Attachment A -Statement of Work.pdf

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Engineering Service Line 6/10/2022

SCOPE OF WORK

A. GENERAL INFORMATION

1. Title of Project: Hemodialysis Water Testing

2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this scope of work (SOW), except as may otherwise be specified. Contractor shall support and maintain testing services for dialysis water through a certified laboratory capable of providing bacterial assays of dialysis water in accordance with ANSI/AAMI 13959, 2014. ANSI/AAMI 13959:2014 Specifies minimum requirements for water to be used in hemodialysis and related therapies. This International Standard includes water to be used in the preparation of concentrates, dialysis fluids for hemodialysis, hemodiafiltration and hemofiltration, and for the reprocessing of hemodialyzers. The operation of water treatment equipment and the final mixing of treated water with concentrates to produce dialysis fluid are excluded from this International Standard. Those operations are the sole responsibility of dialysis professionals.

Included in Scope

a. Contractor shall provide testing services for the following amount of equipment:

• 18 Dialysis Machines

• 18 Reverse Osmosis Machines

• 3 Tablo Machines

b. Contractor shall provide testing services at the following frequencies:

• Quarterly: AAMI Panel Test = 84 Tests Annually

• Monthly: Bacteria Colony Count Test = 468 Tests Annually

• Monthly: Endotoxin Test = 468 Tests Annually

c. Contractor shall ship an adequate number of appropriate sample containers to the Medical Center monthly and include a preprinted and prepaid return label for overnight shipping.

Contractor shall provide:

1. Shipping Containers

2. Freezer Packs

3. Requisition of required monthly and/or quarterly testing

4. Test tubes and bottles

d. Contractor shall process and test water samples collected by Medical Center staff.

e. Contractor shall ensure the testing lab utilizes one of the following methods:

(1) Seven (7) days incubation: tryptone glucose extract agar (TGEA) or Reasoner's 2A supplemented with 4% sodium bicarbonate, or equivalent. Blood or chocolate agar shall not

2 508-22-3-537-0108 be used. Incubation temperatures of 17·c to 23 ·c, and an incubation time of 168 hours (7 days); or

(2) 48 hours incubation: Trypticase soy agar (TSA, a soybean casein digest agar) or standards method agar and plate count agar (also known as TGYE), incubated at 35 •c for 48 hours.

f. Any test results found to be above the allowable limits per ANSI/AAMI standards, the Laboratory shall contact the POC Mr. William Kirby and the COR Mr. Adam Doty immediately via phone or email so that mitigation measures can be enacted in a timely manner.

g. Provide a written and certified electronic copy of the results to the Contracting Officer's Representative (COR) and Point of Contact (POC) for dialysis via email within 1-week of obtaining test results.

h. Additional Samples: On occasions re-testing is required upon initial results observed through the monthly and quarterly requirements. The contract shall allot for additional funds to cover additional tests with all required shipping costs and materials in the amount of $ 4000.00 per year.

i. Billing cycles will be conducted monthly for the life of the contract.

2. 3. Background: Atlanta Healthcare System located at 1670 Clairmont Road, Decatur, GA 30033- 4004 requires a contract with a certified laboratory capable of providing bacterial assays of dialysis water in accordance with ANSI/AAMI 13959, 2014. Emergency contracts have been put in place to meet the required testing frequency for Dialysis prior to establishing a base plus four option year contract. This is a re-occurring requirement.

3. Performance Period:

Base Year 9/3/2022 to 9/2/2023

OY 1: 9/03/2023 - 9/02/2024

OY 2: 9/03/2024 - 9/02/2025

OY 3: 9/03/2025 - 9/02/2026

OY 4: 9/03/2026 - 9/02/2027

4. Type of Contract: Firm Fixed Price

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kickoff meeting or has advised the contractor that a kick-off meeting is waived.

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C. GENERAL REQUIREMENTS

The contractor shall provide the specific deliverables described with-in the performance period stated in included in scope section of the SOW.

D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Contractor shall provide monthly shipping of materials as described in the SOW and at the intervals given in the Schedule for Deliverables section of the contract. Contractor shall provide monthly and quarterly to include re-inspection results as described in the reporting requirements of the SOW.

E. EVALUATED TASKS AND ASSOCIATED DELIVERABLES

Contractor must have the capability of providing certified laboratory analysis of dialysis water described in the statement of work in accordance with ANSI/AAMI 13959:2014. A minimum of 5 years’ experience is required.

F. SCHEDULE FOR DELIVERABLES

Monthly: Ship an adequate number of appropriate sample containers. (Bacteria Colony Count Tests)

Monthly: Ship an adequate number of appropriate sample containers. (Endotoxin Tests)

Quarterly: Ship an adequate number of appropriate sample containers. (AAMI Panel Tests)

Shipping Address:

1670 Clairmont Road

Decatur Ga, 30033

Room Number & Building Number

ATTN: Dialysis Staff

G. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

H. REPORTING REQUIREMENTS:

Monthly: Written and certified electronic copy of monthly results to both the Dialysis point of contact and the contracting officer representative.

Quarterly: Written and certified electronic copy of quarterly results to both Dialysis point of contact and the contracting officer representative.

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Immediate Contact: Any test results that are out of range per ANSI/AAMI standards shall be immediately reported to the COR and POC upon findings both verbally and a written certified electronic copy via email.

POC: William.Kirby@va.gov (404) 321 - 6111 Ext. 20-2315

COR: Adam.doty1@va.gov (404) 889 - 7966

I. TRAVEL: N/A.

J. GOVERNMENT RESPONSIBILITIES:

1. VA Dialysis Employees will order, receive, and store sample collection kits received from the Contractor.

2. VA Dialysis Employees will collect water samples from designated dialysis machines as required for monthly, quarterly and re-testing purposes.

3. VA Dialysis Employees will ship water samples collected to the contractor using the contractors pre-paid shipping labels and vendor.

4. Additional Samples: On occasions re-testing is required upon initial results observed through the monthly and quarterly requirements. The contract shall allot for additional funds to cover additional tests with all required shipping costs and materials as described in the SOW. VA Dialysis Employees will schedule all retesting needed as described in government responsibilities Items 1, 2, and 3.

The C&A requirements do not apply, and that a Security Accreditation Package is not required.

K. CONTRACTOR REQUIREMENTS

The government will determine on a SR basis what positions are considered key personnel. The contractor shall identify, by name, the key management and technical personnel who will work under this task order at the time the work is being negotiated.

If a key person becomes unavailable to complete the SR, the proposed Substitutions of key personnel shall be made only as approved directed by the Contracting Officer and the COR. The government will not dictate specific experience and education requirements of the employees initially proposed to perform the work stated herein. The contractor shall submit a resume of qualifications for the COR and all other direct employees proposed for the project. All Contractor employees will be approved by the COR prior to bringing on duty. If, at any time from date of award to the end of the contract, non-key personnel Contractor personnel are no longer available, HES/HIS reserves the right to review the qualifications of the proposed replacement personnel and to reject individuals who do not meet the qualifications set forth in the TLO. Team personnel proposed by the contractor should possess some of the following knowledge and/or skills:

The contractor must notify VHA in advance and we will approve or reject proposed contractor key personnel for the performance of this contract. The contractor shall submit a resume of qualifications to the COR for key personnel and all other direct employees proposed for the project. All Contractor employees will be approved by the COR prior to bringing on duty. If, at any time from date of award to the end of the contract, Contractor personnel are no longer available, the VHA will approve the qualifications of proposed replacement personnel and will reject individuals who do not meet mailto:William.Kirby@va.gov mailto:Adam.doty1@va.gov

5 508-22-3-537-0108 qualifications set forth herein. The contractor must inform the VHA COR, and Project Manager/Task Manager when personnel are removed from the contract for any reason. The Contractor shall remove any employee from the performance of this contract within five (5) workdays of receiving notice from the Contracting Officer that the employee's performance is unsatisfactory. All Contractor employees are subject to immediate removal from performance of this contract when they are involved in a violation of the law, VA security, confidentiality requirements and/or other disciplinary reasons.

• The contractor must inform the VHA COR, and Project Manager/Task Manager when personnel are removed from the contract for any reason.

• If a key person becomes unavailable to complete the SR, proposed Substitutions of key personnel shall be made only if approved by the COR and Project Manager.

• The contractor shall submit a resume of qualifications to the COR for all direct employees proposed for the project. All Contractor employees will be approved by the COR prior to bringing on duty.

L. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order.

No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.