36C24918Q9699-001.doc

STATEMENT OF WORK

TVHS PHARMACY

Primary and Secondary Engineering Control

Sterile Preparation Testing and Certification

PURPOSE: VA Tennessee Valley Healthcare System (TVHS) Pharmacy, Nashville and Murfreesboro, are required to meet certification standards outlined under USP Standard 797 concerning the operation of Compounding Isolators, Compounding Aseptic Isolators, and Clean Rooms used in compounding sterile preparations and sterile hazardous drug preparations in TVHS Pharmacies.

SERVICE: Provide all labor, materials, and equipment necessary to perform monthly viable surface, monthly air microbiological sampling, and semi-annual (April an October) Controlled Environment Testing Association (CETA) certification on primary engineering controls, secondary engineering controls, and sterile preparation areas of TVHS Pharmacies located in Building 3, Rooms G12H, G12J, and G12k -York Campus and Building 1, Rooms G105B, G105C, G105D, and G105E Nashville Campus.

GENERAL:

1)

WARRANTY

The contractor shall warranty all work against defects in materials, equipment and workmanship.

2) PRODUCT INFORMATION

All chemical cleaning solutions/disinfectants used by the vendor in the performance of work shall have the appropriate SDS available on the job site.

3) INSPECTION

Upon completion of each facility survey, the Pharmacy COR shall be immediately notified and informed of any deficiencies associated with Primary and/or Secondary Engineering Controls.

The vendor will ensure that all items used during certification are removed from the rooms upon completion of the process.

Any terminal or additional cleaning required prior to the continuation of services will be the responsibility of the medical center.

Any ceiling panels chipped, broken, or stained during the certification process will be provided to the vendor at no cost for immediate replacement by vendor personnel.

All inspections and certification work must be accomplished under dynamic operating conditions, in compliance with USP 797 standards and all local Pharmacy policies.

4) STANDARD OF PERFORMANCE

Any person and/or company performing CETA certification on sterile compounding areas at TVHS, Nashville and Murfreesboro, must be a Registered Cleanroom Certification Professional for Sterile Compounding Facilities and listed with the CETA National Board of Testing (CNBT).

Vendor must provide both the Pharmacy and Engineering COR with appropriate documentation verifying this requirement prior to start of any work associated with sterile compounding certifications of Primary and Secondary Engineering Controls, viable surface testing, and air microbiological testing at TVHS.

Vendor is a NEBB Certified Cleanroom Performance Testing Firm. Vendor must utilize NSF Accredited Individuals, NEBB Certified Technicians, CETA Registered Cleanroom Professionals for Sterile Compounding Facilities.

5) PRELEMINARY REPORT

Upon completion of tests for the engineering systems, Air exchanges, non-viable Particulates, Airflow, Seals, and Pressures, the results of those tests with a Pass/Fail designation for the applicable ISO standard will be provided within 72 hours. Report will be communicated electronically to the Pharmacy COR, Chief of Pharmacy and the Engineering COR.

6) FINAL REPORT

Upon completion of each semiannual CETA certification the vendor shall provide a complete report indicating all test results within twenty (20) business days. Report will be communicated electronically to the Pharmacy COR, Chief of Pharmacy and the Engineering COR.

The report shall include a cover page indicating any deficiencies identified on any of the primary and/or secondary Engineering control systems, results of viable surface testing and air microbiological testing.

All reports will be separated by the site location, building number and room number. Each site report will include a cover page.

Vendor will develop and provide a sampling diagram to test ISO regulated areas for the absence or presence of unwanted bioload.

If CFU levels measured during viable sampling exceed USP797 threshold levels, the report will at minimum identify genus and, when possible, species of any microorganism recovered on the monthly and semi-annual reports, in addition to the location of the CFU and specific recommendations for remediation.

Any deficiency noted on the cover page shall include a recommended corrective action for that item.

The room status shall be reported on the cover sheet as a “PASS” or “FAIL”

7) CERTIFICATION

PRIMARY ENGINEERING CONTROLS: Cabinets Primary control shall be certified in compliance with CETA Certification Guide for Sterile Compounding Facilities (CAG-003-2006-11, ANSI 49-2012, and USP 797) Primary certification testing shall include but not be limited to the following:

Placement of Primary Engineering Control

Airflow Velocity

Chamber Pressure test

HEPA filter replacement

HEPA filter integrity leak test

Back-streaming Test Airflow patterns smoke test

Site Installation Assessment test

Non-Viable Particle Counts

Particle Containment Enclosure Test

Volatile HD Containment Test

Hazardous Particle Containment Test

Preparation Ingress and Egress Test

7) CERTIFICATION

SECONDARY ENGINEERING CONTROLS: Rooms Secondary control shall be certified in compliance with CETA Certification for Sterile Compounding Facilities CAG-008-2010 and USP 797.

Secondary certification testing shall include but not be limited to the following:

Airflow - air changes per hour

Airflow – CFM at each point Air Pressure – Negative Positive

Room Volume

HEPA filter replacement (Type C)

HEPA filter smoke test

Smoke pattern testing Non-Viable Particle counts

Temperature

Humidity

HEPA (HIGH EFFICIENCY PARTICULATE AIR) FILTERS: PRIMARY

All HEPA filters will be replaced serving each cabinet during each six (6) month certification cycle.

All cabinet replacement filters will be provided by the vendor as part of this contract Prior to installation of HEPA filters all filter holding devices will be inspected to assure no damage has occurred that would cause failure of the filter during smoke testing.

Upon completion of inspection all newly installed filters shall be visually inspected to ensure correct seating of filter within the housing and correct closing of the housing.

Upon completion of installation and verification of filter seating the vendor shall smoke test the filter and its unit for compliance with USP 797 Standards.

HEPA (HIGH EFFICIENCY PARTICULATE AIR) FILTERS: SECONDARY

All HEPA filters will be replaced serving each room during each six (6) month certification cycle.

All room replacement HEPA (type C) filters will be provided by the vendor as part of this contract.

Prior to installation of HEPA filters all filter holding devices will be inspected to assure no damage has occurred that would cause failure of the filter during smoke testing.

Upon completion of inspection all newly installed filters shall be visually inspected to ensure correct seating of filter within the housing and correct closing of the housing.

Upon completion of installation and verification of filter seating the vendor shall smoke test the filter and its unit for compliance with USP 797 Standards.

VIABLE SURFACE AND AIR MICROBIOLOGICAL TESTING

Monthly - The vendor shall provide monthly viable surface, air microbiologic testing, and procedure observance in all ISO-classified areas, including all TVHS Pharmacy Hoods, Clean Rooms, Anterooms, Pass-Throughs and outer workstations as applicable in accordance with the most current CETA Certification Application Guide on USP 797 Viable Environmental Sampling and Gowning Evaluation.

Viable surface and air microbial testing to include mold and yeast utilizing Malt Extract Agar (MEA) and bacteria using Trypticase Soy Agar (TSA).

9) CONTRACTING OFFICER REPRESENTATIVE (COR)

Contracting Officer Representative (COR) duties will be shared by a representative from Pharmacy and from Engineering Services.

All correspondence and testing results concerning contract performance shall be transmitted electronically to both individuals.

Pharmacy and Engineering COR’s must maintain 6-part file to include all documentation on contract performance.

Pharmacy COR will be on site at the testing location (Murfreesboro or Nashville) during monthly testing and semi-annual certification.

Pharmacy COR and Engineering COR will be on site (Murfreesboro and Nashville) during semi-annual CETA certifications.

10) GUIDELINES

Cleanroom testing is conducted is strict compliance with CAG-003-2006-11 - “CETA Certification Guide for Sterile Compounding Facilities”. IEST-RP-CC006.3 “TESTING CLEANROOMS”. ISO 14644-1 “CLEANROOMS AND ASSOCIATED CONTROLLED ENVIRONMENTS – PART 1: CLASSIFICATION OF AIR CLEANLINESS”, and NATIONAL ENVIRONMENTAL BALANCING BUREAU (NEBB) – PROCEDURAL STANDARDS for the CERTIFIED TESTING of CLEANROOMS (Third Edition – 2009).

12) TESTING FREQUENCIES

Hours of Work – All work performed in the testing and certification of sterile preparation rooms at TVHS, Murfreesboro and Nashville campuses will be performed during the hours of 7:00 am and 4:30 pm, Monday through Friday, excluding federal holidays, in coordination with Pharmacy Management.

Monthly – Viable Surface and Air Microbial testing will be conducted by the 7th day of each month beginning in October and ending in September of each contract year.

Semi-annual CETA Certification – Semi-annual certification will be performed by the 7th day of April and October of each contract year. Viable surface and air microbial testing for the months of April and October will be conducted along with the certification of primary and secondary engineering controls.

13) PERFORMANCE PERIOD

The contract term is base year plus four option years. Contract terms are as follows.

October 1, 2018 through September 30, 2019 – Base Year

October 1, 2019 through September 30, 2020 – Option Year 1

October 1, 2020 through September 30, 2021 – Option Year 2

October 1. 2021 through September 30, 2022 – Option Year 3

October 1, 2022 through September 1, 2023 – Option Year 4