36C24718Q0660-001.docx

Statement of Work

Sterile Preparation and Research Hood Certifications

1. REQUIREMENT:

This requirement is for a firm-fixed price service contract for semi-annual USP 797 certification for the facility’s sterile compounding areas and research hoods at Dorn VA Medical Center, Columbia, SC.

2. BACKGROUND:

The WJB Dorn VA Medical Center is a 216-bed facility, encompassing acute medical, surgical, psychiatric, and long-term care. The hospital is located in Columbia, South Carolina and provides primary, secondary, and some tertiary care. Annually, the Medical Center serves approximately 56,116 patients. Satellite outpatient clinics are located in Anderson, Greenville, Florence, Orangeburg, Rock Hill, Sumter, and Spartanburg, South Carolina. The Pharmacy, Research, and Pathology Lab services are in need of hood certifications and USP 797 certification.

3. PERIOD OF PERFORMANCE:

This is a requirement for annual sterile compounding and hood certifications with funding for retest, if necessary. This requirement is for Base year and four (4) renewal options. The Period of performance shall be as follows:

Work shall be performed during this period during normal business hours of 8:00am - 5:00pm Monday – Friday, excluding Federal holidays. If extended hours are required by the contractor they must notify COR/ACOR and the owning department prior to scheduling the work.

4. PLACE OF PERFORMANCE:

WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209

The sterile compounding areas are located in the main pharmacy and the fifth floor of building 100, the research hoods are located in building 9, and the pathology lab is on the first floor of building 100 of the main facility. Please schedule with COR/ACOR prior to any service visits.

5. PERFORMANCE REQUIREMENTS:

A. A Contracting Officer Representative (COR) and/or Alternate Contracting Officer Representative (ACOR) shall be assigned to this procurement and written notification shall be provided to the Contractor after award.

a. Scheduling of work performance shall be arranged through the designated COR/ACOR assigned.

B. Contractor shall provide all personnel, parts, tools, glassware, test equipment, service manuals, computer software and necessary upgrades/patches, applications support and schematics necessary to effect repairs and preventive maintenance procedures on the listed equipment during normal working hours, 8:00 AM – 4:30 PM EST Monday through Friday except federal holidays. Layouts of areas and equipment locations will be included below. The following equipment shall be covered under this contract:

a. Semi-annual (every 6 months) USP 797 certifications on all of our facility’s ISO classified compounding areas including both the pharmacy IV prep area and the chemo prep to be inclusive of all of the biological safety cabinets and laminar flow stations in those areas. Equipment and classifications as follows:

i. Pharmacy clean-room: ISO 8 Ante Room, ISO 7 Buffer Room, ISO 7 IV Preparation, and 3x ISO laminar flow stations

ii. Chemotherapy Preparation Facility: ISO 7 Ante Room, ISO 8 Drug Storage room, ISO 7 Chemo Prep Room, 1x ISO 5 isolation hood (one for main chamber and additional for antechamber), and 2x ISO Biological Safety Cabinets

b. Additional certification on the following in our research building and pathology lab:

i. 7 fume hoods

ii. 7 class II biological safety cabinets

iii. 1 class I biological safety cabinet

iv. 2 canopy hoods

v. 2 instrument hoods

Chemo HVAC Supply

Chemo BSC and Isolation box locations

IV Prep HVAC and Laminar Flow Hoods

C. The Contractor’s service representative (CSR) shall contact the COR/ACOR to schedule an inspection or prior to responding to a service call.

D. The contractor’s service representative shall present the field service report to a representative of COR/ACOR for an authorized signature, leaving one legible copy for inclusion in the facility’s Historical Maintenance Record. Contractor shall also provide COR/ACOR with a legible copy of the reports including numerical values of all measurements taken within 5 business days.

EXPERIENCE/CERTIFICATION

All work shall be performed by competent, experienced personnel qualified to work on the specified equipment in accordance with good manufacturing practices.

Contractor shall provide training certificates/competencies for all technicians assigned to perform the service, in accordance with JCAHO standards. Such certificates/competencies are to be submitted to COR/ACOR within 30 days from date of contract award. Failure to provide required documentation shall result in non-payment of invoices for this service.

Per ISO 9001, contractor shall list all the test equipment that had been used along with the details on the service report during any service associated with the equipment to include, but not limited to:

· Test equipment name

· Equipment Calibration due date

· Model

· Serial number

· Manufacturer

REPORTS:

The Contractor’s Service Representative shall present a Field Service Report to the designated COR for an authorized signature, leaving one legible copy for inclusion in the individual facility’s Historical Maintenance Record.

Contractor shall provide the designated COR with a legible copy of the Calibration Reports including numerical values of measurements taken within five (5) business days.

A copy of the Certification\Inspection procedure (including Qualitative and Quantitative tests) used by the Contractor Service Representative for each item listed on the contract, shall be made available upon request

SAFETY:

Contractor shall ensure all tools and equipment are secured at all times.

· Tools and equipment must be removed from open areas or stored in secured location during breaks, lunch, and/or at the end of each work day.

· All debris must be removed from the facility upon completion of service each day.

Contractor shall ensure proper signage and/or blockage of service area is provided and clearly visible to ensure patient/employee safety is adhered to.

Smoking is not permitted within the facilities at any time. All smoking shall be conducted in designated smoking areas only.

6. INVOICES:

a. Payment shall be made monthly in arrears, invoices shall be prepared by the Contractor, and submitted through Tungsten Network (formerly known as OB10) http://www.tungsten-network.com/us/en/. A properly prepared invoice shall contain:

· Invoice Number and Date

· Contractor’s Name and Address

· Accurate Purchase Order Number

· Supply or Service provided

· Period Supply or Service Provided

· Total Amount Due

b. Please begin submitting your electronic invoices through the Tungsten Network for payment processing, free of charge.

c. If you have questions about the e-invoicing program or Tungsten Network, contact information is as follows:

· Tungsten e-Invoice Setup Information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 1-877-353-9791

· FSC e-invoice email: vafsccshd@va.gov

d. Web Address: HTTP://WWW.FSC.VA.GOV/EINVOICE.ASP

7. TERMINATION FOR CONVENIENCE: In accordance with FAR 52.212-4 (l) The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience.

8. RECORDS MANAGEMENT LANGUAGE FOR CONTRACTS:

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

a. 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.

b. 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.

c. 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.

d. 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.

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

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

g. 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.

h. 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.].

i. No disposition of documents shall 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. Shallful 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.

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