SOURCES SOUGHT
65 -- Laboratory Automation System - Enclosures
- Notice Date
- 4/17/2014
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMLC, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N62645-14-RFI-02
- Archive Date
- 6/3/2014
- Point of Contact
- Nicholas J Dankanich, Phone: 3016198419
- E-Mail Address
-
nicholas.dankanich@med.navy.mil
(nicholas.dankanich@med.navy.mil)
- Small Business Set-Aside
- N/A
- Description
- Enclosure 5: Current Accessioning System Diagram Enclosure 4: Sample Bottle Labels Enclosure 3: List of Discrepancies Enclosure 2: Sample Chain of Custody Form Enclosure 1: Navy IA Requirements Laboratory Automation System - Description of Government Needs Enclosures: (1) Navy IA requirements (2) Sample Chain of Custody Form (USEPCOM 8-3-R-E, front and back) (3) List of Discrepancies (4) Sample Bottle Labels (5) Current Accessioning System Diagram This is a Request for Information (RFI); the Government is not requesting offers or proposals at this time. Any responses to this RFI received by the Government will not be accepted to form a binding contract. This is a market survey for planning purposes and no award will be made as a result of this RFI. If a solicitation is issued, the Government does not guarantee that it will be issued to RFI respondents. The Government is also requesting that restrictive or proprietary markings not be used in response to the RFI. Responses to this RFI will not be returned. Not responding to this RFI does not preclude participation in any future solicitation, if one is issued. Objectives: Navy Drug Screening Laboratory - Great Lakes is interested in automating some or its entire sample accessioning process. Offerors who are capable of providing automation for any portion of the Current Accessioning Process described below should submit a detailed configuration plan for a proposed solution. Configuration specifications requested include but are not limited to: part materials, size, weight, component layout, description of all operator action required, description of operation limitations, and description of required maintenance. Estimated pricing for submitted configuration plans should also be provided. The hierarchy of desired automated functionality is as follows: 1. Verification of sample provider identity on bottles and forms 2. Sample discrepancy assignment 3. Labeling, using Laboratory Accession Numbers, of the specimen bottles, destination test tubes, and chain of custody forms 4. Data entry into the Laboratory Information Management System 5. Sample transfer from the specimen bottles to the destination test tubes Background: Navy Drug Screening Laboratory - Great Lakes processed approximately 300,000 urine specimens from the United States Military Entrance Processing Command (USMEPCOM) in fiscal year (FY) 2013. The current process for accessioning these samples is completely manual and requires tedious visual verification of data that is also bar-coded. The time required for the initial processing of these samples totals approximately 5,250 man hours per year; this equates to three full time staff members. Principles of the Accessioning Process This system will accession specimen bottles for urinalysis drug testing. Accessioning involves matching information on the bottle label with corresponding information on the chain of custody form submitted with a box of specimens. There is one chain of custody form for up to twelve specimen bottles. Any mismatch of information between bottle and form is detected and the specimen is labeled as discrepant. Discrepant specimens are rare, less than 1%. The label supplied on the bottle has information fields in set positions that are identifiable on the basis of field length, informational content, and format. Non-discrepant samples are labeled with a Laboratory Accessioning Number (LAN) printed on the label. The labeled bottles are placed in sequential order onto specialized specimen trays in batches of 100. Discrepant samples must be sequestered or otherwise identified or isolated via a unique LAN. Within the batch, three (3) or more pre-inserted place holder bottles will be identified as such, assigned a LAN, and labeled the same as the specimen bottles. These place holders will eventually be replaced with blind quality control samples by a technician. Accuracy is of primary importance, because the end result from the drug test must hold up in court. Reliability is also very important, because any necessary intervention to mitigate problems lessens the utility of this proposed system. Speed is also important, because this system is meant to increase efficiency of a time-critical process. Current Accessioning Process There are four major steps in the process of accessioning samples that arrive at the laboratory for immunoassay testing. While a single staff member may complete all steps for a given batch of 100, nothing prohibits multiple staff members consecutively completing each step. The basics steps are outlined below. Please see enclosure 4 for Sample Bottle Labels and enclosure 5 for a diagram of the current accessioning process. 1. Box Opening and Checking - A cardboard box of up to 12 bottles arrives at the lab. Each bottle has a label with human readable and redundant, bar-coded information, such as the social security number of the donor, unique specimen number, and collection date. There is also a block in which the donor provides their initials. Bottles have a tamper-evident tape to seal the bottle. Accompanying these samples is a chain of custody form (USMEPCOM Form 40-8-3-R-E) that is on a standard 8.5" by 11" piece of paper. The front of the form contains the same information as the bottles and provides a space for a unique, bar-coded laboratory accession number (LAN) to be applied. There are also spaces to document discrepancies and the final result, if positive. A list of codified discrepancies (enclosure 3) and their corresponding codes to be entered onto the chain of custody form is attached in enclosure 2. The reverse side of the form allows chain of custody entries and packaging discrepancies to be documented. Opening requires a human to physically open the shipping box, examine the specimens for potential tampering (e.g. examination of the tamper-proof tape), and annotate the chain of custody form. Per 100 samples, it takes approximately 30 minutes to open the requisite boxes. 2. Verification and Batching - Verification currently requires the visual comparison of human-readable data contained on the specimen bottle to the same data on form. Any additional discrepancies among the sample/bottle/form are noted during verification on the front of the form. Upon verification of form and bottle data, LANs are assigned to each sample by placing three redundant labels on the bottle lid and one on the form (Block 10) in line with the associated sample data. The bottles are placed on custom sample trays in batches of at most 97 samples. Placeholder bottles (which are empty) are inserted to indicate where blind quality control specimens (3 or more per batch) will be later added. A sample tray holds a total of 100 bottles, which includes both sample bottles and quality control placeholder bottles. 100 bottles take approximately 40 minutes to verify and batch. 3. Pouring - Each bottle is handled one at a time. One of the LAN labels on the lid is transferred to a 16 x 100 mm test tube and the bottle is uncapped and approximately 4 mL is poured into the test tube. One LAN (human-readable only) remains on the bottle lid and the other is transferred to the side of the bottle. The final destination for each of the 4 LANs is as follows: 1 on the chain of custody form, 1 on the bottle lid, 1 on the side of the bottle, and 1 on the test tube. It takes approximately 20 minutes to pour 100 samples into labeled 16 x 100 mm test tubes and label. 4. Form Entry - Data from the chain of custody form are entered into the laboratory testing database known as the Forensic Toxicology Drug Testing Laboratory (FTDTL) Laboratory Information Management System (LIMS). Most data are entered via barcode scanning, but some are hand entered. It takes approximately 15 minutes to enter the form data for 100 samples into the FTDTL-LIMS. Desired Characteristics of Proposed Solutions 1. The bottles which arrive at the lab are standardized Specimen Collection Containers (SCC). Any automation of process components involving the received bottles mentioned above must be compatible with the existing SCC currently in use at the DOD Drug Testing Laboratories. The characteristics of the existing SCC currently in use are: • Cylindrical HDPE 3 oz. (90 ml) capacity bottle. • Diameter 50mm x Height 80mm • Screw cap enclosure Two examples of bottles which meet the SCC requirements available on GSA are: Mfr Part No.: 1655778 Contractor Part No.: 165-5778 Manufacturer: APOINT Contract No.: GS-02F-0156Y (ends: Jun 11, 2017) MAS Schedule/SIN: 81IB/617-2 Made In: UNITED STATES OF AMERICA Mfr Part No.: 6640001655778 Manufacturer: NIB Contract No.: GS-02F-0162R (ends: Jun 20, 2015) MAS Schedule/SIN: 75/75 200 Warranty: STANDARD WARRANTY Made In: UNITED STATES OF AMERICA 2. Any automation of process components involving the received bottles mentioned above must be compatible with the existing specimen bottle trays. The trays are plastic, 39.0 cm wide x 55.5 cm long x 4.2 cm high with 5 troughs. Each trough is 5.5 cm wide separated by 2.0 cm inner walls and holds 10 specimen bottles for a total of 50 bottles per tray. 3. Any automation process components involving the test tubes mentioned above must be compatible with the test tubes and test tube racks and trays currently in use at the DOD Drug Testing Laboratories. The characteristics are listed below: • The instrument that uses these racks and tubes is the Roche/Hitachi Modular Analytics with the d- and p-modules. • The tubes are 16x100mm glass or plastic tubes with false bottoms as shown in the picture. • The trays are Roche part number 4679431. Dimensions: 650mm long x 125mm wide with a 30mm height and a handle that sticks out 35mm • The racks are Roche part number 1903004001. Dimensions: 120mm long x 20mm wide x 70mm high • The test tubes and test tube racks and trays in use are subject to change specifications within the next two (2) years. Thus, any automation process components involving the test tubes should be adaptable. 4. Any automation of process components involving the chain of custody forms mentioned above must be compatible with the existing 8.5" x 11" paper forms. Please see enclosure 2 demonstrating form layout and content. 5. Any automation of process components involving LAN recording must consider: a. Any labels used must be capable of affixing to curved HDPE plastic bottles, borosilicate glass test tubes, plastic test tubes, and paper without "curling" or falling off, even if subjected to up to three (3) freeze-thaw cycles. b. As an option, the system can be configured to work with existing label stock. The existing LAN label stock uses jacket number 641-271 from Barcodes West, 1560 First Avenue South, Seattle, WA 98134. The existing LAN labels have an overall dimension of 2.375 inches x 1.75 inches. Within that size, there are four (4) sections separated by three (3) perforations. Two of the sections measure 0.8125 inches x 1.75 inches; and two of the sections measure 0.375 inches x 1.75 inches. c. It is acceptable for LANs to be printed directly on any of the required destination locations. 6. Any automation of process components involving label reading should be compliant with the Code-128 (DoD samples) and Code-39 (USMEPCOM samples) bar codes currently in use. Additionally, any label reading function of a proposed system should be capable of detecting the presence of handwriting (i.e. initials) in a specified field on the bottles' labels 7. The LANs utilize the following 11-character format: GYYMBBBBNNN where: G: Always "G", signifies Great Lakes YY: Two digit year M: One letter month identifier; A-M excluding I (ex: JAN = A, Dec = M) BBBB: Four digit batch number. Military (MIL) Batch: 0001 to 1999 Recruit Training Command (RTC) Batch: 2000 to 3999 USMEPCOM Batch: 4000 to 9999 NNN: Sample number. Typically 001 to 100. Occasional usage in low 100's. 8. System must meet the Information Assurance standards for the Navy prior to receiving authority to operate (ATO). See enclosure 1 documentation regarding Navy IA contracting requirements. Information assurance requirements will also include compatibility with data-at-rest security solutions and Host-Based Security System compatibility. 9. Electrical - Equipment must be certified for use in a laboratory environment. [preferred operation from a 120 VAC, 15 ampere, 60 cps, single phase line]. 10. Size - Footprint for the entire system should be less than approximately 3ft x 7ft. To ensure responses, including attachments, can be read and evaluated, please submit in Microsoft (MS) Word, MS Excel, or Adobe Acrobat format. Responses including attached files shall not exceed 10 MB in total. Responses exceeding 10 MB may not be transmitted through the Government server. Responses should include: (1) A cover letter on organizational letterhead including the Company name, CAGE code, DUNS code, point of contact, address, phone number, fax number, and e-mail address of the submitting agent; (2) A white paper, consisting of the information requested; and (3) Any attachments and supporting documentation felt to be relevant to a deeper investigation of the response. No telephonic submissions will be honored. All responses shall be submitted at no cost or obligation to the Government. Interested parties should respond within 30 days of the posting date. Interested parties are requested to electronically send their response to the Naval Medical Logistics Command via e-mail to: Nicholas.Dankanich@med.navy.mil (SUBJECT: N6264514RFI02 Laboratory Automation System RFI). No phone calls please.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N62645-14-RFI-02/listing.html)
- Record
- SN03341488-W 20140419/140417234942-9ce659b95ee496fb190b67abad18f4dd (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |