B533--Dialysis Water Testing Amendment 0001

COMBINED SYNOPSIS/SOLICITATION FOR DIALYSIS WATER TESTING AT THE JAMES J. PETERS VA MEDICAL CENTER IN NEW YORK.

(i) This is a combined synopsis/solicitation for a commercial item prepared in accordance with the format in FAR Subpart 12.6 and 13 - Simplified Procedures for Certain Commercial Items , as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

(ii) This solicitation is issued as a request for quote (RFQ). Request for Quote will be submitted through Contract opportunities at beta.SAM.gov on RFQ reference number 36C24221Q0523.

(iii) This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-04, VAAR Update 2008-27.

(iv) This procurement is being issued as a Total Small Business Set-Aside Open Market Solicitation. The North American Industry Classification System (NAICS) code is 541380 Testing Laboratories with a Small Business Size Standard of $16.5 Million.

(v) This is an indefinite delivery indefinite quantity requirement. The guaranteed minimum award amount for this contract for Retesting of dialysis water samples is 5 retests. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from 04/01/2021 through 03/31/2022.

Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor s and Government s rights and obligations with respect to that order to the same extent as if the order were completed during the contract s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after 03/31/2022.

The Contractor shall provide pricing to provide Integrated Pest Management Services. Table is optional. Contractors can use their own pricing table but must ensure each Option Period is priced separately. See table below:

The Contractor shall provide pricing for Dialysis Wates Testing. Below is a template for pricing. Contractors may provide their own pricing document, but it must be broken down to allow price reasonableness determination.

PRICING TABLE FOR: Dialysis Wates Testing.

LINE ITEM

DESCRIPTION

QUANTITY

UNIT

UNIT PRICE

TOTAL PRICE

0001

Base Period: Monthly - Dialysis HPC (Heterotrophic Plate Count) (testing for these machines, 2 Central RO water treatment, 1 Loop end, 7 Portable RO, 4 Tablo, 2 Mix tanks and 8 Hemodialysis (HD) machines).

24

EA

0002

Base Period: Monthly - Dialysis Dialysate LAL (Endotoxin) (testing for these machines, 2 Central RO water treatment, 1 Loop end, 7 Portable RO, 4 Tablo, 2 Mix tanks and 8 Hemodialysis (HD) machines).

24

EA

0003

Base Period: Semi-annually AAMI standards testing of dialysis (Central RO Water Treatment machines)

2

EA

0004

Base Period: Annually - Annual AAMI standards (testing for 4 Tablo machines and 7 Portable RO machines)

11

EA

0005

Base Period: Retesting of Dialysis Water samples

5

EA

Total Base Year:

(vi) Description of requirement:

STATEMENT OF WORK

DIALYSIS WATER TESTING

BACKGROUND: The Department of Veterans Affairs, New York Harbor Healthcare System is currently seeking for a 12-month service contract for dialysis water testing for 44 Hemodialysis (HD) machines, 2 Central Reverse Osmosis (RO) Units and 7 Portable Reverse Osmosis Units located at the James J. Peters VA Medical Center in Bronx NY. The James J. Peters VA Medical Center uses water testing to ensure that the local water being used by the Renal Dialysis to treat patients is safe to use in procedures. The clinic follows established guidelines (clinical/AAMI standard 23500-2011) for testing water on a monthly basis. This service is vital and must continue to receive testing of water for patient s treatment and overall health.

The VA is required to monitor water and dialysate used in the Renal Dialysis section. The purpose of this testing is to avoid potential contamination of the water system which could result in the infection of patients on dialysis. The water system is specialized, but it is used in the dialysis machines which access patient s circularity system in order to accomplish the dialysis. A contamination of the water system would be catastrophic to the patients.

The following is a requirement of the Joint Commission: AAMI (Association for the Advancement of Medical Instrumentation) RD-52 states that dialysis be tested for bacteria and endotoxin monthly. This includes toxic chemicals and dialysis fluid electrolytes. The level of bacteria and endotoxin (LAL) that should be met is the same as that of the water system.

Contractor will be provided with water culture specimen for testing.

SCOPE OF WORK: Contractor shall be a certified laboratory with skills and experience capable of providing bacterial assays of dialysis water in accordance with AAMI standards. Contractor shall provide all materials and equipment necessary to perform water testing services to monitor the quality of water used for dialysis. Contractor shall also in a monthly basis provide sample collection (containers) for water samples (to be kept cool for testing) and shipping (labels/boxes) to and from the laboratory facility through United Parcel Service (UPS).

Monthly quantities and testing are as follows:

Quantity: 24 Dialysis HPC (Heterotrophic Plate Count) (testing for these machines, 2 Central RO water treatment, 1 Loop end, 7 Portable RO, 4 Tablo, 2 Mix tanks and 8 Hemodialysis (HD)machines.

Quantity: 24 Dialysis Dialysate LAL (Endotoxin) (testing for these machines, 2 Central RO water treatment, 1 Loop end, 7 Portable RO, 4 Tablo, 2 Mix tanks and 8 Hemodialysis (HD)machines.

The quantities for AAMI testing of dialysis water are as follows:

Semi-Annually:

Quantity: 2 AAMI standards (testing for Central RO Water Treatment machines)

Annually:

Quantity: 11 Annual AAMI standards (testing for 4 Tablo machines and 7 Portable RO machines)

REQUIREMENTS:Â Contractor shall ensure total viable bacterial count and endotoxin concentration is tested monthly for dialysis machines and Reverse Osmosis system. The number of tests varies every month.

1. The service will include the Contractor providing laboratory testing to monitor water and dialysate in accordance with the Association for the Advancement of Medical Instrumentation (AAMI) recommendations and industry accepted procedures applicable to such laboratory services and pursuant to manufacturer standards.

2. VA personnel will take samples of the water and dialysate periodically during the month and will refrigerate the samples immediately.

3. Multiple samples may be taken at one time which will constitute a batch. Batch size may vary from month to month.

4. The Contractor will conduct LAL Kinetic Turbidimetric tests on samples provided by the Renal Dialysis department to determine the levels of endotoxins present. Approximately twenty (20) samples per month requiring testing to ensure the integrity of the osmotic water system.

5. The Contractor will conduct Microbial tests on the samples to determine Bacterial and Pyrogen levels present. This test is performed for the Renal Dialysis section with approximately twenty (20) samples per month requiring testing.

6. When a positive test is encountered, the Contractor shall contact the VA point of contact immediately via phone or e-mail so that mitigation measures can be enacted in a timely manner and a STAT sample can be taken and delivered to the Contractor for immediate re-test for confirmation of the positive test result.

7. Normal test results shall be reported to the VA within 5 days and 48 hours when expedited.

Contractor shall demonstrate that it is a firm regularly engaged in the field of water testing for dialysis.

GOVERNMENT RESPONSIBILITIES:

1. VA personnel shall take samples of the water and dialysate periodically throughout the month and shall refrigerate the samples immediately.

2. VA personnel shall be responsible for shipping/sending the samples to the laboratory.

REPORTS: The testing lab will perform the required test and provide a written and certified electronic copy of the results to the Point of Contact via e-mail within 5-days of obtaining test results. Contractor shall provide an electronic copy of reports of all tests to:

Department of Veterans Affairs

CP -Renal Department

Attn: Rosemarie Magdangal

E-mail: Rosemarie.Madangal@va.gov

James J. Peters VA Medical Center

130 West Kingsbridge Road

Bronx, NY 10468-3904

PERIOD OF PERFORMANCE: The period of performance for this service will be for one (1) year from 04/01/2021 to 03/31/2022.

CONTRACTING OFFICE ADDRESS:

VISN 2 Network Contracting Office Manhattan

NY Harbor Healthcare System

423 East 23rd Street

New York, NY 10010

(vii) Awardee shall coordinate with the Contracting Officer s Representative (COR) prior to performance.

(viii) The provision at FAR 52.212-1, Instructions to Offerors-Commercial Items (JUNE 2020), applies to this acquisition. All offers must reference:

1) Solicitation number for this requirement as 36C24221Q0523:

2) The time specified in the solicitation for receipt of offers;

3) Name, address and telephone number of offeror;

4) Technical description of services to be performed in accordance with the Statement of Work. This Technical description should address the requirement specifically. Capability statements that are merely an overview of what the contractor offers will be determined incomplete. Please address all the technical evaluation sub-factors. Failure to address all the sub-factors will result in your package being determined incomplete;

5) Terms of any express warranty;

6) Price should be for all services detailed in section v of this document. The pricing must be broken down in a manner that allows for price reasonableness to be determined. Failure to provide complete pricing will result in contractors package being determined to be incomplete;

7) Remit to address, if different than mailing address;

8) A completed copy of the representations and certifications at FAR 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

9) Acknowledgement of any solicitation amendments;

10) Past performance information;

11) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation.

Offers that fail to furnish required representation or information or reject the terms and conditions of the solicitation will be excluded from consideration.

The following provisions are included as addenda to FAR 52.212-1:

52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998)

52.204-7 System for Award Management (OCT 2018)

52.204-16 Commercial and Government Entity Code Reporting (AUG 2020)

52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (OCT 2020)

852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008)

(ix) The provision at FAR 52.212-2, Evaluation-Commercial Items (OCT 2014), applies to this acquisition.

(a) Award will be made to the offeror whose offer is determined to be the lowest price, technically acceptable (LPTA) after price is determined fair and reasonable. The offeror must be a responsible offeror and submit a package that meets all the technical and past performance requirements. Offeror must also meet the terms and conditions of all clauses and provisions. Once offerors are evaluated, the award will be made to the lowest price of responsible offerors, who meet technical criteria in response to this Request for Quotes. A quote may be determined to be unacceptable/incomplete if required information is missing or if the quote materially deviates from the requirements of the RFQ. The following factors will be assessed on a pass/fail basis. All complete quotes will be considered. However, if the lowest price quote is determined to be complete and acceptable under the Technical and Past Performance Factors, the award may be made to that offeror without further evaluation of higher priced quotes.

The Government may perform a comparative evaluation (comparing offers to each other) to select the contractor that is best suited and provides the best value, considering the evaluation factors in this solicitation.

Technical Capability: Technical capability is defined as an offeror s ability to satisfy the solicitation s requirements, providing the highest quality service to the specified facilities. Contractor shall provide a maximum 10-page capability statement demonstrating their ability to meet all of the requirements of the Statement of Work (SOW).

A) Technical Proficiency: Offeror shall submit a proposal that demonstrates that it is a laboratory regularly engaged in dialysis water testing. The proposal shall be comprehensive and demonstrate its understanding of the requirement. The package shall outline the contractor s ability to adequately and satisfactorily perform the services in accordance with the Statement of Work (SOW) and the extent to which potential risks are identified and mitigated.

B) Contractor Experience: The offeror shall provide 3 instances of past experience similar in nature, scope, complexity, and size to that which will be supplied under the prospective contract contemplated by this solicitation. The experience shall reflect of no less than (2) years of dialysis water testing services.

C) Licensing/Certifications: Contractor shall provide proof laboratory certification by New York State in the Clinical Laboratory Evaluation Program or Environmental Laboratory Approval Program for all tests. Contractor shall maintain qualifications throughout entire contract period.

(2) Past performance: Contractor must provide three references for contract of similar scope and magnitude to be evaluated. Relevant past performance information shall include key personnel who have relevant experience, predecessor companies, and subcontractors who will perform major or critical elements of this solicitation. The contractors Past Performance shall also be reviewed in PPIRs; Individuals with no past performance shall receive a neutral rating for this evaluation factor.

(3) Price: Provide a per test price that is inclusive of all testing supplies, packaging materials and return shipping. The government will evaluate offers for award purposes based on the pricing for the total requirement. Offers for partial requirement will not be evaluated and will be deemed non-responsive upon receipt.

(b) Options. N/A

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

Failure to provide the information requested in the evaluation criteria may result in being found non-responsive.

(End of Provision)

(x) The provisions at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (NOV 2020) applies to this acquisition. * All firms or individuals submitting a quote shall include a completed copy of this provision OR have current Representations and Certifications in the System for Award Management (SAM - https://www.sam.gov). Representations, Certifications, and SAM must be current at award. IF NOT CURRENT AND/OR YOU DO NOT SUBMIT A COMPLETED COPY OF THIS PROVISION, YOUR QUOTE WILL BE CONSIDERED NON-RESPONSIVE.

(xi) The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Items (OCT 2018), applies to this acquisition. The following clauses are included as addenda to FAR 52.212-4:

52.252-2 Clauses Incorporated by Reference (FEB) 1998

http://www.acquisition.gov/far/index.html (FAR) and

http://www.va.gov/oal/library/vaar/index.asp (VAAR)

52.204-13 System for Award Management Maintenance (OCT 2018)

52.204-18 Commercial and Government Entity Code Maintenance (AUG 2020)

52.216-18 Ordering (AUG 2020)

52.216-19 Order Limitations (OCT 1995)

52.216-22 Indefinite Quantity (OCT 1995)

52.232-19 Availability of Funds for the Next Fiscal Year (APR 1984)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

(DEVIATION AUG 2020)

852.212-70 Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020)

852.203-70 Commercial Advertising (JAN 2008)

852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (OCT 2019)

852.215-71 Evaluation Factor Commitments (SEP 2019)

852.232-72 Electronic Submission of Payment Requests (NOV 2012)

(xii) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Order- Commercial items (NOV 2020), applies to this acquisition.

The following subparagraphs of FAR 52.212-5 are applicable:

52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020)

52.204-15 Service Contract Reporting Requirements for Indefinite-Delivery Contracts (OCT 2016)

52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020)

52.219-6 Notice of Total Small Business Set-Aside (NOV 2020)

52.219-28 Post Award Small Business Program Representation (NOV 2020)

52.222-3 Convict Labor (JUNE 2003)

52.222-21 Prohibition of Segregated Facilities (APR 2015)

52.222-26 Equal Opportunity (SEP 2016)

52.222-36 Equal Opportunity for Workers with Disabilities (JUN 2020)

52.222-41 Service Contract Labor Standards (AUG 2018)

52.222-42 Statement of Equivalent Rates for Federal Hires (MAY 2014)

52.222-50 Combating Trafficking in Persons (OCT 2020)

52.222-55 Minimum Wages Under Executive Order 13658 (DEC 2015).

52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017)

52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020)

52.232-33 Payment by Electronic Funds Transfer System for Award Management (OCT 2018)

(xiii) The Service Contract Act of 1965 does apply to this procurement.

See attached Wage Determination

(xiv) N/A

(xv) This is an Open-Market Total Small Business Set-Aside combined synopsis/solicitation for Dialysis Water Testing for the James J. Peters VA Medical Center in Bronx, NY as defined herein.  The government intends to award a contract as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

The Quoter shall list exception(s) and rationale for the exception(s). Quotes received without this statement will be assumed to infer that terms and conditions are acceptable without modification, deletion or addition.

Submission shall be received not later than 3:00 PM EST, Tuesday, March 16, 2021. The government shall only accept electronic submissions via email, please send all quotations to Monique.Paltan@va.gov. RFI s will not be accepted after Friday, March 05, 2021 at 2:00 PM EST. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

(xvi) Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to Monique Paltan, Contracting Officer, Monique.Paltan@va.gov.