Attachment 1 - SOW -Controlled Environment Testing.doc

Attachment 1 - STATEMENT OF WORK (SOW)

Controlled Environment Testing

1. Background. Montana Veterans Affairs Health Care System (MTVAHCS) has a requirement for a Controlled Environment Testing Association (CETA) certified contractor to perform numerous testing procedures to establish an industry-based minimum set of criteria appropriate for performance evaluation and certification of facility and environmental controls used for compounding sterile preparations.

2. Scope. The vendor shall provide all personnel, supervision, professional expertise, labor, vehicles, lodging, transportation, services, and quality control to ensure all the requirements for performance, evaluation and certification of facility and environmental controls for compounding sterile preparations are performed in a manner that will meet or exceed the requirements to maintain a fully functioning facility in accordance with this Statement of Work (SOW).

The vendor shall thoroughly review the specifications and be familiar with the area of coverage prior to submitting their offer in order to be fully aware of the supplies and/or services required. Failure to do so will not relieve the offeror from performing in accordance with the strict intent and meaning of the specifications without additional cost to the Government.

Environmental controls being tested are defined as Primary Engineering Controls (PEC) and Secondary Engineering Controls (SEC).

PECs include Biological Safety Cabinets (BSC), Laminar Airflow Workbenches (LAFW), Compounding Aseptic Isolators (CAI), and Compounding Aseptic Containment Isolators (CACI). Each of these PECs may have specific manufacturer required testing criteria which the certifier is required to obtain and follow.

SECs include Cleanroom Suites, Segregated Compounding Areas (SCA), and Containment Segregated Compounding Areas (C-SCA).

Airflow testing: Airflow testing, airflow measurements, airflow balancing, room airflow exchange rate calculations, smoke tests, room differential pressure measurements, nonviable particle count in dynamic conditions measurements are performed to determine acceptability of the air velocity, the room air exchange rate, and the room pressure differential between adjacent rooms. The Air Changes Per Hour (ACPH) from Heating, Ventilation, and Air Conditioning (HVAC) system, ACPH contributed from the Primary Engineering Control (PEC) (if applicable), and the total ACPH must be documented on the certification report.

HEPA filter integrity testing: HEPA filters must be leak tested and must include documentation of any repair.

Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). Smoke testing must be documented via video recording.

Viable Sampling: The microbiological air and surface monitoring program must include viable impact volumetric airborne particulate sampling and surface sampling. Monitoring must be conducted in all classified areas during dynamic operating conditions. Provide bacterial and fungal testing in PECs and SECs and other locations, during dynamic conditions, per viable sampling maps and directions from pharmacy. Provide positive and negative control sampling media/plates. If viable levels measured during air or surface sampling exceed action levels, an attempt must be made to identify any microorganism recovered to the genus level with the assistance of a microbiologist.

Verification of room pressure/temperature/humidity gauge readings. An attempt will be made to resolve any deviation, in the displayed readings, that are outside of acceptable thresholds.

The number of personnel present in each PEC and SEC during testing must be documented.

Adjust HVAC system to provide the required ACPH, differential pressures, airflows, etc.

Other tests may be performed per applicable guidelines and may include Inflow and Downflow air measurement tests, alarm testing, smoke pattern testing, lighting, vibration, noise, and electrical inspections.

This certification shall maintain the accreditation of the primary and secondary engineering controls, necessary for compounding sterile products, by the following as applicable: PEC manufacturer specifications, CETA controlled application guides (CAG), The Joint Commission (TJC) standards, Food and Drug Administration (FDA), Veteran’s Health Administration (VHA) Directive 1108.12, United States Pharmacopeia (USP) Chapter 797, and USP Chapter 800.

3. Certification. The onsite Technician, performing services, must be certified through CETA. Documentation from the CETA organization must confirm that the Technician is credentialed for Sterile Compounding Facilities (SCF). This will ensure that the certificate holders possess the fundamental knowledge required to certify sterile compounding facilities per industry guidelines.

4. Facilities.

Fort Harrison VA Medical Center (VAMC)

3687 Veterans Drive

Fort Harrison, MT 59636

Equipment:

Within the Fort Harrison building

One (1) - Shared nonhazardous/hazardous Ante Room

One (1) - Hazardous Sterile Compounding Buffer Room

One (1) - Class II A2 Biological Safety Cabinet

One (1) - Non-hazardous Sterile Compounding Buffer Room

One (1) - Six-foot (6’) LAFW in a non-hazardous buffer room.

Two (2) - HEPA filtered passthroughs

One (1) - Four Foot (4’) Laminar Airflow Workbench (LAFW) in a Segregated Compounding Area

One (1) - Compounding Aseptic Containment Isolator (CACI) in a Containment Segregated Compounding Area (C-SCA)

Dr. J Medicine Crow VA Community Based Outpatient Clinic (CBOC)

1775 Spring Creek Lane

Billings, Montana 59102 Equipment:

One (1) Compounding Aseptic Isolator in a Segregated Compounding Area

5. Specific Tasks.

Contingency C-SCA

(Fort Harrison)

C-SCA: Viable Sampling (air & surface), ACPH, Differential Pressure

CACI: Viable Sampling (air & surface, main chamber & passthrough), non-viable particle count (NVPC), Smoke Video

Contingency SCA

(Fort Harrison)

SCA: Viable Sampling (air & surface)

LAFW: Viable Sampling (air & surface), NVPC, Smoke Video

Sterile Compounding Suite

(Fort Harrison)

Hazardous Buffer Room: Viable Sampling (1 air & 2 surface), NVPC, ACPH, Differential Pressure

Hazardous Buffer Room: HEPA

Hazardous Buffer Room HEPA pass-through: Viable Sampling (air & surface), HEPA

Hazardous Buffer Room BSC: Viable Sampling (air & surface), NVPC, Smoke Video

Hazardous Ante Room: Viable Sampling (1 air & 2 surface), NVPC, ACPH, Differential Pressure

Hazardous Ante Room HEPA

Non-Hazardous Buffer Room: Viable Sampling (1 air & 2 surface), NVPC, ACPH, Differential Pressure

Non-Hazardous Buffer Room HEPA

Non-Hazardous Buffer Room HEPA pass-through: Viable Sampling (air & surface), HEPA

Non-Hazardous Buffer Room LAFW: Viable Sampling (2 air & 2 surface), NVPC, Smoke Video

All Compounding Locations

(Fort Harrison and Billings)

Parts

Labor & Repairs

Segregated Compounding Area

(Billings)

SCA: Viable Sampling (air & surface)

CAI: Viable Sampling (2 air & 2 surface), NVPC, Smoke Video

2 Control Plates

Development of USP Reports for Pharmacy

Travel to Billings, MT (from Helena)

Travel to Billings, MT (not tied to Helena site visit)

6. Performance Monitoring.

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

a) Date of Testing

b) Name of contractor, contact information, and contract number.

c) Name and certification of technician who performed services.

d) Confirmation that the most current version of CETA Certification Guide, and USP Chapters 797 & 800 were used.

e) Equipment identification and calibration information dates of the Contractor’s equipment used during the testing.

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

g) Location of the data collected.

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

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

j) Recommendations for repairs or improvements.

k) ISO classification designation

l) ACPH

m) Pressure differential verification

n) Temperature verification

o) Humidity verification

p) Viable air and surface sampling

q) Number of personnel present during testing

r) Identification of actionable levels of microbial growth to genus level if possible

s) HEPA filter leak testing and any repairs

t) Recorded dynamic airflow smoke visualization testing of direct compounding areas via a video (Smoke studies will be provided in a readily accessible format.)

u) Signature of the technician performing services or other vendor official authorizing final report

7. Security Requirements.

No access to patient records, data or VA computer systems is needed.

8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

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

Pharmacy will provide staff as needed for smoke study videos.

Pharmacy will provide viable sampling locations upon request.

9. Other Pertinent Information or Special Considerations.

The Contractor (or Representative) shall contact the COR to schedule work and before beginning of work on site.

a. Identification of Possible Follow-on Work. Additional visits may be required to resample, retest, repair, etc. Twice yearly visits for each location are required.

b. Identification of Potential Conflicts of Interest (COI). None

c. Identification of Non-Disclosure Requirements. Contractor will not have access to any sensitive or proprietary information during contract performance.

d. Packaging, Packing and Shipping Instructions.

Fort Harrison VA Medical Center (VAMC) c/o Pharmacy

3687 Veterans Drive

Fort Harrison, MT 59636

Dr. J Medicine Crow VA Community Based Outpatient Clinic (CBOC) c/o Pharmacy

1775 Spring Creek Lane

Billings, Montana 59102

e. Inspection and Acceptance Criteria.

i) After work is completed, the contractor is to submit in writing, a complete report of services performed for each item of equipment and must include a listing of replacement parts, when applicable.

ii) The vendor will electronically report ventilation and sampling data to Montana VA Healthcare System Pharmacy.

iii) The report shall have guidance on interpreting results, possible contamination pathways and proper corrective actions to remediate contamination.

iv) All reports shall be provided to Point of Contract (POC) within 14 business days of work being completed.

v) The contractor shall supply every Primary Engineering Control that passes required certification specifications with a certification sticker.

COR or designated pharmacy personnel will evaluate certification reports for completeness. All certification and recertification records must be reviewed by facility’s designated person(s) to ensure that the classified environments meet the minimum requirements.

10. Risk Control.

Materials and equipment, used in testing and certification, will be cleaned/disinfected as much as possible before entering areas used for compounding. Movement of equipment into compounding areas will be done under the supervision of pharmacy staff.

11. Place of Performance.

Fort Harrison VA Medical Center (VAMC) c/o Pharmacy

3687 Veterans Drive

Fort Harrison, MT 59636

Dr. J Medicine Crow VA Community Based Outpatient Clinic (CBOC) c/o Pharmacy

1775 Spring Creek Lane

Billings, Montana 59102

12. Period of Performance. Certification shall be performed no later than six (6) months from previous certification and every six (6) months thereafter.

Last certification date:

Fort Harrison – March 4, 2025 Billings – March 13, 2024 Estimated Period of Performance:

Base Year:

August 01, 2025 to July 31, 2026

Contract Period 1:

August 01, 2026 to July 31, 2027

Contract Period 2:

August 01, 2027 to July 31, 2028

Contract Period 3:

August 01, 2028 to July 31, 2029

Contract Period 4:

August 01, 2029 to July 31, 2030

13. Deliverables.

a. Certification Reports. Written Certification Reports are to be submitted within 14 business days following each certification visit in a readily accessible format and delivered to designated staff members.

b. Smoke Study Videos. Performed during certification activities are to be submitted with the certification report to designated staff members in a readily accessible format. Vendor will work with COR to determine a format that is readily accessible.