RFI FBO - High-performance liquid chromatography (HPLC) PM
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THIS IS A SOURCES SOUGHT NOTICE:
This is NOT a request for proposals; this is an industry inquiry for Market Research. A solicitation shall not be issued at this time. The intent of the procurement is to locate potential contractors for solicitation. The below specification defines the effort required for the purchase and period of performance.
PERFORMANCE WORK STATEMENT
1. VA FACILITY:
Cooperative Studies Program
Clinical Research Pharmacy Coordinating Center
New Mexico VA Health Care System
Albuquerque, New Mexico
2. TITLE:
High-performance liquid chromatography (HPLC) Maintenance
3. BACKGROUND:
The VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center in Albuquerque, NM supports the conduct of clinical studies throughout the Department of Veterans Affairs. B Part of this effort involves testing pharmaceutical products used in the studies to ensure patient safety is protected through various chemical analyses. B PM of Agilent equipment and receiving annual validation is critical for testing and is required under cGMP and ISO guidelines.
4. SCOPE:
This requirement is for procurement Agilent CrossLab Silver with Operational Qualification/Repair Qualification (OQ/RQ) services for the Agilent Technologies equipment listed in this document. B The contractor shall perform an annual preventative maintenance visit, validate the equipment for use, and throughout the rest of a performance period shall provide telephone support and repair services as necessary and as contained in the requested level of support Agilent CrossLab Silver with OQ/RQ.
5. SPECIFIC TASKS:
a. Service technicians shall be certified on/by Agilent Technologies equipment to perform any services/maintenance on the enclosed specified equipment. Contractor shall provide documentation/copy of certification with proposal submittals and upon award.
b. Provide Agilent CrossLab Silver with OQ and RQ for equipment listed in the enclosed PWS paragraph 5.t.
c. The Contractor shall provide standard service to include telephone support to isolate; resolve hardware/software problems; Service Center Repair; on-site hardware troubleshooting and fully certified/validated repair no later than 5 business days or sooner.
d. Contractor shall provide unlimited on-site repair services to restore equipment to optimal
operating conditions.
e. The Contractor shall include all labor, travel costs, service parts, and including consumable parts required for repair. All parts shall be Original Equipment Manufacturer (OEM) parts are to be of manufacturer or equivalent and fully compatible with current Agilent equipment.
f. The Contractor shall include one Agilent CrossLab Preventative Maintenance Program.
g. The Contractor shall include one Agilent CrossLab Operational Qualification/Performance Verification (OQ/PV) and Agilent CrossLab Repair Qualification (RQ).
h. PM OQ service shall consists of system testing using a chemical test sample kit of known concentration to verify proper equipment operation; also, software tools are used as part of the process. Contractor shall configure test parameters according to the Government s requirements.
i. Contractor shall utilize a checklist for each step of protocols in accordance with manufacturer s recommendations.
j. Service technician shall Repair Qualification that recertifies equipment after a repair has occurred.
k. If offers proposed service is not the requested Crosslab Silver with Operational Qualification/Repair Qualification (OQ/RQ), proposal shall include sufficient details for comparison during technical review.
l. Annual preventive maintenance shall be completed when scheduled and validation documentation provided. Validation of equipment shall be completed immediately after PM services. Validation shall be performed on all equipment on an annual basis and within the same month of the last service certification date and in such a way that validation does not expire.
m. Contractor shall provide recertification/validation verification and equipment validation report to SME/COR in an electronic format. Files shall be in PDF format and shall be electronically delivered to the SME/COR
n. Equipment Shall be fully RQ requalified no later than 24-hours after repairs. Shall ensure the equipment remains continuously in conformance with the specifications used.
o. Contractor shall provide a 100% service repair guarantee. The equipment shall be repaired or replaced with equivalent equipment. Parts shall be of OEM; refurbished, used, or grey market parts shall NOT be accepted. Equipment replacement shall require written modification to the task order.
p. Normal wear and tear items, such as liners, seals, lamps, and tubing, shall be included when needed to complete repairs.
q. On-site emergency repair response shall be performed, validated and recertified no later than 48-hours of service call. (non-business days do not count in this time period since user is closed on Federal Holidays/Weekends)
r. All preventive maintenance, corrective maintenance, emergency repairs, and validations shall be performed by a fully trained and certified Field Service Engineer (FSE).
s. The Contracting Officer (CO) may request proof of training and certification, from the Contractor, at any time during the period of performance.
t. Equipment to be supported
System Name
Serial Number
Model Description
Frequency of Service
Last Calibration Date (tracked by System vs Sub-component)
1290 UPLC
SYSTEM 1
B
LC 1290 System
B
DEBAF03769
1290 Infinity
Diode-Array Detector
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAC09789
1290 Thermostatted Column Compartment
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAP02400
1290 Infinity Autosampler
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAN01232
1290 Infinity Quaternary Pump
At least one time on an annual basis and within the same month of last service certification date.
October 2017
System Name
Serial Number
Model Description
Frequency of Service
Last Calibration Date (tracked by System vs Sub-component)
1290 UPLC
SYSTEM 2
B
LC 1290 System
B
DEBAN01225
1290 Infinity Quaternary Pump
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAC09713
1290 Thermostatted Column Compartment
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAF03782
1290 Infinity
Diode-Array Detector
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAP06224
1290 Infinity Autosampler
At least one time on an annual basis and within the same month of last service certification date.
October 2017
System Name
Serial Number
Model Description
Frequency of Service
Last Calibration Date (tracked by System vs Sub-component)
1290 UPLC
SYSTEM 3
B
LC 1290 System
B
DEBAF03750
1290 Infinity
Diode-Array Detector
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAP06225
1290 Infinity Autosampler
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAC09725
1290 Thermostatted Column Compartment
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAN01227
1290 Infinity Quaternary Pump
At least one time on an annual basis and within the same month of last service certification date.
October 2017
System Name
Serial Number
Model Description
Frequency of Service
Last Calibration Date (tracked by System vs Sub-component)
1290 UPLC
SYSTEM 4
B
LC 1290 System
B
DEBAF03751
1290 Infinity
Diode-Array Detector
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAC09647
1290 Thermostatted Column Compartment
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAN01231
1290 Infinity Quaternary Pump
At least one time on an annual basis and within the same month of last service certification date.
October 2017
B
DEBAP06203
1290 Infinity Autosampler
At least one time on an annual basis and within the same month of last service certification date.
October 2017
System Name
Serial Number
Model Description
Frequency of Service
Last Calibration Date (tracked by System vs Sub-component)
6850 GC
GC 6850 System
B
CN11538007
6850 Series gas chromatograph system
At least one time on an annual basis and within the same month of last service certification date.
April 2018
B
US15370611
7693A Autoinjector
At least one time on an annual basis and within the same month of last service certification date.
April 2018
6. SECURITY REQUIREMENTS:
Contractor FSE shall perform maintenance on scientific equipment which is not connected to any VA network. Contractor FSE shall not have access to patient records, VA sensitive information or to any IT system connected to the VA network.
The C&A requirements do not apply and a Security Accreditation Package is not required.
When on facility grounds, contractor FSE shall sigh-in and be escorted by a SME/COR/CSPCRPCC employee at all times as mandated and strictly enforced in facility security policy.
7. PLACE OF PERFORMANCE:
VA Cooperative Studies Program
Clinical Research Pharmacy Coordinating Center
2401 Centre Avenue, SE
Albuquerque, NM B 87106
8. ESTIMATED PERIOD OF PERFORMANCE:
11/01/18 thru 10/31/19 - Base Year
11/01/19 thru10/31/20 - Option Year One
11/01/20 thru 10/31/21 - Option Year Two
11/01/21 thru 10/31/22 - Option Year Three
11/01/22 thru 10/31/23 - Option Year Four
9. HOURS OF COVERAGE:
a. Delivery schedule consists of actual preventative maintenance visit and validation. B Scheduling shall be coordinated with the subject matter expert (SME) or through the COR. B Schedule timing shall be based on the equipment certification/calibration dates and equipment. See paragraph 5.t0. equipment details for frequency requirements.
b. Normal hours of coverage are Monday through Friday from 8:00 am to 4:00 pm New Mexico time (MST). All service/repairs shall be performed during normal hours of coverage unless requested or approved by the SME in coordination with the COR.
c. Preventive maintenance shall be performed as scheduled by the SME or COR. Preventive maintenance shall be performed during normal hours of coverage.
d. Work performed outside the normal hours of coverage shall be approved by the COR. Funding for services that are outside the normal coverage hours or on holidays shall have approved funding prior to any service being allowed.
NOTE: Hardware/software update/upgrade installations shall be scheduled and performed during normal hours of coverage at no additional charge to the government.
e. Federal Holidays observed are located at the following link:
https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/
f. A copy of a packing slip with purchase order number shall be furnished at the time the order is delivered.
10. PARKING, SMOKING, AND VA REGULATIONS:
a. It is the responsibility of the Contractor to park in the appropriate designated parking areas. Contractor shall not invalidate or make reimbursement for parking violations of the Contractor under any conditions. Smoking is prohibited inside any VA facility. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.
11. ACRONYMS:
a. CO-Contracting Officer. B The Federal employee who is warranted by the Government to enter into contracts on behalf of the Government and is the only person authorized to make changes to those contracts
b. COR-Contracting Officer's Representative. B Individual designated by the CO to place orders, furnish technical guidance, advice, certify invoices, and provide general supervision of the work performed under the executed contract
c. CSPCRPCC-Cooperative Studies Program Clinical Research Pharmacy Coordinating Center
d. FSE - Field Service Engineer
e. GMP - Good Manufacturing Practice
f. HPLCs - High-performance liquid chromatography
g. ISO - International Standards Organization
h. OEM - Original Equipment Manufacturer
h. OQ/PV - Operational Qualification/Performance Verification
i. OQ/RQ Operational Qualification/Repair Qualification
j. PM - Preventive Maintenance
k. PWS Performance Work Statement
l. NMVAHCS-New Mexico Veterans Affairs Healthcare System
m. SME - Subject Matter Expert
n. VAMC-Department of Veterans Affairs Medical Center
16. SOURCES SOUGHT DETAILS
NAICS CODE: 811219 - Other Electronic and Precision Equipment Repair and Maintenance
Small Business manufacturers for this NAICS code have a size standard.B The term of the contract is intended to be base contract plus 4 option years.
It is anticipated that a Request for Quotes shall be issued in Aug 2018. Award of contract is contemplated by Oct 2018.
This notice is published to conduct market research to determine if there is a sufficient number of certified Service Disabled Veteran Owned Small Businesses (SDVOSB), Veteran Owned Small Businesses (VOSB), Small Businesses (SB), or Large Business capable of performing the requirements to warrant a socio-economic set-aside or full & open competition. It is strongly recommended that interested parties register in the US Department of Veterans Affairs Vet Biz database and the Small Business Administration (SBA) database. Registration may be accomplished at http://www.vip.vetbiz.gov/ and www.sba.gov/, respectively.
17. INTERESTED PARTIES RESPONDING VIA EMAIL TO THIS SOURCES SOUGHT REQUEST SHALL SUBMIT THE FOLLOWING INFORMATION AT A MINIMUM:
Company name, address, point of contact, phone number.
DUNS number and company social-economic status.
Lead time on delivery/ETA/Installation.
Can your firm provide all services or just partial? (If partial, which line item?)
Intentions of subcontracting program to include set-asides. Yes or No.
(5a) If yes to (5), as the prime contractor, your firm shall confirm if it will comply with
15 USC 657s and 13 CFR 125.6 - limitations on subcontracting.
Bottom line, your firm shall conduct over 50% of the service performance.
If SDVOSB or VOSB, proof of registration in the VA Vet Biz websites or intention of registration prior to submission of offers to a solicitation - http://www.vip.vetbiz.gov/
Any other pertinent company documentation or product information.
If potential contractors are interested in a site visit, contractor shall confirm interest via RFI response.
The response date to this Sources Sought notice is Aug 20, 2018 at 12:00 pm EST time.
Electronic submissions are preferred via email address of: dena.hallaren@va.gov. This market research is for informational and planning purposes only to determine if a socio-economic set-aside, or full & open competition, or sole-source procurement is appropriate. The Government shall not pay any costs for responses submitted.
NO ADDITIONAL INFORMATION IS AVAILABLE OTHER THAN WHAT IS NOTED HEREIN.
ALL FIRMS SHALL NOT TO CALL THE INDIVIDUAL VA MEDICAL CENTERS REQUESTING MORE INFORMATION. DIRECT ALL QUESTIONS TO POC ONLY.
18. IMPORTANT INFORMATION:
The Government is not obligated to nor shall it pay for or reimburse any costs associated with responding to these sources sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to a particular acquisition approach. The Government will in no way be bound to this information if any solicitation is issued. The VA is mandated by Public Law 109-461 to consider a total set-aside for Service Disabled Veteran Owned Small Business set aside. However, if response by Service Disabled Veteran Owned Small Business firms proves inadequate, an alternate set-aside or full and open competition may be determined.
19. DISCLAIMER
This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.
SUBMIT RESPONSES VIA EMAIL- dena.hallaren@va.gov
WITH THE FOLLOWING TITLE IN SUBJECT LINE:
RFI FBO - High-performance liquid chromatography (
RESPONSES ARE DUE 09-20-2018 12:00PM EST
For Official Use Only Email
