P01 - STATEMENT OF WORK - PARENTERAL NUTRITION COMPOUNDING - MEMPHIS VAMC - W.pdf

STATEMENT OF WORK (SOW)

1. Contract Title:

Customized Patient Specific Parenteral Nutrition with Same Day Delivery for Lt. Col. Luke

Weathers, Jr. VAMC / 116 N. Pauline St., Memphis, TN 38105.

2. Background.

Pharmacy Service at the Lt. Col. Luke Weathers, Jr. VAMC is looking to outsource the Parenteral

Nutrition compounding process in order to meet the needs of patients requiring parenteral nutrition. Vendor MUST be able to deliver orders placed late as 3pm by 7pm.

3. Scope.

Pharmacy Service at the Lt. Col. Luke Weathers Jr VAMC is requesting customized, patient-specific parenteral nutrition compounding services with same day delivery for the Inpatient Pharmacy. This requirement will be a Base Plus 4 Ordering Periods for the local delivery of a total of 445 bags per year of Compounding Customized Patient Specific Parenteral Nutrition.

Period of Performance is as follows.

Base Period: 02/17/2025 – 09/30/2025

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

4. Specific Tasks

The contractor shall provide customized, patient specific PNs with same day delivery.

5. Lt. Col. Luke Weathers, Jr. VAMC Expectations of Vendor:

a. Vendor must be approved by Pharmacy Compounding Accreditation Board

i. Vendor will be visited, at minimum, once annually by Lt. Col. Luke Weathers, Jr. VAMC Pharmacy Services to review compounding practices and requirements.

b. Daily Schedule

i. Vendor Hours of Operation

1. Vendor hours of operation will cover 7 days per week including holidays.

2. Assistance after hours MUST be available 24 hours by phone at no additional charge.

ii. Order Transmission Times

1. Parenteral Nutrition may be ordered seven days per week.

2. Vendor will receive orders throughout the day with the cutoff time being 15:00 (3pm).

iii. Delivery time

1. Parenteral Nutrition ordered by 15:00 (3pm) will be delivered by 19:00

(7pm).

iv. Nonstandard/Late Deliveries

1. Vendor will make every effort to accommodate late or early orders.

2. Delivery will be arranged on a case-by-case basis.

c. Ordering

i. Order will be submitted via fax by Lt. Col. Luke Weathers, Jr. VAMC pharmacist using standardized order form template.

1. Included cover sheet will include ordering pharmacist contact information.

ii. All orders will be screened using the Vendor’s standard minimum/maximum values.

iii. Vendor will provide Lt. Col. Luke Weathers, Jr. VAMC with inventory information if the change in inventory prohibits parenteral nutrition from being compounded as ordered.

d. Delivery

i. Location of Delivery

1. Vendor will deliver all products to the Inpatient Pharmacy at the Lt.

Col. Luke Weathers, Jr. VAMC- 116 N. Pauline Street, Memphis, TN, 38105, DB1102

ii. Receipt of Delivery

1. Upon receipt of the Vendor shipment, the receiving Lt. Col. Luke

Weathers, Jr. VAMC employee will verify the count of parenteral nutrition bags and sign the Vendor packing list as confirmation of receipt.

2. Lt. Col. Luke Weathers, Jr. VAMC Pharmacy Service will retain one copy of the packing list.

e. Labeling

i. Vendor will label all parenteral nutrition bags in compliance with USP General

Chapter <797> and applicable laws and regulations.

ii. Labels are to include at a minimum:

1. Patient Name

2. Assigned internal identification number

3. Active ingredient(s) and their amount(s), concentration(s)

4. Administration instructions

a. Rate of administration

5. Storage conditions if other than controlled room temperature

6. Beyond Use Date

a. The contractor solutions shall have a minimum stability of 24-hour expiration as well as all solution bags shall be labeled with expiration date and time.

7. Dosage form

8. Total amount or volume

a. Order volume must be listed on the PN bag.

b. Compound volume must be listed on the PN.

c. Overfill must be listed on the label.

9. Route(s) of administration

10. Indicate the preparation is compounded

11. Compounding facility name and contact information

iii. Labels are to include when applicable

1. Route(s) of administration

2. Special handling instructions

3. Warning statements

f. Product Recall

i. Vendor shall notify the Contracting Officer administering the contract within three (3) business days of any recall, removal, modification, or defect of items supplied under contract for appropriate action.

ii. Resolution in such circumstances may be made by replacement of item at no cost to the Lt. Col. Luke Weathers, Jr. VAMC, full credit of item toward future purchase, or any other method agreeable to both parties. Any freight costs incurred as a result shall be borne by the Vendor or credited to the Lt. Col.

Luke Weathers, Jr. VAMC as appropriate.

g. Returns

i. Any item found to be defective or technically unacceptable, as verified by the

Vendor and/or Lt. Col Luke Weathers, Jr. VAMC pharmacy staff, shall be returned to the Vendor and replaced or credited in the same manner as specified under Product Recall.

ii. The Vendor shall not be liable for replacement or crediting the Lt. Col. Luke Weathers, Jr. VAMC for any item due to misuse or abuse by the Lt. Col. Luke Weathers, Jr. VAMC personnel.

h. Vendor Communication with the Lt. Col. Luke Weathers, Jr. VAMC

i. Daily communication with the Lt. Col. Luke Weathers, Jr. VAMC pharmacists will occur as needed by telephone or fax to discuss prescription content, order entry, delivery exceptions and to confirm that all orders have been received.

i. Quality

i. Vendor will:

1. Meet all applicable federal, state, and JCAHO requirements for quality assurance.

2. Make quality reporting information available to the Lt. Col. Luke Weathers, Jr. VAMC upon request.

a. If requested, able to provide quarterly quality assurance reports required by USP <797> to include environmental monitoring and control media fill validation, final product testing, personnel credentials status, and employee training.

3. Follow standard operating procedures and guidelines outlined in USP <797>.

4. Comply with all applicable local, state, and federal rules and regulations.

5. Use only fully trained and qualified employees.

6. Ensure all final products are checked by a licensed pharmacist.

7. Security compliance

a. See security requirements below.

8. Record management compliance

a. See Records management obligations below

j. Invoicing

i. Contractor shall submit monthly electronic invoices through VA ‘s invoice presentment and payment system (IPPS). The invoice should be itemized by prescription number and should include PO number, date of service, sold to information, billing period, packing slip number, patient RX number, product group, description, quantity, unit of measure, unit price, extended price and grand total .

ii. Invoices summited via Tungsten Network -https://authentication.

Tungsten -network.com/login.

k. Contact numbers for Vendor

i. Fax: (901) 872-7595

1. Call (901) 872-2648 after faxing after-hours or on weekends

ii. Phone: (901) 872-2648

iii. After hours: (901) 872-2648 and (901) 485-8199

iv. Lt. Col. Luke Weathers, Jr. VAMC will be notified of any changes in contact information

6. Vendor Expectations of the Lt. Col. Luke Weathers, Jr. VAMC:

a. Order Cutoff Times

i. Orders will be submitted by 15:00, except in extenuating circumstances.

b. The Lt. Col. Luke Weathers, Jr. VAMC changes

i. Changes in policies, systems, order forms, and formulary will be communicated to Vendor with sufficient time to respond to the changes.

c. Order Clarification

i. The Lt. Col. Luke Weathers, Jr. VAMC shall respond to Vendor order clarification questions with at least one hour remaining before scheduled delivery.

ii. Clarifications can be directed to the pharmacist at the phone number listed on the order cover sheet or the 24/7 Pharmacy phone at (901) 523-8990 ext.

16776.

d. Order Correctness

i. The Lt. Col. Luke Weathers, Jr. VAMC will check all orders for therapeutic correctness before submitting to Vendor.

e. The Lt. Col. Luke Weathers, Jr. VAMC pharmacy personnel will check all Vendor parenteral nutrition against the original provider’s orders before dispensing to the patient.

f. The Lt. Col. Luke Weathers, Jr. VAMC Primary Contacts

i. Ordering Pharmacist: contact information available on fax cover sheet

ii. 24/7 Pharmacy Phone: (901) 523-8990 ext. 16776

iii. Pharmacy Resident office: (901) 523-8990 ext. 16745

iv. Inpatient Pharmacy Supervisor: (901) 523-8990 ext. 17362

v. Sterile Compounding Program Manager: (901) 523-8990 ext. 16003

vi. The Vendor will be notified of any changes in contact information.

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/subcontractor 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 services security controls, if applicable, shall meet or exceed VA’s minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with

VA’s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor 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 health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

The following standard Items relate to records generated in executing this contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C. Chapter 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part

1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government ‘IT’ equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government

Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of

1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion

[draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the

Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules

10. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract.

The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

4. SECURITY INCIDENT INVESTIGATION

a. The term “security incident” means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches

VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/subcontractor’s notice to VA shall identify the information involved, the circumstances surrounding the incident

(including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

5. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised

(made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy

Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

APPENDIX B

VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(END OF CLAUSE)

APPENDIX C

TRAINING

a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to

VA information and information systems;

The contractor will go to TMS website (www.tms.va.gov) to self -enroll for the following training.

(2) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior

Training #10176.

(3) Successfully complete the appropriate VA Privacy and HIPAA Focused Training #10203 and; (4) successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security

Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.