Performance Work Statement.pdf

PERFORMANCE WORK STATEMENT

Location

Delivery Times- Three standard deliveries shall be made: additional deliveries and emergency deliveries shall be made as follows.

West Palm Beach, VAMC

Contractor must provide daily routine deliveries as well as emergent deliveries. Routine weekday (M-F) delivery times; between 6:00 am and 6:30 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 12:30 am and 1:00 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within approximately 120 minutes, after hours of receiving the order by phone or electronic order (web ordering).

VA Caribbean Healthcare System emergent deliveries. Routine weekday (M-F) delivery times; between 6:00 am and 6:30 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 12:30 am and 1:00 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within approximately

Bay Pines VA Healthcare System emergent deliveries. Routine weekday (M-F) delivery times; between 6:00 am and 6:30 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 12:30 am and 1:00 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within approximately 120 minutes, after hours of receiving the

Lee County Healthcare Center

Routine weekday (M-F) delivery times; between 7:30 am and 8:00 am for 1st delivery Monday through Friday and between 9:30 am and 10:00 am (2nd delivery) and between 12:30 pm and 1:00 pm (3rd delivery). No weekend deliveries, outpatient clinic (if this changes for the future, concur with WPB times). Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 for second run on weekends (if this is the future state). VA may require additional orders within approximately 90 minutes during business hours and within approximately 120 minutes after hours of receiving the order by phone or electronic order (web ordering).

Orlando Veteran Affairs Medical Center emergent deliveries. Routine weekday (M-F) delivery times; between 6:30 am and 7:00 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 11:00 am and 11:30 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within approximately

Viera Outpatient Clinic emergent deliveries. Routine weekday (M-F) delivery times; between 7:30 am and 8:00 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 11:00 am and 11:30 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within

NFSG Veterans Health System emergent deliveries. Routine weekday (M-F) delivery times; between 6:00 am and 6:30 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 12:30 am and 1:00 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within approximately

Lake City Veterans Affairs Medical Center emergent deliveries. Routine weekday (M-F) delivery times; between 6:00 am and 6:30 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 12:30 am and 1:00 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within approximately

Malcolm Randall VA Medical Center emergent deliveries. Routine weekday (M-F) delivery times; between 6:00 am and 6:30 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 12:30 am and 1:00 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within

Jacksonville OPC emergent deliveries. Routine weekday (M-F) delivery times; between 6:00 am and 6:30 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 12:30 am and 1:00 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within approximately

James Haley Veterans Hospital emergent deliveries. Routine weekday (M-F) delivery times; between 6:00 am and 6:30 am for 1st delivery Monday through Friday and between 9:00 am and 9:30 am (2nd daily delivery) and between 12:30 am and 1:00 pm (3rd delivery) and between 2:00 pm and 2:30 pm (4th delivery). Saturday and Sunday scheduled deliveries are between 7:00 am and 7:30 am and between 12:00 am and 12:30 am. Cut off for ordering is 90 minutes before delivery, Monday through Friday and 4:30 am for first run and 8:15 am for second run on weekends. However, VA may require Additional orders within approximately 90 minutes during business hours and within approximately

VA248-16-R-1148

Miami VA Healthcare System

First delivery shall be no earlier than 7:00 am and no later than 8:00 am, whereas the nuclear medicine technologist shall be contacted for access to enter secured hot lab (Room #A207C) and PETCT trailer or PET/CT hot lab at the MVAHS. Second delivery, if required, shall occur no later than 1030 AM EST. Third delivery, if required, shall occur no later than 130 PM EST. Additional deliveries occurring Monday through Friday during working hours (0700 AM to 0430 PM EST) shall arrive within approximately one (1) hour from the time the phone request is placed. Additional deliveries occurring after working hours and weekends shall arrive within approximately two (2) hours from the time the phone request is placed.

1)

DELIVERY/SCOPE

Location Information Management Software Hardware System-

West Palm Beach, VAMC Nuclear Medicine Information System (NMIS EC2) VA Caribbean Healthcare System Nuclear Medicine Information System (NMIS Version 16.09) BayPines VA Healthcare System Nuclear Medicine Information System (NMIS EC2) Lee County Healthcare Center Nuclear Medicine Information System (NMIS EC2) Orlando Veteran Affairs Medical Center Syntrac Viera Outpatient Clinic Syntrac

NFSG Veterans Health System

EC2 NMIS Version 15 on Windows 7 Desktop built by IRM and connected and backed up to North Florida/South Georgia Veterans Health System.

Lake City Veterans Affairs Medical Center Nuclear Medicine Information System (NMIS EC2)

Malcolm Randall VA Medical Center Nuclear Medicine Information System (NMIS EC2) Jacksonville OPC Nuclear Medicine Information System (NMIS EC2) James Haley Veterans Hospital Nuclear Medicine Information System (NMIS EC2) Miami VA Healthcare System Nuclear Medicine Information System (NMIS EC2)

• Requests for additional doses during regular work hours (Monday through Saturday 6:00 am to 4:30 pm) shall be delivered within approximately 90 minutes of placing the order. Emergency and priority studies consist of 20%- 30% of the daily schedule and may include Saturday.

• The first daily delivery shall be made to Nuclear Medicine by 6:30 a.m. unless prior authorization arrangements have been made. Delivery shall be made directly to a Nuclear Medicine Technologist on duty or VA Police (after hours).

Subsequent deliveries will likewise be made as needed as described above. All packaging of radioactive materials shall be clearly labeled radioactive on the outside of the shipping carton and comply with all applicable regulating agencies. The Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

• The Contractor shall demonstrate their ability to perform and provide the manufacture and delivery of radiopharmaceuticals by supplying any/all documentation and licensure which supports their ability meet all Nuclear Regulatory Commission, Department of Transportation, Food and Drug Administration (F.D.A) approved radiopharmaceuticals and drugs, OSHA and all other Federal and State agency rules and regulations (Federal and State).

The Contractor shall be Joint Commission Accredited.

• The contractor submitting an offer related to the associated solicitation shall possess/hold and maintain current/ active licensure - in the name of the contractor -- allowing them to perform and provide the manufacture and delivery of all radiopharmaceuticals specifically required by the VAMC as specified in the price schedule.

• Contractor shall accept returns for credit under the following conditions:

a. Product(s) ordered or shipped in error

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container (specifically authorized for return by manufacturer)

• Ordering: Contractor will be furnished the name(s) of individuals authorized to purchase against the Contract. VA Medical Center will provide its own Contracting Officer's Representative (COR).

• Delivery personnel will be bonded by the contractor.

• Contractor shall provide evidence of special driver's licenses required for transporting hazardous materials.

• Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, etc. All waste shall be picked up with the next delivery.

• All radiopharmaceuticals shall be delivered in properly shielded containers with disposable impenetrable biohazard liners. Shipping containers and their labeling must comply with all federal and state regulations.

• Any recalled/incorrectly delivered dose for any reason shall be credited for the full amount.

• It is the offeror's responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method.

• Additional call back fees shall not be charged for regular work hours (M-F 6:00 am to 4:30

pm) on days not observed as a holiday by the VA, i.e. Christmas Eve, Good Friday, etc.

• Federal Holidays

-New Year's Day -Martin Luther King's Birthday -President's Day -Memorial Day -Independence Day -Labor Day -Columbus Day -Veterans' Day -Thanksgiving -Christmas Day

-Any other day declared a Federal Holiday by the US President.

• Contractor shall provide 24 hour on-call service for emergency procedures.

• Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, patient education, etc.

• Contractor shall provide 12 categories continuing education units per year specific for all Nuclear Medicine Technologist.

• All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date.

• The Radiopharmacy shall be USP <797> compliant for sterile compounding and shall provide a statement to this effect.

• Product information including supplier's source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided upon request at no additional charge.

• Consultation service regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge.

2) PERSONNEL AUTHORIZED TO PLACE ORDERS: The following personnel are authorized to telephone and/or fax radiopharmaceutical orders:

• Supervisory Nuclear Medicine Technologist

• Nuclear Medicine Technologists

• Program Support Assistant

• Other VA Medical Center Staff as designated

3) INVOICING:

• Contracting Officer's Representative (COR) shall be provided with a copy of invoice at the end of each week for approval before submission to the Department of Veteran Affairs Financial Services Center for processing. Said invoices will be sent the COR via e-mail and then reviewed for accuracy. The contractor will correct any discrepancies identified within 48 hours. A new invoice will be generated and then sent to the COR before invoice is finalized.

• Contractor shall be paid monthly, in arrears, upon submission of a properly prepared invoice for services/supplies during the period. Contractor shall submit a monthly invoice within 15 days after the end of the month being billed. The invoice will be accurate and include the contract number, date of services, and an itemized listing of charges for each line item. Invoices shall be submitted electronically to Imaging Service COR for certification.

• Contractor shall submit certified invoices monthly. Invoices at a minimum shall show period covered, billing date, name of preparation, quantity and amount.

4) PERFORMANCE/QUALITY:

• Incorrectly delivered doses shall not exceed one per quarter.

• Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. 4 per year.

• It is the offeror's responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method.

• All technetium products shall be tested for molybdenum contamination and the amount of molybdenum present shall be stated.

• Contractor shall provide complete documentation of quality control results upon request. Product information including supplier's source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier's license and procedures shall be provided at no additional charge.

• Contractor will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Only those products that pass Quality Control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of Quality Control performance of any item upon request of the VA Nuclear Medicine Service.

• All products are purchased subject to acceptance by the VA, Nuclear Medicine

Service. Products that fail to meet Quality Control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicine's Quality Control when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials.

5)

6)

7) CONTRACTOR PERSONNEL AND MANAGEMENT:

QUALIFICATIONS:

POLICY

8) NON-PERSONAL SERVICE STATEMENT:

9) PERSONNEL QUALIFICATIONS:

10)MODIFICATION

DOCUMENTS

FAR Federal Acquisition Regulation VAAR Veterans Administration Acquisition Regulation DOT Code of Federal Regulations, Title 49, Parts 100-177.

FDA Code of Federal Regulations, Title 21, Parts 200-299.

VHA Directive 1105.01, Management of Radioactive Materials

VHA

Handbook 1200.06, Control of Hazardous Agents in VA Research Laboratories.

Joint Commission Standards expected to be effective in 2015 USP US Pharmacopeia Convention Federal, State, Local, Industry, Manufacturer and any other Governing Body

The contractor shall be responsible to follow: Any and all Laws, Codes, Policies, Procedures, Standards, and any other applicable doctrine legal or otherwise must be strictly adhered to.

12 ) Glossary Acronyms used in this PWS are listed below

FAR Federal Acquisition Regulation VAAR Veterans Administration Acquisition Regulations CFR Code of Federal Regulations NRC Nuclear Regulatory Commissions DOT Department of Transportation FDA Food and Drug Administration OSHA Occupational Safety and Health Administration QASP Quality Assurance Surveillance Plan AQL Acceptable Quality Level CDR Contract Discrepancy Report CLIN Contract Line-Item Numbers VHA Veterans Health Administration LEU Low Enriched Uranium HEU High Enriched Uranium

PRICE/COST SCHEDULE

See attached document: Price Schedule - James A Haley.

See attached document: Price Schedule- Orlando Veteran Affairs Medical Center, FL, Viera Outpatient Clinic, FL.

See attached document: Price Schedule - West Palm Beach Veterans Affairs Medical Center, FL.

See attached document: Price Schedule - Miami VA Healthcare System, FL.

See attached document: Price Schedule- North Florida South Georgia.

See attached document: Price Schedule - VA Caribbean.

See attached document: Price Schedule - Bay Pines- Lee County.

Performance Period (POP): The contractor shall begin the work required under this SOW by December 5, 2022, through September 30, 2023, with four option years available. POP may be adjusted based on contract award date.

DELIVERY SCHEDULE

Base Year 12/06/2022 to 09/30/2023 Option Year-1 10/01/2023 to 09/30/2024 Option Year-2 10/01/2024 to 09/30/2025 Option Year-3 10/01/2025 to 09/30/2026 Option Year-4 10/01/2026 to 09/30/2027