SOURCES SOUGHT
65 -- Requirement: Lease of Chemistry Analyzer (non-personal service) and delivery of test reagents to US. Army Medical Facilities located in Belgium, Italy and Germany.
- Notice Date
- 4/23/2013
- Notice Type
- Sources Sought
- NAICS
- 621511
— Medical Laboratories
- Contracting Office
- European Regional Contracting Office, ATTN:MCAA E, Building 3705, Landstuhl, Germany APO, AE 09180
- ZIP Code
- 09180
- Solicitation Number
- W9114F-13-T-0022
- Response Due
- 4/30/2013
- Archive Date
- 6/22/2013
- Point of Contact
- Reinhold Moebus, 001149-63718657
- E-Mail Address
-
European Regional Contracting Office
(reinhold.moebus@amedd.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Source Sought Notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified sources; (2) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. The NAICS code is 621511 and the Size Standard is $4M. Your responses to the information requested will assist the Government in determining the appropriate acquisition method. The Europe Regional Contracting Office (ERCO) is seeking qualified sources to provide non-personal services for lease of analyzers and providing of test reagents, maintenance, onsite and offside training, emergency services for chemistry and Immunology Analyzers at Germany (Stuttgart, Wiesbaden, Grafenwoehr and Landstuhl), Belgium (SHAPE) and Italy (Vicenza) Type of Contract - The Government intends to award an IDIQ Firm, Fixed-Price contract for a base period of 01 Feb 2014 through 31 January 2015 with four (4) one-year options to the successful offeror SCOPE OF WORK. The Contractor shall provide non-personal services to include, all personnel, equipment, tools, materials, supervision, training, and other items and services necessary to provide a chemistry/immunoassay analyzer systems and reagents as described in Section 5 of this Performance Work Statement (PWS). The analyzer systems will be located in four separate locations in Germany, one location in Italy and one location in Belgium as shown below. Lease of this FDA approved equipment shall include delivery, installation, reagents, middleware and materials necessary to perform the specified chemistry/immunoassays to the standards of this PWS and analyzer removal at the end of the contract. The analyzers must be delivered to the following testing sites no later than 01 November 2013 and fully operational and able to report patient specimens no later than 01 February 2014. Site Requirements: Electrical current will be supplied at 220 volts and 50 hertz LocationAnalyzer Type / Facility RestrictionTypical Thru-put Landstuhl Regional Medical Center (LRMC), Department of Pathology, Core Laboratory Building 3711, Room F203 66849 Landstuhl, Germany 2 Chemistry 2 Immunoassay Maximum size: Two spaces each 420 cm x 160 cm Immunometric assays: 200 tests per hour Enzymatic/rate: 800 tests per hour Colorimetric/photometric assays: 800 tests per hour ISE assays: 1200 tests per hour U.S. Army Health Clinic-USAHC, SHAPE Laboratory, Unit 21414 Brussels, Belgium 1 Chemistry The lab doors are ~ 88 cm wide. Instrument should not weigh more than 400 kilos. 10-50 test/hour U.S. Army Health Clinic, Grafenwoehr (USAHCG) Grafenwoehr Lager, Bldg 475 92655 Grafenwoehr, Germany 1 Chemistry Maximum size: 200 cm deep, 250 cm wide, 260 cm high Enzymatic/rate: 10-50 tests/hour Colorimetric/photometric assays: 10-50 tests/hour ISE assays: 10-50 tests per hour U.S. Army Health Clinic- Vicenza (USAMHC) Laboratory Vicenza, Italy 1 Chemistry 1 Immunoassay Maximum size: Freestanding space 385 cm length, 110 cm depth, Bench top space 230 cm length, 70.5 cm depth Immunometric assays: 10-50 tests/hour Enzymatic/rate: 10-50 tests/hour Colorimetric/photometric assays: 300 tests per hour ISE assays: 100 tests per hour USAHC-Stuttgart Pennsylvania Strasse Building 2300, Rm.175 70569 Stuttgart, Germany 1 Chemistry Maximum size: Height - 207 cm, Width - 91 CM, Weight - 90 kilos Chemistry assays: 10-50 tests/hour U.S. Army Health Clinic- Wiesbaden Laboratory Service BLDG 1040, Room 146 Wiesbaden-Erbenheim 65205 Germany 1 Chemistry Maximum size: Bench space available: 50cm (l) and 70 cm (d). Freestanding space available: 100 cm (l) and 50 cm (d). Maximum weight for bench top: 90 Kg Chemistry assays: 49,000/year CONTRACTOR: The Contracting Officer may require the Contractor to meet with the Contracting Officer, contract administrator and COR, as deemed necessary. The Contractor shall provide a dedicated Program Manager (PM), who shall be responsible for the initial instrument implementation, instrument upgrades, implementation of new methods or procedures and optimization of workflow processes and procedures. The PM, and an alternate who shall act for the Contractor when the PM is absent, shall be designated in writing to the Contracting Officer and Contracting Officer Representative (COR) within 10 days of contract award. The PM and alternate PM shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. NORMAL HOURS OF OPERATION. The Contractor shall perform the services required under this contract during the following hours: Monday through Friday between the hours of 0730 - 1630 for all six testing locations. SITE VISIT: Contractor must coordinate and conduct a site visit at each of the six testing locations in Germany, Belgium and Italy for the purpose of surveying and assessing current laboratory set-up, laboratory environmental control, and available utilities with regard to potential placement of their instruments in the laboratory. A site visit will be co-ordinated and conducted on 03 Jun 2013, 10:00hrs at Landstuhl Regional Medical Center, Landstuhl, Germany; on 04 Junr 2013, 10:00hrs at Stuttgart, Germany; on 06 Jun 2013, 1500hrs at Vicenza Italy; on 10 Jun 2013, 10:00hrs at Grafenwoehr, Germany; on 11 Jun 2013, 10:00hrs at Wiesbaden, Germany and 12 Jun 2013, 14:00 at SHAPE, Belgium. ANALYZERS: Each analyzer system must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system for 5 to 7 minutes. The UPS must ensure enough power to have seamless, uninterrupted testing for approximately 10 minutes in the event of a power outage. The Analyzers must be delivered to the location within (8)-eight weeks after contract award but no later than 01 November 2013. Equipment set-up, on-site training, method validation studies, and analytical measurement range/linearity verification, must be completed by Contractor personnel within a period of time to ensure that equipment is fully operational and reporting patient results no later than 01 February 2013. During the initial implementation, a technical representative must be available on site throughout the entire implementation period. EMERGENCY ORDERS: Emergency orders will be delivered within 24 hours after the order is placed to include weekends and Federal Holidays and be of the same lot number of calibrators/standards, reagents/reagent packs, or quality control materials currently in use for the assay(s) for which supplies are being requested. All orders must be shipped through Customs to the six test sites. REPAIR WORK: The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition. Upon notification of equipment failure, the Contractor's qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors Customer Service quote mark Hotline quote mark and will be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact for the LRMC testing site. Service will be rendered on-site by the next business day at Vicenza, SHAPE, Wiesbaden and Stuttgart testing sites. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. If the equipment cannot be repaired, a replacement instrument will be provided within 72 hours. TRAINING: The Contractor will provide two (2) training slots per analyzer, per contract year, for each of the six testing sites, at the Contractor's training site, at no additional cost to the U.S. Government. The training will encompass basic operation, maintenance, troubleshooting and software training. The contractor is responsible for all applicable transportations costs (public and private), lodging, and meal costs for the trainees. This requirement applies to all six Government sites (LRMC, Grafenwoehr, Vicenza, SHAPE, Wiesbaden, Stuttgart). Travel costs will not exceed the current JTR/JFTR. Travel benefits shall be provided in-kind (rather than in cash). For all six Government testing sites: The Contractor shall provide on-site training annually (once per year) at no additional cost to the Government. The training will encompass basic operation, maintenance and troubleshooting and software training. BUSINESS TO BUSSINESS : All Contractor systems that will communicate with Department of Defense (DoD) systems will interconnect through the established Military Healthcare System (MHS) Virtual Private Network (VPN) Business to Business (B2B) gateway. For all Web applications, Contractors will connect to a Defense Information Systems Agency (DISA)-established Web Demilitarized Zone (DMZ). All software must be able to pass MITC testing and review and be awarded a Certificate of Networthiness (CoN) from NETCOM. Submission of the CoN must be completed within six (6) months of contract award. TECHNICAL EVALUATION FACTORS The Offeror must show compliance with the requirements in the solicitation by submitting a written offer which describes the forty-two (42) technical sub-factors as listed below. Additionally the Offeror has to answer 9 informal Questions The following technical sub-factors shall be used to evaluate offers: Sub-factor 01: Does your service response include direct hotline telephonic customer service and support, 24 hours/7 days a week and ability to responds on-site within four (4) hours? Is emergency on-site response by a Contractor qualified service technician possible 24 hours a day 7 days a week? (PWS 5.4.2 and 5.4.3.6) Sub-factor 02: Does your response include an analyzer system from a single contractor? (PWS 1.1.; 5.1.1.) Sub-factor 03: Is there system redundancy for the LRMC site? (PWS 5.1.1.). Sub-factor 04: Does your response include any and all analyzers, peripherals (e.g. uninterruptable power sources (UPS), instrument specific computer terminals and CPU's, etc), robotics, pre-analytics, and processing systems? (PWS 5.1.1. and 5.1.1.2). Sub-factor 05: Does your response include a water system (e.g. filtered, de-ionized etc.)? If required, who will provide it? (PWS 5.1.6.) Sub-factor 06: Is the proposed individual analyzer(s) fully automated, with discrete random access capabilities for chemistry, immunometric, potentiometric, and colorimetric assays within a single platform? (PWS 5.2.1.). Sub-factor 07: Is there an optional separate specimen point of entry for STAT specimens? (PWS 5.2.1.1.) Sub-factor 08: Is there a single point of specimen entry for routine analysis? (PWS 5.2.1.1.) Sub-factor 09: Does the proposed analyzer system provide open channels to accommodate third party assays? (PWS 5.1.1.; 5.2.9.) Sub-factor 10: Does your response include an analyzer will be capable of accommodating both Becton-Dickinson and Greinier tubes? (PWS 5.2.2.). Sub-factor 11: Does your response include an analyzer that has STAT interrupt capability? (PWS 5.2.2.) Sub-factor 12: Does the proposed analyzer have a primary tube sampling system capable of handling 100mm x 16mm, 100mm x 13mm, 75mm x 13m, and 64mm x 10.25 test tubes with standard or Hemaguard caps? (PWS 5.2.2.). Sub-factor 13: Does your response include an analyzer with the minimum analyzer throughput that meets the requirements described in 5.2. Table 1 (PWS 5.2. and 5.2.4) Sub-factor 14: Does your response include an analyzer system that can analyze the assays listed in Table 2 of the PWS from the same specimen with a maximum turn-around-time (automated pre-analytical processing to certification) of 45 minutes? (PWS 5.2.4.2.; 5.2.4.1.; Table 2) Sub-factor 15: Does your response include an analyzer system that comes equipped with an un-interruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system for 10 minutes? (PWS 5.2.7.) Sub-factor 16: Is the proposed analyzer system approved by the FDA? (PWS 5.2.8. and 1.1). Sub-factor 17: Does the proposed analyzer system have the ability to maintain reagents on-board at proper storage temperatures for assays listed in Tables 1-6 in Appendix 1 of the PWS? (PWS 5.3.1.) Sub-factor 18: Does the proposed analyzer system perform all of required assays listed in Appendix 1 of the PWS? (PWS 5.3.19 (all); 5.3.12.). Sub-factor 19: Is the proposed analyzer system capable of maintaining calibration curves for all of the assays listed as required in 5.3.6. and Appendix 1 of the PWS? Sub-factor 20: Are the assays listed in Table 4 of the PWS capable of being present on the analyzer at all times? (PWS 5.3.9.). Sub-factor 21: Are the assays listed in Table 4 of the PWS approved by the FDA for plasma as well as serum samples? (PWS 5.3.8.) Sub-factor 22: Does the proposed analyzer system allow removal of reagent packs for undetermined periods of time and replacement of reagent packs (the original or new) without need for recalibration? (PWS 5.3.9.). Sub-factor 23: Are the assays listed in Table 6 of the PWS are approved by the FDA for CSF and Body Fluid samples? (PWS 5.3.11.) Sub-factor 24: Are the assays listed in Table 5 of the PWS are approved by the FDA for urine samples? (PWS 5.3.10.). Sub-factor 25: Are quality control materials provided as described in the PWS? (PWS 5.3.18) Sub-factor 26: Do reagents have a minimum shelf life of six (6) months upon receipt? (PWS 5.3.17.). Sub-factor 27: Does the proposed analyzer system include a software program with the capability to write user defined QC Statistic Rules? (PWS 5.6.2.2.). Sub-factor 28: Does the proposed analyzer system include a software program/data manager for auto verification of results? (PWS 5.6.2.2.). Sub-factor 29: Does the proposed analyzer system include a software program that allows for viewing and maintaining QC data across multiple levels and lots for connected analyzers? (PWS 5.6.2.2.) Sub-factor 30: Does the proposed analyzer system include a software program capable of maintaining an action log of comments from QC review? (PWS 5.6.2.2.). Sub-factor 31: Does the proposed analyzer system include a software program that provides real-time access to QC charts graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics? (PWS 5.6.2.2.) Sub-factor 32: Does the proposed analyzer system include a software program include the ability to apply Westgard quality control decision rules in real-time? (PWS 5.6.2.2.) Sub-factor 33: Copy of offeror's valid Entsorgungsfachbetrieb Certificate. Is the proposed analyzer system capable of interfacing with the military hospital computer system (i.e. CHCS)? (PWS 5.6.1.) Sub-factor 34: Does the proposed analyzer system have an approved bi-directional interface between CHCS and analyzer? (PWS 5.6.1.). Sub-factor 35: Does the proposed analyzer system meet the minimum requirements for middleware as described in the PWS? (PWS 5.6.6., 5.6.6.1-3) Sub-factor 36: Does the proposed analyzer system have software that provides a single operator interface for workload management, data management, and instrument operational status monitoring? (PWS 5.6.3.1). Sub-factor 37: Has a General Project Manager that meets the requirements of the PWS been identified? (PWS 7.2.1.) Sub-factor 38: Has an IT-specific Project Manager that meets the requirements of the PWS been identified (PWS 7.2.4.). Sub-factor 39: Do the General Project Manager and IT Project Manager hold current PMP certification through a nationally recognized accrediting agency (e.g. The Project Management Institute)? (PWS 7.2.6.). Sub-factor 40: Is the analyzer(s) capable of running a comprehensive metabolic panel with less than 0.5 ml? (PWS 5.2.3.1). Sub-factor 41: Does the analyzer(s) have a range suitable for analyzing neonate specimens? (PWS 5.2.3.2) Sub-factor 42: Are the creatinine and cholesterol assays traceable to nationally recognized reference methodology? (PWS 5.2.3.3). Also the offeror has to describe in writing how they will comply with the following nine informal questions: Question #1 - Describe B2B/Con capabilities/compliance. (PWS 6.4) Question #2 - The total number of analyzers and pre-analytical/track system components required as determined by the minimum throughput, available menu requirements, and patient acuity. (Provide rationale for the number and type of component/analyzer required) (PWS 5.1.1. and 5.2.1.2. and Table 1 and Appendix 1, Tables 1-6) Question #3 - Provide a description of the required facilities changes to the layout of the laboratory, to include but not limited to environmental control, utilities, existing structure, site preparation etc. (PWS5.1.2. and 7.3.). Question #4 - Description of training, both on-site and at the vendor site. (PWS 5.5. (all)) Question #5 - Describe Data Management System/Middleware capabilities to include QC software module. (PWS 5.6. (all)) Question #6 - Describe Program/Project Management Services. (PWS 7.2. (all)). Question #7 - Provide a list of third party esoteric (i.e. third party) assays that are known to be on the analyzer system, along with a reference as to who is currently using the assays. (PWS 5.2.9.) Question #8 - Describe the Thin Client-type data management system. (PWS 5.6.4.1 and 5.6.4.2) Question #9 - Describe the remote diagnostic and troubleshooting capabilities.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA19/W9114F-13-T-0022/listing.html)
- Place of Performance
- Address: European Regional Contracting Office ATTN:MCAA E, Building 3705 Landstuhl, Germany APO AE
- Zip Code: 09180
- Zip Code: 09180
- Record
- SN03043786-W 20130425/130423235405-4547dbbbcd4316262b36aba3700dd423 (fbodaily.com)
- Source
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