36C26320Q0242-005.docx

36C26320Q0242

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

437-20-2-6058-0278 36C26320Q0242 02-05-2020 David A. Raad 605-720-6851 02-19-2020

11:59 PM MST

36C568 Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 113 Comanche Rd.

Fort Meade

SD

57741 David A. Raad david.raad@va.gov X X Y 621511 $35 Million N/A X 36C437 Department of Veterans Affairs

FARGO VAMC

2101 N Elm Street Fargo

ND

58102 36C568 Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 113 Comanche Rd.

Fort Meade

SD

57741

Department of Veterans Affairs

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin

TX

78714-9971 X See CONTINUATION Page This solicitation is to provide service to VAMC Fargo See attached Statement Of Work (SOW), Fume Hood Service and Certification, base year plus 4 option years Period of Performance: 03/01/2020 - 02/28/2021 Submit any written questions via email by February 12, 2020 **No telephonic questions will be accepted.** Responses to questions will be posted as an amendment to the solicitation.

Note block 30 - this document must be signed and returned to the Contracting Officer by the Offer Due Date in order to be considered. Email ALL required and completed documents to: David Raad at david.raad@va.gov Solicitation will close at 11:59 PM MST on February 19, 2020 See CONTINUATION Page 437-3600162-6058-855100 Operating Equipment M\T\R 2542 Operating Services-010050192 437-20-2-6058-0278 X X X Pamela P. Phillips 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 36C263 Pamela P. Phillips Department of Veterans Affairs Network 23 Contracting Office (NCO 23)

113 Comanche Rd.

Fort Meade SD 57741

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

FMS-VA-2(101)

Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

Pharmacy Compounded Sterile and Non- Sterile USP Compliance Program Contract Period: Base POP Begin: 03-01-2020 POP End: 02-28-2021

OPTION YEAR. Pharmacy Compounded Sterile and Non- Sterile USP Compliance Program Contract Period: Option 1 POP Begin: 03-01-2021 POP End: 02-28-2022

OPTION YEAR. Pharmacy Compounded Sterile and Non- Sterile USP Compliance Program Contract Period: Option 2 POP Begin: 03-01-2022 POP End: 02-28-2023

OPTION YEAR. Pharmacy Compounded Sterile and Non- Sterile USP Compliance Program Contract Period: Option 3 POP Begin: 03-01-2023 POP End: 02-29-2024

OPTION YEAR. Pharmacy Compounded Sterile and Non- Sterile USP Compliance Program Contract Period: Option 4 POP Begin: 03-01-2024 POP End: 02-28-2025

Page 1 of Page 1 of Pharmacy’s Compounded Sterile and Non-Sterile Preparations USP Compliance Program Statement of Work

1. SCOPE:

The contractor shall provide all labor, equipment, materials (including replacement parts), supplies, tools, transportation, and travel necessary to perform all inspections, testing, certifications/recertifications, preventative maintenance and repair or replacement of High-Efficiency Particulate Air (HEPA) and other filters, as required throughout the contract period at Fargo Veterans Affairs Healthcare System (VAHCS) upon request.

The contractor shall perform routine work detailed in this performance of work statement (PWS) on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer Representavie (COR).

If additional testing/certification, troubleshooting, adjustment or repair is required, the contractor shall provide for additional services/certifications of the engineering controls to ensure continuation of pharmacy operations in full compliance with USP 795, USP 797, USP 800, and any and all applicable CETA Application Guides. These additional site visits will only be utilized at the request of the COR. The additional site visit(s) line item shall include all costs associated with travel, per diem, lodging, mileage, movement/shipping of equipment, overnight pay or any other costs the contractor may incur in visiting the facility outside of the normal semiannual visits. The cost must cover a site visit which may exceed a single work day (depending on the additional work required).The contractor shall perform unscheduled work or emergency requests within five (5) days of a request from the COR.

Fargo VAHCS uses a variety of engineering controls to limit employee exposures to hazardous contaminants while also providing a safe and effecitive preparation for patients. Fargo VAHCS’ Pharmacy Service has both secondary engineering controls (SECs) and containment secondary engineering controls (C-SECs) which make up the USP 797 and USP 800 compliant cleanroom suite. The cleanroom suite contains a variety of primary engineering controls (PECs) and contaiment primary engineering controls (C-PECs). The PECs include laminar airflow work-benches (LAFW) or compounding aseptic isolators (CAIs) for all non-hazardous sterile compounding and the C-PECs include externally vented Class II biological safety cabinets (BSCs), an externally vented compounding aseptic containment isolator (CACI) for hazardous sterile compounding, and a containment ventilated enclosure (CVE) for hazardous non-sterile compounding.

The number of cleanrooms, segregated compoudning areas (SCAs), LAFWs, CAIs, CACIs, CVEs, and BSCs in service may change throughout the contract period. Table A is the Government's best estimate of the number and type expected to be tested, sampled, serviced, and certified 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 without 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. PLACE OF PERFORMANCE:

A. Fargo VA Medical Center 2101 North Elm Street Fargo, ND 58102

3. CONTRACTOR QUALIFICATIONS:

A. Contractor must have a CETA National Board of Testing (CNBT) accredited Registered Cleanroom Certification Professional for Sterile Compounding Facilities with 3 or more years of experience. All cleanroom performance testing must be supervised or performed by an individual with the aforementioned accreditations. Furthermore, all technicians performing the work must be qualified by education and experience. VHA Directive 1108.12 requires that all vendors that conduct certifications/assessments of primary and secondary engineering controls be registered with CETA. Verification of experience may be requested by Fargo VAHCS. This requirement may be fulfilled by providing two pharmacy cleanroom references directly to the CO.

B. Copies of pertinent certifications and/or licenses will also be required.

4. GENERAL REQUIREMENTS:

The contractor shall perform all required facility related testing and sampling according to the most current versions of CAG-003-2006, CAG-002-2006, and/or their replacement application guides to determine whether the facility’s cleanroom suite, C-SCA, LAFWs, CAIs, CACIs, and/or BSCs used for sterile compounding can be certified for use under current USP 797 and USP 800 standards. Similarly, the contractor shall perform all required facility related testing and sampling to determine if the C-SEC and CVE utilized for non-sterile HD compounding can be certified for use under current USP 795 and USP 800 standards. CETA CAGs are the mandatory standard and no “equivalent” standards may be used for certification purposes.

A. Depending on CETA and manufacturer guidance for the type of PEC, facility related testing for PEC and C-PEC certification will include, but is not limited to the following:

1) Airflow Velocity Tests (main chamber AND pass-through chamber for CAIs and CACIs)

2) HEPA Filter Integrity Test

3) Induction Leak/Backstreaming Test

4) Cabinet Leak Test

5) Non-Viable Particle Count Tests

6) Viable Impact Volumetric Airborne Particulate Sampling (bacterial and fungal)

7) Viable Surface Sampling (bacterial and fungal)

8) Airflow Visualization Test (dynamic operating conditions)

9) Exhaust Alarm Test (for BSC and/or CACI certification only)

10) Chamber Pressure Testing (main chamber and pass-through chamber for CAIs and CACIs)

11) Preparation Ingress and Egress Test

12) Particle Containment Integrity and Enclosure Leak Test B. Facility related testing for cleanroom suite certification will include, but is not limited to the following:

1) Airflow Velocity Testing

2) Air Changes Per Hour (ACPH) Testing/Air Exchange Rate Testing

3) Pressure Differential Testing of Each Opening (reported in water columns)

4) Airflow Displacement (when applicable)

5) Airflow Visualization Tests

6) HEPA Filter Integrity Testing

7) Non-Viable Particle Count Tests under dynamic operating conditions

8) Viable Impact Volumetric Airborne Particulate Sampling (bacterial and fungal)

9) Viable Surface Sampling (bacterial and fungal)

C. Facility related testing for C-SEC where non-sterile HD compounding is performed will include, but is not limited to the following:

1) Air Changes Per Hour (ACPH) Testing/Air Exchange Rate Testing

2) Pressure Differential Testing of Each Opening

D. Facility related testing for CVE certification will include, but is not limited to the following:

1) Airflow Velocity Tests

2) HEPA Filter Integrity Tests

3) Particle Containment Integrity and Enclosure Leak Tests

5. PERFORMANCE REQUIREMENT DETAILS:

A. All compounding areas used to prepare either Category 1 or Category 2 CSPs must be certified using procedures outlined in the most current Controlled Environment Testing Association (CETA) certification guide for Sterile Compounding Facilities. Recertification of ALL classified areas must be performed no less than every 6 months.

B. Additionally, per USP 797 requirements recertification testing must be re-performed if there are changes to the classified area(s). Such changes include but are not limited to: redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality.

C. 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) 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.

D. Total airborne particle count testing must be performed in all classified areas. This testing must be conducted under dynamic operating conditions. When performing this testing in a PEC, personnel shall avoid disturbing the unidirectional airflow within the PEC. The contractor shall derive the minimum number of sampling locations in the C-SECs using Annex A in the ISO 14644-1.2 standard.

E. Environmental monitoring (microbiological air and surface monitoring) must be repeated whenever equipment within the room is relocated, after servicing of the facility or equipment within the cleanroom suite, in response to identified problems or trends, or after any other alteration is performed within the cleanroom suite that could be reasonably expected to affect the quality of air (ie. HVAC alterations, changing of HEPA filters, etc.)

F. Viable volumetric active air sampling utilizing an impaction device must be performed in all classified areas at least every 6 months. This sampling must be conducted under dynamic operating conditions. When performing this sampling in a PEC, personnel shall avoid disturbing the unidirectional airflow within the PEC.

1) A general microbiological growth media that supports growth of bacteria and fungi must be used. Certificates of analysis from the manufacturer verifying the media meets expected growth promotion, pH, and sterilization requirements must be provided.

2) The manufacturer’s instructions for operation of the impaction device must be followed.

3) A minimum of 1 cubic meter or 1000 liters of air from each location must be sampled.

4) Immediately retrieve and cover media devices following conclusion of sampling.

5) Media devices should be inverted to prevent condensate from dropping onto the agar and affecting the accuracy of the CFU reading.

6) Inverted media must be incubated by contractor at 30 to 35 degrees Celsius for no less than 48 hours prior to examining the media for growth. The total number of discrete colonies of microorganisms must be recorded.

7) This media must remain inverted and be further incubated by contractor at 20 to 25 degrees Celsius for no less than 5 additional days at which time the total number of discrete colonies of microorganisms must be recorded.

8) Alternatively, the preferred method for performing this sampling entails collecting two samples at each location and incubating the samples concurrently as the overall incubation period will be decreased allowing for more timely delivery of results.

a) Both samples may be trypticase soy agar (TSA) or one sample may be TSA and the other sample a fungal media such as malt extract agar (MEA) or sabouraud dextrose agar (SDA).

b) If using this method, contractor will incubate samples in separate calibrated incubators (ie. incubate one at 30 to 35 degrees Celsius for a minimum of 48 hours and the other sample at 20 to 25 degrees Celsius for a minimum of 5 days). If fungal media is used for one sample this is the sample that must be incubated for a minimum of 5 days.

9) Incubator temperature must be monitored by contractor during incubation. This can be accomplished by manually monitoring or via use of a continuous recording device. The results of monitoring must be documented.

10) Results must be reported by contractor as CFU per cubic meter of air and the document must note the sample type, sample location, and sample date.

11) If the results of viable air sampling exceed the action levels identified by USP 797, the contractor will at minimum identify the organism recovered to the genus level and when possible provide the species. This information along with all other certification/recertification documents will be provided to Fargo VAHCS.

G. Airflow visualization testing must be performed under dynamic operating conditions. This can be suitably accomplished by performing a smoke pattern test in each PEC demonstrating unidirectional airflow and sweeping action over and away from the preparation. Similarly, a smoke pattern test can be utilized to demonstrate proper airflow in a SEC following relocation of equipment located within a SEC. The testing must show that first air conditions are achieved at the critical site during all compounding tasks within the respective PEC. This may mean that the contractor provides movement of the smoke source and/or multiple camera angles to ensure that each compounding task is effectively shown to be completed within an area receiving first air. It is important that the contractor recognize that this testing is beyond the typical scope of an equipment certification as these videos are to capture both the effective operation of the PEC and also the effective compounding techniques of the pharmacy staff. The contractor should understand that coordination with the pharmacy staff and management is imperative in collecting useful PEC smoke visualization videos as intended by CAG-003-2006. Results of this testing must be documented on all certification/recertification reports.

H. In addition to the testing/sampling performed every 6 months as part of recertification testing, viable surface sampling of all classified areas and pass-through chambers connecting to classified areas must be performed at a minimum frequency of once per month. This testing will include sampling all five PECs, the work area near the PECs (estimated as at least one location in each buffer room), pass-through located between the negative pressure HD buffer room and negative pressure HD storage area, pass-through located between the inpatient pharmacy and the ante-room, and frequently touched surfaces (suggested for contractor to identify at least one area in each SEC).

1) Monthly surface sampling may be performed by pharmacy personnel. Sampling must be performed at the end of compounding activity, but prior to cleaning and disinfecting the area.

2) Surface sampling devices for sampling flat surfaces must have a raised convex surface and contain a general microbiological growth media. Certificates of analysis from the manufacturer verifying the media meets expected growth promotion, pH, and sterilization requirements must be provided. Contractor will be required to supply the surface sampling devices and the postage required for shipping samples from Fargo VAHCS to the contractor for incubaion and analysis.

3) The cover of the sampling device must be removed immediately prior to sampling. Using a rolling motion, the media surface must be firmly pressed against the surface being sampled. The media device shall be covered and inverted immediately following sampling.

4) Any residue left from the media device must be removed from the surface utilizing 70% IPA.

5) Inverted media must be incubated by contractor at 30 to 35 degrees Celsius for no less than 48 hours prior to examining the media for growth. The total number of discrete colonies of microorganisms must be recorded.

6) This media must remain inverted and be further incubated by contractor at 20 to 25 degrees Celsius for no less than 5 additional days at which time the total number of discrete colonies of microorganisms must be recorded.

7) Alternatively, the preferred method for performing this sampling entails collecting two samples at each location and incubating the samples concurrently as the overall incubation period will be decreased allowing for more timely delivery of results.

a) Both samples may be TSA or one sample may be TSA and the other sample a fungal media such as MEA or SDA.

b) Contractor will incubate samples in separate calibrated incubators (ie. incubate one at 30 to 35 degrees Celsius for a minimum of 48 hours and the other sample at 20 to 25 degrees Celsius for a minimum of 5 days). If fungal media is used for one sample this is the sample that must be incubated for a minimum of 5 days.

8) Incubator temperature must be monitored by contractor during incubation. This can be accomplished by manually monitoring or via use of a continuous recording device. The results of monitoring must be documented.

9) Results must be reported by contractor as CFU per sample and the document must note the sample type, sample location, and sample date.

10) If the results of viable surface sampling exceed the action levels identified by USP 797, the contractor will at minimum identify the organism recovered to the genus level and when possible provide the species. Contractor will provide this information to Fargo VAHCS.

I. Areas used strictly to prepare compounded non-sterile preparations (CNSPs) do not require unidirectional airflow or ISO Classification. However, when used to prepare hazardous CNSPs the C-PEC must be certified at the minimum frequency recommended by the manufacturer or every 12 months, whichever is more frequent. Furthermore, the C-SEC must be certified in that it maintains at least 12 ACPH and a negative pressure between 0.01 and 0.03 inches of water column relative to adjacent areas.

6. ADDITIONAL REQUIREMENTS:

A. Scheduling of work: The contractor must coordinate a schedule with the COR or designee to provide the services at the required intervals. Each sampling/testing session will be conducted during normal business hours, Monday through Friday from 08:00 to 16:30. Routine services must be scheduled with the COR or designee at least two (2) weeks in advance. This is to notify all personnel using the equipment/facilities well in advance to allow their workflow to be adjusted and enable the equipment and/or rooms to be available for certification procedures.

1) Two (2) LAFW certifications are required at a minimum of every 6 months, or whenever the device is relocated, major service to the equipment is performed, or another issue arises.

2) Two (2) BSC certifications are required at a minimum of every 6 months, or whenever the device is relocated, major service to the equipment is performed, or another issue arises.

3) One (1) CACI certification is required at a minimum of every 6 months, or whenever the device is relocated, major service to the equipment is performed, or another issue arises.

4) Three (3) ISO Classified room certifications are required at a minimum of every 6 months, or whenever the room is altered, major service to the facility is performed, or another issue arises.

5) One (1) CVE certification is required at a minimum frequency recommended by the manufacturer or every 12 months whichever is sooner, or whenever the device is relocated, major service to the equipment is performed, or another issue arises.

6) One (1) C-SCA for non-sterile HD compounding certification is required at a minimum of every 12 months, or whenever the room is altered, major service to the facility is performed, or another issue arises.

7) One (1) HEPA-filtered pass-through is required to be certified at a minimum of every 6 months, or whenever major service is performed or another issue arises.

8) Any certification failures and/or sampling results at or above action levels determined by USP 797 will result in mandatory re-testing/resampling following action deemed appropriate by the Chief of Pharmacy to remediate the likely cause. This re-testing/resampling shall occur no later than one week after results at or above an action level are reported.

9) Additional testing/sampling may also be required after any of the following:

a) Any patient incident in which the compounded material is suspect

b) Problems with CSP are discovered upon end-product evaluation

c) Significant changes in workflow or addition of new procedures or equipment

d) Observation of incorrect work practices such as gowning, technique, material flow, cleaning, etc.

e) Other changes that could be reasonably expected to impact the sterile compounding environment (ie. changes to cleaning agents utilized, etc.)

B. Certification Reports- The contractor shall provide to the COR or designee a certificate for each classified and unclassified area that has been certified prior to leaving the facility. Any classified or unclassified area that is not certifiable must be brought to the attention of the COR or designee by the contractor prior to leaving the facility. In addition, the engineering control in question will be marked as such with clear signage that the unit is out of service until further notice. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information: company name, address, and phone number, unit make, model, and serial number, location (room number), certification date, recertification date, and technician signature. Failure to follow these procedures may result in delay of payment or nonpayment. Each certification report from the contractor shall contain, at a minimum, the following information:

1) Contractor name, address and contact information also listing contract personnel with appropriate accreditations.

2) Confirming remark that the most current version of this CAG was referenced for this certification and the actual date the certification was completed.

3) Simple and clear method of identification of the approximate location of the collected data in relation to the physical layout of the equipment or facility tested, including specific and clear nomenclature for the data locations.

4) Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process.

5) Date and time testing/sampling was performed.

6) Date of next required certification.

7) Pressure differentials in water columns.

8) Nonviable particle counts and the most up-to-date corresponding action levels for the ISO classification.

9) Results of all leak/integrity tests performed.

10) Comparison of data recorded against expected values or specific equipment performance criteria established in Fargo VAHCS Pharmacy Service Standard Operating Procedures (SOP). In the absence of a current Fargo VAHCS Pharmacy Service SOP, the contractor’s SOP, current USP 797 and USP 800 standards, recommended practices, and manufacturer’s specifications will be used.

11) Safety data sheets (SDS) for all chemical products that will be used during certification procedures.

12) A list of equipment utilized in data collection to include make, model, serial number, and calibration date.

13) A copy of the current calibration documentation for each piece of equipment utilized in data collection, when applicable.

14) A written interpretation of the Airflow Visualization Test which is to be video recorded and transmitted to Fargo VAHCS in a mutually agreed upon manner

15) The ACPH from the HVAC system, ACPH contributed from the PEC, and the total ACPH.

16) The number of personnel present in each PEC and SEC during particle count tests and dynamic airflow smoke pattern tests.

17) Pass/Fail notifications, where applicable.

18) Listing of replacement parts provided, when applicable.

C. Sampling Reports: The contractor must contact the COR or designee upon completion of work to verbally report any sampling issues before the contractor leaves the facility. Larger formal reports that include viable sampling results must be submitted to the COR or designee within fifteen (15) business days following the collection of the viable air sampling and /or surface sampling. These formal reports may be delivered electronically via email if previously agreed upon by both parties. Results of viable air samples and/or surface sampling must be submitted to the COR within one (1) business day of the receipt of the results from a properly accredited laboratory. Furthermore, any laboratory results equal to or greater than the action levels described within USP 797 must be immediately relayed to the COR or designee. Laboratory analyzing viable samples shall be American Industrial Hygiene Association (AIHA) accredited for all USP 797 viable sampling. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Each sampling report from the contractor shall contain, at a minimum, the following information:

1) Contractor name, address and contact information also listing contract personnel with appropriate accreditations.

2) All viable sample results (CFUs)

3) If the result(s) of viable sampling exceed the action levels identified by USP 797, the contractor will at minimum identify the organism recovered to the genus level and when possible provide the species.

4) An SOP or protocol that describes the procedures used for sampling along with the volume, ISO classification, method of collection, frequency, activity level, action levels, response to exceeded concern levels, media types, laboratory analysis, incubation time and temperature.

5) A sampling map of the cleanroom suite and all PECs/C-PECs noting the locations and types of samples to be taken where applicable.

6) A closed chain of custody.

7) Growth and Sterility Control Reports (where applicable).

7. Excluded services: The contractor shall not be obligated to provide services under this contract for damage to or destruction of instrument(s) covered where such damage or destruction is a result of or caused by:

A. Fire or explosion of any origin, riot, civil commotion, aircraft, war

B. Act of God or other force of nature including but not limited to lightning, windstorm, hail, flood, earthquake

C. VAMC misuse or abuse of such instrument

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

E. Installation of unauthorized field modifications.

8. Schedule of Insurance: The contractor shall procure and maintain for the entire contract period, Workmen's Compensation and employer's general liability insurance. The contractor shall provide proof of insurance for the entire contract period with their technical proposal. The parties agree that such personnel shall not be considered a VA employee for any purpose and shall be considered employees of the contractor.

9. Operational Coverage: The contractor shall perform certification services during normal work hours of 8:00am to 4:30pm, Monday-Friday (excluding weekends and federal holidays). Exception: work may be performed outside of regular administrative working hours when deemed necessary. The contractor shall receive prior approval from the COR for irregular testing hours.

10. Price Schedule: The contract rate is an all-inclusive rate. No separate fees will be allowed.

11. Environment of Care: The contractor shall maintain a clean and safe environment at all times.

12. Contracting with Parties Listed on the OIG List of Excluded Individuals/Entities: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal payments due to fraud and/or abuse of the Medicare and Medicaid programs. The list of excluded individuals/entities can be found on the OIG web site at www.hhs.gov/oig. With submittal of proposal, the contractor shall provide evidence than none of the contractor’s employees are on the Excluded Parties list.

13. Invoices/Payments: This provision shall survive the termination or ending of the contract. Payment for services rendered by the contractor under the terms of this contract will be made upon receipt of a properly executed invoice. Invoice to be submitted within fourteen (14) workdays following completion of the contractors rendered services. VA will verify services performed and certify invoice for payment within thirty (30) days following date of receipt of sampling reports. Any identified discrepancy in billings shall be cause for extending provisions of this paragraph until the discrepancy or other identified problem with the billing invoice has been resolved. Invoices shall:

A. Be electronically prepared and submitted

B. Contain an invoice number and date

C. Contain the contractor’s name and address

D. Clearly state the terms of any discounts offered

E. Include the current fiscal year and purchase order number

F. Include the period of performance covered by the invoice

G. Accept payment for services rendered under this contract as payment in full. This provision shall survive the termination or ending of the contract.

14. Contract Performance Monitoring: The government reserves the right to monitor services in accordance with Performance Based Matrix.

15. Period of Performance: The contract term is for 12 months with four options of 12 months each beginning upon signature of the contract. Fargo VAHCS shall unilaterally renew or terminate the contract.

16. Information Security Officer, Information Protection: The contractor will not have access to VA desktop computers nor online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. Certification and accreditation requirements do not apply, and a Security Accreditation Package is not required as the contractor will not be provided access to a VA internal trusted network.

17. Privacy Officer: The contractor will not have access to Patient Health Information (PHI) nor have the capability of accessing patient information during the services provided to the VA. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

18. Records Management Obligations:

A. Applicability: This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions: “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. The term Federal record:

1) includes [Agency] records.

2) does not include personal materials.

3) applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4) may include deliverables and documentation associated with deliverables.

C. Requirements:

1) Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2) In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3) In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4) Fargo VAHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Fargo VAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Fargo VAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5) The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Fargo VAHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6) The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Fargo VAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7) The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Fargo VAHCS policy.

8) The Contractor shall not create or maintain any records containing any non-public Fargo VAHCS information that are not specifically tied to or authorized by the contract.

9) The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10) The Fargo VAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Fargo VAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

D. Flowdown of Requirements to Subcontractors:

1) The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2) Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

19. Security: The contractor shall be liable for security of all areas accessed by the 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. Contractor shall be responsible to physically ensure such accesses are secured to prevent unauthorized entry.

20. Contractor Personnel Badges and Parking: The contractor technician shall acquire an access badge upon entrance into Fargo VAHCS buildings. Contractor shall safeguard the access badge and report any lost, stolen, or destroyed badges to police services. Contractor shall ensure technicians properly display their access badges. Access badges shall be worn at or above the waist (facing forward). Access badges shall be returned to the COR, or designee at the end of each site visit. Contractor shall ensure technician parks in the appropriate designated parking areas. Parking information shall be coordinated with the COR. Contractor shall be aware that Fargo VAHCS does not validate or make reimbursement for parking violations of the contractor technician under any circumstance.

21. Interference to Normal Function: Contractor may be required to adjust 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 Fargo VAHCS and rescheduled at no additional cost to the government. Contractor personnel shall inform the COR 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 COR or designee.

22. APPENDIX:

Table A

Facility Location Cleanroom Type*

LAFW/ BSC/ CAI/ CACI/ CVE

Fargo VAHCS Inpatient Pharmacy Ante-room

N/A

N/A

Fargo VAHCS Inpatient Pharmacy Positive Pressure Non-Hazardous Buffer Room

LAFW

Mfg: Nuaire Model: NU-340-630 AireGard ES

LAFW

Model: NU-340-630 AireGard ES

Fargo VAHCS Inpatient Pharmacy Negative Pressure Hazardous Buffer Room

Class II, Type A2 BSC

Model: NU-543-600 LabGard ES

Class II, Type A2 BSC

Model: NU-543-600 LabGard ES

CACI

Model: NU-NTE797-400

Fargo VAHCS Inpatient Pharmacy Negative Pressure HD Non-Sterile C-SCA

CVE

Model: NU-813-300 LabGard

Diagram A

Laminar Airflow Workbenches

Compounding Aseptic Containment Isolator Diagram B

Biological Safety Cabinets

HEPA-filtered pass-through Diagram C

Containment Ventilated Enclosure

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…