Compounding Pharmacy Performance Work Statement DRAFT.pdf

VA CENTRAL CALIFORNIA HEALTH CARE SYSTEM

FRESNO, CALIFORNIA

PHARMACY SERVICE

PERFORMANCE WORK STATEMENT

1. GENERAL:

SERVICES REQUIRED: The Department of Veterans Affairs, Central California Health

Care System (VACCHCS) requires a pharmacy contractor to prepare and deliver to

VACCHCS pharmacy located at 2615 E Clinton Ave Fresno, CA 93703. IV chemotherapy and other hazardous drug (HD) products as requested by the VACCHCS pharmacy on an on-demand basis. Because of the critical need of these services to be provided in a timely manner, only vendors within a 150-mile radius of the Fresno VA Medical Center need to respond to this RFQ. This service is required a contingency to VA in house hazardous medication preparation. No guarantee of need of the service can be provided to the contractor. This contract will be base year plus 4 option years.

2. PROCEDURE:

Contractor will send a representative to VACCHCS by am every business day and the VA requires the service. The representative will drop the finished orders for infusion that day at the VA infusion center and pick up the orders and supplies required for the following day (if any). The VACCHCS pharmacist will provide the contractor representative with the patient specific order labels for the orders required for the following day. The labels will contain all the information required by the contractor pharmacist to prepare the sterile HD medication order(s) for the VA patient(s). In addition, the VA Pharmacy will provide the contractor representative with all additional non-medication supplies to complete the order to a ready to be infused to the patient form. This may include but is not limited to diluent IV tubing sets and empty, sterile CADD cassettes). It is the contractor’s responsibility to prepare the HD IV medications as indicated on the VA order label-in use a USP 797/800 certified suite following all USP 797, 800, joint commission, FDA and other regulations required for HD medication preparation. The contractor will then transport the completed order(s) to the

VACCHCS pharmacy the following morning. The cutoff time for delivery of the completed orders is 8:00 A.M. Urgent orders requiring same day delivery will be provided as required by VA whenever practical (delivery plus compounding time is sufficient).

i. PLACE OF PERFORMANCE: Services shall be performed at the Contractor’s facility in an USP 797/800 certified hazardous drug sterile IV preparation suite.

Contractor will follow all applicable regulations and standards for safety in preparing sterile HD IV solutions.

ii. HOURS OF OPERATION: VACCHCS pharmacy is a 24/7 operation, however this service is only required during operation of the VA ambulatory infusion clinic (AIC when the VA pharmacy cannot provide the needed medications. Normal duty hours for the AIC are 7:30 A.M. TO 4:30 P.M. Monday through Friday. The Contractor shall provide services on an as needed basis as scheduled by the VA Chief, Pharmacy

Services.

Standard daily services when needed would require a once a day (by 9 a.m.) drop off of finished

HD medication ordered the previous day and corresponding, pickup medications orders (RX labels) medications and supplies for the following business day. For standard daily delivery the contractor hours would be at the discretions of the contractor providing the completed orders are delivered to VACCHCS pharmacy by 8 A.M. the following business day and the expiration dating of the products delivered extend until at least 6pm the day of delivery.

Urgent (same day requests) will require contractor hours of operation to meet an urgent request.

This would very likely be daytime hours during VA AIC business hours as stated above. In order to provide the products needed to the VA in time to satisfy patient needs (delivered same day prior to 3 P.M.) The contractor will not be required, except in case of emergency, to furnish such services on a national holiday. VA observes the following 11 holidays:

New Year’s Day Labor Day

Martin Luther King’s Birthday Columbus Day

Washington’s Birthday Veterans Day

Memorial Day Thanksgiving

Juneteenth Independence Day Christmas

Independence Day

i. DELIVERY LOCATION: Deliveries will be made Monday through Friday

(excluding holidays which are listed above) by 9 A.M., except in the case of emergency same day requests.

ii. Transportation of the chemotherapy and other HD medications will be done by a

(Department of Transportation) certified driver supplied by the contractor, the contractor is responsible for maintaining compliance with all federal, state and other regulations government transport of the medications.

iii. Delivery Commitment: Time of delivery is no later than 8:00 A.M. except when the specified by agreement of the VACCHCS and the contractor.

iv. AUTHORITY: 38 USC 8153, HEALTH Care Resources (HCR) Sharing Authority

v. POLICY AND REGULATIONS: The Contractor shall comply with all applicable

OSHA, USP 800, Joint Commission, federal and state laws and regulations as required for performing the type of services required, including the Center for

Medicare and Medicaid Services.

vi. Privacy Act of 1974 (5 U.S.C. 522a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

vii. VHA Handbook 1907.01 Health Information Management and Health Records:

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791

viii. CONTRACT COMPLIANCE: Contract Compliance and clinical performance shall be monitored by the Contracting Officer’s Representative (COR). COR:

Christopher Cervantes

Christopher.Cervantes@va.gov

(559) 225-6100 ext.: 5691

3. CONTRACTOR QUALIFICATIONS:

i. LICENSING AND ACCREDITATION: The Contractor shall maintain current request.

ii. Contractor shall have all licenses, permits, accreditation and certificates required by law including USP 797/800 certification for the HD preparation area and other areas of the pharmacy and facility as required by USP 797/800.

iii. Contractor/Sub-Contractor shall be accredited by Centers for Prevention and Disease

Control (CDC) under CLIA if contractor is engaged in interstate commerce.

iv. CONTRTACTOR PERSONNEL: Contractor shall provide the services of a fully trained, regist4d and licensed Pharmacist trained and certified competent in preparing

If a technician is used by the contractor to prepare the medication documentation

v. Perform the services covered by this contact, the Contractor's personnel shall be licensed in a State, Territory, or Commonwealth of the United States or the District of

Columbia. Qualifications shall be subject to the review by the VA Chief of Staff and approval by the VA facility Director.

vi. The Contractor's personnel shall be responsible and able to show evidence of reliability, ability and experience. Verified references of ability and qualifications may be accepted by the Contracting Officer to satisfy these requirements. This includes all current external and internal IV suite testing and certification for sterility and functionality of equipment and of rooms used in the preparation of chemotherapy and other HD. The contractor will provide up to date training and certification records for those staff involved in the preparation, finished product checking (Verification of all aspects of the completed product are as required in the VA order, correct medications, strengths, diluents and volume) and transport of chemotherapy and other

HD. The contractor will provide documents indicating active and current licensure of all staff involved in the transport, preparation and checking of chemotherapy and other H.D.

vii. The Contractor Pharmacist shall work and communicate effectively while remaining courteous, tactful, and understanding when interacting with others, even in potentially difficult situations.

4. CONTRACTOR TASKS:

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 mailto:Christopher.Cervantes@va.gov

i. CLINICAL DUTIES:

Contractor shall compound IV chemotherapy/HD medication as ordered by VA supplied order (recipe) adhering to all relevant USP 797/800 standards

(http://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/general-chapter-800.pdf) in a timely fashion as defined by VA patient need.

ii. Duties involved include verifying medication(s) and diluent(s) supplied by VA are not expired and do not appear to have any defects (cracked container, leaks, precipitation or other debris, cracked stoppers/lids, inappropriate color changes), verifying the medication was transported correctly between VA and the contractor, verifying supplied medications and diluents supplied by VA against the supplied label, drawing up correct quantities from the supplied medication stock, removing an equal amount of diluent from the bag to account for the volume of medication required to compound the recipe, inspecting all drawn up and finished products for precipitation, cores or other defects, labeling each product accurately, providing a final inspection and initialing each medication label.

iii. The contractor is responsible for ensuring the medications supplied by VA are stored under conditions as recommended by the manufacturer for each medication once received, during compounding and after completion of compounding. Contractor will return any unused medication, diluent, IV tubing and CADD cassettes to VA pharmacy in the condition they were supplied to the contractor by VA pharmacy.

iv. The Contractor shall affix a label to the finished product that clearly lists all ingredients contained within the product (both active and inactive), add any recommended warning or storage requirement labels (Refrigerate/warning chemotherapy) and attach to the medication container a label that notes the item’s expiration date and time. Once properly labelled, they will place the finished product in a suitable transportation container (sealed plastic box or cooler) and enclose the National Drug Code, lot numbers and expiration date for all the ingredients used in the container.

v. The contractor will transport the finish product to the VA pharmacy using DOT licensed transportation and following all applicable rules and precautions required to transport hazardous materials specifically IV chemotherapy products.

vi. ADMINISTRATIVE: Patient Safety Compliance and Reporting: Contract provider(s) shall follow all established patient safety and infection control standards of care.

Contract providers(s) shall make every effort to prevent medication errors. All events related to medication errors, and other breeches of patient safety shall be reported to the

COR per VA Safety Policy. As soon as practical as (but no later than 24 hours) contractor shall notify COR of incident and submit to the COR the Patient Safety

Report, following up with COR as required or requested.

http://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/general-chapter-800.pdf http://www.usp.org/sites/default/files/usp/document/our-work/healthcare-quality-safety/general-chapter-800.pdf

5. VA PROVIDED MATERIALS:

The VA will provide the Contractor's employee with all labels, pharmaceutical medications, all additional non-medication supplies which may include but not limited to diluents, IV tubing sets and empty, sterile CADD cassettes.

6. BILLING/INVOICING:

i. Invoices rendered by the contractor to VACCHCS for services furnished under this agreement, will be invoiced in full for each month in which services were performed.

All payments made under this contract will be made monthly in arrears in accordance with FAR Clause 52.212-4. No advance payments will be authorized.

ii. The fee agreed upon for this contract is $200 per patient specific medication product.

In addition, the contractor will invoice VA $3 for each transportation of HD medications via DOT certified transport (anticipated daily costs are expected to be, but not limited to one-round trip per day at a total of $70).

iii. Payment made during all periods of performance of this agreement shall constitute the total cost for services rendered by the contractor and shall not exceed the amounts specified in the "Schedule of Supplies and Services" without written requests and the written approval from the Contracting Officer.

iv. All invoices applicable to this agreement must be submitted no later than thirty (30) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the Contracting Officer.

v. Invoices will be submitted for services on a monthly basis. At a minimum, each invoice must contain the following: A brief written synopsis of oversight, audit or other services provided during the month, dates services were provided, name of contract person(s) who provided services, Contract Line-Item Number (CLIN), quantity, unit price, and total cost of services provided, contract number, and remittance address. All invoices must include the name, title and phone number of the person notified in the event of defective invoicing. Invoices shall be submitted in accordance with, and at the prices specified in the continuation of SF Form 1449, Schedule of Supplies and Services of this agreement.

vi. The payment for any leave, including sick leave or vacation time, is the responsibility of the contractor. Periods of any absences are not paid by the VA.