S02. 36C25624Q0959.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. UEI: EFT:

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

598-24-3-169-0126

36C25624Q0959 07-18-2024

Caleb Parker (713) 791-1414 ext. 149866 07-30-2024

5:00 PM EDT

36C256 Department of Veterans Affairs Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

X 100

X

561990

$16.5 Million

N/A

36C598

Department of Veterans Affairs Central Arkansas Veterans HCS 2200 Fort Root Drive North Little Rock

AR 72114

36C256

Department of Veterans Affairs Network Contracting Office 16

N/A

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

877-353-9791 512-460-5429

See CONTINUATION Page

The Contractor shall provide all labor, equipment, materials replacement parts, supplies, tools, transportation, and travel necessary to perform all inspections, testing, certifications, preventative maintenance and repair of High-Efficiency Particle (HEPA) and other filter replacement as required to perform Sterile Compound Compliance services in accordance with the Performance Work Statement (PWS).

POC: Caleb Parker / caleb.parker@va.gov

See CONTINUATION Page

Ashley Haslauer Contracting Officer

36C25624Q0959

Table of Contents

SECTION A

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

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

10. INFORMATION SECURITY

The contractor will not have access to VA Desktop computers and nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody

11. PRIVACY

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

12. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

3. VA INFORMATION CUSTODIAL LANGUAGE

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

6. SECURITY INCIDENT INVESTIGATION

7. LIQUIDATED DAMAGES FOR DATA BREACH

8. SECURITY CONTROLS COMPLIANCE TESTING

9. TRAINING

13. RECORDS MANAGEMENT

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 DELIVERY SCHEDULE

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

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) ... 73

C.4 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.5 VAAR 852.219-74 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED

VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION)

C.6 VAAR 852.219-75 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (JAN 2023)

(DEVIATION)

C.7 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.8 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.10 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 80

C.11 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.12 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (MAY 2024)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

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

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

E.6 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.7 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.8 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.9 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.10 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.11 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024)

E.12 VAAR 852.201-70 CONTRACTING OFFICER'S REPRESENTATIVE (DEC 2022)

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 36C256

Department of Veterans Affairs

Network Contracting Office 16

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 []

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.

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

AMENDMENT NO DATE

USP<797> and USP<800>

Sterile Compounding Compliance

Supplemental Quality Management Plan

1. ABBREVIATIONS:

ANSI: American National Standards Institute

C-PEC: Containment Primary Engineering Control

C-SEC: Containment Secondary Engineering Control

CAG: CETA Application Guide

CAVHS: Central Arkansas Veterans Healthcare System

CETA: Controlled Environment Testing Association

CNBT: CETA National Board of testing

CO: Contracting Officer

COR: Contracting Officer Representative

HEPA: High efficiency Particle

ISO: International Organization for Standardization

JLM: John L McClellan Memorial Hospital

NSF: National Sanitation Foundation International

PEC: Primary Engineering Control

POC: Point of Contact

SDS: Safety Data Sheet

SEC: Secondary Engineering Control

SOP: Standard Operating Procedures

Contractor: qualified contracted environmental testing personnel

2. PERIOD OF PERFORMANCE:

09/01/2024-08/31/2025 (Base Year) 09/01/2025-08/31/2026 (Option Year 1) 09/01/2026-08/31/2027 (Option Year 2) 09/01/2027-08/31/2028 (Option Year 3) 09/01/2028-08/31/2029 (Option Year 4)

Term of Contract and Pricing: Firm Fixed Price

3. BACKGROUND & OBJECTIVE

United States Pharmacopeia (USP) has many publications. The USP General Chapter 797 and 800 publications (USP<797>) and (USP<800>) are two of many. They both provide essential quality management information for our facility.

The purpose of USP <797> is to protect the health of patients by reducing the potential for microbial contamination caused by an unclean environment. It was developed for use in healthcare institutions and pharmacies. It also applies to other facilities and areas that prepare, store and dispense compounded sterile preparations (CSPs), such as pharmacy cleanrooms, chemotherapy clinics, satellite pharmacies and other areas where CSPs are prepared within a sterile environment. It is critical to understand the environment and potential sources of contamination and put appropriate controls in place.

Compliance with USP <797> requires the proper design and use of cleanroom facilities.

Proper cleanroom design and environmental controls must be assessed using a comprehensive quality management program which includes an environmental sampling (ES) program. The ES program is designed to provide information to staff and leadership that demonstrates the engineering controls are maintaining an environment within the compounding area that consistently maintains acceptably low viable and nonviable particle levels. To accomplish this the ES program must include viable and nonviable environmental sampling tests as well as certification and testing of primary and secondary engineering controls on a regular basis. The quality management program must also include an environmental nonviable particle testing program designed to certify and test primary engineering controls, such as laminar airflow workbenches (LAFW) and biological safety cabinets (BSC); and secondary engineering controls (i.e. buffer room and ante areas).

Compliance with USP<797> also requires the development of policies and procedures for cleaning, sterility testing, training and validation of personnel, and environmental monitoring. This is assessed objectively using personnel training and competency evaluations of garbing and aseptic work practices. To accomplish this gloved fingertip testing, and media fill testing are used regularly.

The purpose of USP <800> is to promote patient safety, worker safety, and environmental protection for those who handle hazardous drugs. It describes practices and quality standards for receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preparations.

In compliance with USP <797> and USP<800> the CAVHS pharmacy service is seeking a Contractor who can assist us with our CAVHS pharmacy quality management program.

4. SCOPE:

Contract must provide all labor, equipment, materials (including replacement parts), supplies, tools, transportation, and travel necessary to perform all inspections, testing, certifications, preventative maintenance and repair and internal HEPA and other filter replacement, as required throughout the contract period at the CAVHS.

Contractor must perform routine work detailed in this SOW on a regular schedule mutually agreed upon by the Contractor and COR, or designee.

Contractor must provide unscheduled work or emergency request within 7 days of a request from the Contracting Officer’s Representative (COR), or designee. No additional funding will be provided to pay for travel to the CAVHS for service.

CAVHS uses a variety of engineering ventilation controls to maintain employee exposures to hazardous air contaminants below applicable regulatory limits. The CAVHS Pharmacy Service USP 797 compliant cleanroom areas uses a variety of PEC and C-PEC.

These include Class II biological safety cabinets (Class II BSCs) for hazardous sterile drug compounding (as defined by NIOSH and OSHA), and Laminar Airflow Work- Benches (LAFW) for all other sterile drug compounding.

The number of PEC and C-PEC devices in service may change throughout the contract period. The numbers and types of devices in Table A are the Government's best estimate of the number and type expected to be serviced by the contract. The Government reserves the right to delete or add units as required.

If the numbers of listed items will be exceeded, no work is authorized with the prior written approval of the Contracting Officer (CO) to account for it. Work items or services not already included in this SOW, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this 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.

5. CONTRACTOR QUALIFICATIONS:

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

a. Contractor must have a working knowledge of USP<797> Pharmaceutical Compounding-Sterile Preparations (November 1, 2022) and USP Chapter <800> Hazardous Drugs-Handling in Healthcare Settings (December 1, 2019)

b. Contractor must also be familiar with revised USP<797> and USP <800> publications which are soon to be published and enforced.

c. Contractor must have a working knowledge of NSF/ANSI 49-2022 Biosafety Cabinetry: Design, Construction, Performance and Field Certification.

d. Contractor must be able to provide a technician with current certification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities by the CNBT for cleanroom certification. Proof of certification for a specific individual may be confirmed at the following link: CETA-accredited certifier

e. Contractor must provide a technician with current certification as a NSF Class II Biosafety Cabinet Field Certifier for Class II BSC testing and certification. Proof of certification for a NSF-accredited certifier may be confirmed at the following link: NSF Field Certifier Accreditation

f. Note: A Certified Industrial Hygienist (CIH) credential does not waive any of the above certification requirements.

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

h. Contractor must have a specific SOP for changing out biologically contaminated HEPA filters in Class II BSCs, and a specific SOP for changing out HEPA filters contaminated with hazardous drugs in Class II BSCs.

i. Contractor must have working knowledge of the following most recent CETA Documents referenced by USP <797>:

https://www.cetainternational.org/ceta-member-directory#/ http://info.nsf.org/Certified/Biosafety-Certifier/Listings.asp?SrvcStateList=ARKANSAS&Standard=0AC&

i. CAG 001 Applications Guide For The Use Of Compounding Isolators In Compounding Sterile Preparations In Healthcare Facilities (Revised December 2008)

ii. CAG 002 Compounding Isolator Testing Guide (Revised December 2008)

iii. CAG 003 Certification of Sterile Compounding Facilities for USP

Compliance (Revised October 2022)

iv. CAG 004 Biological Decontamination and Disinfection of Accessible

Surfaces in Biosafety Cabinets (Revised September 2020)

v. CAG 005 Servicing Hazardous Drug Compounding Primary Engineering

Controls (Revised 2007)

vi. CAG 006 CETA High Efficiency Filter Application Guide (Revised

January 2023)

vii. CAG 007 Exhaust System Requirements of Class II Biosafety Cabinets

(Revised September 2020)

viii. CAG 008 Certification Matrix for Sterile and Nonsterile USP

Compounding Facilities (Revised March 2022)

ix. CAG 009 Viable Environmental Monitoring for Sterile Compounding

Facilities (Revised September 2020)

x. CAG 010 CETA Application Guide for Informational Notes to Meet the

NSF/ANSI 49:2010a Standard Requirements (Revised July 2011)

xi. CAG 011 Gloved Fingertip Testing for Sterile Compounding Personnel

(revised February 2021)

xii. CAG 013 Media Fill Testing for Sterile Compounding Personnel (Revised

August 2021

xiii. CAG 014 Airflow Visualization Study (Revised April 2022)

j. Contractor must have working knowledge of the following ISO standards:

i. 14644-1:2015 Cleanrooms and associated controlled environments -- Part

1: Classification of air cleanliness by particle concentration

ii. 14644-2:2015 - Cleanrooms and associated controlled environments --

Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

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

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

v. 14698-2:2003 - Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data

6. GENERAL REQUIREMENTS:

Contractor must perform cleanroom certification procedures, sampling, and assessments to ensure the quality management program is being followed. Contractor must be able to provide engineering control testing every 6 months or whenever any PEC or C-PEC is relocated or the physical structure of the SEC or C-SEC is altered in a way which affect airflow patterns. A list of all PEC / C-PEC and SEC / C-SEC are listed below in Table A.

Certification procedures for CAVHS cleanrooms will also include video recorded airflow smoke pattern testing and HEPA filter leak testing in accordance with NSF/ANSI 49

(CAG 010).

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

1) Airflow testing: Airflow testing is performed to determine acceptability of the air velocity and volume, the air exchange reate, and the room pressure differential in doorways between adjacent rooms ot ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.

2) HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

3) Total particle count testing: Total particle count testing must be performed under dynamic operating condtions using calibrated electronic equipment. Calibration of equipment used must be included in the final report.

4) Airflow smoke pattern test: Both static and dynamic smoke studies verifying a continous flow of HEPA filtered air void of turbulence, dead air zones, and refluxing from the HEPA filteres to and across the entire work area and to the air returns must be performed and documented by video. Video of dynamic smoke test must document the demonstration of unidirectional airflow and sweeping action over and away from the preparation(s).Contractor to leave digital video via the prefreed technology by the customer (i.e email, flash drive, etc.) of smoke test on site prior to completion of certification process for each of the listed PECs.

The contractor shall use a NIST traceable or comparable calibrated piece of equipment to perform all testing. 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 backstreaming test. Any failures shall be reported directly to the identified site point of contact(s) as soon as practicable.

b. SEC (C-SEC) certification: Contractor must be available to certify all SEC and C-SEC listed in Table A below every 6 months to include HEPA filter integrity testing, airflow profiling and uniformity testing, particulate monitoring, room pressurization monitoring, temperature and humidity monitoring, air patter analysis, and an airflow smoke pattern test. Contractor must provide a video recorded airflow smoke pattern test for each SEC/C-SEC initially and every 6months, or whenever changes are made to the equipment which would affect airflow patterns. The smoke pattern test must be video recorded and transmitted to CAVHS in a mutually agreed upon manner (Ex. VA approved thumb drive, DVD, etc.). Video must be able to be uploaded and stored on a VA network device to not only provide visual verification that air flows from clean to less clean areas and that unidirectional airflow areas are free from turbulence and reverse flows but also to be available for viewing by internal and external auditors. Contractor must provide all SDS forms for all agents used during certification procedures.

c. Room Supply HEPA Filter Leak Test: Contractor must perform an in-line HEPA filter leak test of each terminal supply diffuser using USP 797 methodology (filter locations found in Appendix section below). This may be included as part of the SEC (C-SEC) certification processes.

d. Air Changes per Hour (ACPH): Contractor must measure the volumetric supply and exhaust for each room using a properly calibrated balometer hood, and then using the total room volume for each room, calculate the room air exchange rate.

A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. Contractor must calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. In the event that a room does not meet USP<797> or USP<800> requirements for ACPH, the Contractor must immediately notify the COR and the pharmacy POC. This may be included as part of the SEC (C-SEC) certification processes.

e. Pressure Requirements: Contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797> and USP<800>. Contractor must report all pressures to an accuracy of 0.001 inches of water colum. This may be included as part of the SEC (C-SEC) certification processes.

f. Nonviable Particle Sampling: Contractor must be available to perform environmental-nonviable particle sampling every 6 months and whenever the PEC (C-PEC) or SEC (C-SEC) are serviced. This may be included as part of the SEC (C-SEC) and PEC (C-PEC) certification processes. Contractor must derive the minimum number of sampling locations using Annex A in the ISO/DIS 14644

1.2015 or most recent standard. Testing shall be performed by a CETA accredited Registered Cleanroom Certified Professional for Sterile Compounding Facilities using current, electronic equipment with results of the following:

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

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

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

g. Viable Environmental Sampling: Contractor must be available to perform viable air sampling of each ISO Class 5, ISO Class 7, and ISO Class 8 area listed below in Table B every 6 months in accordance with the most recent version of CAG-009-2011. Viable surface sampling plan requires testing of each ISO Class 5, ISO Class, and ISO Class 8 area listed below in Table B to be tested every month which is required by USP<797>. Contractor must provide all equipment and media plates necessary to perform viable air sampling and viable surface sampling as shown in the table below.

1) A general microbiogical growth media that supports the growth of bacteria and fungi must be used. COAs from the manufacturer must verify that the media meeets the expected growth promotion, pH, and sterilization requirements. Samples must be incubated in an incubator at temperatures that will promote grwoth of bacteria and fungi. The incubator temperature must be monitored during incubation, either manually or by a continous recording device, and the results must be reviewed and documented as described in the contractor’s SOPs.

2) Quality assuracne results of media plates being used and calibrations of equipment used to incubate media plates must be provided in each report.

3) Air Sampling: Volumetric active air sampling of all classified areas using an impaction device must be conducted in each classified area during dynamic operating conditions every 6 months. A minimum 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. Air sampling sites must be selected in all classified areas and illustrated on a diagram of the cleanroom suite. If levels measured during the viable air monitoring program exceed the levels as defined in USP <797> for the ISO classification levels of the area sampled, the contractor must identify any microorganisms recovered to the genus level with the assistance of a microbiologist and provide the results within one business day of results.

4) Surface Sampling: The contractor must perform surface sampling of all classified areas and pass-through chambers connecting to classified areas for microbial contamination every month. The contractor must perform the surface sampling and the end of compounding activity or shift, but before the area has been cleaned and disinfected. The areas that require surface sampling include, but are not limited to the following: the interior of the PEC and the equipment contained in it, staging or work area(s) near the PEC, and frequently touched surfaces.

Any laboratory results greater than the action level will require notification of the POC(s) within 24 hours upon receipt of results.

5) Reports to include at a minimum: Date and time sampling was taken, both quantitative number of bacterial/fungal isolates reported as colony forming units (CFUs) as well as the species grown, identification of highly pathogenic microorganisms will be highlighted, media lots for samples, comments indicating when dynamic conditions were used, certificates of analysis of media used, results of quality assurance media plates, calibration of equipment used, sketch identifying location of each sample obtained

h. Gloved Fingertip Sampling: Contractor must perform gloved finger tip (GFT) sampling for all who have the potential for compounding sterile compounded products as part of their normal duties. The sampling requirements for those who are naïve to sterile compounding, or those who have not compounded in at least 6 months will be to complete three consecutive gowning GFT samplings (one sampling device per hand) and one post media fill GFT sample (one sampling device per hand). Those who have previously passed initial certification and have compounded sterile compounded products within the last 6 months will only need to take one gowning GFT sampling (one device per hand) and one post media fill GFT sampling (one device per hand). A certificate of analysis must be provided for commercial sterile microbial growth media is sued for the GFT. Gloved fingertip and thumb testing shall be performed in controlled temperature enviroments and incubated in accordance with USP <797> and <800> guidance.

Each sample shall be labeled with a personnel identifier, whether it was from the right or left hand, and the date and time of sampling. Documentation results for gloved fingertip and thumb sampling will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of Contractor must be onsite each month to provide GFT sampling on at least 15 employees each month. Contractor must provide microbial testing results from an accredited environmental testing laboratory in a written report. This report will serve as documented test results within 1.5 weeks of completion of each sample. The Contractor must provide all media plates necessary to perform GFT.

i. Media-Fill Testing: Contractor must perform Media-Fill Testing (MFT) for all who have the potential for compounding sterile compounded products as part of their normal duties. Contractor must be onsite at least once each month to provide

MFT on at least 15 employees. Media Fill Testing will occur in a Laminar Airflow Workbench and simulate the most difficult and challenging compounding procedcures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean-casein digest media. A certificate of analysis (COA) must be provided for commercial sterile microbial growth media used for the media fill testing. Media Fill Testing will occur prior to gloved fingertip and thumb testing for recertification. The Contractor shall incubate media fill tests in controlled temperature environments in accordance with USP <797> and <800> guidance. Documentation of the media fill test will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results and the identification of the observer and the person who reads and documents the results.

Note: CAVHS has approx. 25 pharmacists and 20 technicians. Contractor must provide microbial testing results from an accredited environmental testing laboratory in a written report. This report will serve as documented test results within 2-3 weeks of completion of each sample. Contractor must provide all media broth, vials, and bags necessary to perform MFT.

7. PERFORMANCE REQUIREMENT SUMMARY:

Performance Objective Standard Performance

Threshold Method of Surveillance

PEC certification

(LAFW)

USP<797>

USP<800>

NSF/ANSI 49-

2022 or most recent

CAG-001-2005

CAG-002-2006

CAG-003-2006

CAG-004-2007

CAG-005-2007

CAG-006-2010

CAG-007-2010

CAG-008-2010

CAG-009-2011v3

ISO 14644-1:2015

ISO 14644-2:2015

ISO 14644-3:2005

ISO 14644-9:2012

ISO 14698-2:2003

OSHA

EPA

Zero deviation from the standard (Exception: The SOW requires performance higher than the recommended standard)

Periodic surveillance as determined by the SOW C-PEC certification

(BSC)

SEC and C-SEC certification Viable Air Sampling Viable Surface Sampling Gloved Fingertip Testing Media-Fill Testing

8. ADDITIONAL REQUIREMENTS:

a. Scheduling of work: Contractor must provide current documentation of required technician qualifications listed above. Contractor must also submit a current copy of their most recent standard operating procedures (SOPs) for testing, troubleshooting, repair and certification including documentation of certification equipment calibration to National Institute of Standards and Technology (NIST)-traceable primary standards, a safety plan to include job hazard analysis, respiratory protection program, hazard communication and safety data sheets (SDS) for all chemical products that will be used during the course of this contract prior to scheduling work. A specific SOP for changing out biologically contaminated HEPA filters in Class II BSCs, as well as a specific SOP for changing out HEPA filters contaminated with hazardous drugs in Class II BSCs.

Contractor must contact the COR, or designee to schedule work, prior to beginning work, and at the conclusion of all work. For services performed during normal working hours, the contractor's technician is to report to the COR, or designee to report/sign-in and obtain an identification badge, which shall be worn at all times while the technician is on station. Work must be performed during the facilities regular administrative working hours, Monday through Friday, 8:00 a.m.

- 4:30 p.m. excluding- weekends and Federal holidays. Exception to this will be given when deemed necessary to accommodate evening, night, and weekend staff.

Contractor must receive approval from the COR, or designee for irregular work hours testing.

b. Service Reports- Contractor must provide a certificate sticker for each unit that passes certification before the technician leaves the facility. Any unit that does not pass certification will be marked as such with clear signage that the unit is out of service until further notice. A complete report of services for each unit serviced and must include a listing of replacement parts, when applicable. Contractor must also contact Safety Office and the COR, or designeee upon completion of work to verbally report the status of the unit and any deficiencies identified. The COR, or designee, must sign the service report before the technician(s) leave the facility.

Failure to follow these procedures may result in delay of payment or nonpayment.

Pass/Fail notifications should be included on a per test basis where applicable.

Larger formal reports as required for the pharmacy clean rooms that include viable sampling must be submitted to the COR, or designee within fifteen (15) business days following the collection of the viable sampling. Results of viable samples must be submitted to the COR, or designee within one (1) business day of the receipt of the results from an accredited laboratory. The service reports from the contractor must contain, at a minimum, the following information:

i. Room number and/or location

ii. Room type (e.g. cleanroom, segregated compounding area)

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

iv. Certified technician(s) name

v. Date of testing

vi. Standards used to test PEC and/or SEC

vii. Diagram of room showing the location of supply/exhaust diffusers, equipment, room dimensions, etc

viii. Total room area and volume

ix. Room humidity and temperature

x. Air changes per hour

xi. Pressure differential

xii. Nonviable particle counts

xiii. Diagram with labeling of nonviable particle count locations

xiv. Viable particle sampling certificate of analysis for growth and sterility controls analysis and interpretation

xv. Diagram with labeling of viable particle sampling test locations in room

xvi. Report of actions performed

xvii. Notes or recommendations

xviii. Date of next required certification

xix. PEC service reports must include the following as applicable to type of hood certification:

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

2. Velocity profile and average

3. Direct inflow CFM profile and average

4. HEPA filter leak test

5. Airflow smoke pattern test

6. Sash alarm system test

7. Pressure gage reading

8. Light intensity

9. Sound Level

10. Ground polarity

xx. SEC service reports must include:

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

2. Particle Counts

3. Room Air Changes per Hour

4. Room pressurization test

5. Temperature

6. Humidity

7. Differential pressure between all rooms

8. Airflow Smoke pattern test

c. Excluded services: Contractor must not be obligated to provide services under this agreement for damage to or destruction of instrument(s) covered where such damage or destruction is a result of or caused by:

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

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

iii. VAMC misuse or abuse of such instrument

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

v. Installation of unauthorized field modifications.

d. Schedule of Insurance: Contractor must procure and maintain for the entire contract period, Workmen's Compensation and employer's general liability Insurance. Prior to contract award, the Contractor shall provide proof of insurance for the entire contract period. The parties agree that such personnel shall not be considered a VA employee for any purpose and shall be considered employees of the contractor.

e. Price Schedule: The contract rate is an all-inclusive rate. No separate fees will be allowed for such incidental costs of malpractice insurance coverage, supplies, equipment, etc.

f. Environment of Care: Contractor must maintain a clean and safe environment always.

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

h. Invoices/Payments: This provision shall survive the termination or ending of the contract. Payment for services rendered by the Contractor under the terms of this contract will be made upon receipt of a properly executed invoice. Invoice to be submitted within fourteen (14) workdays following completion of the Contractors rendered services. VA will verify services performed and certify invoice for payment within thirty (30) days following date of receipt of sampling reports.

Any identified discrepancy(s) in billings shall be cause for extending provisions of this paragraph until the discrepancy or other identified problem with the billing invoice has been resolved. Contractor must:

i. Be electronically prepared and submitted in accordance with FAR 52.212- 4(g)

ii. Clearly state the terms of any discounts offered

iii. Include the current fiscal year and purchase order number

iv. Include the period of performance covered by the invoice

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

i. Place of Performance: Contractor must furnish services for the CAVHS located at John L McClellan Memorial Hospital at 4300 West 7th Street, Little Rock, AR 72205.

9. APPENDIX:

Table A

Facility/Location/Room Type PEC (C-PEC) SEC (C-SEC)*

JLM 7D133

Nonhazardous cleanroom

LAFW

Mfg: Germfree Model: BVBI-6SSRX Serial# 6S-15-BVBI-18261

LAFW

Mfg: Germfree Model: BVBI-6SSRX Serial# 6S-15-

BVBI_18262

Buffer room Ante room

JLM 7D132

Hazardous cleanroom

Class II Type A2 BSC Mfg: Germfree Model: BBF-4SS Serial# 4S-15-BR2-19135

Buffer room Ante room

JLM 7D124

Hazardous cleanroom

Class II Type A2 BSC Mfg: Germfree Model: BBF-3SS Serial# 3S-15-BR2-19136

Buffer room Ante room

Table B

Facility/Location/Room Type ISO Class 5 ISO Class 7 ISO Class 8

JLM 7D133

nonhazardous cleanroom

LAFW

Mfg: Germfree Model: BVBI-6SSRX Serial# 6S-15-BVBI-18261

LAFW

Mfg: Germfree Model: BVBI-6SSRX Serial# 6S-15-BVBI-18262

Buffer room Ante room

JLM 7D132

hazardous cleanroom

Class II Type A2 BSC Mfg: Germfree Model: BBF-4SS Serial# 4S-15-BR2-19135

Buffer room Ante room n/a

JLM 7D124

Hazardous cleanroom

Class II Type A2 BSC Mfg: Germfree Model: BBF-3SS Serial# 3S-15-BR2-19136

Buffer room Ante room n/a

Particle Count Diagram 7D-133 Non-Hazardous (from last cert report 3/12/24)

Air Change Rate Diagram 7D-133 Non-Hazardous (from last cert report 3/12/24)

Particle Count Diagram 7D-132 Hazardous (from last cert report 3/12/24)

Air Change Rate Diagram 7D-132 Hazardous (from last cert report 3/12/24)

Note: 7D-124 has not been certified, but it will be for the future. There are no current diagrams for this room and contractor will need to do their own measurements and provide diagrams in each certification report similar to the ones above if awarded the contract. 7D-124 contains one BSC as described in Table A and B and there is one (1) 2X4 HEPA filter in the ante room and one (1) 2X4 HEPA filter in the buffer room of this space.

10. INFORMATION SECURITY

The contractor will not have access to VA Desktop computers and nor will they have access to online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

The C&A requirements do not apply, and a Security Accreditation Package is not required.

11. PRIVACY

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

12. VA INFORMATION AND INFORMATION SYSTEM

SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO

CONTRACTS, AS APPROPRIATE

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontrator shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS).

Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data

- General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor’s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA’s information is returned to the VA or destroyed in accordance with VA’s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor’s firewall and Web…