36C24118Q0303-001.docx

36C24118Q0303

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a

. THIS

CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

DUNS:

DUNS+4:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE.

CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________.

YOUR

OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

36C24118Q0303 04-17-2018 Stephen Clements 603-624-4366x5860 05-14-2018

08:00 AM

90C Department of Veterans Affairs Network Contracting Office 1 (NE) VAMC Manchester 718 Smyth Road, BST Suite 105 Manchester NH 03104 X 811219 $20.5 Million X N/A X Department of Veterans Affairs Connecticut VAMC 950 Campbell Avenue West Haven CT 06516-2770 90C Department of Veterans Affairs Network Contracting Office 1 (NE) VAMC Manchester 718 Smyth Road, BST Suite 105 Manchester NH 03104

All Invoices from the Contractor shall be submitted electronically as per VAAR Clause 852.232-72 Electronic Submission of Payment Request http://www.fsc.va.gov/einvoice.asp 877-353-9791 See CONTINUATION Page This solicitation is a request for quotes (RFQ) for services as described in the Statement of Work, including fume hood and biological safety cabinet certification and maintenance.

The government intends to award a firm fixed price contract with one base year plus 4 option years. Contractor shall provide all necessary personnel, supervision, labor, equipment , materials and disposal necessary to provide the services for Connecticut VAMC.

Quoters should carefully follow instructions included in 52.

212-1 and for evaluation criteria in Section E. Pricing should be identified in the Price/Cost Schedule and the spreadsheet attached in Section D.

Wage Determination#2015-4127 Rev#6 1/10/2018 www.wdol.gov All quotes shall be emailed to stephen.clements3@va.gov.

Any quote not compliant with RFQ requirements will not be considered $0.00 See CONTINUATION Page X X X Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C241 Stephen Clements Department of Veterans Affairs Network Contracting Office 1 (NE) VAMC Manchester 718 Smyth Road, BST Suite 105 Manchester NH 03104

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

All Invoices from the Contractor shall be submitted electronically as per VAAR Clause 852.232-72 Electronic Submission of Payment Request http://www.fsc.va.gov/einvoice.asp ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 LIMITATIONS ON SUBCONTRACTING-- MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes FAR 52.219-4 Notice of Price Evaluation Preference for HubZone Small Business Concerns. 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.

B.3 SUBCONTRACTING COMMITMENTS--MONITORING AND COMPLIANCE (JUN 2011)

This solicitation includes VAAR 852.215-70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors, and VAAR 852.215-71, Evaluation Factor Commitments. Accordingly, any contract resulting from this solicitation will include these clauses. The contractor is advised in performing contract administration functions, the CO may use the services of a support contractor(s) to assist in assessing contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the contractor's business records or other proprietary data to review such business records regarding contract 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 compliance with the subcontracting commitments.

36C24118Q0303

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B.4 PERFORMANCE WORK STATEMENT (PWS)

Fume Hoods, Down Draft Tables, Capture Units, Glove Boxes, Clean Benches, Biological Safety Cabinets, and Clean Rooms Connecticut VAMC

1. SCOPE OF WORK:

The Contractor shall furnish all labor, equipment, materials (including replacement parts), supplies, tools, transportation, and travel necessary to perform all inspections, testing, certifications, preventative maintenance and repair and internal HEPA and other filter replacement, as required throughout the contract period at the VA Connecticut Healthcare System (VAMC): West Haven and Newington divisions.

The Contractor shall perform routine work detailed in this PWS within seventy-two (72) hours of a request from the Contracting Officer’s Representative (COR) and within four (4) hours of an emergency request for service from the COR. No additional funding will be provided to pay for travel to the VAMC for service.

Places of Performance West Haven VAMC - 950 Campbell Avenue, West Haven, CT 06516 Newington VAMC - 555 Willard Avenue, Newington, CT 06111

The VAMC uses a variety of engineering ventilation controls to maintain employee exposures to airborne biologic, chemical and radiological hazardous air contaminants below applicable regulatory limits. These include Class II biological safety cabinets (Class II BSCs), ducted and ductless chemical fume hoods, and custom local exhaust ventilation devices (“capture hoods”). In addition, the In-Patient Pharmacy USP 797 Sterile Cleanroom Facility also uses Class II BSCs, Compounding Aseptic Isolators (CAIs) for non-hazardous drugs, Compounding Aseptic Containment Isolators (CACIs) for hazardous drugs (as defined by NIOSH and OSHA), and Laminar Airflow Work-Benches (LAFW) to maintain I.V. sterility during preparation.

For a list of the relevant items, see Attachment A. The number of items in service may change throughout the contract period. The numbers and types of devices in Attachment A are the Government's best estimate of the number and type expected to be serviced by the contract. The Government reserves the right to delete or add units as required.

If the numbers of listed items will be exceeded, no work is authorized with the prior written approval of the Contracting Officer (CO) to account for it. Work items or services not already included in this PWS, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this PWS. The Government shall not be held responsible for payment for any work performed by the contractor that is outside the scope of this contract or without the prior approval of the CO.

2. CONTRACTOR QUALIFICATIONS:

All inspections, testing and certifications must be performed by properly trained and appropriately accredited on-site field certification technicians. These certified technicians must be trained on all of the types of equipment listed in Attachment A of this PWS. Documentation shall be provided to the VA certifying that each field certification technician has been trained and certified in the work required by this PWS as follows:

- For Class II BSC testing and certification, each on-site field certification technician must hold a current certification as a NSF Class II Biosafety Cabinet Field Certifier. Current certification for a specific individual can be confirmed at: http://info.nsf.org/Certified/Biosafety-Certifier/ [NSF-accredited certifier]

- For fume hood testing and certification, within twelve (12) months of award of the base year of this contract, each on-site certification technician must hold a current certification as a Registered Fume Hood Certified Professional [note: actual name may change] by the Controlled Environmental Testing Association (CETA) National Board of Testing (CNBT).

- For USP 797 Suite testing and certification, each on-site certification technician must hold a current certification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities by the CETA CNBT. Current certification for a specific individual can be confirmed at: http://www.cetainternational.org/find-a-registered-cleanroom-certified-professional-for-sterile-compounding-facilities#/ [CETA-accredited certifier / certifier accreditation program] Note: A Certified Industrial Hygienist (CIH) credential does not waive any of the above certification requirements.

The Contractor shall submit their standard operating procedures (SOPs) for testing, troubleshooting, repair and certification including documentation of certification equipment calibration to National Institute of Standards and Technology (NIST)-traceable primary standards, a safety plan to include job hazard analysis, respiratory protection program, hazard communication and safety data sheets (SDS) for all chemical products that will be used during the course of this contract.

Special requirement: The Contractor shall submit a specific SOP for changing out biologically contaminated HEPA filters in Class II BSCs, and a specific SOP for changing out HEPA filters contaminated with hazardous drugs in In-Patient Pharmacy Class II BSCs and CACIs.

3. PERFORMANCE REQUIREMENTS:

The VA Connecticut Healthcare System has Class II BSCs in Pathology & Laboratory Medicine Service (P&LMS) and Research & Development (R&D) Service, that require NSF/ANSI 49 certification; Class II BSCs, CAIs, CACIs and LAFW in Pharmacy Service that require NSF/ANSI 49 (Class II BSC) or USP 797 and 800 certification, ducted and ductless chemical fume hoods in P&LMS and R&D Service that require ASHRE 110 certification, custom local exhaust ventilation devices (“capture hoods”) in the P&LMS Histology Lab and a downdraft autopsy table in the P&LMS Morgue that require certification per manufacturers specifications, In-Patient Pharmacy USP 797 clean rooms (hazardous drugs (“chemo”)/ nonhazardous drugs/soft wall), IV Rooms (nonhazardous drugs), and ante rooms that require USP 797 and/or USP 800 testing and certification.

The contractor shall certify BSCs, ducted and ductless fume hoods, CAIs, CACIs, and other equipment in accordance with the most current versions of the following reference standards:

- American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE) 110-2016 Methods of Testing Performance of Laboratory Fume Hoods

- Controlled Environmental Testing Association (CETA) Documents Referenced by USP <797>:

•CAG-001-2005 Applications Guide For The Use Of Compounding Isolators In Compounding Sterile Preparations In Healthcare Facilities (Revised December 2008) •CAG-002-2006 Compounding Isolator Testing Guide (Revised December 2008) •CAG-003-2006 Sterile Compounding Facilities (Revised May 2015) •CAG-004-2007 Application Guide for the use of Surface Decontaminants in Biosafety Cabinets •CAG-005-2007 Servicing Hazardous Drug Compounding Primary Engineering Controls •CAG-006-2010 CETA High Efficiency Filter Application Guide •CAG-007-2010 Application Guide for Exhaust System Requirements of Class II, Type B Biosafety Cabinets •CAG-008-2010 CETA Certification Matrix for Sterile Compounding Facilities (Updated January 2012) •CAG-009-2011v3 CETA Certification Application Guide USP <797> Viable Environmental Sampling & Gowning Evaluation

Additional CETA Guidance:

•CAG-000-2007 Application Guide Publication Flowchart

- ISO (International Organization for Standardization) 14644-1:2015 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration

- ISO 14644-2:2015 - Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

- ISO 14644-3:2005 Cleanrooms and associated controlled environments -- Part 3: Test methods

- ISO 14644-9:2012 Cleanrooms and associated controlled environments -- Part 9: Classification of surface cleanliness by particle concentration

- ISO 14698-2:2003 - Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data -NSF (National Sanitation Foundation International)/American National Standards Institute (ANSI) 49-2016 Biosafety Cabinetry: Design, Construction, Performance and Field Certification

- USP (United States Pharmacopeia Convention) Chapter <797> Pharmaceutical Compounding – Sterile Preparations (June 1, 2008)

- USP Chapter <800> Hazardous Drugs – Handling in Healthcare Settings (February 1, 2016) -OSHA (Occupational Safety and Health Administration)

The contractor shall furnish all labor, equipment, materials, replacement parts, supplies (under $25.00), transportation, permits, testing, equipment certificates and incidentals necessary for the performance of the work specified in this PWS.

During the inspection, the contractor shall perform routine maintenance to correct any equipment malfunctions and assure that the equipment meets manufacturer's factory specifications.

Any calibration procedures or adjustments necessary to assure accurate and reliable equipment operation will be performed at this time.

The contractor shall maintain a sufficient stock of all replacement parts meeting or exceeding the original manufacturer's design and specification needed for routine repair and maintenance of the equipment or be able to secure needed parts within two (2) calendar days.

Replacement of Class II BSC internal supply and exhaust HEPA filters and chemical sorbent filters (e.g., for ductless fume hoods) as needed to maintain equipment certification and other replacement parts for the repair will be paid at the actual vendor cost plus the percentage markup quoted on this contract.

All deficiencies and defects shall be itemized and reported as cost of repairs in the contractor’s monthly inspection/maintenance statement. The Contractor shall submit supplier quotes with each invoice request. Repair, replacement of parts or materials shall be performed on an as-needed basis to maintain equipment certification, determined by the servicing technician and approved by the CO and within 2 calendar days of the approval.

WORKING HOURS

All Certifications service shall be performed during normal VA Medical Center working hours of 8:00 a.m. to 4:30 p.m. Monday through Friday, except Federal Holidays, unless no additional labor charges would apply, or if they do, without advance approval by the CO.

Certain patient care support areas such as the pharmacies will need to be completed from 6:00 am to 8:00 am or after 2:30 pm so as not to interfere with drug preparation for units and clinics. The contractor shall include pricing for standard working hour labor rates and non-standard working hour labor rates in the Price/Cost Schedule. It is an estimated that there will be 24 hours per year outside normal working hours.

All work must be arranged in advance with the COR.

All equipment (Class II BSCs, CAI, CACIs, ducted and ductless fume hoods, custom containment devices) and Pharmacy USP 797 Clean Room certifications shall be accomplished using industry standard scientific measurement equipment each calibrated to an applicable NIST-traceable primary standard provided by the Certification contractor.

TESTING AND CERTIFICATION PROCEDURES

The contractor shall supply every unit that passes the required certification specifications with a certification sticker on the same day of the service with the following information:

· Class II BSC and LAFWs: Contractor’s Company name, address and phone number; unit make, model and serial number, report number, location (room number), applicable certification standard, certification date, recertification date, and certification technician’s signature/printed name, pass/fail status.

· CAI and CACI: Contractor’s Company name, address and phone number; unit make, model and serial number; applicable certification standard, certification date, recertification date, report number, technician’s signature/printed name, pass/fail status of the material ingress/ egress test, recovery time of the main chamber, indication that the operator has to wait at least the recovery time before initiating operations after material transfer, and ventilation appropriate for use with volatile / non-volatile hazardous drugs.

· Fume Hood: Contractor’s Company name and address and phone number; unit make, model and serial number; applicable certification standard certification date, recertification date, report number, average face velocity, sash height, and certification technician’s signature/printed name, pass/fail status.

· Capture hoods in P&LM Histology and downdraft autopsy table in P&LM Autopsy Suite – Contractor’s Company name, address and phone number; unit make, model and serial number, report number, location (room number), applicable certification standard, certification date, recertification date, and certification technician’s signature/printed name, pass/fail status Any unit that does not pass required certification specifications will be marked as such with clear signage that states this unit is out of service until further notice. Notify the COR and the supervisor of the service immediately if any units fail the certification, so a contingency plan can be initiated and a repair can be scheduled.

USP 797 and USP 800 TESTING FOR PHARMACY CLEAN ROOMS Primary Engineering Controls (PECs) - All primary engineering controls (PECs) including Class II BSCs, LAFWs, CAls and CACls shall be tested to NSF 49/ANSI (BSCs), CETA CAG-002-2006 (isolators) specifications and/or manufacturer specifications to include any additional USP 797 or 800 nonviable particle testing.

Room Supply HEPA Filter Leak Test - The contractor shall perform an in-line HEPA filter leak test of each terminal supply diffuser using USP 797 methodology.

Air Changes per Hour (ACH) - The contractor shall measure the volumetric supply and exhaust for each room using a properly calibrated balometer hood, and then using the total room volume for each room, calculate the room air exchange rate. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. In the event that a room does not meet USP 797 or USP 800 requirements for ACPH, the contractor shall immediately notify the COR and the pharmacy point of contact.

Pressure Requirements - The contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP 797 and USP 800. The contractor shall report all pressures to an accuracy of 0.0001.

Nonviable Particle Testing - The contractor shall perform environmental-nonviable particle testing semiannually (e.g. every 6 months) and whenever the units are serviced. The contractor shall' derive the minimum number of sampling locations using Annex A in the ISO/DIS 14644 1.2 standard. Testing shall be performed by qualified operators using current, electronic equipment with results of the following:

· ISO Class 5: not more than-3520 particles 0.5 µm and larger size per cubic meter of air for---any LAFVV, BSC, CAI and CACI.

· ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per 'cubic meter of air for any buffer area

· ISO-class--8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any ante area.

Report Requirements - All of the following information should be included in the report for clean room certification. Pass/Fail notifications should be included on a per test basis where applicable.

Room number and/or location

· Room type (e.g. oncology prep room)

· Date of testing

· Date of next required certification

· Standards used to test room

· Notes

· Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

· - Total room area and volume

· Room humidity and temp

· Air changes per hour

· Pressure differential

· Nonviable particle counts

· Viable particle count analysis and interpretation

· Picture of viable particle test locations in room

OTHER REPORTING REQUIREMENTS:

The Contractor shall contact the COR to schedule work, prior to beginning work and at the conclusion of all work. For services performed during normal working hours, the contractor's technician is to report to the COR to report/sign-in and obtain an identification badge, which shall be worn at all times while the technician is on station.

After work is completed, the contractor's technician(s) are to submit in writing, a complete report of services performed for each item of equipment and must include a listing of replacement parts, when applicable. Contractor shall also contact Safety Office and the service’s supervisor or person in charge upon completion of work to verbally report the status of the unit and any deficiencies identified. The COR, or designee, must sign the service report before the technician(s) leave the facility. Failure to follow these procedures may result in delay of payment or nonpayment.

The service report from the contractor must contain, at a minimum, the following information:

1. Date and time of the contractor's arrival on station

2. Service report of actions performed

3. Technician(s) name

4. Class II BSCs, CAIs, CACIs, ducted and ductless fume hoods and specialty local exhaust ventilation devices (e.g., P&LM Histology custom capture hoods, Morgue downdraft autopsy table) reports shall include the following as applicable to type of hood certification:

a. List of equipment used; to include manufacturer make, model, serial number, and date calibrated.

b. Velocity profile and average

c. Direct inflow CFM profile and average

d. HEPA filter leak test

e. Smoke Intrusion test

f. Sash alarm system test

g. Pressure gage reading

h. Light intensity

i. Sound Level

j. Ground polarity

5. Clean Room Test Reports for IV Room, Clean Room, and Ante Room shall include:

a. List of equipment used to include manufacturer make, model, serial number, and date calibrated.

b. Particle Counts

c. Room Air Changes per Hour

d. Room pressurization test

e. Temperature

f. Humidity

g. Differential pressure between all rooms A formal certificate and report for each unit serviced must be submitted to the COR within three (3) business days of the date of service. Courtesy copies of certificate and written reports, for units within the pharmacies, shall be issued to the Pharmacy Service within three (3) business days. :

Larger formal reports as required for the pharmacy clean rooms, CAIs, CACIs, etc. that include viable sampling shall be submitted to the COR within ten (10) business days following the receipt of the viable sampling. Results of viable samples shall be submitted to the COR within one (1) business day of the receipt of the results from the laboratory.

EXCLUDED SERVICES: The contractor shall not be obligated to provide services under this agreement for damage to or destruction of instrument(s) covered where such damage or destruction is:

a. A result of or caused by fire or explosion of any origin, riot, civil commotion, aircraft, war, or any Act of God or other force majure including but not limited to lightning, windstorm, hail, flood, earthquake, or

b. Caused by the VAMC misuse or abuse of such instrument

c. Decontamination due to spillage by VA personnel due to their own negligence

d. Installation of unauthorized field modifications.

4. PERFORMANCE REQUIREMENT SUMMARY:

The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

1:2015, USP 797,

USP 800,

NSF 49,

OSHA,

EPA

perform all Class II BSC, ducted and ductless fume hoods, Pharmacy CAI and CACI inspections, testing, repair, and certifications.

5. SECURITY:

The contractor shall be liable for security of all areas accessed by the service technician(s). All doors, passageways, windows and accesses to equipment and service areas, must be locked and/or secured after passage. In no instance will any door, window or access be rendered unlocked, propped open, mechanism taped open or rendered to prevent securing. The contractor shall be responsible to physically ensure such accesses are secured to prevent unauthorized entry.

Contractor Personnel Badges and Parking:

An access badge will be given to the contractor's employee upon entrance into the VA Connecticut Healthcare System's (VA) buildings. The contractor employee must safeguard the access badge and immediately report any lost, stolen, or destroyed badges to the facility Point of Contact (POC). All contract personnel must properly display their access badges. Access badges must be worn at or above the waist (facing forward). The contractor's employees must return the access badge(s) to the facility POC or designee at the end of each pickup process.

It is the responsibility of the contractor's personnel to park in the appropriate designated parking· areas. Parking information shall be coordinated with each facility POC.

The VA does not validate or make reimbursement for parking violations of the contractor's personnel under and circumstance.

Interference to Normal Function:

Contractor may be required to interrupt their work at any time so as not to interfere with the normal functioning of the facility, including utility services, fire protection (detection and suppression) systems, passage of facility patients, personnel, equipment and carts and patient care activities (e.g. preparing sterile compounds).

In the event of an emergency, contractor services may be stopped by the VA and rescheduled at no additional cost to the government.

Contractor personnel shall inform the facility POC or the designee of the need to gain access to secured areas. If access is required to secure areas, prearranged scheduling will be made with the facility POC or designee.

B.5 PRICE/COST SCHEDULE

ITEM INFORMATION

Contract Period: Base POP Begin: 06-01-2018 POP End: 05-31-2019

Contract Period: Option 1 POP Begin: 06-01-2019 POP End: 05-31-2020

Contract Period: Option 2 POP Begin: 06-01-2020 POP End: 05-31-2021

Contract Period: Option 3 POP Begin: 06-01-2021 POP End: 05-31-2022

Contract Period: Option 4 POP Begin: 06-01-2022 POP End: 05-31-2023

GRAND TOTAL

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN 2017)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments

(9) The specification.

(t) System for Award Management (SAM).

(1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(2)(i) If a Contractor has legally changed its business name, "doing business as" name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in FAR subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day's written notification of its intention to (A) change the name in the SAM database; (B) comply with the requirements of subpart 42.12; and (C) agree in writing to the timeline and procedures specified by the responsible Contracting Officer. The Contractor must provide with the notification sufficient documentation to support the legally changed name.

(ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the SAM information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the "Suspension of Payment" paragraph of the electronic funds transfer (EFT) clause of this contract.

(3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the SAM record to reflect an assignee for the purpose of assignment of claims (see Subpart 32.8, Assignment of Claims). Assignees shall be separately registered in the SAM database. Information provided to the Contractor's SAM record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be considered to be incorrect information within the meaning of the "Suspension of payment" paragraph of the EFT clause of this…