMPLIANCE FOR DENTAL WATERLINES: For facilities who opt into this arrangement, sampling equipment and lab analysis will be provided to the COR for testing their waterlines for compliance with the EPA Safe Drinking Water Act standard for potable water and the “Infection Control Standards for VA Dental Clinic,” dated 21, October 2013. Sampling analysis will be for total colony forming units (cfu) of heterotrophic water bacteria per milliliter of water.

The Contractor will furnish sterile bottles that are appropriate for the analysis, properly preserved, and promptly transported to the facilities.

The Contractor will furnish appropriate shipping containers for the transportation of samples to the laboratory. The shipping containers will be supplied returned labels. w Comprehensive instructions on how samples will be collected, preserved, and transported to the laboratory for analysis will be provided to each facility covered under the contract. The laboratory will follow strict chain of custody procedures upon the receipt of the samples from the facilities.

Sampling is required on a quarterly basis for each waterline in each Dental Clinic.

The facility shall collect the dental waterline samples at the VA Medical Center’s Dental Offices; the COR will coordinate sampling times with the Point of Contract at each of the facilities and shall notify the Point of Contact upon arrival. Each dental waterline will be tested separately. All hand pieces, air-water syringe tips, and any other equipment reprocessed by SPS before collection samples from the waterlines. The air-water syringe itself, if not changed between patients, shall remain on the line while collecting the sample.

Non-routine sampling (outside of the quarterly sampling) may be conducted as needed. Each dental clinic that is included in the contract is allowed non-routine samples numbering up to 10% of the total samples taken from each clinic annually. If sampling over this amount is needed, the contractor will provide a fixed price for the sampling equipment and analysis and for the collection of samples at the appropriate VA Medical Centers. The cost of this sampling will be added to the overall price of the contract.

For non-routine sampling, sampling bottles and supplies must be provided to the requesting COR within 2 business days of being notified of the need to sample.

The laboratory that processes the water samples will be certified by the Environmental Protection Agency or a State environmental protection agency to perform environmental sampling. Proof of certification must be provided before acceptance of the contract. The laboratory will process samples in accordance with procedures outlined in Standard Methods 9215C (spread plate method).

Sampling results will report the number of colony forming units of heterotrophic water bacteria per milliliter of water (cfu/ml), readings of less than 10 or greater than 500 may be recorded as <10 cfu/ml or > 500 cfu/ml.

Provide all sample analysis reports via e-mail to the COR and the Health Care System Point of Contact within 10 calendar days of receiving the sample. If the 10th day falls on a weekend of federally observed holiday, the reports shall be provided no later than the next normal business day. Analytical reports shall include a signed copy of the chain of custody, identification of sampling locations, method detection limits, and a description of test methodology.

The testing laboratory shall have qualified technical support staff for consultation relative to water sample collection, testing, and interpretation of results.

CONTRACTOR QUALIFICATIONS: Assessing and documenting competency of contractors and the contractor's personnel is part of the acquisition process. At a minimum, the contractor's competency will be assessed and documented on an annual basis, or whenever there is a change in the contractor's personnel performing the work.

Contractor shall assist the VISN 10 VA Medical Centers with implementation of corrective and preventative actions if positive sampling results are found.

Contractor shall be familiar with different disinfectant systems, such as, but not limited to, copper silver ionization, chlorine dioxide, monochloramine, etc. to collect and test the sample.

Contractor shall provide credentials/ qualifications for the proposed team members that will be working on the VISN 10 Contract to the Contracting Officer. If there any changes in staff, the Contractor shall provide the new employee's credentials throughout the life of the contract to the Contracting Officer as well.

Formal training, training records and determination of competence shall be described for all those who sample, and this information shall be properly documented. This information will be provided prior to contract award.

Contractor should only use latest downloaded VA Water Safety Data collection sheet which changes without notice – this is critical for facility upload without errors.

See attached document: Updated Price-Cost Schedule - Legionella Testing.

SCOPE: The Department of Veterans Affairs has a requirement for legionella sample collection, analysis, and results management for government-owned buildings in which patients, residents, or visitors stay overnight located in Ann Arbor, Battle Creek, Saginaw, and Detroit, Michigan; Fort Wayne and Marion, Indiana. The facilities mentioned may have other sampling needs that may need to be facilitated as well such as Heterotrophic Plate Count analysis for Dental Clinics and Cooling Towers. The contract will be awarded as a five-year ordering period, Indefinite Delivery – Indefinite Quantity (IDIQ) contract. The Contractor shall perform sampling and analysis following best practices to meet the requirements set forth in VHA Directive 1061, PREVENTION OF HEALTHCARE-ASSOCIATED LEGIONELLA DISEASE AND SCALD INJURY FROM POTABLE WATER DISTRIBUTION SYSTEMS.