36C25720Q0335-022.pdf

Statement of Work Reagent Rental Purchase Agreement for Flow Cytometers and

Laboratory Reagents and Supplies for CD4/CD8 and WBC Immunophenotyping

1. Purpose: Requesting the procurement of two flow cytometers, tables, reagents, consumables, supplies, maintenance, middleware, and off-site customer training for WBC Immunophenotyping for leukemia and lymphoma, and CD4/CD8 testing through reagent rental agreement for the Flow Cytometry testing area at the VA North Texas Health Care System (VANTHCS), Dallas, TX.

WORK STATEMENT

2. Scope: The Contractor will provide two (2) new Flow Cytometers with designated options, one existing BD FACS Sample Preparation Assistant (SPA), all system software, UPSs, monitors, auto-handlers, scanner, printers, instrument stands, technical support, off-site customer training, and business hours service plan for WBC Immunophenotype and CD4/CD8 testing. Current annual testing volume: WBC Immunophenotype – 1,050; CD4/CD8 - 2,050. The Contractor shall:

A. Deliver, install, and set up the instrument and components.

B. Provide test validation guidance and validation supplies.

C. Provide technical support and guidance.

D. Provide reagents, consumables, and supplies as requested by VANTHCS staff.

E. Provide set up for interfaced result reporting, which includes LIS physical connection and translation (drivers), and any required (additional) interface connection license(s).

F. Provide instrument repairs and scheduled preventive maintenance for the instrument and system components.

G. Provide basic and advanced operator training.

3. Location: The analyzer shall be located at and testing will be performed in the Flow Cytometry section of Client Services & Immunopathology, Room 1B-410A, Pathology & Laboratory Medicine Service, VA North Texas Health Care System, 4500 S. Lancaster Rd., Dallas, TX 75216.

4. Performance Requirements: The following are required:

A. Testing Requirements:

1) The test menu must include at least CD4/CD8 and WBC Immunophenotype testing.

2) The system must be capable of 10-color analysis and is expandable to 12-color with minimal hardware changes.

B. System Requirements:

1) Flow Cytometer

a. No laser warm-up time required.

b. Walkaway automation for both tubes and trays.

c. On-board inventory, including tracking and recording of system components.

d. Pre-programed daily start up and shut down to allow maintenance to take place after hours without operator interaction.

e. Requires standardization (calibration) no more than every 60 days.

f. System is compatible with Cytopaint software.

g. The system must acquire at a rate of at least 30,000 events per second.

h. System must exhibit variability of less than 4%.

i. System must provide sensitivity of less than 85 for FITC and less than 20 for PE.

j. The instrument footprint requirement is 34” x 24” x 24” or smaller.

k. Includes instrument workbenches (stands).

C. Connectivity Requirements: (Note: Does not use the following software: Windows XP Embedded Service Pack 3, Windows Server 2003 or Windows XP.)

1) Flow Cytometer:

a. System is fully interfaced with VistA via Data Innovations: System accommodates automated (interfaced) reporting through Data Innovations (DI) to eliminate the need for manual interpretation and manual data entry.

D. Maintenance:

1) The Contractor shall perform preventive maintenance at intervals specified by the manufacturer to ensure proper equipment performance. Preventive Maintenance includes the following:

a) Delivery of parts or materials for Preventive Maintenance.

b) Testing all components for proper test performance. Equipment shall reproduce results according to manufacturer’s specifications.

c) After Preventative Maintenance, the Contractor shall submit a detailed work report for notice at no additional cost.

d) The Contractor shall provide all preventive service materials at no additional cost the government.

E. Technical Support:

1) Support Personnel will be available by during business hours each business day, and live representatives via the Contractor’s message center will be available by telephone at all other times.

2) Technical support shall be available via telephone during business days (and by message center after hours) to provide troubleshooting assistance or to answer testing inquiries.

3) On-site technical support shall be available for escalations within 48 hours.

F. On-site Repairs:

1) For issues that the Contractor determines to require on-site support, the Contractor shall dispatch one or more Support Personnel, normally within 48 business hours after documentation.

2) The Contractor shall submit a detailed work report to include all required materials.

3) The Contractor shall provide all parts and materials at no additional cost the government.

4) The Contractor shall remove all parts, equipment or materials replaced, or upgraded by the

Contractor due to and not limited to repairs, replacements, recall, and upgrades without any cost to the government.

G. Training: The contractor shall provide the following:

1) Two (2) initial off-site operator training for each analyzer.

2) Three (3) off-site Multicolor classes.

3) One additional off-site Basic Operator class per year.

4) Handouts and training materials in sufficient quantity for each participant. These are off-the-shelf courses. The contractor shall provide lesson plan, course materials and media (DVD’s, CD’s, videos, etc. if required), and editable procedures at no additional cost.

5) Additional on-site training as requested by VANTHCS at no additional charge.

H. Safety:

1) The Contractor shall immediately notify VANTHCS of any changes in reagent kit composition, procedure modification, recall notification, or any changes that will affect the performance of the test or procedure according to FDA regulations.

I. Test Performance:

1) All tests, procedures, and equipment must perform at manufacturer’s specifications.

Deviations from the performance specifications shall be corrected by the Contractor.

2) Test performance will be evaluated by and not limited for performance thru peer comparison, quality control and CAP peer evaluation.

3) The vendor shall reimburse VANTHCS for any costs and/or supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

5. Period of Performance: Cost per Test Purchase Agreement for the analyzer will be in effect for a contract year, with options to extend contract for and four (4) additional one (1) year periods:

Base period - Option 1 - Option 2 - Option 3 - Option 4 -

Reference Price/Cost Schedule

The vendor shall remove all equipment within 90 days after notification of the expiration of the terms of this agreement but not until the completion of new vendor's equipment installation inclusive of completed cross over studies. Vendor shall be responsible for removing the hard drive and turning it over to the VANTHCS for destruction prior to removal of any analyzer.

6. Deliverables and Supplies: This order is for the cost per test procurement of an instrument/system for testing by flow cytometry. Reagents and supplies will be purchased under the terms of the reagent rental purchase agreement.

A. The Contractor shall deliver all supplies necessary for test performance at no Government cost.

B. The Contractor shall deliver all and not limited to operational, maintenance, troubleshooting, small repairs, equipment specifications, and test manuals.

C. The Contractor shall install the equipment and perform test verification according to manufacturer specification and CAP requirements.

D. The Contractor shall provide supplies: reagents and consumables for WBC

Immunophenotyping and CD4/CD8 testing. Additional testing may be added at the discretion of VANTHCS. Any additional testing shall be negotiated between the Contractor and

VANTHCS.

E. In the event that requested supplies are on back-order, Contractor is to provide information as to the estimated time of availability.

F. The Contractor shall deliver all invoices for review according to the established contract at the end of each billing cycle.

G. All items not contracted shall be specifically detailed on the invoice including description, quantity acquired, and government cost.

H. Any changes in reagents or equipment modifications shall be immediately disclosed by the Contractor electronically as well as by postal mail with supporting documentation of the change, and detailed guidance for implementation within twenty-four hours of its application.

I. Additional charges incurred by the government to provide the continuity of contracted tests to patients and not limited to out sourcing, transportation, and or any other additional cost shall be covered by the Contractor at no additional charge to the government.

7. Contractor Security Contract Requirements: This Contractor requires no access to VANTHCS or any VA information system. The analyzer will be interfaced to the VANTHCS information system through Data Innovations. There will be supervised access when the Contractor is physically present for technical support, service calls, and scheduled preventative maintenance.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

EVALUATION CRITERIA

The Contractor shall provide the following documentation with their offer:

• Flow Cytometer o List of markers and fluorochromes available. Technical team will compare Contractor’s available markers and fluorochromes to desired panels.

o Provide cytometer’s capability of:

Requiring no laser warm-up time.

Walkaway automation for both tubes and trays.

On-board inventory, including tracking and recording of system components.

Pre-programed daily start up and shut down to allow maintenance to take place after hours without operator interaction.

Standardization (calibration) required no more than every 60 days.

Compatibility with Cytopaint software.

Acquiring at a rate of at least 30,000 events per second.

Exhibiting variability of less than 4%.

Providing sensitivity of less than 85 for FITC and less than 20 for PE.

Fitting into the following footprint requirement: 34” x 24” x 24” or smaller.

SECTION B: RECORDS AND QUALITY

1. Records Management: All records (administrative and program specific) created during the period of the contract belong to VANTHCS must be returned to VANTHCS at the end of the contract.

2. Quality Assurance Surveillance Plan (QASP): The Contractor shall be evaluated for Quality, Scheduling, Cost Control, Management, Regulatory, and Customer Satisfaction for the Base and each Option year. Scoring Criteria and Incentives are outlined below:

Scoring – Average score value per category:

• Exceptional – 4

• Very Good – 3

• Satisfactory – 2

• Marginal – 1

• Unsatisfactory <1

Standard Task ID

(CPARS)

Indicator Acceptable Quality Level

Method of Surveillance Incentive

Repeat runs are minimal due to reagent or instrument issues.

1.1 Successful

reporting of results

No more than 2 instances of repeat runs due to a single reagent or instrument issue per quarter.

Exceptional: 0 Very Good: 1 Satisfactory: 2 Marginal: 3 Unsatisfactory: >3

• Troubleshooting records

• Service records

Exercise of Option Period

Minimal unsuccessful performance due to instrument or reagent issues.

1.2 Successful

peer group comparison

90% satisfactory performance to peer group.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

• CAP survey reports Exercise of Option Period

Instrument downtime is minimal.

1.3 Instrument

Repairs

90% satisfactory instrument performance annually.

• Troubleshooting records

• Service Records

• Sendout records

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

• TAT reports

Engineer visit within 48 hours of service designation.

Schedules

2.1 Emergency

Repairs

90% Visits within 48 hours of service designation.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

• Troubleshooting records

• Service records

Exercise of Option Period

Vendor initiates scheduling of preventive maintenance.

2.2 Proactive

Maintenance Service

95% Visits initiated by vendor.

Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85%

• Service records

• Problem records

Telephone Support is responsive.

2.3 Trouble-

shooting via phone

95% Issues resolved within 3 calls or elevated to service.

Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85%

• Troubleshooting records

• Problem records

• Service records

Exercise of Option Period

Invoices are submitted monthly.

Cost Control

3.1 Invoice

Accountability

100% Invoices received through OLCS via Austin, Texas

• Invoice records Exercise of Option Period

Invoices are itemized by service or product received.

3.2 Invoice

Verification

80% Invoices contain all necessary information for proper processing.

Excellent: 95-100% Very Good: 90-94% Satisfactory: 85-89% Marginal: 80-84% Unsatisfactory: <80%

• Invoice records Exercise of Option Period

Backordered reagents and supplies are minimal. Management

4.1 Backorders <5% Backorders per

year.

Excellent: 0% Very Good: 1-2% Satisfactory: 3-4% Marginal: 5% Unsatisfactory: >5%

• Order records

• Invoice records

• Customer communications

Exercise of Option Period

Provides timely follow-up for backorders. Regulatory

6.1 Backorder

Notification

90% timely follow up for backorders

Exceptional: 100%

• Order records

• Invoice records

• Customer communications

Exercise of Option Period

Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

Contractor will provide proactive notification of changes.

6.2 Notification of

changes in reagent and equipment modifications

100% Proactive notifications.

• Quality Bulletins

• Customer Letters

• Customer Contact

Exercise of Option Period

Timely recall notification of reagent and supplies.

6.3 Recall

Notification

100% Recall notifications within 1 month of issuance.

• Quality Bulletins

• Customer Letters

• Customer Contact

Exercise of Option Period

Works with customer to resolve complaints.

Customer Satisfaction

7.1 Substantiated

complaints

No unresolved substantiated customer complaints per year

• Order records

• Invoice records

• Customer communications

• Problem records

• Troubleshooting records

Exercise of Option Period

Timely follow-up on complaints.

7.2 Complaint

Handling

90% Complaint follow-up within 24 hours of initial complaint or within agreed upon timeframe.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

• Order records

• Invoice records

• Customer communications

• Problem records

• Troubleshooting records

Exercise of Option Period

NARA Records Management Language for Contracts (May 2017)

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. [FACILITY] and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of [FACILITY] or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to [FACILITY]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment.

Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to [FACILITY] control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and [FACILITY] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with [FACILITY] policy.

8. The Contractor shall not create or maintain any records containing any non-public [FACILITY] information that are not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The [FACILITY] owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which [FACILITY] shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.