Combined synopsis-Solicitation 1105617 120705.doc

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 1105617. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-58 dated May 18, 2012.

The associated North American Industry Classification System (NAICS) Code is- 334516 Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 employees. This acquisition is set-aside 100% for small business concerns.

The Arkansas Regional Laboratory requires the purchase and installation of a wireless laboratory equipment temperature monitoring system. In order to comply with the Arkansas Regional Laboratory A2LA accreditation for monitoring analytical critical control points, the calibration service for these probes must be provided by an ISO 17025 accredited laboratory. Documentation of this accreditation will be provided in response to this solicitation.

Background:

Temperature is an analytical parameter that influences the outcome of many methods utilized in the regulatory laboratory. As such it is critical that the laboratory accurately document the performance of numerous instruments in the laboratory with regard to temperature stability.

Arkansas Regional Laboratory currently collects temperature data manually, requiring a significant time commitment of technical personnel. Additionally, manual recording is fraught with issues that range from missed instruments (failure to record), incorrect recording (misreading the thermometer/recording the wrong data) and failure to identify/report when an instrument is out of specified temperature range.

An automated wireless temperature monitoring system would significantly improve the accuracy of temperature monitoring throughout the entire laboratory facility. As it removes the human variability associated with failing to document, incorrectly documenting and failure to report temperatures that exceed or fall below the required analytical parameter. It additionally will provide the opportunity to reduce the time commitment with regard to utilization of laboratory personnel, and provide a more uniform collection of critical analytical temperature data throughout the laboratory.

Minimum Performance Requirements:

A. System Requirements The wireless temperature monitoring system shall be a stand-alone system. It shall simultaneously measure, transmit, centrally collect and analyze the temperature data, from multiple instruments in a multi-floor, multi-room laboratory facility (see attachment document titled: “Floor Plan for Temp Monitoring Sys with Dimensions 120621.xls” for full dimensions and layout of the facility and various rooms where the equipment that is to be monitored is located.)

The system shall include a computer controller/server, sufficient to operate the system proposed, that can be centrally located on a multi-floor laboratory facility.

System shall be scalable to address the needs of the laboratory as it continues to expand, shall be able to accommodate changing technologies with minimal changes required to the wireless temperature monitoring system infrastructure.

System shall provide a range of wireless temperature sensing probes that are capable of monitoring temperatures associated with Ultra low freezers to environmental chambers. (-70ºC to 80ºC). All wireless temperature probes shall be of sufficient specificity/sensitivity to calibrate to ±0.2ºC of the specified set temperature monitoring value.

All wireless temperature sensing probes shall be capable of continuous monitoring with on board memory to prevent data loss (min of 25 days of data collected at 15 minute intervals for each individual instrument.) All wireless probes shall be capable of two-way signal transmission at a minimum of 900 MHz. Monitoring system is expandable to incorporate other monitoring probe types to include but not limited to particle counts and/or humidity.

Calibration requirements for all temperature sensing devices shall be supportable by the vendor with regard to calibration standards to cover the requirements outlined in A2LA accreditation standards and ISO 17025 using the AOAC guidelines. Additionally the vendor shall provide documentation of full NIST traceability for all wireless temperature sensing probes utilized in this system.

The vendor shall provide inside delivery, installation, setup, and optimization of the system to meet laboratory needs.

The Contractor shall provide on-site training to approximately 3-5 laboratory personnel. Contractor shall provide all training materials.

Additionally, the vendor shall provide customer support with regard to issues that arise during normal operation conditions. Customer support shall include phone support during regular business hours and shall include on-site visits from a field engineer within 3-5 days of when the original call was placed if the issue cannot be solved remotely.

All components of the system shall be covered by a minimum one year minimum warranty, with full replacement of any/all components that fail or malfunction within that timeframe.

Software Requirements

The system shall include a complete software package that can be optimized to address the current laboratory operations and provides data security that renders it compliant with the requirements of 21 CFR Part 11 http://www.21cfrpart11.com/ . Additionally, the software must already meet the SRT and ART approval requirements for use in the FDA wide technology system (check here to search for a list of approved items: http://apex.test.fda.gov/pls/apex/f?p=130:1:1247557640342953) .

Software shall allow partitioning of instruments into multiple work groups, and be capable of the documenting the following:

1. Identification and current status of each piece of equipment being monitored

2. Alert notification ability (delivered by email, text, phone call) to a cascade of individuals within multiple groups of users.

3. Reporting/tracking ability to include:

All corrective actions

All user logins

All programming change history

All alert frequencies by individual instrument

All alert responses by individual instrument

4. Scheduling ability to include:

Notification of probe recalibration

Notification of preventative maintenance

Automatic data backup

FOB Point Destination. FOB Point of Delivery for Installation Services and Supplies will be the Arkansas Regional Laboratory located in Jefferson, AR 72079.

Place of Performance:

3900 NCTR Road

Building 26, Floors 1 & 2

Jefferson, AR 72079.

Period of Performance:

Delivery, Installation, training, and Govt. acceptance are to occur within 4 months from date of contract award Schedule of Items (Contractor required to complete as part of quote submission):

Total

Contract clauses- The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (FEB 2012), applies to this acquisition. The following addenda have been attached to the clause:

The supplies and/or services delivered hereunder shall be inspected and accepted at destination by the contracting officer’s representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer.

The following additional provisions and/or clauses apply and incorporated by reference and apply to this acquisition. Clauses and provisions can be obtained at https://www.acquisition.gov/far/

52.204-4 Printed or Copied Double-Sided on Recycled Paper.(MAY 2011)

52.204-7 Central Contractor Registration. (FEB 2012) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.htm 352.202-1 Definitions

JAN 2006

352.203-70 Anti-Lobbying

JAN 2006

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations

OCT 2009

352.223-70 Safety and Health

JAN 2006

352.231-71 Pricing of Adjustments

JAN 2001

352.242-71 Tobacco-Free Facilities

JAN 2006

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to:

(1) Direct or negotiate any changes in the statement of work;

(2) Modify or extend the period of performance;

(3) change the delivery schedule;

(4) Authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or

(5) Otherwise change any terms and conditions of this contract.

The Contracting Officer for this order is:

Aaron A. Glazier, Contracting Officer

3900 NCTR Rd

HFT-320

Jefferson, AR. 72079

Phone: (870) 543-7577

Email: aaron.glazier@fda.hhs.gov The COR is responsible for:

(1) Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) Interpreting the statement of work and any other technical performance requirements;

(3) Performing technical evaluation as required;

(4) Performing technical inspections and acceptances required by this contract; and

(5) Assisting in the resolution of technical problems encountered during performance.

The COR for this order is: to be completed at time of award.

Invoice Submission

Payment terms net 15 days after government acceptance of the supplies/services.

Invoices shall be submitted to the attention of the designated Contract Specialist identified below and contain all necessary information per FAR 52.212-4 (g) in accordance with the following instructions.

I. An original and two (2) copies shall be submitted to:

FDA/OC/OA/OFO/OFS

Attn: Division of Payment Services

3900 NCTR Road, HFT-324

Building 50, 6th floor, suite 616

Jefferson, AR 72079 Phone: (870) 543-7446

Fax 870-543-7224

An electronic invoice can be emailed to the following address:

nctrinvoices@fda.hhs.gov II. One copy to the Contracting Officer Representative (COR) or other program center/office designee, clearly marked “courtesy copy only”:

To be completed at time of award.

Questions regarding invoice payments should be directed to the FDA payment office at phone or email reference provided above.

Questions relating to when payment will be received should be directed to the FDA payment office at the email below or at (870) 543-7446 or (870) 543-7042. nctrinvoices@fda.hhs.gov.

The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statues or Executive Orders-Commercial Items (MAY 2012) applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, 209-6, 209-10, 52.219-6, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-36, 52.223-18, 52.225-3, 52.225-13, and 52.232-33.

Solicitation provisions

Contract Type: Commercial Item-Firm Fixed Price.

The provision at FAR 52.212-1 Instructions to Offerors-Commercial Items (FEB 2012) applies to this solicitation. The following addenda have been attached to this provision:

Addendum Paragraph (c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm until September 30, 2012.

The provision at FAR 52.212-2 Evaluation-Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows:

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

(i) Technical capability of the items/services offered to meet or exceed the Government’s requirement.

(ii) Past Performance

(ii) Price.

Technical and past performance is approximately equal to price in determining the best value to the government.

Technical capability will be determined by review of information submitted by the offeror which shall provide sufficient technical information necessary for the Government to conclusively determine that the offered products and services meet the technical requirements as outlined above. Offerors shall specifically address each of the minimum performance requirements stated above to demonstrate that the proposal meets the technical requirements. Contractor quotes shall clearly identify and quantify the components and configuration of what their proposed system shall include to ensure that all equipment listed in the attachment document titled “Floor Plan for Temp Monitoring Sys with Dimensions 120621.xls” are successfully monitored. Offerors may provide technical specifications, descriptive material, literature, brochures and other information which demonstrates the capabilities of the offeror.

Past Performance: Contractor should provide references to at least two previous projects where a similar temperature control system was sold and installed. For each project, please include a thorough description of the project, and the name, telephone number, email address of someone who has knowledge of the project and would be available to answer any follow-up questions the Government might have.

The government is not responsible for locating or securing any information, which is not identified in the proposal, however the Government reserves the right to obtain information for use in the evaluation from any and all sources including sources outside of the Government. Include the firm’s DUNS number with quote.

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. While the document titled “Floor Plan for Temp Monitoring Sys with Dimensions 120621.xls” contains a list of all equipment to be monitored, the floor plans of the building where the equipment is housed, room sizes etc., in order to alleviate risk, interested vendors are HIGHLY ENCOURAGED to come to the facility to view the laboratory firsthand before submitting a binding proposal. Please contact the Contracting Officer for additional information regarding an organized, scheduled site visit.

The government reserves the right to make an award without discussions.

The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (APR 2012), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov.

CCR Requirement - Company shall be registered in the Central Contractor Registration (CCR) system before an award can be made. If company is not registered in CCR, they may do so by going to CCR web site at http://www.ccr.gov.

The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice.

It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any).

Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration.

All responsible sources may submit an offer, which if timely received, shall be considered. The offer shall reference solicitation number 1105617. The offers are due in person, by postal mail or email to the point of contact listed below on or before 12 July, 2012 by 13:00 hours (Central Standard Time in Jefferson, Arkansas) at the Food and Drug Administration, OO/OFBA/OAGS, Attn: Aaron A. Glazier, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502.

For information regarding this solicitation, please contact Aaron Glazier at (870) 543-7577, FAX (870) 543-7990 or email aaron.glazier@fda.hhs.gov.