36C25519Q0519-002.docx

36C25519Q0519

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 SI

GN 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. SIGN

ATURE 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

36C25519Q0519 07- -2019 Juszczak, Janie | Janie.Juszczak@va.gov 913-946-1965 08-02-2019 12:00 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048 X X 621511 $32.5 Million X N/A X Department of Veteran Affairs Network Contracting Office (NCO) 15 3450 S. 4th Street Trafficway Leavenworth KS 66048 36C255 Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

36C255 Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin TX 877-353-9791 512-460-5429 This request for quote is to provide pharmacy hood certification and training of all VA Heartland Health Care Network (VISN 15) facility s primary engineering controls and sterile clean rooms in accordance with the Statement of Work and Schedule of Services and Price.

The governm ent intends to award a firm fixed price contract as a result of this solicitation for one (1) base year and up to four 4) one-year options that may be exercised at the contracting officer's discretion.

This solicitation is a 100% Small Business Set-Aside.

All questions will be sent via e-mail to daniel.thomas va.gov are due July 26, 2019 at 12:00 p.m. CST See price schedule and statement of work for more detail.

The Government reserves the right to issue multiple awards from this solicitation. The Government reserves the right to add additional sites as needed due to growth of VA.

X X X 1(one) Janie Juszczak Contracting Officer 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 36C255 Janie Juszczak Department of Veterans Affairs Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth, KS 66048

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.

Department of Veterans Affairs Financial Services Center http://www.fsc.va.gov/einvoice.asp Austin, TX

B.2 STATEMENT OF WORK

PART I – GENERAL INFORMATION

a. Introduction: This requirement is for testing and certification of all the VA Heartland Health Care Network (VISN 15) facility’s primary engineering controls (PECs) and sterile clean rooms used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, compounding aseptic containment isolators (CACI), compounding aseptic isolators (CAI) and Isolators. Testing and certification will be completed in accordance with United States Pharmacopeia (USP) Chapter <797>, or current guidelines. This requirement also includes personnel training, evaluation and requalification to compound CSPs in accordance with USP <797> or current guidelines.

b. Background: VISN 15 is pursuing VISN-wide contract for standardizing testing criteria appropriate for all PECs used pursuant to current USP Chapter <797> and Chapter <800> standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006. Although USP <797> states that certification procedures “such as” those outlined CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other “such as” procedures that may exist. Depending on the period of performance and option year(s), testing procedures shall be maintained in compliance with all current applicable USP standards.

The USP establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the Draft Guidance on “Insanitary Conditions at Compounding Facilities” which was published in August 2016.

VISN 15 facilities are in the midst of upgrades of existing compounding spaces and new construction of compounding spaces to continuously meet USP 797 and 800 standards. As such, VISN 15 requires vendor to adjust quantity of services to meet the changing needs of the facilities, as upgrades and construction are completed. Adjustments are included in the IGCE to reflect planned work and changing needs in the contract year they are expected.

Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

VISN 15 is also pursuing contracting for qualifying and requalifying personnel who perform sterile compounding to include initial training and qualification of personnel, recertification of personnel, observing hand hygiene and garbing procedures, conducting gloved fingertip and thumb sampling, and media fill testing of personnel at frequencies outlined in current USP <797> (and USP 800 after December 1, 2019). Draft revisions to USP 797 will increase frequency of personnel testing from once yearly to twice yearly if approved, and vendor needs to be able to meet that increased demand for services if those changes are approved.

PART II: SPECIAL WORK REQUIREMENTS

a. PEC Testing and Certification: The contractor shall test and certify each PEC according to USP <797> (and <800> after December 1, 2019) using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006 and CAG-002-2006). All PECs must:

1. be certified to meet ISO Class 5 or better

2. maintain unidirectional airflow

3. be supplied by HEPA filtered air

The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to:

1. Viable and non-viable particle counts

2. Airflow testing

3. HEPA filter leak test

4. Induction leak/back-streaming test

5. Cabinet leak test

6. In-flow velocity test to include exhaust airflow volume rate

7. Surface sampling

Airflow Smoke pattern test under dynamic operating conditions (contractor will provide video documentation of each test to facility POCs).

b. Laminar Flow Hoods (Laminar Airflow Workbench (LAWF), Integrated Vertical Laminar Flow Zone (IVLFW), and Class II Biological Safety Cabinet (BSC)) must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer’s specifications. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices and Induction Leak/Back-streaming Test and IEST-RP-CC034 HEPA Filter Leak Test.

Certifications for Class II Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow) Biosafety Cabinetry. The contractor shall use a National Institute of Standards and Technology (NIST) traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the POCs upon request.

The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test. Any failures shall be reported directly to the identified site point of contact(s) (POC see A.3.2.6) as soon as practicable. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified POC as soon as practicable.

c. Restricted access barrier system (Compounding Aseptic Isolator (CAI), Compounding Aseptic Containment Isolator (CACI), and Isolators (i.e. PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer’s specifications. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable.

d. Hazardous Compounding PECs Hazardous compounding PEC certification is required for:

1. Negative Pressure Hoods

2. Isolators

3. PECs where robotic enclosure is used inside of the PEC

The contractor shall test and certify each hazardous PEC to the manufacturer’s specifications. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the hazardous PEC has an air flow monitor or controller, the contractor shall confirm the unit is calibrated and operating within +/-10% of actual velocity. If it is not calibrated appropriately the contractor shall calibrate the AFM or AFC. The contractor shall use a NIST traceable or comparable calibrated piece of equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, a pass/fail grade for the airflow smoke pattern test and a pass/fail grade for the low flow alarm test. Any failures shall be reported directly to the COR(s) as soon as practicable.

For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

1. Company name, address and phone number

2. Unit make, model and serial number

3. Report number reflecting the room certification

4. Location (room number)

5. Certification date

6. Recertification date

7. Sash height (only for fume hoods)

8. Technician signature

e. All CSP Facilities must be tested and certified in accordance to ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-03-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing and certification services with frequency required by most current USP <797> standards (and USP <800> after December 1, 2019). Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following:

1. Non-Viable Particle Counting under dynamic operating conditions

2. Viable / Microbial Air Testing

3. Viable / Microbial Surface Testing

4. Airflow Volume Measurements

5. Air Velocity Profile

6. Room Air Exchange Rates

7. Room Pressure Measurement

8. In-Place Leak Testing of HEPA Filters

9. Temperature, Relative Humidity Measurements

10. Lighting Measurement

11. Sound Level Measurement

12. Smoke test

13. Electrical leakage and ground circuit resistance and polarity tests

14. Pass-through chamber air quality

f. Viable and Non-viable Particle Counts For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797> (and <800> after December 1, 2019).

g. Air Changes per Hour The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. 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> after December 1, 2019) requirements for ACPH the identified site POC(s) shall be informed immediately.

h. Pressure Requirements The contractor shall include in their report differential pressure readings 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> (or USP <800> when applicable). The contractor shall report all pressures to an accuracy of 0.0001” water column (4 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

i. Viable Environmental Sampling

1. The contractor shall perform viable environmental (air) sampling every 3 months for fungi and bacteria using high volume impaction samplers to conduct the sampling.

2. In addition, quarterly viable environmental surface sampling of classified areas will be performed. When conducted, surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

3. The interior of the PEC and the equipment contained in it

4. Staging or work area(s) near the PEC

5. Frequently touched surfaces

6. Pass-through chamber(s)

7. Air sampling: A sufficient volume of air (1000 liters) shall be tested at each location in order to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.

8. Surface Sampling: The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) or Sab DEX contact plates for sampling of fungi. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

j. Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semi-annually (e.g. every 6 months), or more frequently as needed to verify containment, for those facilities who opt in to this testing. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs.

The drugs required for testing include:

1. Cyclophosphamide

2. Ifosfamide

3. Methotrexate

4. Fluorouracil

5. Platinum-containing drugs

6. Additional Drugs

i. Additional drugs may be requested based upon identified need per site.

ii. Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.

A total of 6 surface samples will be completed per certification. Surface sampling will include the following areas:

1. Interior of PEC and equipment contained in it.

2. Pass-through chambers

3. Surfaces in staging or work areas near PEC

4. Areas adjacent to PECs (e.g. floors directly under C-PEC, staging, and dispensing area)

5. Areas immediately outside the hazardous drug buffer room or C-SCA

6. Patient administration areas

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

1. ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW).

2. ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.

3. ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room.

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.

Reports to include at a minimum:

1. Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown.

2. The identification of highly pathogenic microorganisms will be highlighted in the report.

3. Action level for ISO area tested

4. Executive summary or summary of findings.

5. Room number and/or location

6. Room type (e.g. oncology prep room)

7. Type of PEC certified

8. Serial number of the PEC certified

9. Date and time samples collected and particle counts tested

10. Technician collecting the samples

11. Date of next required certification

12. Standards used to test room

13. Comments indicating when dynamic operating conditions were used

14. Notes

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

16. Sketch identifying location of each sample obtained

17. Total room area and volume

18. Room humidity and temp

19. Room air changes per hour

20. Pressure differentials

21. Nonviable particle counts (cfu’s), action level for target ISO level

22. Viable particle count analysis

23. Sketch of viable particle test location in room

24. Viable sample results (cfu’s), action level

25. Certificates of analysis of media used

26. Comments indicating when dynamic operating conditions were used

l. Report Distribution The contractor will immediately notify identified points of contact with any results indicating failure. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 14 days from certification evaluation.

All completed reports will be provided via email to TBD. In addition, facility specific reports will be provided to the following points of contact:

Contractor will be notified by facility of any updates to identified points of contact list on an as needed basis.

m. Testing Frequency:

1. Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

2. Environmental sampling (air and surface) will be completed quarterly (every 3 months), or more frequently if required to assess corrective actions associated with prior negative results. More frequent testing may be required should USP standards change during the performance period or option year(s).

3. Room HEPA filter testing will be completed at least once yearly, or more frequently, if required, to assess corrective actions associated with prior positive results. More frequent testing may be required should USP standards change during the performance period or option year(s).

4. Environmental wipe sampling for hazardous drug residue will be performed every 6 months, or more frequently if required to verify containment for those facilities who opt to perform this testing as part of their hazardous drug sterile compounding quality assurance activities.

n. Personnel Training Contractor will provide a written training program that describes the required training, frequency of training, and process for evaluation of personnel. Training plan shall include:

1. Hand hygiene

2. Garbing

3. Cleaning and disinfection

4. Calculations, measuring, and mixing

5. Aseptic technique

6. Achieving and/or maintain sterility and apyrogenicity

7. Use of equipment involved in compounding

8. Documentation of the compounding process

9. Principles of high-efficiency particulate air (HEPA)-filtered unidirectional airflow within the ISO Class 5 area

10. Use of primary engineering controls (for both non-hazardous and hazardous compounding)

11. Principles of movement of materials and personnel within the compounding area

It is strongly preferred that vendor provides option for obtaining Accreditation Council for Pharmacy Education (ACPE) continuing education (CE) credits for pharmacists and pharmacy technicians completing yearly competency training.

o. Personnel Competency Assessment Contractor shall provide a written description of training and assessment procedures, consistent with USP <797> (and USP <800> after December 1, 2019), to include general competency training, written testing, hand hygiene and garbing observations, gloved fingertip and thumb sampling, and media fill testing.

1. Contractor shall administer a written test covering the required training elements outlined in A.3.5.7, with a pre-established threshold for pass/fail test scores. Competency testing will coincide with frequency outlined in current USP <797> standards (and USP <800> after December 1, 2019).

2. Contractor shall visually observe compounding personnel while performing hand hygiene and garbing procedures initially, with frequency outlined in current USP <797> standards (and USP <800> after December 1, 2019) for each successfully trained employee.

3. Contractor shall obtain gloved fingertip and thumb samples three separate times after performing a separate and complete hand hygiene and full garbing procedure initially for new personnel.

4. Contractor shall obtain gloved fingertip and thumb sampling after completing the media-fill test, for those personnel who successfully completed initial competency evaluations with frequency outlined in current USP <797> standards (and USP <800> after December 1, 2019).

5. Contractor shall obtain media fill test with frequency outlined in current USP <797> standards (and USP <800> after December 1, 2019) for those personnel who successfully completed initial competency and evaluations.

6. Contractor shall incubate gloved fingertip and thumb samples and media fill tests in controlled temperature environments in accordance with USP <797> guidance (and <800> after December 1, 2019), and report results and action levels to the facility POC as soon as results are available.

7. The contractor will designate at least 2 separate days for each facility to re-qualify successfully trained personnel, to maintain current re-qualification of all staff. If gloved fingertip and thumb samples and/or media fill tests are failed by an employee, contractor will provide re-testing of those employees within 30 days of the date the failed test was performed. Facility will contact contractor upon learning of need for new employee training and contractor will perform training of new employees within a mutually agreed upon time frame.

8. Training and competency assessment frequency will be adjusted, as needed, in compliance with USP standards.

p. Reporting Requirements: Each employee’s written test will be provided to the facility point of contact for competency documentation. A summary of each employee’s training and qualification assessment shall be included in a report to document personnel training.

1. Employee name

2. Date of testing

3. Testing procedures for hazardous and/or non-hazardous compounding

4. Date of next required qualification assessment(s)

5. Written test results noting score and PASS/FAIL result

6. Observed hand hygiene and garbing procedures with PASS/FAIL result

7. Gloved fingertip and thumb samples results including action levels, cfu per hand, and PASS/FAIL result

8. Media fill testing results with PASS/FAIL result

It is also preferred that contractor provide a sterile compounding subject matter expertise development program that provides advanced, comprehensive training on all aspects of USP designed for those who would oversee and maintain responsibility for ongoing compliance of sterile compounding programs. This training would be made available to both facility and VISN pharmacy staff designated to oversee and maintain sterile compounding programs.

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q. Required Services Per Facility:

Summary of quantities needed by Facility

Changes to facility PEC will be communicated in a timely manner to contractor and facility costs will be adjusted accordingly based on these changes. Contractor to provide unit based costs for services to allow for adjustments in equipment.

PART III: SPECIAL CONSIDERATIONS

a. Contractor Furnished Materials:

1. All materials and tools to complete the work identified.

2. Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing.

3. All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal microorganisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments.

b. Government Furnished Materials and Services:

1. The Government will provide all necessary personnel protective equipment (PPE) required for contractors on site.

2. The Government will provide oversight and verification of contractor personnel completion of donning of PPE and hand hygiene prior to testing/sampling.

3. The Government will, on rare occasion, provide office or meeting space to discuss test results, projects, or plans.

4. May also provide desk phone service as needed.

c. Qualifications/References: VISN 15 is seeking a qualified contractor that meets the following specifications:

1. Provide three references showing the completion of at least 3 jobs of similar size and scope at other hospital facilities with at least one of those facilities being a VA Medical Center. Reference information is to include: Hospital/Medical Center name, POC name, email address and phone number.

2. All certifications must be signed by an NSF 49 certified technician. A copy of NSF 49 certifications must be attached to the bid documentation for any technicians that will be performing work at the facility.

3. All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. A copy of the certification must be attached to the bid documentation for the supervisor or project manager of the team that will be performing work at the facility.

4. Provide AIHA accredited laboratory certification for all USP<797> viable sampling analysis. Certification must be attached with bid documentation.

5. Provide copy of clean room certification report for evaluation.

6. If required, contractor (employees performing services at the facility) will attain VA clearance (i.e. attend VA training, identification card, etc.)

d. Security Requirements: There are no security requirements required for this work, as samples are retrieved by the vendor and a test report is received in return.

e. Additional Considerations The contractor (or Representative) shall contact the facility identified COR(s) to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of facility identified POC(s) to ensure services are incorporated into current facility certification cycles.

Local facility COR(s) will provide the contractor with additional facility specific procedures which include: check in and check out procedures; contractor badging requirements; parking procedures; and any additional facility specific procedures. The contractor will be expected to adhere to those procedures. If a contractor is willing to perform services after 4:00pm (CST) this service must be included within the bid pricing as no extra charge. The ability to perform work after hours is not required; however, preferences will be given to contractors that offer flexible work hours.

f. Invoicing Payment will be made monthly in arrears, invoices will be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungstennetwork.com/us/en/. A properly prepared invoice shall contain:

1. Invoice Number and Date

2. Contractor’s Name and Address

3. Accurate Purchase Order Number

4. Supply or Service provided

5. Period Supply or Service Provided

6. Total Amount Due (Continue to next page)

PART III: GENERAL ADMINISTRATION

a. Contract Officer Representative (COR)

(1) Various TBD@va.gov to coordinate this service. The contractor will contact the COR to schedule the work to be completed; upon arrival, the contractor will contact the COR. The COR will escort the contractor to the appropriate area and monitor the work being done. Upon completion of the work, the COR will escort the contractor out of the area.

b. Place of Performance

c. Period of Performance

(1) See Block 3 of SF1449 plus 4 option years.

d. Contract Administration Data

(1) All contract administration functions will be retained by the Department of Veterans Affairs. The Contracting Officer will be the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer will be authorized to make commitments or issue changes that affect price, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

e. Non-Personal Services

(1) This is a non-personal services contract. Personnel rendering services under this contract are not subject either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the government and its employees. The Government shall not exercise any supervision or control over the contract service providers performing services herein. Such contract service providers shall be accountable solely to the Contractor who, in turn, is responsible to the Government.

f. Hours of Operations

(1) Business hours: Monday through Friday, 8:00 a.m. - 4:30 p.m.

(2) Off-duty hours: Friday through Monday, 4:30 pm—8:00am; Monday through Thursday, 4:30 pm—8:00am.

(3) National Holidays: The 10 holidays observed by the Federal Government are:

New Year’s Day;

Martin Luther King’s Birthday;

Presidents Day;

Memorial Day;

Independence Day;

Labor Day;

Columbus Day;

Veterans Day;

Thanksgiving;

Christmas; and any other day specifically declared by the President of the United States to be a national holiday.

g. Quality Control

(1) CONTRACT PERFORMANCE MONITORING. The COR(s)s may perform surveillance of services by any of the methods listed below:

a) Observing actual performance;

b) Inspecting the services to determine whether the performance meets the performance standards; and

c) Review of any other appropriate records.

d) When unacceptable performance occurs, the POC shall inform the Contractor and the Contracting Officer. This will normally be in writing unless circumstances necessitate verbal communication. In any case the POC shall document the discussion and place it in the POC file. When the POC determines that formal written communication is required, the POC shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor program manager. The Contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the Contractor is required to prepare a corrective action plan to document how the Contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the Contractor must present this corrective action plan to the POC. The Government shall review the Contractor corrective action plan to determine acceptability. Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the Contracting Officer.

e) Pursuant to VAAR Provision 852.270-1, Representatives of Contracting Officer representative(s); The Government shall periodically evaluate the Contractor performance by appointing a POC to monitor performance to ensure services are received. The Government representative(s) shall evaluate the Contractor performance through inspections of observations, inspection of services or any other form of documentation and all complaints from VA personnel. The Government may inspect as each task is completed or increase the number of quality assurance inspections if deemed appropriate because of repeated failures or because of repeated customer complaints. Likewise, the Government may decrease the number of quality assurance inspections if performance dictates. The Government Contracting Officer shall make final determination of the validity of customer complaint(s).

f) If any of the services do not conform to contract requirements, the Government may require the Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by re-performance, the Government may require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

g) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements at no additional cost to the Government.

h. Contract Security

The C&A requirements do not apply and a Security Accreditation Package is not required. Also, no BAA required.

36C25519Q0519

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SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)

(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…