36C26319Q0754-001.pdf

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 118

636-20-1-4208-0001

438-20-1-1115-0002

36C26319Q0754 09-12-2019

John Becker (john.becker3@va.gov) 605-336-3230 x7960 09-24-2019

10:00 AM CST

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Sioux Falls SD 57105

X 100

X

541380

$15 Million

N/A

X

Iowa City, Iowa VA Health Care System

Sioux Falls South Dakota VA Health Care

System

See Statement of Work for exact address

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Sioux Falls SD 57105

Tungsten Electronic Invoicing

VA Tungsten Number is: AAA544240062 va.registration@tungsten-network.com

Refer to VAAR Clause 852.232-72

See CONTINUATION Page

Biological Safety Cabinet, Laboratory, Clean Room, Primary

Engineering Controls, and Pharmacy Compounding Fume Hood, Cabinet, and Closet Inspection and Certification Services for the Department of Veterans Affairs, VA Health Care

System for the locations of Iowa City, Iowa and Sioux Falls, South Dakota. See Statement of Work and Price/Cost Schedule for specific requirements.

Period of Performance: 11/1/2019 to 10/31/2020 and includes four (4), one-year option periods.

This is a 100% SDVOSB set-aside; offerors shall be registered and verified as SDVOSB in the Department of

Veterans Affairs Vendor Information Pages (VIP) database at the time of submission of offer and prior to award.

Offerors shall have an active System for Award Management

(SAM) registration at the time of offer and prior to award.

Subcontracting limitations apply; see VAAR 852.219-10.

DOL Wage Determination 2015-5369 Revision 7 dated 12/26/2019 applies to all services performed under this requirement.

Evaluation of Offers: Price Alone

See CONTINUATION Page

636-3600160-4208-822300-2580-0400401X1 636-20-1-4208-0001

438-3600162-1115-850300-2660-0100501X3 438-20-1-1115-0002

X X

Kelly Nussbaum

NCO2316L3-4591

36C26319Q0754

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 STATEMENT OF WORK – IOWA CITY VA HEALTH CARE SYSTEM

B.3 STATEMENT OF WORK – SIOUX FALLS VA HEALTH CARE SYSTEM

B.4 PRICE/COST SCHEDULE

BASE YEAR ITEM INFORMATION

OPTION YEAR 1 ITEM INFORMATION

OPTION YEAR 2 ITEM INFORMATION

OPTION YEAR 3 ITEM INFORMATION

OPTION YEAR 4 ITEM INFORMATION

SECTION C - CONTRACT CLAUSES

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

2018)

C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...55

C.4 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED

SMALL BUSINESS SET-ASIDE (JUL 2019) (DEVIATION)

C.5 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.6 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.7 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.9 52.228-5 INSURANCE—WORK ON A GOVERNMENT INSTALLATION (JAN 1997)

C.10 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.11 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

C.12 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2018)

C.13 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (MAY 2019)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 WAGE DETERMINATION 2015-5369 REV 8 – MINNEHAHA COUNTY, SOUTH

DAKOTA

D.2 WAGE DETERMINATION 2015-4984 REV 9 – JOHNSON COUNTY, IOWA

D.3 IOWA CITY IA VAHCS EQUIPMENT LISTING

D.4 SIOUX FALLS SD VAHCS EQUIPMENT LISTING

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

E.7 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.8 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.9 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (OCT 2018)

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: BUSINESS NAME: ________________________________

DUNS: ________________________________

CONTACT NAME: ________________________________

CONTACT PHONE: ________________________________

CONTACT EMAIL: ________________________________

b. GOVERNMENT: Contracting Officer 36C263 John Becker

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

2501 W. 22nd St.

Sioux Falls SD 57105

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Monthly or within 30 days after completion of service

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

Tungsten Electronic Invoicing

VA Tungsten Number is: AAA544240062 va.registration@tungsten-network.com

Refer to VAAR Clause 852.232-72

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 STATEMENT OF WORK – IOWA CITY VA HEALTH CARE SYSTEM

A.1 INTRODUCTION:

A1.1 Certification of Primary Engineering Controls (PEC)/Hoods Contractor shall provide testing and certification of all the Iowa City VA Health Care System hoods either once a year (every 12 months +/- 30 days) or twice per year (every 6 months +/- 20 days) as described in the price/cost schedule. The term “Hoods” refers to all of the following: Biosafety cabinets, chemical fume hoods, research animal housing units, research animal change stations and a HEPA unit for research animal allergen control during cage changes.

A1.2 Certification of Primary Engineering Controls (PEC) and rooms used for Compounded Sterile Preparations (CSP) The contractor shall also provide testing and certification of all primary engineering controls (PECs) and pharmacy compounding rooms/suites used for preparation of Compounded Sterile Preparations (CSPs).

PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI). Testing and certification of all PECs and compounding rooms/suites will be completed in accordance with the latest version of United States Pharmacopeia (USP) Chapter <797>, and USP Chapter <800> or current guidelines.

A.2 BACKGROUND:

The Iowa City VAHCS is required to maintain all primary engineering controls (PECs) used for staff and product protection. This requirement will describe all testing and certification activities required for all PECs and Pharmacy Compounding areas. PECs are used for personnel protection and/or product protection and must be certified to industry standards to ensure they are providing the required protection.

The Iowa City VAHCS requires 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 or current guidelines. 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. Testing procedures shall be maintained in compliance with all current applicable standards. CAG 001-2005 CETA Guide for the use of Compounding Aseptic Isolators in Healthcare Facilities, Revised December 8, 2008 and CAG-002-2006 CETA Compounding Isolator Testing Guide Revised December 8, 2008, or current guidelines, will also be used as the applicable standard for their respective PEC.

The United States Pharmacopeial (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.

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 - 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

The Iowa City VAHCS also requires the following tasks as outlined in current USP <797> and USP <800 >.

• Monthly surface sampling of described PEC and room surfaces where pharmaceutical compounding of sterile preparations is conducted.

• Semi-annual Hazardous Drug (HD) Wipe Sampling

• A semi-annual airflow Smoke Visualization Study of each PEC under dynamic operating conditions

• 2 hours of USP797/USP800 consulting

A.3 SCOPE OF WORK:

A.3.1 Primary Engineering Control Testing and Certification A3.1.1 Biological Safety Cabinets (BSCs), CACI, CAI All certification of BSC, CAI, CACI shall comply with the latest version of NSF/ANSI Standard 49 Appendix F. The contractor will immediately notify the Government Technical Representative with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the Government Technical Representative. Under no circumstance will repairs be accomplished by the contractor unless specifically covered under the contract. For each BSC 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

• Report number reflecting the room certification

• Location (room number)

• Certification date

• Recertification date

• Technician signature

A3.1.2 Chemical Fume Hoods All certification of Laboratory Chemical Fume hoods will comply with the latest version of ANSI/ASHRAE Standard 110. Face velocity testing and smoke visualization testing will be required; however, the tracer gas containment test using sulfur hexafluoride will not be required. The sash height achieving the required 100 fpm will be marked with a sticker designed for this purpose. A test report will be generated, and any comments or problems noted. Additionally, any fume hoods with face velocity monitors or controllers will be recalibrated to the correct velocity. The contractor will immediately notify the Government Technical Representative with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the Government Technical Representative.

For each unit 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

• Report number reflecting the room certification

• Location (room number)

• Certification date

• Recertification date

• Sash height (only for fume hoods)

• The average recorded face velocity

• Technician signature

A.3.2 CSP PEC Testing and Certification

The contractor shall test and certify each PEC according to USP <797> and <800> using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006), ANSI/NSF-49 and/or the CETA Applications Guide for the Use of Compounding Aseptic Isolators in Compounding Sterile Preparations in Healthcare Facilities (CAG-001- 2005 Revised Dec. 8, 2008) and/or CETA Compounding Isolator Testing Guide (CAG-002-2006 Revised Dec. 8, 2008) or the equivalent. All PECs shall:

• be certified to meet ISO Class 5 or better

• maintain unidirectional airflow

• 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:

• Viable and non-viable particle counts

• Airflow velocity testing

• HEPA filter leak test

• Induction leak/back-streaming test

• Cabinet leak test

• In-flow velocity test to include exhaust airflow volume rate

• Surface microbial and fungal sampling

• Air microbial and fungal sampling

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

Airflow smoke pattern testing will be completed in accordance with CAG-003-2006 for each pharmacy PEC initially and when changes are made to the PEC or room configuration. The testing will be video-recorded, and the contractor must have experience in collecting these videos. The facility will provide a minimum of one pharmacy technician to conduct simulated drug compounding in each PEC during the smoke visualization testing. 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.

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.

A3.2.1 Laminar Flow Hoods (Laminar Airflow Workbench (LAWF), Integrated Vertical Laminar Flow Zone (IVLFW), and 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 (to include 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). 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 Government Technical Representative upon request. Confirmation of this calibration shall be listed in the final certification report.

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.

A3.2.2 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.

A.3.3 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>. 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:

• Non-Viable Particle Counting under dynamic operating conditions

• Viable / Microbial and Fungal Air Testing

• Viable / Microbial and Fungal Surface Testing

• Airflow Volume Measurements

• Air Velocity Profile

• Room Air Exchange Rates

• Room Pressure Measurement (in water columns)

• In-Place Leak Testing of HEPA Filters

• Temperature, Relative Humidity Measurements

• Smoke test under dynamic conditions

A3.3.1 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>. Viable microbial and fungal air and surface sampling will also be required for each room where CSPs are made.

A.3.3.2 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, ante room, segregated compounding area (SCA) and HD storage room and include their findings in the report. In the event that a room does not meet USP<797> or USP <800> requirements for ACPH the identified site POC(s) shall be informed immediately.

A.3.3.3 Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas as well as the static pressure of the hazardous drug SCA. 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).

A.3.3.4 Viable Environmental Sampling

• The contractor shall perform viable environmental (air) sampling every 6 months for fungi and bacteria using high volume impaction samplers to conduct the sampling.

• In addition, semi-annual viable environmental surface sampling of classified areas will be performed. This includes the hazardous and non-hazardous buffer rooms, the ante room and each segregated compounding area. 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.

• The interior of the PEC and the equipment contained in it

• Staging or work area(s) near the PEC

• Frequently touched surfaces

• Pass-through chamber(s)

• 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.

• 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.

• The lab chosen to analyze the samples must be verified prior to testing and be certified.

A.3.3.5 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). 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. Retesting, if required to mitigate any contamination found over a locally established action level, will be done by the Iowa City VAHCS.

The drugs required for testing include:

• Cyclophosphamide

• Doxorubicin HCL

• Etoposide

• Irinotecan HCL

• Paclitaxel

• Cisplatin

• Carboplatin

• Oxaliplatin

• 5-Fluorouracil

• Platinum-containing drugs

• Additional Drugs o Additional drugs may be requested based upon identified need per site.

o 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 30 surface samples will be completed per certification. Surface sampling will include the areas listed on the attached spreadsheet.

• Interior of PEC and equipment contained in it (i.e. camera).

• Pass-through chambers

• Surfaces in staging or work areas near PEC

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

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

• Patient administration areas

A.3.3.6 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 per USP797, Section 4.1.

A.3.3.7. Report Requirements:

The following information shall 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:

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

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

• Action level for ISO area tested

• Executive summary or summary of findings.

• Room number and/or location

• Room type (e.g. oncology prep room)

• Type of PEC certified

• Serial number of the equipment certified

• Building Asset number of the equipment certified

• Date and time samples are collected, and particle counts tested

• Name of Technician collecting the samples

• Date of next required certification

• Standards used to test room or equipment

• Comments indicating when dynamic operating conditions were used

• Notes

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

• Sketch identifying location of each sample obtained

• Total room area and volume

• Room humidity and temp

• Room air changes per hour

• Pressure differentials in water columns

• Nonviable particle counts (CFU’s), action level for target ISO level

• Viable particle count analysis

• Sketch of viable particle test location in room

• Viable sample results (CFU’s), action level

• Certificates of analysis of media used

• Comments indicating when dynamic operating conditions were used

A.3.3.8 Report Distribution The contractor will immediately notify the Government Technical Representative 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 21 days from certification evaluation.

All completed reports will be provided via email to Government Technical Representative. Contractor will be notified by the facility of any updates to identified points of contact list on an as needed basis.

A3.3.9 Testing Frequency:

• Certification procedures for Pharmaceutical Compounding Areas defined in CETA CAG-003-2006 and other references CETA documents, shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months (+ or – 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

• Environmental sampling (air and surface) will be completed semi-annually (every 6 months + or

– 20 days), 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).

• An airflow smoke pattern test under dynamic operating conditions initially and every 6 months per USP 797.

• 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.

• Monthly surface sampling in areas where CSA prepared.

• Class II Biological Safety Cabinets will be certified semi-annually or annually per the equipment/task list.

• 2 hours of consulting time per year.

A3.3.10 Additional trip charges If additional testing, troubleshooting, adjustment or repair is required, the contractor shall provide for 4 additional service visits each contract year. These additional site visits will only be utilized at the request of the Government Technical Representative. The additional site visit 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).

A3.3.11 Test equipment and contractor standards All test equipment will be supplied by the contractor and must be calibrated within the last 12 months to an industry standard and manufacturer specifications. Calibration certification letters for equipment must be kept with the contractor technician for review by the Government Technical Representative at the time of inspection, if needed. All technicians performing the work must be qualified by education and experience. At least one technician performing the work in areas where CSP are prepared must be Controlled Environment Testing Association (CETA) certified and registered as required by VHA Directive

1108.12 (https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=8151). A copy of this publication can be requested from the VA Technical Representative.

STATEMENT OF WORK PART B – SUPPORTING INFORMATION

B.1 Place of Performance and Logistics:

The Iowa City VA Health Care System contains equipment and facilities for CSP at locations listed on the attached list. These locations are all in Iowa City or Coralville, Iowa. The Government Technical Representative will be the primary contact for this contract. This person is the Facility Industrial Hygienist who is located in Building 2, Room 203. They can be contacted at (319) 338-0581 Extension 6843 to discuss certification/inspection inquiries. Inspections must be scheduled with the Government Technical Representative 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.

B.1.A. Required Services and Equipment List.

See IOWA CITY VAHCS EQUIPMENT LISTING ATTACHMENT for a detailed list of equipment and tasks required. This attachment contains a detailed equipment/task list for Pharmacy/CSP areas, a detailed equipment list for non-pharmacy equipment, a hazardous drug wipe sampling plan in all areas using or compounding hazardous drugs, a plan for monthly surface sampling for microbial and fungal contamination in CSP areas.

B.2 Period of Performance: See Price/Cost Schedule for performance periods.

B.3 Special Considerations:

B.3.1 Contractor Furnished Materials:

• All materials and tools to complete the work identified.

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

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

B.3.2 Qualifications/References:

• All contractor performed certifications must be signed by an NSF 49 certified technician.

• All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. The CETA-certified technician must be onsite and working within the clean room areas while testing is being conducted. Supervision or oversight from a different location is not allowed.

• Laboratory shall be American Industrial Hygiene Association (AIHA) accredited for all USP<797> viable sampling analysis.

• For Hazardous Drug wipe sampling, Laboratory shall be AIHA accredited.

B.3.3 Additional Considerations The Contractor or Contractor’s Representative shall contact the Government Technical Representative to schedule work and prior to the beginning of work. Scheduling of work will be at the direction of the Government Technical Representative to ensure services are incorporated into current facility certification cycles.

The Government Technical Representative 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 https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=8151 those procedures. Services are to be performed during the hours between 8:00 AM and 4:00 PM Central Standard Time (CST), Monday through Friday, excluding federal holidays. Due to the workload of the pharmacy during business hours, the contractor may need to work after 4:00 PM CST to accommodate the compounding schedule at the pharmacy.

B.3 STATEMENT OF WORK – SIOUX FALLS VA HEALTH CARE SYSTEM

The Contractor shall furnish all labor, equipment, transportation, permits, testing and incidentals necessary for the performance of the work specified in this Statement of Work.

I: Background- The Sioux Falls VA Medical Center (SFVAMC) in Sioux Falls, SD is seeking services to test, repair and certify a variety of pharmacy equipment, pharmacy clean rooms, and laboratory equipment on an annual and semiannual basis.

Annual Inspection and Certification of Research Laboratory and Podiatry Research: Biological Safety Cabinets (2), Fume Hoods (7), Animal Bedding Disposal Station (1), Animal Cage Changing Station (1), Animal Cage Rack (2) Podiatry: Fume Hood (1)

Semiannual Inspection and Certification of Pharmacy and Clinical Laboratory Pharmacy: Biological Safety Cabinets (5), Clean Room Testing Compounding Rooms (3), Cleanroom Testing Ante room (2), Verify Engineering Controls in Containment Segregated Compounding Area Room (2), Containment Ventilated Enclosure (CVE) for Nonsterile Compounding (1), Hazardous Drug (HD) Storage/Nonsterile HD Compounding Room (1), HD Receiving Room (1).

Clinical Laboratory: Biological Safety Cabinets (3), Fume Hoods (1), Grossing Station (1)

II: Contractor Qualifications Contractor that meets the following specifications:

• All Biological Safety Cabinet (BSC) certifications must be signed by a National Sanitation Foundation (NSF) 49 certified technician.

• All United States Pharmacopeia (USP) certification work must be performed by a Controlled Environment Testing Association (CETA) Registered Cleanroom Certification Professional for Sterile Compounding Facility.

III: Testing and certifying standards Biological Safety Cabinet and Laminar Airflow Workstation Testing and Certification.

BSC’s must be tested to NSF 49 (2106), USP <797>/<800> and manufacturer testing protocols. The contractor shall certify all Class II biosafety cabinets using NSF/American National Standards Institute (ANSI) 49, Annex F and manufacturer testing protocols. The contractor shall provide NSF 49 (2106), USP <797>/<800> and NSF/ANSI 49, Annex F documents. All equipment used to certify biological safety cabinets shall have National Institute of Standards and Technology (NIST) traceable or comparable calibration certification. Any unit that fails to meet NSF 49 criteria shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. Additionally, all BSC’s used for pharmaceutical compounding must be certified to USP <797> and USP <800> testing requirements to include viable and non-viable particle testing.

Laminar Airflow Workstation’s (LAFW’s) must be tested to IEST RP-CC-002.3 and manufacturer testing protocols. The contractor shall provide IEST RP-CC-002.3 documents. Any unit that fails to meet the testing criteria shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice.

Animal changing stations and grossing stations must be tested to the manufacturer’s requirements.

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

BSC’s, Animal Cage Changing & Bedding Disposal Stations, Grossing Stations and LAFWs:

• Company name and address

• Unit make, model and serial number

• Report number

• Location (room number)

• Certification date

• Recertification date

• Technician signature

Chemical Fume Hood Testing and Certification.

The contractor shall test and certify each fume hood to manufacturer’s specifications as well as The American Conference of Government Industrial Hygienists (ACGIH) or American Society of Heating, Refrigeration, and Air-Conditioning Engineers (ASHRAE) 110 testing requirements. The contractor shall provide ACGIH and ASHRAE 110 documents. Tests shall include: face velocity test, airflow smoke pattern test and low flow alarm test. In the event that the fume hood has an Air Flow Monitor (AFM) or Air Flow Controller (AFC), the contractor shall confirm the unit is calibrated. If it is not calibrated appropriately, the contractor shall calibrate the AFM or AFC. The contractor shall use NIST traceable or comparable calibrated equipment to calculate the face velocity. The contractor shall report each individual face velocity reading and the average of those readings, pass/fail grade for the airflow smoke pattern test and low flow alarm test. Any failures shall be reported directly to the VA Technical Representative.

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

• Chemical Fume Hoods:

• Company name and address

• Average face velocity

• Report number

• Safe sash height

• Location (room number)

• Certification date

• Recertification date

• Technician signature

For any unit that fails to pass required certification tests, the VA Technical Representative shall be notified immediately so that arrangement for repairs can be made. The contractor shall mark each failing unit or room with signage that states this unit is out of service until further notice.

IV: USP<797> and USP <800> Testing for Pharmacy Clean Rooms

HEPA Filter Leak Test The contractor shall perform a proper High Efficiency Particulate Air (HEPA) filter leak test of the room air supply HEPA filters. An aerosol photometer with linear or expanded logarithmic scale shall be used.

The instrument shall be capable of indicating 100% upstream concentration with a minimum aerosol concentration of 10µg/L of polyalphaolefin (PAO) particles, or an equivalent fluid that provides the same particle size distribution. It shall also be capable of detecting an aerosol concentration in the downstream equal to 10-5 of the upstream concentration of the same particles. The sampling rate of air shall be 1 ft3/min. Probe area shall have a maximum open area of 1.7 in2 and a minimum dimension of

0.50 in.

An aerosol generator of the Laskin nozzle type shall be used to create an aerosol by flowing air through liquid PAO or equivalent substitute. When a Laskin nozzle generator is used, the compressed air supplied to the generator should be adjusted to a minimum of 23 psi.

The contractor shall calculate the upstream concentration and locate a point to introduce aerosol that will allow for adequate mixing.

Air Changes per Hour The contractor shall calculate the total room volume for each buffer and ante room. A sketch of the room with dimensions, exhaust/supply diffuser locations, particle count (both viable and non-viable) locations and equipment locations shall be included in the report. The contractor shall calculate Air Changes Per Hour (ACPH) for each buffer and ante room and include the findings in the report. The negative pressure segregated compounding areas or drug storage areas shall all be tested for air changes per hour. In the event that a room does not meet USP<797> or USP <800> requirements for ACPH, the VA Technical Representative shall be informed immediately.

Pressure Requirements The contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797>/<800>. The contractor shall report all pressures to an accuracy of four decimal places (i.e, “0.0001”).

Viable Environmental Sampling The contractor shall perform viable environmental sampling semiannually (e.g. every 6 months) for fungi and bacteria using high volume sampling pumps capable of achieving and maintaining the required minimum flow rate of 28 liters per minute and impaction samplers to conduct the sampling. A minimum of 1,000 liters of air shall be tested at each location in order to maximize sensitivity. The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) or Sabouraud Dextrose (Sab Dex) contact plates for sampling of fungi. Both bacteria and fungi surface samples will also be collected within each space. Any laboratory results equal to or greater than the action level will require notification of the VA Technical Represntative immediately upon receipt of results.

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 International Standards Organization (ISO)/Draft International Standards (DIS) 14644-1.2 standard. The contractor shall be responsible for supplying Annex A in the ISO/DIS 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

• ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any LAFW and BSC.

• 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 ante area providing access to negative pressure buffer room (setting found in satellite pharmacy)

• ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any ante area providing access to positive pressure buffer room only (setting found in main pharmacy)

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

• Room number and/or location

• Room type (e.g. oncology buffer room)

• Date of testing

• Date of next required certification

• Standards used to test room

• Notes

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

• Total room area and volume

• Room humidity and temp

• Air changes per hour

• Pressure differential

• Nonviable particle counts

• Viable particle count analysis

• Photo of viable particle test location in room (both surface and air sample locations)

• Video of smoke testing performed in area(s)

• Copy of lab report

• Findings and recommendations

The contractor shall include 2 extra site visits each contract year in order to accommodate recertification requirements and/or repairs. Under no circumstance will repairs be accomplished by the contractor unless specifically covered under the contract.

Required Services and Equipment List. See SIOUX FALLS VAHCS EQUIPMENT LISTING ATTACHMENT for a detailed list of equipment and tasks required.

B.4 PRICE/COST SCHEDULE

BASE YEAR ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 IOWA CITY VAHCS

Environmental Testing and Certification Services for the Iowa City VA Health Care System, 601 Highway 6 West, Iowa City, IA 52246. Contractor shall provide testing and certification as required for the following: Biological Safety Cabinets, Laminar Airflow Workstations, Chemical Fume Hoods, Compounding Aseptic Containment Isolators, Compounding Aseptic Isolators, Research Animal Housing Units, Research Animal Change Stations, HEPA Units, Primary Engineering Controls, and Pharmacy Compounding Rooms/Suites. Services to include surface sampling, hazardous drug wipe sampling, and USP797/USP800 consulting.

Contract Period: Base POP Begin: 11-01-2019 POP End: 10-31-2020

0001AA

2.00 EA ____________ ____________

Barrier Isolator/Glovebox (CACI or CAI), vented units Semi

Annual CACI BW110C Contract Period: Base

0001AB

Barrier Isolator/Glovebox (CACI or CAI), non-vented units Semi

Annual CAI 4W120 Contract Period: Base

0001AC

14.00 EA ____________ ____________

Class II Biological Safety Cabinet (BSC) Semi Annual 8W19A

(Qty2), 8W19C (Qty 2), 4W120, BS04G, BW110C (7 Units) Contract Period: Base

0001AD

8.00 EA ____________ ____________

Clean Room HEPA Filter Test (per filter) Semi Annual 8W19A

(Qty2), 8W19B, 8W19C (4 Units) Contract Period: Base

0001AE

6.00 EA ____________ ____________

Clean room suite certification per USP797 and USP800

Specifications (ACPH, Pressure Relationships, Nonviable air

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

sampling etc.) for ISO Class 7 spaces Semi Annual 8W19A, 8W19C, 8W19B (3 Units) Contract Period: Base

0001AF

Room certification for Segregated compounding areas (SCA) spaces & new hazardous drug storage area - Pressure differential, 12 ACPH Semi Annual BW110C, 4W120, BS04G, 8W19D (4 Units) Contract Period: Base

0001AG

30.00 EA ____________ ____________

Viable Air and Surface sampling in PECs and Rooms for fungal and microbial contamination Semi Annual 8W19A, 8W19APEC (Qty 2), 8W19B, 8W19C, 8W19C PEC (Qty 2), 4W120, 4W120 Laminar Workstation, 4W120 CAI, BW110C, BW110C Isolator, BW110C BSC, BS04G, BS04G PEC (15 Units) Contract Period: Base

0001AH

2.00 HR ____________ ____________

USP-797 / USP-800 Consulting per hour Semi Annual

Contract Period: Base

0001AJ

12.00 EA ____________ ____________

Plates, lab fees for monthly surface sampling. (PEC, Camera, Cart, 2 passthroughs). ICVAHCS staff will conduct the surface sampling and send plates to the lab. Once a Month See equipment/task list- 25 samples. ICVAHCS Staff would conduct the monthly sampling for the 10 months and send to lab. Contract would allow purchase of the plates and send to site. Contactor conduct sampling on the months they are here.

Contract Period: Base

0001AK

Wipe Test (Hazardous material traces) Semi Annual See equipment/task list - 30 samples. 3 kits needed each time (10 samples per kit). ICVAHCS staff will conduct wipe tests and send them to the lab. Contract would allow purchase of the kit monthly and send to site. Any remediation & follow-up wipe testing would be paid for and done by ICVAHCS.

Contract Period: Base

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001AL

18.00 EA ____________ ____________

Smoke Visualization study for each PEC Semi Annual 8W19A

(Qty 2), 8W19C (Qty 2), 4W120 CAI, 4W120 Laminar Workstation, BW110C CACI, BW110C BSC, BS04G (9 Units) Contract Period: Base

0001AM

10.00 EA ____________ ____________

Smoke Visualization study for each Room Semi Annual

8W18A, 8W19C, 4W120, BW110C, BS04G (5 Units) Contract Period: Base

0001AN

40.00 EA ____________ ____________

Class II Biological Safety Cabinet (BSC) Yearly See attached list, 36 exist now but added 4 to contract so have money when Research adds a BSC (40 Units) Contract Period: Base

0001AP

Biological Safety Cabinet (BSC) Semi Annual BW119A

Contract Period: Base

0001AQ

19.00 EA ____________ ____________

Fume Hood Yearly (19 Units)

Contract Period: Base

0001AR

Research Animal Housing Unit Yearly (18 Units)

Contract Period: Base

0001AS

Research Animal change station Yearly (8 Units)

Contract Period: Base

0001AT

1.00 EA ____________ ____________

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

Hepa filtration Biobubble Yearly (1 Unit) Contract Period: Base

0001AU

Trip Charge

Contract Period: Base

0002 SIOUX FALLS VAHCS

Inspection and Certification Service for the Sioux Falls VA Health Care System 2501 W. 22nd Street, Sioux Falls, SD 57105.

Contract Period: Base

0002AA

Certification Service Company Mobilization

Contract Period: Base

0002AB

20.00 EA ____________ ____________

Certification of BSC

Contract Period: Base

0002AC

Certification of Fume Hoods

Contract Period: Base

0002AD

3.00 EA ____________ ____________

Certification of Cage Rack

Contract Period: Base

0002AE

Certification of Bedding Disposal Station

Contract Period: Base

0002AF

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

Certification of Grossing Station Contract Period: Base

0002AG

Certification of HEPA

Contract Period: Base

0002AH

Certification of Room

Contract Period: Base

0002AJ

Certification of CVE

Contract Period: Base

0002AK

Certification of LAFW

Contract Period: Base

0002AL

4.00 EA ____________ ____________

HEPA Filter Leak Test

Contract Period: Base

0002AM

Cleanroom Testing Compounding Rooms

Contract Period: Base

0002AN

Cleanroom Testing Ante Room

Contract Period: Base

0002AP

Environmental Sampling

Contract Period: Base

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0002AQ

Bacterial Air Sampling

Contract Period: Base

0002AR

Fungal Air Sampling

Contract Period: Base

0002AS

Bacterial - Fungal Surface Sampling

Contract Period: Base

0002AT

Smoke Visualization Test with Video

Contract Period: Base

BASE YEAR TOTAL

OPTION YEAR 1 ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIE…