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SAMDAILY.US - ISSUE OF APRIL 13, 2023 SAM #7807
SOLICITATION NOTICE

65 -- PHADIA 250 ALLERGEY TESTING INSTRUMENTS

Notice Date

4/11/2023 2:27:54 PM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

250-NETWORK CONTRACT OFFICE 10 (36C250) DAYTON OH 45428 USA
 

ZIP Code

45428
 

Solicitation Number

36C25023Q0515
 

Response Due

4/14/2023 2:00:00 PM
 

Archive Date

07/13/2023
 

Point of Contact

Gina P. Crank, Contracting Officer, Phone: 614 625 1236, Fax: NA
 

E-Mail Address

gina.crank@va.gov
(gina.crank@va.gov)
 

Awardee

null
 

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) 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. The Government reserves the right to make no award from this solicitation.   This is a request for quote (RFQ), and the solicitation number is 36C25023Q0515. The Government anticipates awarding a firm-fixed price Purchase Order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circulars 2023-02, effective 03/16/2023. The associated NAICS Code is 339112, Surgical and Medical Instrument Manufacturing. The Department of Veterans Affairs, Network Contracting Office 10, is soliciting quotes from all sources to supply the Columbus VA Ambulatory Center a system to test for allergy and autoimmune disease to support the facilities testing needs. Respondents to this solicitation must fully demonstrate their capability by supplying detailed quote information, along with any other documents necessary to support the requirements below. However, we believe Thermo Fisher Scientific s Phadia 250, is the only system that offers Autoimmune and ImmunoCAP allergy assays on a single platform.   Quotes are to be provided to Gina P. Crank, Contracting Officer, via email at gina.crank@va.gov, no later than April 14, 2023, by 5:00 PM EST. No telephone calls will be accepted. No submission received after the above-mentioned date and time will be accepted.  ITEM INFORMATION ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 UN $ $ PHADIA 250 ImmunoCAP Instrument LOCAL STOCK NUMBER: PHADIA 250 Funding/Req. Number: 1 757-23-1-096-0077 0002 1.00 UN $ $ Gold Plan Service Level Coverage Years 2-5 Funding/Req. Number: 1 757-23-1-096-0077 GRAND TOTAL $   STATEMENT OF WORK (SOW) Contract Number: Task Order Number: IFCAP Tracking Number: 757-23-1-096-0077 Follow-on to Contract and Task Order Number: Not Applicable 1. Contracting Officer s Representative (COR Name: Marie Brown Section: Pathology & Laboratory Medicine Services Address: 420 North James Rd., Columbus, Ohio 43219 Phone Number: 614-257-5225 Fax Number: 614-257-5629 E-Mail Address: Marie.Brown@va.gov 2. Contract Title. Allergy and Autoimmune Disease ImmunoCAP and EliA autoimmune EliA Testing with expanded menu. 3. Background. The current testing is being referred out to our reference laboratory and as testing request needs continues to increase, the limitations imposed by Cerner has become more cumbersome due to the length of time (usually months) it takes to request additional testing to be added, therefore forcing our providers to utilize community care to provide the testing needed. 4. Scope. Columbus VA ACC needs to expand the testing menu for allergy and autoimmune disease. This will allow the providers real time results for better patient outcomes. 5. Specific Tasks. 5.1 Task 1-Supply a non-Waived allergy and autoimmune ImmunoCAP and EliA autoimmune EliA testing analyzer to help practitioners determine allergy and autoimmune disease states. 5.1.1 Subtask 1 - Automated processing of Thermo Scientific EliA autoimmune and ImmunoCAP allergy assays on a single platform. 5.1. TASK1 Subtask1 No more than 15 minutes for setup with extensive walk away time. 5.1. TASK1 Subtask2 Expansive Allergy testing menu with a minimum 650 tests and the ability to add more tests when they are developed and become available for use. 5.1. TASK1 Subtask3 Autoimmune testing menu with a minimum of 30 tests and the ability to add more tests when they are developed and become available for use. 5.1. TASK1 Subtask4 One master isotype calibration curve per assay group (IgG, IgE, IgM, IgA) . 5.1. TASK1 Subtask5 On-board reagent storage and dilutions 5.1. TASK1 Subtask6 On Board Carrier Storage with a minimum of 150 storage slots with the ability to hold a minimum of 10-16 assays in each carrier. 5.2 Task 2. Operational Features 5.2.1 Subtask 1. The instrumentation shall perform all analysis for the required test with the precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical Laboratory Standards Institute CLSI). 5.2.2 Subtask 1. The instrumentation shall meet test menu, volume, turnaround time and efficiency requirements. 5.2.3. Subtask 1. The instrumentation must have a minimum throughput of 60 tests per hour. 5.2.3 Subtask 1. Vendor is responsible for providing everything required for installation, implementation and operation of the universal interface box, including the software license fee that may be required for the instrument is added to existing universal interface system e.g., ports, cards, cables software, licenses, etc.) If there are any software upgrades in the instrument during its life, or changes in the VA Medical Centers computerized system, the vendor is responsible for seeing that the interface can accommodate any changes in the VA Medical Centers data stream going to or from VA s computerized patient record and system in general. 5.2.4 Subtask 1. The vendor shall include all ancillary components that are customarily sold or provided with the model of equipment needed by the Laboratory for efficient operations, e.g., starter kits, tables/stands etc. 5.2.5 Subtask 1. The vendor shall provide to the VA Facility a PC computer CD of their procedure manual, or an on-line procedure manual in the instrument software. The procedure shall be formulated in accordance with current approved CLSI guidelines. 5.2.6 Subtask1. On-site/priority response time of between 24 and 36 business hours excluding weekends and holidays, unlimited on-site service visits per year (which includes two preventive maintenance visits annually with Preventive Maintenance kits) with labor and travel included and parts and consumables included for unlimited on-site service visits per year, telephone support, mandatory instrument operating software updates, access to annual service reports upon request, on-site support by a Seller technical specialist. 5.2.7 Subtask 1. Live Customer Support/Hotline Monday-Friday 0800-2000. 5.2.8 Subtask 1. Contractor must provide a timeline for phase-in, delivery and installation of equipment and training of end users. The timeline shall be included with the proposal. 5.2.9 Subtask 1. Training: 1. The vendor shall provide off-site instrument training at the Vendor s training facility. This shall include training on the operation of the system, data manipulation, and basic trouble shooting and repair. 2. Training will be provided to two Key Operators at no cost. Training is to include all costs of off-site training, e.g., transportation (air and ground) room and board. 5.2.10 Subtask 1. Disposal 1. Vendor shall remove all non-biohazardous trash created by the installation of the new machines. Deliverables: 6. Performance Monitoring Standard and Quality of Performance- This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order is accepted by the Government. This also includes replacement, substitute machines and machines that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the installation date. It shall end when the equipment has met the standard of performance for a period of 30 consecutive calendar days by operating in conformance with the Contractor s technical specification or as quoted in any contract at an effectiveness level of 90% or more. In the event that equipment does not meet the standard of performance during the initial 30 consecutive calendar days, the standard of performance tests shall continue on a day-by-day basis until the standard of performance is met for a total of 30 consecutive days. If the equipment fails to meet the standard of performance after 90 calendar days from the installation date, the user may, at his/her option, request a replacement or terminate the order in accordance with the provisions of FAR 52.212-4 entitled Termination for cause. (The Contractor shall receive revenue for tests reported during the 90-day acceptance period.) Operational use time for performance testing for a system is defined as the accumulated time during which the machine is in actual use. System failure downtime is that period of time when any machine in the system is inoperable due to equipment failure. Downtime for each incident shall start from the time the Government makes a bona fide attempt to contact the Contractor s designated representative at the prearranged contact point until the system or machine(s) is returned to the Government in proper operating condition. During the performance period for a system, a minimum of 100 hours of operational use time with productive or simulated work shall be required as a basis for computation of the effectiveness level. However, in computing the effectiveness level, the actual number of operational use hours shall be used when in excess of the minimum of 100 hours. [reference: Master FSS] The Government will maintain daily records to satisfy the requirements of the Standard and Quality of Performance section and shall notify the Contractor in writing of the date of the first day of the successful period of operation. Operations use time and downtime shall be measured in hours and whole minutes. During the term of the contract, should the repair record of any individual piece of laboratory equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the COR to replace the malfunctioning equipment with new equipment. The responsibility for maintaining the equipment furnished in good condition in accordance with manufacturer s instructions, shall be solely that of the Contractor. [reference: Master FSS] Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement for equipment. . 7. Security Requirements The vendor shall provide all ancillary support equipment to fully operate the instrumentation as defined in these specifications. Remote access for the system to troubleshoot will be provided through the National VPN interface site to site connection. Site to site requirements include but may not be limited to the following: MUST support #DES or AES IPSEC encryption (FIPS 140-2 Certified Must sign legal agreement with the VA Memorandum of Understanding/Interconnection Security Agreement(MOU/ISA) Communication must be limited to explicit VA and Vendor systems using a limited set of protocols Dedicated PC to analyzer shall have anti-virus software installed. Will surrender the hard drive upon termination of contract. Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. The term security incident means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. To the extent known by the contractor/subcontractor, the contractor/subcontractor s notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. The contractor/subcontractor shall provide notice to VA of a security incident as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a) date of occurrence; (b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; 6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8) Known misuses of data containing sensitive personal information, if any; (9) Assessment of the potential harm to the affected individuals; (10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1) Notification; (2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3) Data breach analysis; (4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI). N/A 9. Other Pertinent Information or Special Considerations. a. Identification of Possible Follow-on Work. Any additional work that may result from completion of this contract, which may be added at a later date as a modification to this contract, or that may be helpful to the contractor in determining the best overall approach for the contract. b. Identification of Potential Conflicts of Interest (COI). N/A c. Identification of Non-Disclosure Requirements. N/A d. Packaging, Packing and Shipping Instructions. Vendor will need to coordinate delivery with Logistics services prior to delivery to allow the appropriate checks on the analyzers before delivery to P&LMs needs to provide information to the Logistics Dock prior to delivery. Logistics e. Inspection and Acceptance Criteria. The COR is responsible for certifying that the work done under the contract is performed to time and standard. They are also responsible to assure the inspection and acceptance of products provided incidental to services. A demo period or trial is not inspection of a product. 10. Risk Control N/A 11. Place of Performance. Chalmers P. Wylie VA Ambulatory Care Center 420 N. James Road Columbus, OH 43219 12. Period of Performance. 30 Days ARO 13. Delivery Schedule. SOW Task# Deliverable Title Format Number Calendar Days After CO Start 1 Allergy/Autoimmune Analyzer Equipment 1 30 2 Training Face to Face TBD 45 3 Reagents for implementation reagents TBD 37 4 Reagent Schedule electronically 1 45 The 11 Federal Holidays observed by the Federal Government are: New Year s Day January 1 Martin Luther King s Birthday 3rd Monday in January Presidents Day 3rd Monday in February Memorial Day Last Monday in May Juneteenth Day June 19 Independence Day July 4 Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11 Thanksgiving Day 4th Thursday in November Christmas Day December 25th The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday. The following solicitation provisions apply to this acquisition: FAR 52.212-1, INSTRUCTIONS TO OFFERORS COMMERCIAL ITEMS (MARCH 2023) FAR 52.212-3, OFFERORS REPRESENTATIONS AND CERTIFICATIONS COMMERCIAL ITEMS (DEC 2022) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS (DEC 2022) ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The following clauses are incorporated into 52.212-4 as an addendum to this contract: FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) FAR 52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (AUG 2020) FAR 52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS SUBCONTRACTORS (MARCH 2023) VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) 852.203-70, 852.232-72, 852,233-70, 852.233-71 852.246-71, 852.247-71, 852.270-1 VAAR 852.212-71 GRAY MARKET LANGUAGE (FEB 2023) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (MARCH 2023) The following subparagraphs of FAR 52.212-5 are applicable: [52.203-6, 52.204-10, 52.209-6, 52.219-6, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, 52.232-18, 52.232-19, and 52.232-33.] All quoters shall submit the following: A completed schedule with pricing, adequate documentation detailing the capabilities of the product. All quotes shall be sent to the electronically via email to Gina P. Crank @ gina.crank@va.gov. Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government. The award will be made to the response most advantageous to the Government. Responses should contain your best terms and conditions. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows: ""The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."" OR ""The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"" Quoters shall list exception(s) and rationale for the exception(s), if any. Submission of your response shall be received not later than April 14, 2023 by 5:00 PM EST to gina.crank@va.gov Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Point of Contact listed below. Point of Contact Gina P. Crank Contracting Officer Network Contract Office (NCO) 10 Office: 614-625-1236 Email: gina.crank@va.gov
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/ac359fc89cb5473f84478b70f24bfa85/view)
 

Place of Performance

Address: Chalmers P. Wylie Ambulatory Care Center 420 North James Road 43219-1834, USA

Zip Code: 43219-1834

Country: USA
 

Record

SN06647253-F 20230413/230411230110 (samdaily.us)
 

Source

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

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