Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF NOVEMBER 22, 2020 SAM #6933
SOLICITATION NOTICE

M -- Freezer Repository Services to store and maintain government owned freezers and clinical serum/plasma samples for ongoing and long-term Hepatitis and other Infectious Disease purposes

Notice Date

11/20/2020 11:51:25 AM
 

Notice Type

Presolicitation
 

NAICS

493120 — Refrigerated Warehousing and Storage
 

Contracting Office

NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
 

ZIP Code

20892
 

Solicitation Number

21-001255
 

Response Due

11/30/2020 6:00:00 AM
 

Archive Date

12/15/2020
 

Point of Contact

Christopher Lauver, Barbara Taylor, Phone: 3015945915
 

E-Mail Address

christopher.lauver@nih.gov, taylorb@cc.nih.gov
(christopher.lauver@nih.gov, taylorb@cc.nih.gov)
 

Description

INTRODUCTION �THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). �The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to: Precision for Medicine, Inc. 8425 Precision Way Unit M� Frederick, MD, 21701-2903,�� UNITED STATES� NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE �The intended procurement is classified under NAICS code 493120 with a Size Standard $30.0 Million. �REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-9, October 26, 2020.� This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold. �STATUTORY AUTHORITY �This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. GENERAL INFORMATION 1. Title: Freezer Repository Services to store and maintain government owned freezers and clinical serum/plasma samples for ongoing and long-term Hepatitis and other Infectious Disease purposes 2. Background Information: The Transfusion-Transmitted Viruses (TTV) laboratory within the Infectious Diseases Section (IDS) in the Department of Transfusion Medicine (DTM) collects and stores aliquots of serum/plasma from research protocol consented patients within the NIH Clinical Center.� These samples are used for potential testing of infectious disease markers for research purposes.� These samples have chronicled the history of Hepatitis C and other infectious markers from their actual discovery to diagnosis to disease progress or recovery.� Some of these samples have been used to assist with the development of new assays, expanded research on the progress of the disease and have aided in the discovery of new agents/disease so are extremely rare and important There are currently over 180K samples requiring storage with additional research samples collected on an ongoing basis.� In order to access these samples for ongoing research, the department must utilize a repository that can provide an accurate inventory of the samples that are also easily accessible as well as queried for data and sample collection.� The samples must be stored in an environment that is monitored 24/7 and are maintained in an environment that will limit degradation, i.e., limit freeze/thaws, maintain temperatures of (-70deg C to -99deg C) or other temperatures as required by the government.� The database utilized for the sample data must be accurate to reflect the correct samples with the correct data, and the staffing performing the functions of data entry and sample management must be adequately trained and competency maintained to ensure sample integrity and data integrity. 3. Period of Performance:� 12/01/2020 � 11/30/2021. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) These services include the storage and maintenance of Government-owned freezers which currently includes 18 freezers (2 chest freezers and 16 upright freezers) in a highly maintained environment, into which the Dept. will store, monitor, inventory and retrieve samples.� The repository must utilize a database that manages and tracks the specimen inventory accurately and reliably. This system must track sample identities, identifies location in the freezer and also must provide reporting options including historical information related to each vial such as study ID, freeze thaw information, retrieval and return information, volume and sample type.� The database should be accessible to the government for query purposes or the information readily available. Currently the government has 18 freezers which consists of the 2 chest freezers and 16 upright freezers) and an inventory of >180,000 samples. � Tasks and associated Deliverables The contractor shall: Demonstrate the ability to Convert and Maintain legacy data if conversion is necessary. ������������� Convert existing legacy data to a format fully supported by the new database system. ������������� Provide a data element mapping guide from legacy data to the new database (if needed) ������������� The conversion programmatic routine shall produce a report that clearly shows a record by record accounting of converted data. ������������� The conversion programmatic routine shall produce an outlier report that shows records with conversion errors and records that did not convert. ������������� Provide a record by record plan of action for those records that do not convert ������������� Demonstrate a �data byte for byte� transfer of data from the converted database to the new database. Utilize an Inventory management system that will manage and track specimen inventory.� The information must contain but is not limited to the following: ������������� Primary identifier, ������������� Specimen type; ie. Plasma, serum, CSF, tissue, whole blood, etc.� ������������� Volume ������������� Collection date, ������������� Must track the number of freeze/ thaw each sample has undergone as well as track the dates of each freeze/thaw ������������� Retrieval information and storage location. ������������� Should also provide reporting options such as all historical information of the samples such as freeze thaw information, retrieval information and volume remaining ������������� Shall permit an efficient user interface compatible with Microsoft Windows 10 Operating System Maintain an accurate electronic inventory of samples ������������� Readily accessible to designated DTM staff ������������� Readily queried by designated DTM staff by select sample information not limited to sample ID, study ID, study name, sample type, date, name (if historical samples) ������������� Ability to generate reports by designated DTM staff with specific criteria such as by date ranges, study ID, study name, sample type, patient name (if historical samples) ������������� Must track and maintain positive identification of all vials, location of all vials and historical information such as volume, availability and other historical information on the vial located within the repository to ensure the ability of accessing the correct samples by the Infectious disease section for ongoing purposes. ������������� The electronic inventory must be updated whenever a new action has occurred in the repository, i.e., new samples added, retrieved, thawed or edits. ������������� The electronic inventory system must maintain and track all new actions of samples.� I.e., freeze thaws, volume of samples removed, volume of sample remaining and must maintain an audit trail of the staff member performing these updates. ������������� A mechanism must be in place to obtain files of inventory via upload, disk or equivalent. Inventory samples upon receipt into Inventory management system ������������� Must have the ability to store serum, plasma, cerebral spinal fluid (CSF), tissue, whole blood, and other biological specimen types upon request ������������� Must maintain sample suitability requirements (i.e. frozen) during process of delivery and receipt ������������� Receive samples with an importable electronic manifest ������������� Receive samples with barcoded vials ������������� Receive samples with non-barcoded vials (historical samples that have been maintained frozen).� ������������� Ability to Receive, accession and store samples in GLASS vials (these are historical samples) Maintain samples in appropriate storage units ������������� Capable of storage at -60�C to -90�C or colder (or other temperature as required by the COR ������������� Capable of maintaining storage at temperature ���������� Storage in government owned units and/or rented units from contractor that have �� ��������Been maintained according to manufacturer instructions and local standard operation ������������� standards.� ������������� Procedures are in place to ensure Routine preventive maintenance and repairs are performed on all units on a scheduled basis and as needed to maintain appropriate storage ������������� Procedures in place to ensure adequate storage of samples if units fail Maintain samples in a monitored facility ������������� Continuous temperature monitoring 24/7 of units to ensure accurate storage of samples (i.e. manual and automated monitoring systems) ������������� Procedures in place to address units out of compliance of storage temperature (eg., Maintenance of units to return to use, move contents to another unit until unit can be fixed and placed back in service. The COR must be notified of movement of samples due to and any corrective action taken on government owned units.eg., unit has lost power and cannot maintain temperature and samples have to be moved.� This movement must also be captured in the electronic inventory management system. DTM staff must be notified of any government owned units that have been removed from service as well as action needed such as replacement of government owned units. Retrieve and deliver samples upon request by DTM IDS staff ������������� Requests for sample retrieval or delivery will be either by phone or be email and on an as needed basis ������������� Requests for sample pick up from DTM shall be retrieved from DTM within 3 days of request or by approved upon timeframe of DTM staff ������������� Requests for delivery of less than 100 samples requested from the repository must be delivered within 24-72 hours or an agreed upon timeframe by DTM staff ������������� Requests for delivery of greater than 100 samples should be delivered within 1 week of the request or by an agreed upon timeframe by DTM� IDS staff Have a robust Quality and training program for staff to ensure: ������������� Technicians performing retrieval and accessioning of samples have been adequately trained and demonstrate and maintain competency to perform function ������������� Technicians performing the maintenance and monitoring of equipment have been adequately trained and demonstrate and maintain competency to perform function ������������� Staff maintaining and managing the electronic inventory management system have been adequately trained, demonstrate and maintain competency to perform function ������������� Supervisors and managers monitoring and managing the repository have been adequately trained, have developed and maintained a robust quality and training plan ������������������������������ Reporting ������������� The contractor shall provide the following reports upon request:� Lists of samples in storage by sample ID, date range, sample type, study ID or other sample criteria; lists of samples by freezer; storage reports of freezer; report of samples, sample storage, Inventory of freezers.� This is not an inclusive list of reports� �������������� Deliveries and pickups will be from the following NIH/CC/DTM (Dept. of Transfusion Medicine) Transfusion Transmitted Viruses Laboratory (TTVL) 9000 Rockville Pike Building 10 Room 1N/315 Rockville, MD� 20892 Delivery/pick up Requirements All shipments shall be packaged and delivered in accordance to DOT/IATA requirements to maintain stability of the samples and in accordance with IATA standards or regulations and within a timely manner. The vendor shall guarantee that all required materials shall be delivered in immediate, usable and acceptable condition The Vendor will notify TTVL of the expected delivery arrival or delay All samples to be picked up for delivery to the contractor will occur within one week or an agreed upon timeframe CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This is a requirement for the continuation of storage. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research. �CLOSING STATEMENT This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. � A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. �All responses must be received by November 30, 2020, 9:00 AM Eastern time and must reference pre-solicitation number 21-001255. Responses may be submitted electronically to Mr. Christopher Lauver, Contracting Specialist at christopher.lauver@nih.gov. Fax responses will not be accepted. �""All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.""
 

Web Link

SAM.gov Permalink
(https://beta.sam.gov/opp/e9380a435962445abc7d887960d2371f/view)
 

Place of Performance

Address: Bethesda, MD 20892, USA

Zip Code: 20892

Country: USA
 

Record

SN05857922-F 20201122/201120230142 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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