36C26322Q0434.docx

36C26322Q0434

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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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

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

36C26322Q0434 04-19-2022 Cameron Rick 651-293-3036 05-03-2022 12:00pm

CDT

36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul

MN

55101 Cameron Rick cameron.rick@va.gov X 541380 $16.5 Million N/A X 36C568 Department of Veterans Affairs Ft. Meade VAMC 113 Comanche Road Ft. Meade

SD

57741 36C263 Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul

MN

55101

Y Department of Veterans Affairs Financial Services Center PO Box 149971 Austin

TX

78714-9971 See CONTINUATION Page This solicitation is to provide service to the Ft. Meade & Hot Springs VAMCs.

See attached SOW for Pharmacy and Laboratory Certification of Equipment and Rooms services in the VAMC facilities.

Note block 30 - This document must be signed and returned in order to be considered. Email all required and completed documents to: cameron.rick@va.gov.

Submit written questions via email by 12:00pm April 27, 2022 **No telephonic questions will be accepted.** Responses to questions will be posted as an amendment to the solicitation.

Solicitation will close at 12:00 PM CDT on May 03, 2022.

This solicitation is a total VOSB set-aside.

See CONTINUATION Page X X Pamela Phillips 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 Phillips Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

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

3. INVOICES: Invoices shall be submitted in arrears:

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

Department of Veterans Affairs Financial Services Center PO Box 149971

Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

STATEMENT OF WORK

Pharmacy and Laboratory Certification of Equipment and Rooms

1.0 General:

1.1 Background

VA Black Hills Health Care System (BHHCS) is requesting a service contract for the certification of laboratory class II biologic safety cabinets (BSC), certification of pharmacy United States Pharmacopeia (USP) 795, 797, and 800 equipment and rooms, and the decontamination of two (2) laboratory class II BSC.

1.2 Objective

The contractor will perform work detailed in this statement of work (SOW) on the date and time mutually agreed upon by the Contractor and Contracting Officer Representavie (COR). The contractor shall notify the COR or authorized representative at least two weeks in advance of the date of planned testing or certification. The contractor is responsible for contacting the COR for the scheduling of services.

1.2 Scope of Work

Pharmacy: Will be certified every 5-6 months with each site, Fort Meade and Hot Springs alternating certification every 3 months. This will result in off set certification dates for both sites.

Laboratory: Will be certified annually at Fort Meade and Hot Springs. Decomissioning decontamination of laboratory hoods will occur within the first year of this contract.

Bidders will not have the opportunity to inspect equipment or spaces listed before submitting bids.

The contractor shall provide all labor, equipment, materials (including replacement parts), supplies, tools, transportation, and round trip travel necessary to perform all inspections, testing, certifications/recertifications, preventative maintenance and repairs for all equipment and rooms listed below as required throughout the contract period in accordance with manufacturer recommendations or practice standards. Parts that cost less than or equal to $100.00 dollars will be provided by the contractor. Minor repairs are repairs that can be completed on site, in less than three (3) hours at no additional cost. Preventative maintenance also includes replacement of High-Efficiency Particulate Air (HEPA) filters for all equipment and rooms listed below as recommended/required.

If traveling to both Fort Meade and Hot Springs in a single trip, travel will be charged at the further of the two sites not both.

The contractor shall conduct a rate recovery test of the cleanrooms (including the containment segregated compounding area (C-SCA)) to determine impacts to temperature, humidity, pressure differentials, air changes per hour (ACPH), and internationalclassification for standards (ISO) classification when the heating, ventilation, and air conditioning (HVAC) and exhaust is shut off. May include viables as determined. Rate recovery test limited to rooms B36, B37 and B38 at Fort Meade and rooms D016B, D016C and D016D at Hot Springs. The goal of this testing is to detemine the amount of time the rooms remain functional for compounding sterile compounds and to determine the level of cleaning needed with outages. The requested time frame is up to 6 hours or until failure. Rate recovery testing will occur within the first year of this contract.

Additional Services as needed:

· If certification fails parameters that cause the shut-down of equipment or rooms or decreases the beyound use dating (BUD) of compounded products, repair and/or recertification must be coordinated with the COR or authroized representative within two business days upon determination of failure. Repair and/or recertification should be conducted within 2 weeks and must be conducted within 4 weeks of failure.

· Recertification of rooms and equipment for either equipment failure, room or equipment changes causing a need for certification, or an additional certification needed in a years timeframe to meet the requirements for receiving results.

BHHCS uses a variety of engineering controls to limit employee exposures to hazardous contaminants while also providing a safe and effective preparation for patients.

Pharmacy: 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 and the C-SCA. The cleanroom suite and the C-SCA contain a variety of primary engineering controls (PECs) and contaiment primary engineering controls (C-PECs). The PECs include laminar airflow work-benches (LAFW) 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. HEPA-filtered pass throughs are also present in the cleanroom suites.

Lab: The class II BSC used for processing and culturing biosafety agents are comprised of externally vented class II BSC type A1, class II BSC type A/B3, and recirculated air with class II BSC type A2 devices.

Section 5 below is the best estimate of the number and types of rooms and equipment expected to be tested, sampled, serviced, and certified by the contractor. BHHCS reserves the right to delete or add units as required. No work is authorized outside the scope of this SOW without the prior written approval of the Contracting Officer (CO). Only the CO has the right to obligate funding or order work not expressly detailed in this SOW. 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.

1.3 Place of Performance

VA Black Hills Health Care System

Fort Meade VA Building 148 Police Office Badging location Building 113 Hood/Room locations 113 Comanche Road Fort Meade, SD 57741

Hot Springs VA Building 14 Engineering Badging Building 12 Hood/Room locations 500 North 5th Street Hot Springs, SD 57747

2.0 Specific Requirements/Tasks

2.1 CONTRACTOR QUALIFICATIONS:

Contractor must have a current controlled enviroment testing association (CETA) National Board of Testing (CNBT) accredited Cleanroom Certified Technician for Sterile Compounding Facilities with 5 or more years of experience. All cleanroom performance testing and signing of reports must be performed by an individual with the aforementioned accreditations. Furthermore, per VHA Directive 1108.12; All vendors used to conduct primary and secondary engineering controls certifications/assessments must be registered with CETA. In addition, the contractor must certify against NSF/ANSI 49 standards for biosafety level 2 clinical microbiology operations. Verification of experience may be requested by BHHCS. Contractor shall provide references as proof, prior to bid, of 5+ years the company has performed equipment and room certifications as outlined in this SOW. Contractor shall provide two recent certification reports from two sites, similar in scope, prior to bid.

Copies of pertinent certifications and/or licenses will also be required prior to beginning any work.

2.2 GENERAL REQUIREMENTS BY CONTRACTOR:

2.2.1 Attendance of an on-site pre-certification meeting with identified BHHCS staff to review site policies, operations, hazardous drug areas/equipment, etc. prior to beginning any work.

2.2.2 Ensure equipment functions in conformance with the most up to date published edition of the applicable standards including the USP, CETA, American Soceity of Heating, Refridgerating and Air-Conditioning Engineers (ASHRAE), Clinical and Laboratory Standards institute (CLSI), National Sanitation Foundation (NSF)/American National Standards Institute (ANSI), National Institutes of Health (NIH), Enviromental Protection Agency (EPA), Joint Commission, Underwriter Laboratories (UL), Occupational Safety and Health Administration (OSHA), CNBT and VA standards.

2.2.3 Any classified or unclassified room or equipment that is not certifiable must be communicated to the COR or authroized representative, by the contractor, within 30 minutes of failure or inability to certify. 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. Any "Failed" room or equipment tested must be communicated verbally and in writing. The COR or authorized representative may request recommendations from contractor in developing a corrective action plan.

2.2.4 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, date tested, reference report number, recertification month/year, and technician signature.

3.0 Description of Work:

3.1 Pharmacy:

3.1.1 The contractor shall perform all required facility related testing and sampling according to manufacturer recommendations and to the current versions of CETA application guides (CAGs) to determine whether the facility’s rooms and equipment, as detetailed below, meet certification requirements as outlined in the current version of USP 795, 797 and 800. CETA CAGs are the mandatory standard and no “equivalent” standards may be used for certification purposes.

3.2 Laboratory:

3.2.1 The contractor shall perform all required facility related testing and sampling according to manufacturer recommendations and to the most current versions of NSF/ANSI 49 and/or their replacement application guides to determine whether the facility’s laboratory BSCs used for culturing level 2 biosafety agents can be certified for use under current Clinical and Laboratory Standards Institute approved clinical laboratory safety guidelines (CLSI GP17 A3).

3.2.2 The contractor shall appropriately decontaminate unused laboraotry class II BSC, to include appropriate disposal of used HEPA filters. The decontamination shall be performed to the extent the BSC can be safely removed and safe construction can take place after removal.

3.3 For Meade, SD (See Appendix A, B, E, & F):

3.3.1 Pharmacy:

3.3.1.1 Rooms:

· Building 113, Room B31, Hazardous drug storage/Non-sterile hazardous drug compounding, One in-ceiling HEPA Filter FFU-1

· Building 113, Room B36, Pharmacy Sterile Non-Haz Buffer (PHSC1), 8.04 m2 (ISO 7), One in-ceiling HEPA Filter FFU-2

· Building 113, Room B37, Ante-Room (PHAR1), 7.41 m2 (ISO 7), One in-ceiling HEPA Filter FFU-2

· Building 113, Room B38, Sterile Hazardous Buffer (PHAR1), 13.45 m2 (ISO 7), Two in-ceiling HEPA Filter FFU-2

· Building 113, Room B39, Pharmacy receiving/Hazardous drug storage room

· Building 113, Room B40, Hazardous waste storage room

· Building 113, Room 191F, Hazardous drug storage, One in-ceiling HEPA Filter FFU-1

· Building 113, Room 237 or a similar room, Temporary/Backup Non-Haz SCA

· Building 113, Room 128G or a similar room, Temporary/Backup Haz C-SCA

3.3.1.2 Equipment:

· Pharmacy AireGard ES 5-foot Horizontal Laminar Airflow Workstation (NU-240-530), SN: 202358112020, Building 113, Room B36, qty:1

· Pass-through, Building 113, Room B36, qty:1 (Pass-through from B36 to general pharmacy area) Clean Air Products, Pass through wall mount HEPA Filter Stainless Steel - Model: CAP18WFBHF-SST-12Wx12Hx12D

· Pharmacy LabGard ES AIR 4-foot Class II, Type A2 Biosafety Cabinet (NU-543-400), SN: 194505101519, Building 113, Room B38, qty:1

· Pharmacy NuAire, CACI, NU-NR 800-400, SN:185656042518, Building 113, Room B38, qty:1

· Pass-through, Building 113, Room B38, qty:1 (Pass-through from B38 to general pharmacy area) Clean Air Products, Pass through wall mount HEPA Filter Stainless Steel - Model: CAP18WFBHF-SST-12Wx12Hx12D

· Pharmacy LabGard 4 foot Bench Top Containment Ventilated Enclosure (NU-813-400), SN: 194380100819, Building 113, Room B31, qty:1

· Mid wall air exhaust, Building 113, Room B39, qty:1

· Mid wall air exhaust, Building 113, Room 191F, qty 1

· PharmGard Positive Pressure Recirculating Compounding Aseptic Isolator (CAI), Nuaire NU-PR797-400, Serial Number 112300012507 or LFWB, Building 113, Room 237 or similar room, qty 1

· BSC Hood or rental unit, Building 113, Room 128G or similar room, qty 1

3.3.2 Lab:

3.3.2.1 Equipment:

· NuAire NU – 425-400, Class II Type A/B3, Biological Safety Cabinet, SN: 14898030102, Room 138, Qty:1

3.4 Hot Springs (See Appendix C, D, & F drawings):

3.4.1 Pharmacy:

3.4.1.2 Rooms:

· Building 12, Room D012, Pharmacy Receiving 17.84 m2

· Building 12, Room D016B, Pharmacy Sterile Non-Haz Buffer, 6.93 m2 (ISO 7), One in-ceiling HEPA Filter FFU-2

· Building 12, Room D016C, Pharmacy Ante-Room, 7.05 m2 (ISO 8), One in-ceiling HEPA Filter FFU-2

· Building 12, Room D016D, Pharmacy Hazardous Drug Containment Segregated Compounding Area (C-SCA), 5.77 m2, One in-ceiling HEPA Filter FFU-2

· Building 12, Room D016E, Pharmacy Non-Sterile Hazardous Drug Compounding/HD Storage, 11.89 m2

· Building 12, Room D005, Hazardous Waste Storage Room, 10.41 m2

3.4.1.3 Equipment:

· Pharmacy AireGard ES 4 foot Horizontal Laminar Airflow Workstation (NU-240-430), SN: 202459112420, Building 12, Room, D016B, qty:1

· Pharmacy LabGard ES AIR 4 foot Class II, Type A2 Biosafety Cabinet (NU-543-400), SN: 19444810119, Building 12, Room, D016D, qty:1

· Pharmacy LabGard 4 foot Bench Top Containment Ventilated Enclosure (NU-813-400), SN: 194381100819, Building 12, Room, D016E, qty:1

· Mid wall air exhaust, Building 12, Room D012, Qty:1

· Pass-through, Building 12 Room D016B, qty:1 (Pass-through from D016B to D016C) Clean Air Products, Pass through wall mount HEPA Filter Stainless Steel - Model: CAP18WFBHF-SST-12Wx12Hx12D

3.4.2 Lab:

3.4.2.1 Equipment:

· LabGard ES 4 foot, Class II Type A2, Biological Safety Cabinet, SN: 198175042320, Room 400, qty:1

· Decomissioning decontaminate: Labconco Model 70152, BSC class II type A1, SN 2577, room 400, qty: 1, outlined in red on appendix D

· Decomissioning decontaminate: The Baker Company Model VBM600, BSC class II type A1, SN SG-21586V, room 400, qty: 1, outlined in red on appendix D

3.5 Secondary Engineering Control (SEC) Testing:

3.5.1 Contractor must calculate the total room volume for all rooms being tested/certified. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations must be included in the report. The report provided will specify measured flow rates detailing returns and supply that were obtained during the testing.

3.5.2 Facility related testing for rooms and equipment certifications (listed above 5C and 5D) will include but is not limited to the below. It is expected the contractor will provide guidance on this prior to the site visit to vet out any discrepancies or missed tests. The following guidelines will be followed USP 795, 797, 800, CAG-006-2010, CAG-002-2006, GAG-003-2006, NSF/ANSI 49.

· Airflow test

· HEPA filter integrity testing for ceiling units, pass-throughs, and hoods.

· Induction leak/backstreaming test

· Dynamic Airflow viualization test (smoke pattern) in hoods and if needed in the rooms

· Airflow smoke pattern test shall be provided digitally, capable of being viewed on Windows 10 computer system

· Chamber pressure test

· Site installation assessment tests

· Particle containment integreity test and enclosure leak test

· Cabinet integrity/leak test

· Exhaust Alarm Test (for BCS and/or CACI certification only)

· Vibration test upon request

· Noise level test upon request

· Air Changes Per Hour (ACPH)/Air Change Rate Testing

· Verification of Temperature and Humidity

· Pressure differential testing of each opening (reported in inch water column)

· The contractor should report all pressures to an accuracy of 0.001” water column (3 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s)

3.6 Environmental sampling:

3.6.1 Non-Viable Particle Testing: The contractor shall perform environmental nonviable particle testing. The contractor shall derive the minimum number of sampling locations using current CAG-003-2006 and report based on ISO Standard 14644-1. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

3.6.1.1 ISO Class 5: not more than 3520 particles 0.5 μm and larger size per cubic meter of air.

3.6.1.2 ISO Class 7: not more than 352,000 particles 0.5 μm and larger size per cubic meter of air.

3.6.1.3 ISO Class 8: not more than 3,520,000 particles 0.5 μm and larger size per cubic meter of air.

3.6.2 Viable air sampling: bacterial and fungal testing for air quality in accordance with USP 797 and CAG-009.

3.6.2.1 A high volume impaction sampler device shall be used. Each air sample shall be a minimum of 1000 liters of air volume in all classified areas. Air samples shall be collecting during dynamic operations. The number of samples taken may be adjusted based on the contractor’s recommendations.

3.6.2.1.1 Each PEC shall have 1 bacterial and 1 fungal air test performed. One sample TSA and the other fungal media (e.g., malt extract agar (MEA) or sabouraud dextrose agar (SDA)). Control samples will be submitted and positive control will be inoculated per CETA.

3.6.2.1.2 Each classified area shall have 4 bacterial and 4 fungal air tests performed. One plate can be used as outlined in USP 797 for dual incubation or if requested both samples could be TSA or one sample could be TSA and the other fungal media (e.g., malt extract agar (MEA) or sabouraud dextrose agar (SDA)). Control samples will be submitted, and positive control will be inoculated per CETA.

3.6.2.1.3 Each pass-through shall have 1 bacterial and 1 fungal air tests performed. One plate can be used as outlined in USP 797 for dual incubation or if requested both samples could be TSA or one sample could be TSA and the other fungal media (e.g., malt extract agar (MEA) or sabouraud dextrose agar (SDA)). Control samples will be submitted, and positive control will be inoculated per CETA.

3.6.3 Viable Surface Sampling: bacterial and fungal testing in accordance with USP 797 and CAG-009.

3.6.3.1 Surface sampling should be performed at the end of significant compounding activity. Surface areas to be tested shall include inside each PEC, staging areas for compounding activity within the cleanrooms, frequently touched areas, and pass-throughs.

3.6.3.1.1 Each PEC shall have 1 bacterial and 1 fungal surface sample performed. If equipment is present in the PEC it will also be sampled as written in previous sentence. One sample TSA and the other fungal media (e.g., malt extract agar (MEA) or sabouraud dextrose agar (SDA)). Control samples will be submitted, and positive control will be inoculated per CETA.

3.6.3.1.2 Each classified room shall have 1 bacterial and 1 fungal surface sample performed. One plate can be used as outlined in USP 797 for dual incubation or if requested both samples could be TSA or one sample could be TSA and the other fungal media (e.g., malt extract agar (MEA) or sabouraud dextrose agar (SDA)). Control samples will be submitted, and positive control will be inoculated per CETA.

3.6.3.1.3 Each pass-through shall have 1 bacterial and 1 fungal surface sample performed. One plate can be used as outlined in USP 797 for dual incubation or if requested both samples could be or one sample could be TSA and the other fungal media (e.g., malt extract agar (MEA) or sabouraud dextrose agar (SDA)). Control samples will be submitted, and positive control will be inoculated per CETA.

4.0 Performance Requirement Details:

4.1 Technician(s) performing certifications must:

4.1.1 Be certified by the CETA National Board of Testing (CNBT) for Pharmacy Sterile Compounding Facilities. It is required the technician have 5 or more years of experience in testing pharmacy sterile compounding areas. It is also required that the technician have at least 5 years of experience in certifying NUAIRE equipment specifically CVE, LFWB, and BSCs (contractor shall provide contact references as proof, prior to bid).

4.1.1.1 For reference, this technician will be identified as the “Lead Technician”

4.1.2 Any vendor technician that does not meet the requirements of 4.1.1 must comply with the following requirements:

4.1.2.1 Technicians without CNBT certification

· Technician must be actively supervised by the Lead Technician (same room or direct oversight during actives)

· The uncertified technician shall not work independently of the Lead Technician during the certification process.

4.1.2.2 Technicians with CNBT certification but without 5-years’ experience

· The technician can work independently of the Lead Technician, but they must both be actively working within the pharmacy space and available to collaborate to address any concerns.

4.1.3 Only the Lead Technician shall sign the test reports and equipment labels.

4.1.4 Provide copies of pertinent certifications and/or licenses.

4.1.5 Be a direct employee of the contractor. Hence outsourcing of technicians will not be accepted.

4.1.6 Be competent in United States Pharmacopeia (USP) relevant codes: 795, 797 and 800. The USP and CETA standards have not been provided due to copyright laws, hence the contractor shall have their own copy.

· GENERAL NOTE: USP 797 states that certification procedures “such as” those outlined in CAG-003-2006 shall be performed, BHHCS is specifically requiring that the current CAG-003-2006 be used in lieu or any other “such as” procedures that may exist.

4.1.7 Be competent in NSF International Standard / American National Standard 49 and Clinical Laboratory Standards Institute GP17 A3. NSF/ANSI and CLSI standards have not been provided due to copyright laws, hence the contractor shall have their own copy.

4.1.8 Be proficient with the VA HVAC design guide relative to pharmacy type rooms regarding potential conflicts i.e. ACPH with USP. (See Attachment 3)

4.1.9 Become familiar (prior to site visit) and be compliant with the BHHCS Donning and Doffing Cleanroom Suites policies and procedures (Attachments 1-2). This is a living document.

4.1.10 Become familiar and compliant with BHHCS policies and procedures pertaining to safety, fire, severe weather, and emergency procedures, once onsite.

5.0 Additional Requirements:

5.1 Certification Reports- The contractor shall provide to the COR or authorized representative a certification report for rooms and equipment within 15 business days from testing date. Pharmacy and lab reports will be two separate reports and each emailed to the corresponding COR and authorized representative.

5.1.1 Each certification report from the contractor shall contain items outlined in GAG-003-2006 and at a minimum, the following information:

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

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

5.1.1.3 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.

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

5.1.1.5 Collected data will be compared to expected values or specific equipment performance criteria established in Standard Operating Procedures supplied by the client. In the absence of client SOPs, the certifying organizations SOPs or industry accepted standards, recommended practices and manufacturer’s specifications would be used.

5.1.1.6 Date and time testing/sampling was performed.

5.1.1.7 Date of next required certification.

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

5.1.1.9 A copy, upon request, of the current calibration documentation for each piece of equipment utilized in data collection, when applicable.

5.1.1.10 A written interpretation of the airflow smoke pattern test that was recorded and a backup file shall be provided via portable flash drive to the COR or authorized representative.

5.1.1.11 Communication between the COR or authorized representative to aid in developing recommendations and mitigation strategies will be provided at no additional cost.

5.1.1.12 Fail notifications, as described above in general requirements by contractor.

5.1.1.13 Listing of repairs performed and replacement parts provided, when applicable.

5.1.1.14 Reports will indicate what catergory of sterile compounding can be completed in the rooms containing hoods.

5.1.1.15 The contractor shall calculate air changes per hour (ACPH) and include their findings in the report. Documentation of ACPH from HVAC, Hood (if applicable) and the total ACPH must be separately identified on the certification report.

6.0 Enviromental Sampling Reports:

6.1 The contractor must contact the COR or authroized representative upon completion of work to verbally report any sampling issues before the contractor leaves the facility.

6.2 Failed air or surface samples must be verbally communicated to the COR or authroized representative within one (1) business day of the receipt of the results from a properly accredited laboratory. If the deadline is unable to be met, the contractor, will immediately relay both verbally and in writing (email) to the COR or authorized representative with explanation and new time line.

6.3 Reports that include viable sampling results must be submitted via email to the COR or authorized representative within 15 business days following the collection of the viable air sampling and/or surface sampling. If the deadline is unable to be met, the contractor, will immediately relay both verbally and in writing (email) to the COR or authorized representative with explanation and new time line.

6.4 Each sampling report from the contractor shall contain outlined items in current CAG-009 and at a minimum, the following information:

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

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

6.4.3 Media type, lot numbers and expiration dates. Provide certificate of analysis of media upon request.

6.4.4 All microorganisms recovered will be identified to the genus level and if able to the species level.

6.4.5 Purpose of sampling, volume sampled, date and time collected, ISO classification, method of collection, activity level (include # of people present), action levels, media types, laboratory analysis, incubation time and temperature.

6.4.6 List of equipment used, identification number, callibration due date.

6.4.7 Processing lab name and address, date samples receivied by lab, total microbial count in CFU, incubation tempatures, dates and time.

6.4.8 Any deviations or noted possible contamination.

6.4.9 A chain of custody form.

6.4.10 Growth and sterility control reports. If any negative control fails or a positive control has no growth, all enviromental resampling will be conducted at no cost.

6.4.11 An SOP or protocol that describes the procedures used for sampling to be provided upon request.

7.0 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.

8.0 Contract Monitoring and Oversight Management:

Quality assurance and administrative oversight of the overall contract agreement and basic processes of contract operations are the primary responsibilities of the COR.

Attachments:

Attachment 1: FM Donning and Doffing Cleanroom Suites.pptx Attachment 2: HS Donning and Doffing Cleanroom Suites.pptx Attachment 3: VA HVAC design guide Rev Nov 1, 2021 36C26322Q0434

Page 1 of Page 1 of VHA Supplemental Contract Requirements for Combatting COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

1. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

In-Ceiling HEPA Filter Test Contract Period: Base POP Begin: 05-15-2022 POP End: 05-14-2023

Cleanroom Certification

Room Certification

Cleanroom Non-viable Count

Cleanroom/Hoods Viable Air and Surface Sampling

Pass through testing of HEPA filter

Mid wall Air Exhaust

Horizontal Laminar Airflow Workstation

LabGard ES AIR 4-foot Class II, Type A2

LabGard 4 foot Bench Top Containment Ventilated Enclosure

Rate Recovery Test; Base Only

Pharmacy NuAire, CACI (semi-annual)

NuAire NU – 425- 400, Class II Type A/B3, Biological Safety Cabinet (annual)

LabGard ES 4 foot, Class II Type A2, Biological Safety Cabinet (annual)

Decomissioning decontaminate BSC class II type A1; Base Only

Resampling due to failures; As needed

USP 797/795/800 troubleshoot consulting; As needed

Recertification of hood; As needed

Recertification of room; As needed

Service Call; As needed

In-Ceiling HEPA Filter Test Contract Period: Option 1

Cleanroom Certification

POP Begin: 05-15-2023 POP End: 05-14-2024

Room Certification

Cleanroom Non-viable Count

Cleanroom/Hoods Viable Air and Surface Sampling

Pass through testing of HEPA filter

Mid wall Air Exhaust

Horizontal Laminar Airflow Workstation

LabGard ES AIR 4-foot Class II, Type A2

LabGard 4 foot Bench Top Containment Ventilated Enclosure

Pharmacy NuAire, CACI (semi-annual)

NuAire NU – 425- 400, Class II Type A/B3, Biological Safety Cabinet (annual)

LabGard ES 4 foot, Class II Type A2, Biological Safety Cabinet (annual)

Resampling due to failures; As needed

USP 797/795/800 troubleshoot consulting; As needed

Recertification of hood; As needed

Recertification of room; As needed

Service Call; As needed

In-Ceiling HEPA Filter Test Contract Period: Option 2 POP Begin: 05-15-2024 POP End: 05-14-2025

Cleanroom Certification

Room Certification

Cleanroom Non-viable Count

Cleanroom/Hoods Viable Air and Surface Sampling

Pass through testing of HEPA filter

Mid wall Air Exhaust

Horizontal Laminar Airflow Workstation

LabGard ES AIR 4-foot Class II, Type A2

LabGard 4 foot Bench Top Containment Ventilated Enclosure

Pharmacy NuAire, CACI (semi-annual)

NuAire NU – 425- 400, Class II Type A/B3, Biological Safety Cabinet (annual)

LabGard ES 4 foot, Class II Type A2, Biological Safety Cabinet (annual)

Resampling due to failures; As needed

USP 797/795/800 troubleshoot consulting; As needed

Recertification of hood; As needed

Recertification of room; As needed

Service Call; As needed

In-Ceiling HEPA Filter Test Contract Period: Option 3 POP Begin: 05-15-2025 POP End: 05-14-2026

Cleanroom Certification

Room Certification

Cleanroom Non-viable Count

Cleanroom/Hoods Viable Air and Surface Sampling

Pass through testing of HEPA filter

Mid wall Air Exhaust

Horizontal Laminar Airflow Workstation

LabGard ES AIR 4-foot Class II, Type A2

LabGard 4 foot Bench Top Containment Ventilated Enclosure

Pharmacy NuAire, CACI (semi-annual)

NuAire NU – 425- 400, Class II Type A/B3, Biological Safety Cabinet (annual)

LabGard ES 4 foot, Class II Type A2, Biological Safety Cabinet (annual)

Resampling due to failures; As needed

USP 797/795/800 troubleshoot consulting; As needed

Recertification of hood; As needed

Recertification of room; As needed

Service Call; As needed

In-Ceiling HEPA Filter Test Contract Period: Option 4 POP Begin: 05-15-2026 POP End: 05-14-2027

Cleanroom Certification

Room Certification

Cleanroom Non-viable Count

Cleanroom/Hoods Viable Air and Surface Sampling

Pass through testing of HEPA filter

Mid wall Air Exhaust

Horizontal Laminar Airflow Workstation

LabGard ES AIR 4-foot Class II, Type A2

LabGard 4 foot Bench Top Containment Ventilated Enclosure

Pharmacy NuAire, CACI (semi-annual)

NuAire NU – 425- 400, Class II Type A/B3, Biological Safety Cabinet (annual)

LabGard ES 4 foot, Class II Type A2, Biological Safety Cabinet (annual)

Resampling due to failures; As needed

USP 797/795/800 troubleshoot consulting; As needed

Recertification of hood; As needed

Recertification of room; As needed

Service Call; As needed

B.3 TERMS AND CONDITIONS

The Contractor agrees to the following terms of a Blanket Purchase Agreement (BPA) EXCLUSIVELY WITH the Department of Veterans Affairs:

B.4 ADMINISTRATIVE DATA

A Blanket Purchase Agreement (BPA) is hereby established between and the Department of Veterans Affairs under the following terms and conditions incorporated in this BPA:

Primary Point of Contact:

Alternate Point of Contact:

DUNS NUMBER:

Cognizant Office (Include complete address):

Department of Veterans Affairs

NETWORK 23 CONTRACTING OFFICE

316 Robert Street N. STE. 506 St. Paul MN 55101

B.5 PRICING

Contract Services as listed below, with associated pricing, can be ordered under this BPA. The Contractor shall be allowed to vary within the categories for successful and efficient task completion not to exceed funded values of each order awarded under this agreement. As proposed, the Contractor will apply applicable extended/tier pricing to all categories used in the performance of orders issued under this Agreement. Orders may be awarded on a basis only. All Calls/Orders placed against this BPA are subject to the terms and conditions of the referenced BPA, the Contractor's proposal and this Agreement, except where noted below. Contractor's proposal dated is hereby referenced.

B.6 GENERAL SERVICES ORDERS

a. The BPA holder shall furnish all the necessary qualified personnel, materials, facilities and management resources to furnish the services set forth in the Statement of Objectives (SOO) or the Performance Work Statement (PWS) within the terms specified and at the price(s) stated.

b. It is understood and agreed that the BPA holder shall provide Fixed-Price proposals when requested by the Contracting Officer (CO). The contractor's proposal shall be priced using labor rates and labor categories here in provided. The CO will issue Fixed Priced Orders upon completion of negotiations of contractor proposals.

B.7 NONPERSONAL SERVICES

a. In performance of this contract, the BPA holder will provide services as required by program offices to support management of their overall mission. This will be based upon the order's performance work statement for the specific effort. Orders will be formally issued to the BPA holder as opposed to individual BPA holder employees.

b. The services required under the Agreement constitute professional and management services within the definition provided by FAR 37.201. Under this Agreement the Government will obtain professional services, which are essential to the Department of Veterans Affairs mission but not otherwise available within Department of Veterans Affairs.

c. The Government will neither supervise BPA holder employees nor control the method by which the BPA holder performs the required tasks. Under no circumstances shall the Government assign tasks to, or prepare work schedules for, individual BPA holder employees. It shall be the responsibility of the BPA holder to manage their employees and to guard against any actions that are of the nature of personal services, or give the perception of personal services. If the BPA holder feels that any actions constitute, or are perceived to constitute personal services, it shall be the BPA holder's further responsibility to notify the Contracting Officer immediately.

d. These services shall not be used to perform work of a policy/ decision making or management nature. All decisions relative to programs supported by BPA holders will be the sole responsibility of the Government. Support services will not be ordered to circumvent personnel ceilings, pay limitations, or competitive employment procedures.

B.8 AUTHORIZED LIMITS

The Government estimates, but does not guarantee, that individual BPA Orders placed against this Agreement may reach /per Order. This Order Limit may be increased by mutual agreement of the parties as necessary, in whole or part. The authorized Ceiling Limit of the Agreement is set at over the period covered by the Agreement; this ceiling is also not a guarantee. The Ceiling Limit may also be raised in association with Order Limit increases or other conditions which, by mutual agreement of the parties, maybe considered necessary. Authorization for individual orders above the stated order and/or Ceiling Limits must be coordinated through the Contracting Officer before larger valued orders can be issued and prior to commencement of work. All unauthorized work, regardless of amount, will be processed through the ratification process.

B.9 OBLIGATION OF FUNDS

This BPA does not obligate any funds.