Vision analyzer amendment to add medical record security information

Awarded Award Notice Posted

Solicitation number
VA24417Q1447
Agency
Veterans Integrated Service Network 4 Veterans Health Administration, Department of Veterans Affairs
Awarded
to Ortho-Clinical Diagnostics, Inc.
Set-aside
No set-aside

Opportunity facts

Contract number
VA24417P5504 Federal contract award
NAICS code
334516 Analytical Laboratory Instrument Manufacturing
PSC
Not on record
Place of performance
Lebanon VA Medical Center 1700 S. Lincoln Ave Lebanon, PA 17042 17042, United States

Notice details come from SAM.gov. Updated .

Notice text

2 versions

As posted on SAM.gov.

Update #2 · Latest ·

Added: Aug 01, 2017 2:03 pm Modified: Aug 01, 2017 2:45 pmTrack Changes RECORDS MANAGEMENT OBLIGATIONS

A.  Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.  

B.  Definitions

Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.  

The term Federal record:

includes [Agency] records. 

does not include personal materials.

applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

may include deliverables and documentation associated with deliverables.

C.  Requirements

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. 

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. 

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. 

[Agency] 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 [Agency] 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 [Agency]. The agency must report promptly to NARA in accordance with 36 CFR 1230.

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 [Agency] 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).

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 [Agency] guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

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

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. 

The [Agency] 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 [Agency] 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.

Training.  All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. 

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] 

D.  Flowdown of requirements to subcontractors

The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. 

Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

Update #1 ·

Added: Aug 01, 2017 2:03 pm

Combined Synopsis/Solicitation









(i) This is a combined synopsis/solicitation for VISION ANALYZER, BRAND NAME OR EQUAL, as prepared in accordance with the format in Subpart 12.6, 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. A firm-fixed price purchase order is anticipated.

(ii) The solicitation number is VA244-17-Q-1447 and is issued as a request for quotation (RFQ).

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95

(iv) This solicitation is UNRESTRICTED and the associated NAICS code 334516

(v) Contract Line Items (CLIN):

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

Ortho Vision Analyzer Gel MFG # 6904577.

Includes: -1 Year Vision Warranty (Silver Service) -Sample Racks - qty 6 -Offsite Intructor Training Slot -Shipping



1.00

EA

__________________

__________________

0002

Ortho Vision Table MFG # 6904701



1.00

EA

__________________

__________________









GRAND TOTAL

__________________



(vi) Comparable products must be brand name or equal in the following specifications:

Title of Project: Ortho Clinical Diagnostics VISION Analyzer

Scope of Work: The vendor shall provide all resources necessary to accomplish the deliverables described in this statement of need (SON), except as may otherwise be specified. Contractor shall provide (1) Ortho Clinical Diagnostics VISION Analyzer with Warranty (Silver Service), Sample Racks, (1) Ortho VISION Table, and deliver within 30-days from the date of notice of contract award to the Lebanon Veterans Affairs Medical Center. The contractor will also be responsible for picking up, decontaminating, packaging, and shipping the ProVue Analyzer for trade-in with Ortho Clinical Diagnostics.

Background:

The Lebanon VA Medical Center (LVAMC) has a need for (1) Ortho Clinical Diagnostics VISION Analyzer with Warranty (Silver Service), Sample Racks, and (1) Ortho VISION Table to replace (1) PROVUE Analyzer being used in the clinical laboratory blood bank.

Performance Period: Delivery shall occur within 30 days of receipt of contract

Type of Contract: Firm Fixed Price Delivery Order.

General Requirement

1. The Lebanon VA Medical Center (LVAMC) has a need for the Ortho Clinical Diagnostics VISION Analyzer to replace one of the Provue Analyzers used for testing in the Blood Bank. The analyzer must meet the unique needs of immunohematology labs through the propriety benefits of responsive automation. There is a need for additional samples to be loaded without waiting or delaying the current testing process. The analyzer must be able to minimally perform ABO/Rh Type, Antibody Screening and Identification, Donor Confirmation, and Crossmatch. Additional features are as follows:

The Ortho VISION Table is needed to support the analyzer.

The Vision Analyzer will include a total of 6 Racks per Analyzer

Training: One Instructor Training off site slot shall be provided with the acquisition of the Ortho VISION. The vendor will also provide local operator training sessions as needed by a field engineer or lab specialist.

A standard One Year Warranty (Silver Service) and Shipping of the new Analyzer will be included.

Decontamination, packaging, and return shipping of the trade-in ProVue Analyzer will be provided by the vendor at no cost within 90 days of the new analyzer installation.

Delivery

Contractor Shall provide delivery of (1) Ortho Clinical Diagnostics VISION Analyzer with Warranty (Silver Service), Sample Racks, and (1) Ortho VISION Table within 30 days of contract award to the Lebanon VA Medical Center located at 1700 S. Lincoln Ave., Lebanon, PA 17042; Attn: Warehouse.



The Bio Medical Engineer will need to perform a safety check and enter the equipment into the system for annual Preventative Maintenance (PM Checks. Placement in the Blood Bank shall be coordinated through The Quality Management Technologist or Laboratory Manager.



Delivery to the facility shall be coordinated at least 72 hours prior to required delivery date with the Warehouse Supervisor.

Warehouse Supervisor: Dean Steckbeck,

Phone: (717) 272-6621 x4077

Email: Dean.Steckbeck@va.gov



Note: The Warehouse Supervisor has no authority to change the terms and conditions of the awarded contract.

(viii) The provision at 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition and the following clauses AND instructions are added as addenda:



CLAUSES:

52.211-6 Brand Name or Equal (AUG 1999)

52.214-21 Descriptive Literature (APR 2002)

852.211-73 Brand Name or Equal. (JAN 2008)



(ix) Evaluation of this requirement will be based on PRICE ONLY.

(x) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov.

(xi) The clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and the following clauses are added as addenda:

(End of Clause)

52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://farsite.hill.af.mil

https://acquisition.gov/far

(End of Clause)



852.203-70 Commercial Advertising (JAN 2008)

852.246-71 Inspection (Jan 2008)

(xii) The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders -- Commercial Items, applies to this acquisition and the following additional FAR clauses cited in the clause are applicable to the acquisition:

52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2015)

52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015)

52.219-28 Post Award Small Business Program Representation (JUL 2013)

52.222-19 Child Labor--Cooperation with Authorities and Remedies (FEB 2016) (E.O. 13126)

52.222-21 Prohibition of Segregated Facilities (APR 2015)

52.222-26 Equal Opportunity (APR 2015)

52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014)

52.222-50 Combating Trafficking in Persons (MAR 2015)

52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)

52.225-3 Buy American--Free Trade Agreements--Israeli Trade Act (MAY 2014)

52.225-13 Restrictions on Certain Foreign Purchases (JUNE 2008)

52.232-34 Payment by Electronic Funds Transfer--Other than System for Award Management (JUL 2013)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors

(xiii) There are no additional contract requirements, terms or conditions.

(xiv) The Defense Priorities and Allocations System (DPAS) ratings are NOT APPLICABLE.

(xv) Quotes must be emailed to amanda.saunders@va.gov and received no later than NOON EST on the 8/8/2017 close date. Quote may be submitted on this document or the vendor s own form.

(xvi) For information regarding the solicitation, please contact Amanda Saunders at amanda.saunders@va.gov

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