36C25720Q0439-026.docx

Statement of Work Pharmacy Services –Pharmacy Compounding

INTRODUCTION

1.1 The Contractor shall provide hazardous compounded sterile product (CSP) services for patient use for the VA North Texas Health Care System (VANTHCS) and Amarillo Health Care System. The contractor must be a U.S. based company capable of providing hazardous CSP which have been prepared within a cleanroom which has been certified by a Controlled Environmental Testing Association National Board of Testing (CNBT) as a Registered Cleanroom Certification Professional and biological safety cabinets which have been certified by a National Sanitation Foundation (NSF) Biosafety Field Certifier. The contractor must be able to comply with all USP 797 and USP 800 standards for the preparation of hazardous CSP. The contractor must be able to provide next day delivery of hazardous CSP to the VANTHCS.

1.2 This contract is for non-personal services. It does not create employment rights with the U.S.

Government whether actual, inherent, or implied. By agreeing to perform the services described in these specifications, the Contractor acknowledges that he/she is not, and shall not become, an employee of the U.S. Government. The Contractor further agrees that he/she shall not bring any cause of action in any forum claiming that he/she has become an employee of the U.S. Government.

1.3. This contract is a “non-personal services Contract” as defined in FAR 37.101. It is, therefore, understood and agreed that the Contractor and/or the Contractor’s employees or subcontractor:

1.4. Shall perform the services specified herein as independent Contractors, not as employees of the government.

1.5. Shall manage and administer the work required and bear sole responsibility for complying with any and all technical, schedule, or financial requirements or constraints attendant to the performance of this Contract.

1.6. Shall be free from supervision or control by any government employee with respect to the manner or method of performance of the services specified; but

1.7. Shall, pursuant to the government’s right and obligation to inspect, accept, or reject the work, comply with such general direction of the Contracting Officer, or the duly authorized representative of the Contracting Officer as is necessary to ensure accomplishment of the Contract objectives.

OBJECTIVES

The hazardous CSP Contractor and COR from the VANTHCS will work together to increase the efficiency of the hazardous CSP preparation process and both parties will collaborate to enhance services and increase efficiency as it relates to the delivery of hazardous CSP preparations.

SCOPE

1. HAZARDOUS CSP PREPARATION PROVIDED BY CONTRACTOR

a. The hazardous CSP preparation contractor shall provide chemotherapeutic preparations pursuant to a medication order from a VA Oncologist or Hematologist. The preparations will be prepared in a cleanroom certified to CETA (CAG 003-2006) standards. The Contractor will review authorized physician medication orders that are faxed, scanned, or transmitted during the required time periods identified in the Statement of Work.

b. The contractor will provide next day delivery of any preparations via contracted carrier. The contracted carried will deliver preparations to the VANTHCS.

d. The Contractor will:

i. Provide a daily shift ‘’sign off’ (by fax, voicemail, or web-based as agreed to by the COR at the VANTHCS) to include a summary of outstanding issues for follow-up by VA Pharmacy staff.

ii. Provide monthly report of activities under the contract (i.e., number of orders) furnished to the VANTHCS. This report will be monthly and sent to the COR at the facility.

iii. Upon award provide any relevant policies and procedures for the ordering, delivery and invoicing of preparation services.

iv. Comply with all applicable policies, rules and regulations of the VANTHCS of which they have been duly notified and shall not knowingly engage in any activity detrimental to the interest of the VANTHCS.

v. Comply with all applicable standards of the Joint Commission including maintenance of competency training for all staff providing services to the VANTHCS.

2. CHEMOTHERAPEUTIC PHARMACY SERVICES PROVIDED BY GOVERNMENT

a. VANTHCS will provide the following:

i. Medication orders to be prepared

ii. List of VANTHCS contact telephone numbers

iii. Pager directory

iv. List of important medical center points-of-contact; Administrative Officer of the Day (AODs); Pharmacist, phone numbers and pager numbers.

3. OPERATIONAL DAYS AND TIMES

a. Administrative Work Hours for the VANTHCS are stated in the Price Schedule, exclusive of these holidays: New Year’s Day, Martin Luther King’s Birthday, Presidents’ Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans’ Day, Thanksgiving Day, Christmas Day, and any other day designated a holiday by federal law, Executive Order, or Presidential proclamation.

4. DEFINITIONS and ACRONYMS

a. AQL: Acceptable Quality Level

b. Acceptable Quality Level: An AQL is the maximum allowable degree of deviation from the standard and it is expressed as either a percentage of deviation from the performance standard or as an absolute number; an AQL with a deviation of zero, for example, means that no deviation from the standard is acceptable.

c. Business Day: A period between 8:00 a.m. and 5:00 p.m., Monday through Friday, excluding Federal Holidays.

d. Contract: An agreement between two or more parties that is legally binding.

e. CDR: Contract Discrepancy Report

f. Contract Discrepancy Report: Formal documentation of a Contractor’s failure to some aspect of a Contract that explains why performance was unsatisfactory, how performance will be returned to satisfactory levels and how recurrence of the problem will be prevented in the future.

g. CO: Contracting Officer

h. Contracting Officer: A Government official with designated authority to enter into, administer, and terminate a Contract, and to make related determinations and findings on behalf of the Government.

i. COR: Contracting Officer Representative

j. Contracting Officer’s Representative: A Government official designated by the CO that’s responsible for providing Contract oversight and technical guidance to the Contracting Officer.

k. Contractor: The entity that enters into a Contract with the government resulting from award of any subsequent Contract.

l. EA: Each

m. Emergency: An immediate risk to a person's life or long-term health as determined by Veterans Affairs physician or another VA authorized provider.

n. FAR: Federal Acquisition Regulation.

o. HIPAA: Health Insurance Portability and Accountability Act.

p. HR: Hour

q. IAW: In accordance with.

r. Quality Assurance Surveillance Plan (QASP): A written document that’s used by the Government to monitor a Contractor’s quality assurance program.

s. Solicitation: A request to submit offers or quotations to the government.

t. TJC: The Joint Commission

u. The Joint Commission: An organization that sets standards by which health care quality is measured.

v. The Schedule: The following portions of a Contract are considered part of the schedule: Contract form (SF 1449), price/cost schedule, performance of work statement, packaging and marking, inspection and acceptance, deliveries or performance, Contract administration data, and special Contract requirements.

5. THE JOINT COMMISSION AND OTHER SPECIAL REQUIREMENTS

a. THE JOINT COMMISSION: The Contractor will be responsible to ensure that contractor employees providing work on this contract are fully trained and completely competent to perform the required work. Although this contract does not require TJC accreditation or other regulatory requirements regarding worker competency, the contractor must perform the required work in accordance with the TJC standards.

b. EXPECTATIONS OF CONTRACTOR:

i. The Contractor will review authorized physician medication orders at specified time periods identified in the statement of work. After review, Contractor will prepare any chemotherapeutic preparations and provide next day delivery of the finished product.

ii. The Contractor will provide and document a general orientation for all contractor pharmacists and or technicians who provide work on this contract before commencement of work. Documentation of the orientation will be provided to the Contracting Officer. This orientation will include the following topics:

1. Fire and safety policy and procedure

2. Infection control policy and procedure

3. Emergency Preparedness/Disaster policy and procedure

iii. The VA will monitor the Contractor employees’ work to ensure contract compliance.

iv. Notwithstanding other contract requirements, upon request of the Contracting Officer, the Contractor will remove from the work site, any Contractor employee who does not comply with orientation requirements or meet competency requirements for the work being performed.

v. Where the contract does not require TJC accreditation or other regulatory body requirements, the Contractor must perform the required work IAW the TJC standards. A copy of these standards may be obtained from TJC, One renaissance Blvd., Oakbrook Terrace, IL 60181.

c. HEALTH AND HUMAN SERVICES (HHS)/OFFICE OF INSPECTOR GENERAL (OIG): To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the Contractor is required to check the HHS - OIG, List of excluded individuals/entities on the OIG Website www.hhs.gov/oig for each person providing services under this contract. Further, the Contractor is required to certify in its proposal that all persons listed in the Contractor’s proposal have been compared against the OIG list and are not listed. During the performance of this contract, the Contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities.

d. RECORDS MANAGEMENT:

i. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

ii. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

iii. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

iv. VANTHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VANTHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VANTHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

v. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the indefinite delivery contract. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VANTHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

vi. The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VANTHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

vii. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VANTHCS policy.

viii. The Contractor shall not create or maintain any records containing any non-public VANTHCS information that are not specifically tied to or authorized by the contract.

ix. The 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 from public disclosure by an exemption to the Freedom of Information Act.

x. The VANTHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VANTHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

xi. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #3873736, Records Management for Records Officers and Liaisons. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

e. PRIVACY POLICY TRAINING: Contractor personnel must complete VHA national Privacy Policy training or other VHA approved privacy training for Contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually-identifiable Health Information as determined by the VHA. Proof of training (e.g., training completion certificate) must be provided to the COR and the Information Security Officer at each facility (to be named upon award) for each Contractor employee providing the services under this Contract.

f. PROTECTED HEALTH INFORMATION (PHI): Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPPA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information.

g. END OF CONTRACT RESPONSIBILITY: The Contractor agrees to provide self-certification that the data destruction requirements have been met and sent to the VA Contracting Officer within 30 days of termination of the contract.

6. CONTRACTOR QUALITY ASSURANCE: Contractor personnel preparing chemotherapeutic preparations must have the education, training and experience appropriate to performing the scope of services needed. It is the responsibility of the Contractor to have an on-going quality assurance (QA) program consistent with the standards that will support the expectations stated in the SOW, and to resolve identified problems. The written plan shall delineate the objectives of the quality assurance activities, scope of the activities, activities for monitoring and evaluation, methods of implementation of the monitoring and evaluation activities, methods for reporting results, mechanisms for taking follow-up action and responsibilities of staff for each activity of the quality assurance program. Results of the Contractor’s QA program will be forwarded to the COR on a quarterly basis or upon request within 48 hours. The plan shall be provided with the Contractor’s proposal and a VA Pharmacist approved copy shall be included as a part of any subsequent award.

a. QUARTERLY REPORTS: The Contractor shall evaluate the quality of medication orders and document the findings, conclusions, recommendations and actions taken. The report shall include information on special incidents, customer satisfaction, and performance improvement. Copies of aggregated data shall be forwarded to the COR by the due date listed below.

Data Collection Month Report Due on or Before

7. GOVERNMENT QUALITY ASSURANCE SURVEILLANCE

a. PERFORMANCE REQUIREMENT SUMMARY: The following Performance Requirement Summary (PRS) lists the Contract’s special requirements listed in paragraph 6, their associated performance standards, the Acceptable Quality Levels (AQL), and the methods of surveillance.

b. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP): The QASP be used to document the Contractor’s performance. The QASP includes various methods of assessing performance to ensure Contract requirements are being met.

c. EVALUATION OF PRS AND QASP: The PRS and QASP will be incorporated into any subsequent Contract. The Contractor will be given the opportunity to correct or address any adverse findings resulting from observations throughout the Period of Performance. Furthermore, failure to correct any major nonconformance could result in termination of the Contract for cause and/or adversely impact the Contractor’s ability to be selected for future Contracts as documented in the Contractor Performance Assessment Report System (CPARS).

i. Price/Cost Schedule: This is an Indefinite-Delivery Contract. Accordingly, all quantities are estimates and funds are not obligated on this Contract at award; rather, funds are obligated via task orders issued against the contract. The Minimum Value will be obligated through a delivery order upon award. Notwithstanding the $0 award amount, the value of all task orders that may be placed against this Contract during its performance period is estimated to be:

Minimum Value: $ 20,000.00 (Total minimum order for supplies and services that will be acquired under this contract)

Maximum Value: $ 3,100,000 (All funds are subject to the availability of funds per clause 53.232-19). The period of performance for this contract is 10-1-2019 through 09-30-2020. Quantities of each line item are broken out separately by year in order to allow contractor to provide adjusted annual pricing for each year of the contract if they choose.

Service Requirement Performance Standard AQL

1. Privacy Policy Training: Contractor personnel complete Privacy Policy Training annually 0%

2. Ordering Procedures: Chemotherapeutic preparations will be prepared in a timely manner 2%

3. Records Management: Maintain 100% accountability of all records without data breach 0%

Clarification on the Coverage of Federal Holidays, Night Shift and Weekends

VA North Texas