36C249-27-AP-0005 - Sterile Compounding Certification - (TVHS Pharmacy)   3

TVHS VAMC Pharmacy Service Statement of Work Sterile Compounding Bi-annual Certification, Monthly Viable Testing, and Personnel Gloved Fingertip and Media Fill Testing BACKGROUND: The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of Compounded Sterile Preparations (CSPs). The Joint Commission (TJC) established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. Additionally, the Food and Drug Administration (FDA) has the authority to inspect VA medical facilities. VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile Preparations, dated November 1, 2023, defines organizational responsibility for USP <797> standards for cleanroom design and engineering controls and environmental monitoring and biannual certification of these areas. It is VHA policy that each VA medical facility that provides CSPs have a pharmaceutical CSP program in place that conforms to the standards in USP Chapter <797> Pharmaceutical Compounding Sterile Compounding Sterile Preparations USP Chapter <797> standards require successful biannual certification of the areas and equipment and monthly environmental testing of the same and Chapter USP<800> requires further testing of hazardous drug areas. In addition, USP Chapter <797> requires biannual gloved fingertip and media fill testing of all compounding personnel. OBJECTIVE: VA Tennessee Valley Healthcare System (TVHS) seeks a contract for biannual certification, monthly viable surface and air testing, and personnel required testing. All testing must be in accordance with all applicable USP Chapter <797> and USP Chapter <800> standards, VHA Directive, medical center policies, standard operating procedures, and Controlled Environment Testing Association (CETA) guides. SCOPE OF WORK Bi-annual Certification: All primary and secondary engineering controls (SECs) must be tested to the most current CETA Certification and USP <797>, USP<800> guidelines every 6 months. Viable air sampling with genus (and species if available) identification if actionable level of colony forming units (cfus) are found Viable surface sampling with genus identification (and species if available) if actionable level of colony forming units (cfus) are found Primary engineering control certifications for biologic safety cabinets and laminar airflow workstations to include (if applicable) Non-viable particle count Downflow Velocity test HEPA filter integrity leak test (and patching if needed) Low airflow alarm test Video airflow smoke studies Secondary engineering control certifications to include: Air changes Pressure differentials Non-viable particle counts Temperature and pressure monitor verification (note on report measured matches/does not match within 10%) HEPA filter integrity leak test (and patching if needed) Hazardous drug storage room testing to include: Air exchanges Pressure differential Temperature and pressure monitor verification. Monthly Viable Testing: All primary and secondary engineering controls must be tested for viable growth to the most current CETA Certification and USP797/USP800 guidelines monthly at both campuses. The Contractor will perform testing within the first 10 days of each month. Viable air sampling with genus (and species if available) identification if actionable level of colony forming units (cfus) are found Viable surface sampling with genus identification (and species if available) if actionable level of colony forming units (cfus) are found Provide a viable sampling results report no later than 12 business days after testing completed. Provide retesting within the same month/prior to next scheduled time if there is a failure or other issue if requested by TVHS. Retesting should occur within 5 business days upon request by TVHS. Personnel Testing: Contractor will provide testing supplies for gloved fingertip and media fill testing for employees. Media must be in compliance with USP Chapter<797> TVHS designated employees will oversee the testing of compounders but utilizing supplies and lab services provided by the contractor. Contractor will provide Certified Environmental Microbiology Laboratory - ISO/IEC 17025:2005 Accreditation to incubate and report. Incubation, processing and reporting must be in accordance with USP Chapter <797>. Billing: All above services and other items (ie. per diem, travel etc.) billed in an itemized fashion and separately for each campus. Period of Performance Ordering Period 1: 10/01/2025-09/30/2026 Ordering Period 2: 10/01/2026-09/30/2027 Ordering Period 3: 10/01/2027-09/30/2028 Ordering Period 4: 10/01/2028-09/30/2029 Locations: Department of Veterans Affairs Tennessee Valley Healthcare System 1310 24th Avenue South Nashville, TN 37212-2637 Alvin C. York VAMC 3400 Lebanon Pike Murfreesboro, TN 37129-1237 REPORTING REQUIREMENTS: The Contractor must provide a preliminary report at the time of certification testing completion, viable sampling results reports no later than 12 business days after testing completed, and a comprehensive biannual certification electronic report no later than 45 business days after testing is completed, unless greater time is agreed upon in advance by the COR. Personnel testing reports must be received no later than 12 business days. All reports must include all items required by USP<797>, USP <800> and CETA testing. If the contractor cannot report within the specified timeline, an extension must be requested and agreed upon by TVHS. CONTRACTOR QUALIFICATIONS: The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work listed in Section 3. All testing and observations must be performed by properly trained and appropriately accredited on-site field certification technicians. These certified technicians must be trained on all the types of equipment listed in this SOW. All training and competency must be recent and in-date. 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: Contractor must have a working knowledge of most recent publications of USP<797> Pharmaceutical Compounding-Sterile Preparations Contractor must have a working knowledge of NSF/ANSI 49-2016 Biosafety Cabinetry: Design, Construction, Performance and Field Certification. 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 current CETA-accredited certification for a specific individual must be provided to facility s POC for the technician performing the work and/or the person who reviews and signs and reviews the reports. Contractor must follow all TVHS facility SOPs for the sterile compounding area at all times. Note: A Certified Industrial Hygienist (CIH) credential does not waive any of the above certification requirements. Technicians must successfully demonstrate competency in garbing and hand hygiene when performing work in classified areas. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (buffer room, ante room), the Contractor will always maintain a clean work area by wearing appropriate personal protective equipment (set forth by USP <797> standards) and cleaning any equipment with at least 70% sterile isopropyl alcohol. Contractor must have working knowledge of current ISO standards. Contractor must have technicians available in a reasonable proximity to the facilities to eliminate/minimize travel expenses, to meet the time frames for testing and to accommodate possible multiple dates for testing each month if there is a failure. PLACE OF PERFORMANCE: Tennessee Valley Healthcare System has two campuses requiring testing: Nashville VA Medical Center, 1310 24th Ave S, Nashville, Tennessee 37212 and Alvin C. York VA Medical Center, 3400 Lebanon Pike, Murfreesboro, TN. Nashville VA campus has the following needs for each biannual certification every 6 months (2 months per contract year in addition to monthly air and surface viable sampling): Biologic safety cabinet certifications (including videos of smoke studies and filter integrity) #2 Laminar airflow workstation certifications (including videos of smoke studies and filter integrity) #2 Secondary engineering control certifications (each with 1 HEPA filter with patching if needed) #6 Hazardous drug storage room certification #1 Murfreesboro VA campus has the following needs for each biannual certification (2 months per contract year in addition to monthly air and surface viable sampling): Biologic safety cabinet certifications (including videos of smoke studies) #1 Laminar airflow workstation certifications (including videos of smoke studies) #2 Secondary engineering control certifications (each with 1 HEPA filter with patching if needed) #5 Hazardous drug storage room certification #1 Nashville VA campus has the following needs for monthly viable sampling (12 months per contract year): Viable air samples (including one control) #11 Viable surface samples (including one control) #23 Murfreesboro VA campus has the following needs for monthly viable sampling (12 months per contract year): Viable air samples (including one control) #9 Viable surface samples (including one control) #17 In addition to above testing, would also like to include in the contract, in case of failure or other needs, the following extra testing if needed at either campus: Viable surface samples #40 Viable air samples #10 Secondary engineering control certification (each with 2 HEPA filter) #4 Biologic safety cabinet certification (including videos of smoke studies) #2 Laminar airflow workstation certification (including videos of smoke studies) #2 HEPA filter integrity test (with patching if needed) #2 HEPA filter changed and tested (with patching if needed) #2 Travel cost for one trip #4 Personnel Testing needs are below for both campuses combined: Initial full testing kit (8 fingertip plates, 1 surface plate, 1 media fill) #20 Ongoing full testing kit (4 fingertip plates, 1 surface plate, 1 media fill) #190 Ongoing glove fingertip garbing retests (2 plates per test) = #30 Initial glove fingertip garbing retests (6 plates per test) = #10 Lab processing per each item listed for supply needs in 6.6.1 through 6.6.4 TERM OF CONTRACT AND PRICING: This contract is for four 12 month ordering periods (48 months). All pricing to be given and billed per line item completed. Travel expenses and any other costs not listed above must be listed separately. Report generation may be built into prices above or listed separately. Invoices should be submitted monthly for total work completed and may be combined for both campuses if completed during the same travel time. PERFORMANCE PERIOD: The contract term is for 12 months with three additional ordering periods of 12 months each beginning upon signature and to start October 1, 2025. TVHS will issue a delivery order only for the current fiscal year. The VA's obligation under this contract shall terminate at the end of each fiscal year. TVHS shall unilaterally renew by issuing a renewal delivery order that shall be effective on the first day of each succeeding fiscal year. HOURS OF WORK: Work required in the performance of the contract shall be performed during hours agreed upon between the Contractor and TVHS Sterile Compounding Program Manager and/or Pharmacy Supervisors. The Contractor shall provide services during the facility hours of operation, except for the following federal holidays set by law (5 U.S.C. 6103), or as approved by the Ordering Contracting Officer. The following are recognized United States (US) federal holidays: New Year s Day: January 1st Martin Luther King, Jr. s Birthday President s Day Memorial Day Juneteenth Independence Day Independence Day: July 4th Labor Day Columbus Day Veteran s Day: November 11th Thanksgiving Day Christmas Day: December 25th GOVERNMENT RESPONSIBILITIES: The government will work in concert with the Contractor to help enable completion of the work of the contract. CONFIDENTIALITY AND NONDISCLOSURE: It is agreed that: The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. VA NOTICE 24-12 April 22, 2024 VA INFORMATION AND INFORMATION SYSTEM SECURITY AND PRIVACY LANGUAGE FOR INCLUSION IN CONTRACTS, AS APPROPRIATE GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Regarding this software contract, the Contractors, contractor personnel, subcontractors and subcontractor personnel will have access to log into the VA system using his PIV card to perform updates to their software but will not have access to patient or employee records or be required to have access to patient or employee records on behalf of VA. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language. The Contractors, contractor personnel, subcontractors and subcontractor personnel will not have access to the VA systems or VASI. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter contract ) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data General. VA information will not be co-mingled with any other data on the contractor s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations. The contractor s firewall and web services security controls, as applicable, shall meet or exceed VA s minimum requirements. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. 5705, Confidentiality of medical quality- assurance records and/or Title 38 U.S.C. 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above- mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO. SECURITY INCIDENT INVESTIGATION. Regarding this software contract, the Contractors, contractor personnel, subcontractors and subcontractor personnel will NOT have access to the VA systems or VASI. "The Authorization requirements do not apply, and that a Security Accreditation Package is not required". 2. The purpose of this amendment is to incorporate the following answers to questions submitted by interested vendors: Q: Are the total Viable Sampling Locations listed for each locations include both Bacterial and Fungal samples. A: Yes- these can be single plate method or double plate method. Q: Are the total Viable Sampling Locations listed for each location including the Pos & Neg controls per media type? A: Sampling location numbers include positive and negative primary and secondary engineering controls. Q: What are the primary engineering controls A: The primary engineering controls are listed in the SOW but listed here for clarity: Nashville- 2 BSCs and 2 LAFWs Murfreesboro- 1 BSC and 2 LAFWs Q: Are you able to provide MFR, Model and SN or each hood ? A: Including specs for each Q: Can you supply the dimensions on the cleanroom and the qty of HEPA in each room ? (Can you provide a Reflective Ceiling plan?) A: 1 HEPA per SEC. Defer to engineering for room plans/measurements. Q: How many magneheic gauges do you have in each location ? and should they be included in this certification service? A: This service is not included in this certification

Background
The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of Compounded Sterile Preparations (CSPs).

The Joint Commission (TJC) has established new Medication Compounding (MC) standards based on USP standards. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities. VHA Directive 1108.12 defines organizational responsibility for USP <797> standards for cleanroom design and engineering controls, requiring biannual certification and monthly environmental testing for VA medical facilities providing CSPs.

Work Details
The contract includes:
1. Bi-annual Certification: Testing of primary and secondary engineering controls every 6 months according to CETA Certification and USP <797>, <800> guidelines. This includes viable air sampling with genus identification, viable surface sampling, certifications for biologic safety cabinets and laminar airflow workstations, non-viable particle count tests, downflow velocity tests, HEPA filter integrity leak tests, low airflow alarm tests, video airflow smoke studies, air changes verification, pressure differentials checks, temperature and pressure monitor verification.

2. Monthly Viable Testing: Conducting monthly viable growth testing on primary and secondary engineering controls within the first 10 days of each month at both campuses. This includes viable air sampling with genus identification and surface sampling with genus identification.

3. Personnel Testing: Providing testing supplies for gloved fingertip and media fill testing in compliance with USP Chapter <797>. TVHS employees will oversee the testing using contractor-provided supplies. The contractor must provide a Certified Environmental Microbiology Laboratory to incubate and report results.

Period of Performance
The contract will be performed over four ordering periods from October 1, 2025 to September 30, 2029.

Place of Performance
The services will be performed at two campuses of the Tennessee Valley Healthcare System:
- Nashville VA Medical Center located at 1310 24th Avenue South, Nashville, TN 37212-2637;
- Alvin C. York VAMC located at 3400 Lebanon Pike, Murfreesboro, TN 37129-1237.