SOW IV Certification.docx

Statement of Work

Contractor Pending Compete

2237: 575-26-3-036-0138 POC: Shauna Hartbauer Pharmacy Administrative Officer, FAC-COR Shauna.hartbauer@va.gov 9702420731 ext. 4426

1. General Objectives and Requirements A. Purpose: To ensure the comprehensive certification of all sterile compounding hoods and rooms.

B. Authority for the Contract:

i. 38 U.S. Code § 7301.b “The primary function of the Veterans Health Administration is to provide a complete medical and hospital service for the medical care and treatment of veterans, as provided in this title and in regulations prescribed by the Secretary pursuant to this title.”

ii. COR/POC: Shauna Hartbauer Email: shauna.hartbauer@va.gov Phone: 9702420731 ext. 4426

2. Background. The VA Western Colorado Health Care System, located in Grand Junction, CO, maintains segregated compounding areas (SCA)s and a containment segregated compounding area (C-SCA) which are used to aseptically compound non-hazardous and hazardous drugs, respectively. These areas and their equipment require regular testing and certification to ensure compliance with applicable standards and to maintain a safe and controlled environment for the preparation of medications. This project involves engaging a certified contractor to furnish all necessary labor, equipment, and software to execute comprehensive testing and certification of the sterile compounding areas and associated equipment. The goal is to ensure the facility's continuous compliance with regulatory requirements and to uphold the safety and efficacy of compounded medications for patient use.

3. Period of Performance.

A. Base Year: 05/15/2026 through 05/14/2027 B. Option Year 1: 05/15/2027 through 05/14/2028 C. Option Year 2: 05/15/2028 through 05/14/2029 D. Option Year 3: 05/15/2029 through 05/14/2030 E. Option Year 4: 05/15/2030 through 05/14/2031

4. Hours of Operation.

A. Normal hours of operation are Monday through Friday, 0800 to 1700, except Federal Holidays listed below and any other day declared a federal holiday by the President of the United States. The Contractor may schedule work outside of normal hours with prior approval of Contracting Officer (CO) and/or station Contracting Officer’s Representative (COR) and/or the Chief of Pharmacy.

Christmas Day

5. Scope.

A. Contractors must be certified by the Controlled Environment Testing Association (CETA). The inspection contractor shall furnish labor, equipment, and software necessary to provide testing and certification of the Pharmacy Sterile Compounding suite and equipment. The equipment is located at Grand Junction, CO, on the campus of the VA Western Colorado Health Care System.

B. Inspections shall include the following testing and certification of primary and secondary engineering controls:

i. Non-viable and viable testing and certification of one compounding aseptic containment isolator (CACI)

a. Serial number: CHEMOSV001-51

ii. Non-viable and viable testing and certification of one compounding aseptic isolator (CAI)

a. Serial number: Micro 4x2 LF-12

iii. Non-viable and viable testing and certification of one Laminar Airflow Workbench (LAFW)

a. Serial number: 4S-15-BH-19812

iv. Pressure differential and air exchange testing of one containment segregated compounding area (C-SCA) C. The contractor shall perform appropriate tests and procedures to be employed on the various primary and secondary engineering controls. The tests used will comply with current Controlled Environment Testing Association (CETA) standards, United States Pharmacopeia Chapters <797> and <800>, and current NSF standards.

6. Qualifications of Field Service Engineers/Technicians. Technicians performing inspection and certification must be CETA certified.

5. Response Times A. Inspections are to be performed semi-annually (every 6 months) according to the following schedule:

i. Certification C-SCA, CACI AND LAFW – May

ii. Certification CAI - August

iii. Certification C-SCA, CACI AND LAFW - November

iv. Certification CAI - February B. If any of the above inspections fail certification during their scheduled semi-annual dates, the contractor will address the issues in coordination with the compounded sterile products (CSP) pharmacist.

i. The contractor will repair any mechanical issues at the time of certification if within the scope of their expertise and if all necessary parts and equipment are available.

ii. If the required parts and equipment are not available at the time of certification failure, the contractor will work with the CSP pharmacist to order the needed items and return to repair and recertify the failed hood as soon as possible.

C. The Contractor (or Representative) shall contact the COR and CSP pharmacist to schedule work and prior to beginning work on site.

D. The Contractor shall conduct a joint inspection with the CSP pharmacist upon certification and testing of equipment

6. Parts.

A. The contractor shall furnish all parts and consumables required to conduct testing and the price of the parts and consumables shall be included in the price of this contract.

7. Service Tools and Test Equipment.

A. The contractor shall provide all tools, test equipment, manuals, and diagnostic software necessary to perform the work.

8. Documentation of Service and Inspections (Quality Assurance).

A. The Contractor shall provide documentation of the services rendered for each scheduled inspection. The documentation shall contain the following information:

i. Date of Testing

ii. Name of contractor, contact information, and contract number.

iii. Name and certification of technician who performed services.

iv. Confirmation that the most current version of CETA Certification Guide was used.

v. Calibration certificates of the Contractor’s equipment used during the testing.

vi. Contractor service ESR number/log number.

vii. Identification of equipment serviced: Inventory ID number, Manufacturer's name, device name, model number & serial number, any other manufacturer's identification numbers.

viii. Itemized Description of Service Performed (including, if applicable, costs associated with after-normal-working-hour services) including Labor and Travel, Parts (with part numbers), Materials and Circuit Location of problem/corrective action.

ix. Location of the data collected.

x. Explanation of test procedures used and justification for any deviations from established industry practices encountered during the certification process.

xi. Comparison of collected data with expected values or specific equipment performance criteria.

xii. Recommendations for repairs or improvements.

xiii. Signatures of the FSE/T performing services described.

9. List of Testing and Certification Requirements.

A. Contractor shall describe proposed tests for each listed area including but not restricted to the tests listed here, based on Contractor’s expertise in the applicable standards.

i. Chemo preparation area (637 cubic feet). Pressurization to be negative to Anteroom. Supply Air:760 CFM; Exhaust Air:900 CFM; Outside Air:380 CFM; Return Air: 0 CFM; Flow Differential: -140 CFM; minimum air changes per hour: 30; Minimum pressure differential -0.01 inch to -0.03 inch.

a. Test Room Airflow and Pressure

b. Air Changes per Hour

ii. Compounding Aseptic Containment Isolator (Chemosphere: Isotech 19CS07P14)

a. Test Airflow and Pressure

b. Air Changes per Hour

c. Test Laminar Air Flow (Laminar Airflow visualization study)

d. Test HEPA Filter Integrity

e. Calibrate pressure gauge

f. Viable Airborne Particle Sample, with Colony ID

g. Viable Surface Particle Sample, with Colony ID

h. Environmental non-viable particle count

iii. Laminar Airflow Workbench (LAFW) Serial number: 4S-15-BH-19812

a. Test Airflow and Pressure

b. Air Changes per Hour

c. Test Laminar Air Flow (Laminar Airflow visualization study)

d. Test HEPA Filter Integrity

e. Calibrate pressure gauge

f. Viable Airborne Particle Sample, with Colony ID

g. Viable Surface Particle Sample, with Colony ID

h. Environmental non-viable particle count

iv. Compounding Aseptic Isolator (Microsphere: Isotech 015G07P34)

a. Test Airflow and Pressure

b. Air Changes per Hour

c. Test Laminar Air Flow (Laminar Airflow visualization study)

d. Test HEPA Filter Integrity

e. Calibrate pressure gauge

f. Viable Airborne Particle Sample, with Colony ID

g. Viable Surface Particle Sample, with Colony ID

h. Environmental non-viable particle count

10. Risk Control. The Contractor shall be escorted by the Agency. The Contractor may need passes from the on-station Police Department.

11. Invoices and Payment. Payment will be made in arrears of each inspection. Invoices must include, as a minimum, the following information: Contract Number, Purchase Order Number, Equipment covered (to include serial #s) and date of service. Any additional charges must be approved by the Contracting Officer before service is initiated.

12. Safety Requirements. The Contractor is solely responsible for compliance with all federal, state and local laws, the Occupational, Safety and Health Act (OSHA) (Public Law 91-596) and the resulting standards, OSHA Standards 29 CFR 1910 and 1926, as applicable, and the protection of their employees and subcontractor employees.

13. VA Regulations. Contractor employees always wear visible identification when on Station. Consumption of tobacco and other substances legal for use in the State of Colorado is not permitted on VA property, in any form. Possession of firearms is prohibited. Containers, including personal bags and toolboxes, are subject to search at the discretion of the VA Police.

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