P09 - SOW Pharmacy HD Compounding.pdf

Statement of Work

Pharmacy Services – Procurement of hazardous sterile compounded products

INTRODUCTION

1.1 The Contractor shall provide chemotherapy preparation services for patient use for the Amarillo VA Medical Center. The contractor must be a U.S. based company capable of providing chemotherapy preparation in CETA CAG certified primary engineering control and secondary engineering control environment. The contractor must be able to provide next day delivery of compounded chemotherapy preparations.

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 chemotherapy preparation Contractor and COR from the Amarillo VA Medical Center will work together to increase the efficiency of the chemotherapy preparation process and both parties will collaborate to enhance services and increase efficiency as it relates to the delivery of chemotherapeutic preparations.

SCOPE

1. CHEMOTHERAPY PREPARATION PROVIDED BY CONTRACTOR

a. The chemotherapy preparation contractor shall provide chemotherapeutic preparations pursuant to a medication order from a VA Oncologist or Hematologist. The chemotherapeutic preparations will be prepared in an ISO 5 CETA CAG certified primary engineering control and an ISO 7 CETA CAG certified secondary engineering control. 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 chemotherapy preparations via contracted carrier. The contracted carried will deliver preparations to the Amarillo VA Medical Center in Amarillo, TX.

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 Amarillo VA Medical Center) 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 Amarillo VA Medical Center. 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 chemotherapeutic preparation services.

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

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

2. CHEMOTHERAPEUTIC PHARMACY SERVICES PROVIDED BY GOVERNMENT

a. Amarillo VA Medical Center will provide the following:

i. Chemotherapeutic medication orders to be prepared

ii. List of Amarillo VA contact telephone numbers

iii. Pager directory

iv. List of important medical center points-of-contact; Health Administrative Specialist on Duty (HODs); Pharmacist, phone numbers and pager numbers.

3. OPERATIONAL DAYS AND TIMES

a. Administrative Work Hours for the Amarillo VA 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, Juneteenth, 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. Citations to pertinent laws, codes and regulations such as 44 U.S.C. chapters 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.

ii. 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.

iii. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the Contract using Government Records.

iv. 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.

v. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the Contract.

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

vii. 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.

viii. 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 competition [draft, final, etc.].

ix. No disposition of documents will be allowed without the prior written consent of the Agency Records Manager. 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.

x. 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.

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

January, February, March April 10th

April, May, June July 10th

July, August, September October 10th

October, November, December January 10th

7. GOVERNMENT QUALITY ASSURANCE SURVEILLANCE

a. 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.

b. EVALUATION OF QASP: The 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: $ $240,000 (All funds are subject to the availability of funds per clause 53.232-19). The period of performance for this contract is 6/1/2025 through 5/31/2026 for the base. 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.

QASP-Quality Assurance Surveillance Plan

Service Requirement Performance Standard AQL

Service

Requirement Performance Standard AQL

Privacy Policy

Training B.4.6, Paragraph C

Contractor personnel complete Privacy Policy Training annually 0%

Ordering

Procedures B.4.6, Paragraph A

Chemotherapeutic preparations will be processed in a timely manner 2%

Records

Management B.4.6, Paragraph B

Maintain 100% accountability of all records without data breach 0%

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

Amarillo Service Start Service End Monday at 8:00 a.m. Monday at 4:00 p.m.

Tuesday at 8:00 a.m. Tuesday at 4:00 p.m.

Wednesday at 8:00 a.m. Wednesday at 4:00 p.m.

Thursday at 8:00 a.m. Thursday at 4:00 p.m.

Friday at 8:00 a.m. Friday at 4:00 p.m.