Service Contract for certification fume hoods, clean benches clean rooms, chemo isolators, and biological safety cabinets.

This is a Combined Synopsis/Solicitation for commercial items prepared in accordance with the format in FAR 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.



Solicitation number VA249-16-Q-0772 is issued as a Request for Quotation (RFQ).



The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular.



SET-ASIDE: This requirement is Total Service-Disabled Veteran-Owned Small Business Set-Aside. The NAICS is 541990 and the small business size standard is $15 Million. In accordance with VAAR 852.219-11, any SDVOSB submitting a quote for this action must be verified for ownership and control and is so listed in the vendor information pages database (http://www.vetbiz.gov) - upon submission of quote. Only qualified offerors may submit bids.

Introduction: The government anticipates awarding a Firm Fixed Price award, lowest price technically acceptable (LPTA). The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforms to the solicitation requirements.



Description of Services: The VAMC Louisville is requesting a base year + (4) one-year option service contract for certification fume hoods, clean benches, clean rooms, chemo isolators, and biological safety cabinets. The system will be in patient rooms and public area via closed television equipment located within the confines of the hospital. See Statement of Work (SOW) and Line Item Cline for complete details.



Period/Place of Performance: VAMC Louisville, Robley Rex VA Medical Center, 800 Zorn Avenue, Louisville, KY 40206.



Base Year: October 1, 2016 thru September 30, 2017 with (4) one-year option periods to renew through September 30, 2021.



The following FAR clauses and provisions apply to this solicitation:



52.203-16 Preventing Personal Conflicts of Interest

52.203-17 Contractor Employee Whistleblower Rights and Requirement to Inform

Employees of Whistleblower Rights



52.203-98 Prohibition on Contracting with Entities that Require Certain Internal

Confidentiality Agreements - Representation



52.203-99 Prohibition on Contracting With Entities That Require Certain Internal

Confidentiality Agreements



52.204-9 Personal Identity Verification of Contractor Personnel



52.204-16 Commercial and Government Entity Code Reporting



52.204-17 Ownership or Control of Offeror



52.204-18 Commercial and Government Entity Code Maintenance



52.209-7 Information Regarding Responsibility Matters



52.212-1 Instructions to Offerors-Commercial Items



52.212-3 Offeror Representations and Certifications-Commercial Items



52.212-4 Contract Terms and Conditions-Commercial Items



52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive

Orders-Commercial Items



52.216-1 Type of Contract



52.217-5 Evaluation of Options



52.217-8 Option to Extend Services



52.217-9 Option to Extend the Term of the Contract



52.232-38 Submission of Electronic Funds Transfer Information with Offer



52.233-2 Service of Protest



The following VAAR clauses and provisions apply to this solicitation:

852.203-70 Commercial Advertising

852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business

Evaluation Factors



852.219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside

852.232-72 Electronic Submission of Payment Requests

852.237-70 Contractor Responsibilities

852.270-1 Representatives of Contracting Officers



Full text can be obtained at http://www.acquisition.gov/far/index.html

LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service Disabled Veteran-Owned and Veteran-Owned Small Business Factors, and VAAR 852.217-71, Evaluation Factors. Accordingly, any contract resulting from this solicitation will include this clause. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) retained by VA to assist in assessing the contractor's compliance with the limitations on subcontracting or percentage of work performance requirements specified in the clause. To that end, the support contractor(s) may require access to contractor's offices where the contractor's business records or other proprietary data are retained and to review such business records regarding the contractor's compliance with this requirement. All support contractors conducting this review on behalf of VA will be required to sign an "Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement" to ensure the contractor's business records or other proprietary data reviewed or obtained in the course of assisting the CO in assessing the contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs. Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the contractor to protect proprietary information as required by FAR 9.505-4, obtaining access to proprietary information, paragraph (b). The contractor is required to cooperate fully and make available any records as may be required to enable the CO to assess the contractor's compliance with the limitations on subcontracting or percentage of work performance requirement.

Submission of Quote:



The Offeror shall submit their quote on company letterhead and shall include unit price, total, unit quantity, terms of any express warranty, unit price, overall total price, applicable shipping charges and item description as specified above, as offered discounts, proposed delivery time, name, address, and telephone number of the offeror, firm's DUNS# and ORCA document in SAM at www.sam.gov. Complete copy of 52.212-3 Offerors Representations and Certifications- Commercial Items, and ORCA document.



The offeror shall provide sufficient evidence that they possess adequate resources, capability, experience, responsibility and integrity to meet the technical capabilities to comply with the requirements of the resulting contract.



The offeror shall provide past performance evidence. This assessment is based on the offeror's record of relevant and recent past performance information that pertains to services outlined in the solicitation requirements.



The offeror shall provide evidence that all workers (engineers, technicians and helpers) must have certification/documentation as evidence of their degree of training and skills in order to perform the requirements in the solicitation. Certification/documentation must be submitted at the time of offer.



All quotes received without this documentation will not be considered.



All questions should be emailed to dewayne.knowles@va.gov, by Tuesday, August 30, 2016 by 8:00am CST. The subject line must specify VA249-16-Q-0772 - Service contract for certification fume hoods, clean benches, clean rooms, chemo isolators, and biological safety cabinets. All responses to questions will be incorporated into a written amendment posted to the Federal Business Opportunities website (www.fbo.gov). Offerors are encouraged to monitor the Federal Business Opportunities website with respect to this solicitation because any amendments to this Solicitation will be posted on the website (www.fbo.gov). There will be no automated email notification of amendments.



Quotes must be received by Tuesday, September 07, 2016 8:00am CST. Email your quote to dewayne.knowles@va.gov. The subject line must specify VA249-16-Q-0775 - Service contract for certification fume hoods, clean benches, clean rooms, chemo isolators, and biological safety cabinets. There will be no automated email notification of receipt of quotes. All quotes received without requested documentation will not be considered. Each vendor shall submit a copy of the following with the vendor's bid package:

A. Copy of accreditation from the American Board of Industrial Hygiene (ABIH) for the CIH(s) which will be performing the review of each field certification report.



B. Copy of accreditation from NSF for each field technician which may perform services at the Robley Rex VAMC. If additional technicians are utilized during the contract term, copies of the technician's accreditation must be provided before any work is performed.



C. At least three past performance examples which document projects of similar scope and size to the work required at the Robley Rex VAMC. At least one past project must be a VA medical facility to show the vendor is familiar with VA contract and technical requirements.



In addition, the quote should be broken down as such:

Base Year: 10-01-2016 - 09-30-2017 $

Option Year 1: 10-01-2017 - 09-30-2018 $

Option Year 2: 10-01-2018 - 09-30-2019 $

Option Year 3: 10-01-2019 - 09-30-2020 $

Option Year 4: 10-01-2020 - 09-30-2021 $

Total For Base & Option Year $



The solicitation package will be posted on FedBizOpps, which can be accessed at www.fedbizopps.gov. The Government will not provide paper copies of the solicitation. Telephone, written, or facsimile, requests, for the solicitation package will not be honored. All interested parties MUST be registered in the System for Award Management (SAM) Database and have completed On-Line Representation and Certifications Application (ORCA) in order to receive a contract award. If you are not registered with SAM, you may request an application via phone at 866-606-8220 or register on-line at https://www.sam.gov. To keep informed of changes: Check www.fedbizopps.gov frequently.

DISCLAIMER AND IMPORTANT NOTES: The government is in no way obligated to do business with or award a contract to any firm or its affiliates or otherwise pay for the information provided in this synopsis.

STATEMENT OF WORK



1. SCOPE: Contractor shall furnish all labor, transportation, parts, and expertise necessary to provide certifications to the fume hoods, clean benches, clean rooms, chemo isolators, and biological safety cabinets listed below in Attachment 1. Also listed in Attachment 1 is the desired certification frequency for each piece of equipment (annual or semi-annual). Annual certifications will be completed in November and semi-annual certifications will be performed in November/May.



2. CONTRACT PERIOD: Contract period shall be 10/1/2016 - 9/30/2017. Contract will contain provisions for additional option years (up to 4)



3. QUALIFICATIONS: Vendor must be certified to provide comprehensive testing and certification of the equipment list below in Attachment 1. All clean room testing is performed in accordance and compliant with Current Good Manufacturing Practices [cGMP], Institute of Environmental Sciences Technologies [IEST], and International Organization for Standardization [ISO], including: IEST-RP-CC-006.X, Federal Standard 209E, NSF/ANSI 49, ISO 14644-1, FDA Guidelines, and Current USP Standards.



Chemical fume hood testing and services include velocity profiling, smoke testing, ANSI and ASHRAE 110 testing, smoke visualization testing, cross-draft testing, VAV testing (variable air-volume testing), and tracer gas containment testing.



Biological safety cabinet (BSC) testing and certification shall include all testing required by NSF/ANSI 49 Annex F and all field testing must be performed by an NSF 49 accredited technician. For equipment utilized in pharmacy clean rooms, testing to current USP standards shall be completed to include both viable and non-viable particle testing. Viable particle counts shall include both bacterial and fungal spore tests. Both surface and airborne samples shall be collected.



The contractor shall certify all isolator units to CAG-002-2006 specifications and manufacturer requirements. All equipment used to certify isolators shall have NIST traceable or comparable calibration certification. Any unit that fails to meet CAG-002-2006 specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. Testing to current USP standards shall be completed to include both viable and non-viable particle testing. Viable particle counts shall include both bacterial and fungal spore tests. Both surface and airborne samples shall be collected.



TB Lab and TB Ante Room shall be tested for correct performance. Test reports shall include the following for each room:



a. Room drawing indicating the location of all doors, supply diffusers, exhaust/return vents, and BSCs.

b. Room dimensions and room volume.

c. Data showing all supply air flow and the data collection method.

d. Data showing all exhaust air flow and the data collection method.

e. Total air changes per hour.

f. Static pressure differential between the room being tested and any exterior space connected to that room. All static pressure measurements will be reported to at least one ten thousandth of an inch of water column (four decimal points).



Pharmacy clean rooms and ante rooms shall also be tested to current USP standards. Test reports shall include the following for each room:



g. Room drawing indicating the location of all doors, supply diffusers, exhaust/return vents, all non-viable particle counts collected and any PECs as defined by current USP standards.

h. Room dimensions and room volume.

i. Data showing all supply air flow and the data collection method.

j. Data showing all exhaust air flow and the data collection method.

k. Total air changes per hour. The final report shall also indicate whether or not this meets current USP requirements.

l. Static pressure differential between the room being tested and any exterior space connected to that room. All static pressure measurements will be reported to at least one ten thousandth of an inch of water column (four decimal points). The final report shall indicate whether or not this meets current USP requirements.

m. The total number of non-viable particle counts collected (based upon the most recent version of ISO 14644-1), the resulting average particle count and whether or not this meets current USP requirements.



n. Each room supply HEPA filter shall be leak tested in accordance with IEST-RP-CC034. Results must indicate the method for determining the upstream concentration, the total downstream concentration measured, the location of any leaks or previous patches, and the location of any new patches.



4. U.S LEGAL HOLIDAYS:

The following is a list of U.S. Government holidays. If the holiday falls on a Saturday, the proceeding Friday is observed as the holiday; if the holiday falls on a Sunday, the following Monday is observed as the holiday.

HOLIDAY DATE

New Year's Day Jan 1

Martin Luther King's Birthday 3rd Monday in Jan

President's Day 3rd Monday in Feb

Memorial Day Last Monday in May

Independence Day July 4

Labor Day 1st Monday in Sep

Columbus Day 2nd Monday in Oct

Veterans Day Nov 11

Thanksgiving Day 4th Thursday in Nov

Christmas Day Dec 25



5. SERVICES TO BE PROVIDED:



A. General:



1) Contractor will provide the necessary manpower, supervision, tools, and parts to properly execute the air flow certifications listed in Attachment 1. All containers, including toolkits, can be subject to search at any time.



2) A "Field Service Report" (FSR) must be generated and a copy given to the Robley Rex VAMC's Contracting Officer's Representative (COR) or designee after each site visit.



B. Documentation: Certification labels shall be placed on all equipment certified.



1) BSC stickers must contain, at a minimum, all information required by NSF/ANSI 49 and the vendor's report number. The sticker must be signed by the NSF-accredited technician which performed the field certification.

2) Fume hood stickers must contain the safe working height of the sash, the average inflow velocity measured at that height, company contact information, the report number, the date of testing, the date of certification expiration and the signature of the technician performing the field tests.

3) Isolator stickers must contain the make, model and serial number of the isolator, the report number, the date of testing, the date of certification expiration and the signature of the technician performing the field tests.

4) Room certification labels shall be provided for all rooms tested which meet the testing requirements for the respective room. Labels shall be protected from water and cleaning agents (i.e. laminated paper or vinyl document).



6. SPECIAL INSTRUCTIONS:



A. Contractor Check-In: Upon arrival, the contractor will check-in with the authorized VCS attendant to receive an identification sticker, prior to performing service(s) at the Robley Rex VA Medical Center. The contractor shall wear visible identification at all times while on the premises of the Robley Rex VA Medical Center, displaying name and company ID.



B. Hours of operation: Normal hours of operation for Biomed are 7:00 am to 4:30 pm Eastern. Any work being performed outside of the normal hours of operation will require prior approval by the biomedical supervisor. Any work performed after hours, will also be required to be escorted by biomed personnel.



C. Tool Storage: Tools may be stored onsite for the duration of the work being performed. Tools should be stored in biomed overnight, to ensure the equipment/tools are safeguarded from possible theft.



D. Deficiencies: All deficiencies noted will be immediately reported to a biomed representative at the time the finding is made to give opportunity to remediate the deficiency before moving on to the next device. A quote for remediation and retesting shall be provided within 7 business days of identifying the deficiency.



E. Documentation: At the conclusion of each visit, the contractor will provide a written service report indicating the date of service, the model, serial number, and location of equipment serviced; the name of the representative, and the services performed. A clear indication of all findings for each piece of equipment (or room) shall be included within the report along with the vendor's recommendations on how to correct the deficiency. The reports will be delivered to the Biomedical Engineering Shop, Room B039. An electronic copy may be emailed to the Biomedical Engineering Point of Contact.



F. Bid Submission Requirements: Each vendor shall submit a copy of the following with the vendor's bid package:



1) Copy of accreditation from the American Board of Industrial Hygiene (ABIH) for the CIH(s) which will be performing the review of each field certification report.

2) Copy of accreditation from NSF for each field technician which may perform services at the Robley Rex VAMC. If additional technicians are utilized during the contract term, copies of the technician's accreditation must be provided before any work is performed.

3) At least three past performance examples which document projects of similar scope and size to the work required at the Robley Rex VAMC. At least one past project must be a VA medical facility to show the vendor is familiar with VA contract and technical requirements.



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Attachment 1: EQUIPMENT LIST



FORMA MOD# 1126 BSC

S/N= 11239-56, EE11431

RM# A-912

ONE ANNUAL CERTIFICATION REQUIRED



LABCONCO FUME HOOD MOD# 72822-98-58895

S/N= 182647, EE17649

RM# C-222

ONE ANNUAL CERTIFICATION REQUIRED



BAKER MOD# SG403A-HE BSC

S/N= 100884, EE53450

RM# B363

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED



BAKER MOD# SG403A-HE BSC

S/N= 103647, EE60317

RM# B361

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED



BAKER MOD# SG403A-HE BSC

S/N= 100544, EE52037

RM# B363

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED



BAKER MOD# SG-403A BSC

S/N= 88153, EE32975

RM# B363 MICRO / TB

CLEANROOM TESTING TO INCLUDE:

-AIRFLOW VOLUME READINGS for A.C.P.H.

-DIFFERENTIAL PRESSURE READINGS between ROOMS

-AIRBORNE NON-VIABLE PARTICLE COUNTS IN ROOMS

-HEPA FILTER INTEGRITY TESTING

-ROOM DRAWINGS WITH DIMENSIONS

RM/AREA = B363 TB ROOM 1 / TB ROOM 2

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED



?

BAKER MOD# SG-403A BSC

S/N= 88155, EE32976

RM# B363 TB ROOM

CLEANROOM TESTING TO INCLUDE:

-AIRFLOW VOLUME READINGS for A.C.P.H.

-DIFFERENTIAL PRESSURE READINGS between ROOMS

-AIRBORNE NON-VIABLE PARTICLE COUNTS IN ROOMS

-HEPA FILTER INTEGRITY TESTING

-ROOM DRAWINGS WITH DIMENSIONS

RM/AREA = B363 TB ANTEROOM

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED



TB Ante Room

RM# B363 TB Ante Room



TB Room

RM# B363A TB Room 1



BAKER ISOLATOR MOD# SS 600

S/N= 89406, EE33377

RM/AREA = A033 I.V. PREP / MIXING AREA

CLEANROOM TESTING TO INCLUDE:

-AIRFLOW VOLUME READINGS for A.C.P.H.

-DIFFERENTIAL PRESSURE READINGS between ROOMS

-AIRBORNE NON-VIABLE PARTICLE COUNTS IN ROOMS

-HEPA FILTER INTEGRITY TESTING

-ROOM DRAWINGS WITH DIMENSIONS

RM/AREA = A033 I.V. PREP / MIXING AREA

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED (requires USP testing)



BAKER ISOLATOR MOD# SS 600

S/N= 89436, EE33378

RM/AREA = A033 I.V. PREP / MIXING AREA

CLEANROOM TESTING TO INCLUDE:

-AIRFLOW VOLUME READINGS for A.C.P.H.

-DIFFERENTIAL PRESSURE READINGS between ROOMS

-AIRBORNE NON-VIABLE PARTICLE COUNTS IN ROOMS

-HEPA FILTER INTEGRITY TESTING

-ROOM DRAWINGS WITH DIMENSIONS

RM/AREA = A033 ANTEROOM

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED (requires USP testing)



BAKER ISOLATOR MOD# CS 600

S/N= 86887, EE33485

RM# A033 CHEMO PREP

CLEANROOM TESTING TO INCLUDE:

-AIRFLOW VOLUME READINGS for A.C.P.H.

-DIFFERENTIAL PRESSURE READINGS between ROOMS

-AIRBORNE NON-VIABLE PARTICLE COUNTS IN ROOMS

-HEPA FILTER INTEGRITY TESTING

-ROOM DRAWINGS WITH DIMENSIONS

RM/AREA = A033 CHEMO PREP

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED (requires USP testing)



Inpatient Oncology Clean Room

RM# A-003-1

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED (requires USP testing)



Inpatient Pharmacy Ante Room

RM# A-003-1

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED (requires USP testing)





Inpatient IV Prep Room

RM# A-003-1

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED





BAKER ISOLATOR MOD# CS 600

S/N= 95638, EE41252

RM# A333

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED (requires USP testing)



Oncology Ante Room

RM# A333A

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED



Oncology Prep Room

RM# A333B

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED



Oncology Buffer Room

RM# A333C

TWO SEMI-ANNUAL CERTIFICATIONS REQUIRED (requires USP testing)



LABCONCO MOD# 3955200 FUME ABSORBER

S/N= 080384606, EE39399

RM# B-405

ONE ANNUAL CERTIFICATION REQUIRED



THERMO/SHANDON LIPSHAW FUME HOOD MOD# GROSS LAB SR B21102

S/N= B210906046, EE32924

RM# B-405

ONE ANNUAL CERTIFICATION REQUIRED



NUAIRE MOD# NU-201-230 CLEAN BENCH

S/N= 55065-AAV, EE12036

RM# B-813

ONE ANNUAL CERTIFICATION REQUIRED



NUAIRE MOD# NU-408-424 BSC

S/N= 1637-KX, EE11203

RM# 12-111

ONE ANNUAL CERTIFICATION REQUIRED



LABCONCO FUME HOOD

S/N# 182812, EE18133

RM# A-348

ONE ANNUAL CERTIFICATION REQUIRED



THERMO/SHANDON LIPSHAW GROSS LAB SR MOD# 97002 FUME STATION

S/N= 9700200153, EE18025

RM# A-348B

ONE ANNUAL CERTIFICATION REQUIRED



LABCONCO FUME HOOD MOD# 72816

S/N= FH-050400-1BB, EE9183

RM# A-348B

ONE ANNUAL CERTIFICATION REQUIRED



NUAIRE MOD# NU-425-400 BSC

S/N= 55585-AAX, EE11916

RM# A-937

ONE ANNUAL CERTIFICATION REQUIRED



LAB FABRICATIONS 5 FT FUME HOOD

S/N= FH-111704-1RG, EE26533

RM# A-949

ONE ANNUAL CERTIFICATION REQUIRED



NUAIRE MOD# NU-425-400 BSC

S/N= 105681040706, EE30596

RM# A-950

ONE ANNUAL CERTIFICATION REQUIRED



BIOCLEAN MOD# TBH5500 CLEAN BENCH

S/N= C850456, EE17160

RM# BLDG 12 - 111

ONE ANNUAL CERTIFICATION REQUIRED



NUAIRE MOD# NU-124-SPEC CLEAN BENCH

S/N= 69290-ADW, EE15299

RM# BLDG 12 - 113

ONE ANNUAL CERTIFICATION REQUIRED



BAKER FUME HOOD MOD# M100982-1/FH4C

S/N= 110000, EE# 70002

RM# C302

ONE ANNUAL CERTIFICATION REQUIRED



BAKER MOD# B60-112 BSC

S/N= SP-33061-V, EE18132

RM# 19-102

ONE ANNUAL CERTIFICATION REQUIRED

Awaiting Research confirmation that they will repair filter issue



FORMA MOD# 1100 BSC

S/N= 13550-545, EE18139

RM# 19-106

ONE ANNUAL CERTIFICATION REQUIRED



BAKER MOD# SGII-400 BSC

S/N= 62833, EE18140

RM# 19-112

ONE ANNUAL CERTIFICATION REQUIRED



LABCONCO MOD# 48805-00 FUME HOOD

S/N= 981241427D, EE17633

RM# 19-203

ONE ANNUAL CERTIFICATION REQUIRED



LABCONCO FUME HOOD MOD# 70198

S/N= 26744, EE10764

RM# 19-102

ONE ANNUAL CERTIFICATION REQUIRED



ASTEC BFC10 UNIT

S/N= 8494 26/97, EE20538

RM# 19-112

ONE ANNUAL CERTIFICATION REQUIRED



ASTEC BFC10 UNIT

S/N= 4236, EE20537

RM# 19-112

ONE ANNUAL CERTIFICATION REQUIRED



ASTEC BFC10 UNIT

S/N= 3451 12/98, EE15930

RM# 19-102

ONE ANNUAL CERTIFICATION REQUIRED