D.1_PWS 2026-2031 Sterile Compounding Services Contract - 10152026.pdf

PERFORMANCE WORK STATEMENT

South Texas Veterans Health Care System

Certification of Sterile Compounding Services

South Texas Veterans Health Care System

Audie L. Murphy Memorial VA Hospital 7400 Merton Minter Blvd.

San Antonio, TX

1. BACKGROUND: The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of Compounded Sterile Preparations (CSPs). The Joint Commission (TJC) established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. Additionally, the Food and

Drug Administration (FDA) has the authority to inspect VA medical facilities using the USP standards.

VHA Directive 1108.12, Management and Monitoring of Pharmaceutical Compounded Sterile

Preparations, dated February 14, 2024, defines organizational responsibility for USP <797> and USP <800> standards for cleanroom design and engineering controls, environmental monitoring and cleaning of primary and secondary engineering controls, and the core competencies for personnel involved in the processes of compounding sterile preparations including HDs (both sterile and nonsterile dosage form preparations). It is VHA policy that each VA medical facility that provides CSPs have a pharmaceutical CSP program in place that conforms to the standards in USP Chapter <797> “Pharmaceutical Compounding‐Sterile

Compounding” and USP <800> “Hazardous Drugs – Handling in Healthcare Settings.”

According to VHA Directive 1108.12, and that all VA medical facilities must establish a separate and dedicated contract for all applicable USP <797> and USP <800> CSP performance evaluations, testing, and certifications requirements.

2. OBJECTIVE: South Texas Veterans Healthcare System seeks a contractor, for testing and certification of the Audie L. Murphy Memorial VA Hospital Pharmacy Service’s primary engineering controls (PECs) and secondary engineering controls (SECs) used for preparation of Compounded Sterile Preparations (CSPs) in addition to testing of compounding personnel for aseptic technique by gloved fingertip and thumb sampling and media fill testing. PECs include biological safety cabinets (BSCs) and laminar airflow workstations (LAFWs) hoods.

Testing and certification will be completed in accordance with United States Pharmacopeia

(USP) Chapter <797> and <800> guidelines using Controlled Environment Testing

Association (CETA) Certified National Board of Testing (CNBT) certified individuals/companies to establish consistent PEC certification procedures using the

Certification Guide for Sterile Compounding Facilities CAG-003-2006. USP <797> implies

Controlled Environment Testing Association (CETA) Controlled Applications Guides (CAGs)

“or equivalent” may be used. CETA CAGs define certification procedures to assess the PEC is performing and operating as designed to maintain a sterile environment for the preparation of CSPs. According to VHA Directive 1108.12, VA adopted CETA CAGs as the mandatory standard; no “equivalent” standards may be used. All vendors used to conduct primary and secondary engineering controls certifications/assessments must be registered with CETA, as

Registered Certified Professionals for Sterile Compounding Facilities (RCP SCF).

3. DEFINITIONS:

Anteroom. An anteroom is an International Organization for Standardization (ISO) Class 8 or cleaner room with fixed walls and doors where personnel’s hand hygiene, garbing procedures and other activities that generate high particulate levels may be performed.

The anteroom is the transition room between the unclassified area of the facility and the buffer room. NOTE: An ISO Class 7 anteroom is required when compounding hazardous drugs in compliance with USP.

Biological Safety Cabinet. A Biological Safety Cabinet (BSC) is a ventilated cabinet used for preparation of hazardous CSPs for personnel, product, and environmental protection having an open front with inward airflow for personnel protection, downward high-efficiency particulate air (HEPA)-filtered laminar airflow for product protection, and HEPA-filtered exhausted air for environmental protection. A BSC is an example of a Containment Primary Engineering Control (C-PEC).

Buffer Room. A Buffer room is an ISO Class 7 or cleaner room with fixed walls and doors where PEC(s) that generate and maintain an ISO Class 5 environment are physically located. The buffer room may only be accessed through the anteroom or another buffer room.

Classified area. A classified area is one that maintains an air quality classification based on the ISO standards (also known as ISO class).

Cleanroom Suite. A cleanroom suite is a room with a classified buffer and anteroom in which the concentration of airborne particles is controlled to meet a specified airborne particulate cleanliness class. Microorganisms in the environment are monitored so that a microbial level for air and surface are not exceeded for a specified cleanliness class.

Compounded Sterile Preparation. A compounded sterile preparation (CSP) is a formulation intended to be sterile that is created by combining, diluting, pooling, or otherwise altering a drug product or bulk drug substance. A product produced by reconstituting a conventionally manufactured product for an individual patient strictly in accordance with the directions contained in the approved labeling provided by the product manufacturer is not considered a CSP within the standards of USP.

Containment Primary Engineering Control. A Containment Primary Engineering Control (C-PEC) is a type of Primary Engineering Control (PEC) that is a ventilated device designed and operated to minimize worker environmental exposures to hazardous drugs by controlling emissions of airborne contamination.

Controlled Environment Testing Association Controlled Application Guide.

Controlled Environment Testing Association (CETA) Controlled Application Guide (CAG) standards define certification procedures to assess the PEC and SEC are performing and operating as designed to maintain a sterile environment for the preparation of CSPs.

USP and USP standards make specified CETA CAG guidelines enforceable by inclusion.

Hazardous Drug. A hazardous drug (HD) is any drug identified by at least one of the following six-criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low dose in humans or animals, genotoxicity, or newly approved drugs that mimic existing hazardous drugs in structure or toxicity.

High-efficiency Particulate Air Filtration. A high-efficiency particulate air filtration is an extended-medium, dry- type filter in a rigid frame, having a minimum particle collection efficiency of 99.97% as defined with the American Society of heating, Refrigeration and Airconditioning Engineering (ASHRAE).

International Organization for Standardization Class. An international organization for standardization class is an internationally agreed upon air quality classification standard defined by the International Organization for Standardization (ISO).

Laminar Airflow Workstation. A Laminar Airflow Workstation (LAFW), also known as a Laminar Air Flow Hood or Laminar Flow Clean Bench, is a device that is a type of Laminar Airflow System (LAFS) that provides an ISO Class 5 or better environment for sterile compounding. The device provides a unidirectional HEPA filtered airflow. A LAFW may be either horizontal or vertically oriented. Use of these devices is recommended for the non-hazardous cleanrooms. These devices can be 100 percent re-circulatory type.

Microbial Contamination. Microbial contamination is the presence of microorganisms in or on an item.

Premium Travel: Premium travel refers to travel performed under conditions that require an elevated or expedited response beyond routine scheduled maintenance services. Premium travel applies when circumstances trigger emergency, after-hours, or otherwise non-standard response timelines.

Primary Engineering Control/Containment-Primary Engineering Control (PEC/C- PEC). Primary Engineering Control/Containment-Primary Engineering Control is a device that provides an ISO Class 5 environment for the exposure of critical sites when compounding hazardous and non-hazardous CSPs. Such devices provide unidirectional airflow and include Class II Biological Safety Cabinets for hazardous CSPs and Laminar Airflow Workbench (LAFW) for non-hazardous CSPs.

Quality Assurance. Quality Assurance (QA) is a system of procedures, activities and oversight that ensures that operational and quality standards are consistently met. A quality assurance program for compounded preparations must be established and maintained at the facility level. All records, certifications, evaluations and documents are created as part of the compounding quality-assurance program and are confidential and privileged and may not be disclosed except under limited circumstances as authorized by 38 U.S.C. § 5705 and its implementing regulations.

Secondary Engineering Control. Secondary Engineering Control (SEC) is a space such as a buffer area which generally serves as the core for the location of the PEC and an ante area for hand hygiene and garbing.

Segregated Compounding Area. A segregated compounding area (SCA) is a designated, unclassified space, area, or room with a defined perimeter that contains a PEC and is suitable for preparation of low risk or Category 1 CSPs only.

Standard Operating Procedure. A Standard Operating Procedure (SOP) is a written procedure describing operations, testing, sampling and interpretation of results, and corrective actions that relates to the operations that are taking place.

Standard Travel. Standard travel refers to all routine travel required to perform scheduled maintenance services. Standard travel applies when services are performed during normal business hours under standard response timelines.

Unclassified space. A space not required to meet any air cleanliness classification based on the ISO.

Unidirectional Air. Unidirectional air is an airflow moving in a single direction in a robust and uniform manner and at sufficient speed to reproducibly sweep particles away from the critical site.

NOTE: For definitions of other relevant terms please see USP <797> and <800>.

4. SCOPE OF WORK

4.1. Primary Engineering Controls (PECs) Certification: Certification procedures defined in

CETA CAG-003-2026 must be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months or whenever the PEC or room is relocated or altered or altered or when major service to the sterile compounding facility is performed. Certification of PECs must include the following:

4.1.1.1. Airflow testing: Airflow testing is performed to determine acceptability of the air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The air changes per hour (ACPH) from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.

4.1.1.2. High-Efficiency Particulate Air (HEPA) filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

4.1.1.3. Total particle count testing: Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment.

Calibration of equipment used must be included in the final report.

4.1.1.4. Airflow smoke pattern test: Both static and dynamic smoke studies verifying a continuous flow of HEPA filtered air void of turbulence, dead air zones, and refluxing from the HEPA filters to and across the entire work area and to the air returns must be performed and documented by video. Video of dynamic smoke test must document the demonstration of unidirectional airflow and sweeping action over and away from the preparation(s). Contractor to leave digital video via the preferred technology by the customer (i.e. email, flash drive, etc.) of smoke test on site prior to completion of certification process for each of the listed PECs.

4.1.2. The contractor shall test and certify each PEC to the most current version of the

Institute of Environmental Sciences (IEST) Recommended Practice (RP) CC002

(Unidirectional-flow, clean-air devices) and to the manufacturer’s specifications.

The contractor shall use a NIST traceable or comparable calibrated piece of equipment to perform all testing. The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back streaming test. Any failures shall be reported directly to the identified site point of contact(s) within 24 hours.

4.1.3. Horizontal Laminar Flow Hoods certifications shall be certified according to the

IEST RP-CC002 Testing Laminar Air Flow Devices.

4.1.4. The contractor shall certify all Class II biological safety cabinets to the current version (2024or higher) of NSF/ANSI 49. All equipment used to certify biological safety cabinets shall have National Institute of Standards and Technology (NIST) traceable or comparable calibration certification. Any unit that fails to meet

NSF/ANSI 49 specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable.

4.1.5. The list of tests includes, but is not limited to:

4.1.5.1. HEPA filter leak test

4.1.5.2. Cabinet leak test

4.1.5.3. Inflow velocity test to include exhaust airflow volume rate

4.1.5.4. Airflow Smoke pattern test

4.1.5.5. Electrical leakage and ground circuit resistance and polarity tests

4.1.5.6. Lighting intensity test

4.1.5.7. Vibration test

4.1.5.8. Noise level test

4.1.5.9. Ultraviolet (UV) lamp test

4.1.6. For each PEC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

4.1.6.1. Company name and address

4.1.6.2. Unit make, model and serial number

4.1.6.3. Report number

4.1.6.4. Location (room number)

4.1.6.5. Certification date

4.1.6.6. Recertification date

4.1.6.7. Technician name and signature

4.1.7. The contractor will perform recertification testing as needed. Any failure upon recertification will be retested for that specific failure according to CETA standards within one week, or at a date/time coordinated with the Contracting Officer

Representative (COR), from STVHCS informing the certification company that the issue has been remediated.

4.2. Secondary Engineering Controls (SECs) Certification: The contractor will provide comprehensive cleanroom testing and certification services every 6 months to include:

4.2.1.1. HEPA filter integrity testing: HEPA filters must be leak tested after installation and as part of recertification.

4.2.1.2. Airflow profiling and uniformity testing

4.2.1.3. Particulate monitoring

4.2.1.4. Room pressurization monitoring

4.2.1.5. Temperature and Humidity monitoring

4.2.1.6. Air pattern analysis

4.2.1.7. Airflow smoke pattern test (commissioning of new sterile compounding areas): Both static and dynamic smoke studies verifying a continuous flow of

HEPA filtered air void of turbulence, dead air zones, and refluxing from the

HEPA filters to and across the entire work area and to the air returns must be performed and documented by video. Video of dynamic smoke test must document the demonstration of unidirectional airflow and sweeping action over and away from the preparation(s). Contractor to leave video of smoke test on site prior to completion of certification process for each of the listed

SECs.

4.2.2. Air Changes per Hour: The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer, ante, and hazardous drug storage room and include their findings in the report. In the event that a room does not meet

USP<797> requirements for ACPH the identified site POC(s) shall be informed immediately.

4.2.3. Pressure Requirements: The contractor shall include in their report differential pressure readings from each buffer/ante room and hazardous drug storage room to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797> and USP <800>. The contractor shall report all pressures to an accuracy of 0.0001” water column (4 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

4.2.4. Pass-through chambers must be included in the facility’s certification to ensure that particles are not compromising the air quality of the negative-pressure buffer room.

4.2.5. The contractor will perform recertification testing as needed. Any failure upon recertification will be retested for that specific failure according to CETA standards within one week, or at a date/time coordinated with the COR, from STVHCS informing the certification company that the issue has been remediated.

4.3. Non-Viable Testing: The contractor shall perform environmental nonviable particle testing at least once every 6 months. The contractor shall derive the minimum number of sampling locations using the ISO 14644-1:2015 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results of the following:

4.3.1. ISO Class 5: not more than 3520 particles 0.5 µm and larger size per cubic meter of air for any area primary engineering control (BSC or LAFW).

4.3.2. ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per cubic meter of air for any buffer area or hazardous compounding ante room.

4.3.3. ISO Class 8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any non-hazardous compounding ante room.

4.3.4. The contractor will perform recertification testing as needed. Any failure upon recertification will be retested for that specific failure according to CETA standards within one week, or at a date/time coordinated with the COR, from STVHCS informing the certification company that the issue has been remediated.

4.4. Viable Environmental Testing: The contractor shall perform viable environmental (air and surface) sampling every month for fungi and bacteria using high volume impaction samplers to conduct the sampling.

4.4.1. A general microbiological growth media that supports the growth of bacteria and fungi must be used. COAs from the manufacturer must verify that the media meets the expected growth promotion, pH, and sterilization requirements. Samples must be incubated in an incubator at temperatures that will promote growth of bacteria and fungi. The incubator temperature must be monitored during incubation, either manually or by a continuous recording device, and the results must be reviewed and documented as described in the Contractor’s SOPs.

4.4.2. Quality assurance results of media plates being used and calibrations of equipment used to incubate media plates must be provided in each report.

4.4.3. Air Sampling: Volumetric active air sampling of all classified areas using an impaction device must be conducted in each classified area during dynamic operating conditions every month. A minimum volume of air (1000 liters) shall be tested at each location in order to maximize sensitivity. Samples of less than 1000 liters will not be acceptable. Air sampling sites must be selected in all classified areas and illustrated on a diagram of the cleanroom suite.

4.4.3.1. If levels measured during the viable air monitoring program exceed the levels as defined in USP <797> for the ISO classification levels of the area sampled, the Contractor must identify any microorganisms recovered to the genus level with the assistance of a microbiologist and provide the results within one business day of results.

4.4.4. Surface Sampling: The Contractor must perform surface sampling of all classified areas and pass-through chambers connecting to classified areas for microbial contamination every month. The Contractor must perform the surface sampling at the end of compounding activity or shift, but before the area has been cleaned and disinfected

4.4.5. The areas that require surface sampling include, but are not limited to the following:

4.4.5.1. The interior of the PEC and the equipment contained in it

4.4.5.2. Staging or work area(s) near the PEC

4.4.5.3. Frequently touched surfaces

4.4.6. Any laboratory results equal to or greater than the action level will require notification of the POC(s) within 24 hours upon receipt of results.

4.4.7. Reports to include at a minimum:

4.4.7.1. Date and time sampling was taken.

4.4.7.2. Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates reported as colony forming units (CFUs) as well as the species grown.

4.4.7.3. Report shall immediately notify the site identified POC(s) of any highly pathogenic microorganisms identified.

4.4.7.4. The identification of highly pathogenic microorganisms will be highlighted in the report.

4.4.7.5. Media lots used for samples

4.4.7.6. Comments indicating when dynamic conditions were used

4.4.7.7. Certificates of analysis of media used

4.4.7.8. Results of quality assurance media plates

4.4.7.9. Calibration of equipment used

4.4.7.10. Sketch identifying location of each sample obtained

4.4.8. The contractor will perform retesting as needed. For any surface or air sample testing showing above the USP 797 allowable CFU count or an objectionable organism, the primary engineering control or secondary engineering control in which the finding occurred will be retested for the air or surface sample no later than one week after results are reported.

4.5. Environmental Quality and Control: The Contractor must perform environmental wipe sampling for hazardous drug surface residue every 6 months or more frequently as needed to verify containment.

4.5.1. The kits used to complete wipe sampling must be verified prior to use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs. The drugs required for testing include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-containing drugs.

4.5.2. Additional drugs may be requested based upon identified need per site. Upon identified need, the applicable site will work directly with the contractor where additional cost will be clarified and agreed upon by both parties prior to testing.

4.5.3. A total of 6 surface samples in each designated area will be completed per certification. Surface sampling will include the following areas:

4.5.3.1. Interior of the containment-primary engineering control (C-PEC) and equipment contained in it

4.5.3.2. Pass-through chambers

4.5.3.3. Surfaces in staging or work areas near the C-PEC

4.5.3.4. Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)

4.5.3.5. Areas immediately outside the hazardous drug buffer room or the containment-segregated compounding area (C-SCA).

4.5.4. If any measurable contamination is found, the Contractor must report the results directly to the site identified point(s) of contact (POC) as soon as practicable and no later than 48 hours of receiving results. The Contractor must repeat the wipe sampling within 5 business days to validate that the facility’s corrective action has been effective.

4.6. Personnel Testing: All compounding personnel must perform gloved fingertip and thumb testing and media-fill testing to assess their garbing and hand hygiene competency and aseptic manipulation practices initially and every 6 months thereafter.

4.6.1. The Contractor will schedule subsequent personnel testing after completing initial qualification testing.

4.6.2. The Contractor will perform personnel testing within five business days of being notified of a new employee requirement.

4.6.3. The ALM Memorial VA Hospital will be responsible for notifying the Contractor when an employee no longer requires personnel testing.

4.6.4. Media Fill Testing

4.6.4.1. Media Fill Testing will occur in a Laminar Airflow Workstation (LAFW) or

Biological Safety Cabinet (BSC) and simulate the most difficult and challenging compounding procedures and processing conditions encountered by the person replacing all the components used in the CSPs with soybean– casein digest media and verification of hazardous drug containment if applicable.

4.6.4.2. A certificate of analysis (COA) must be provided for commercial sterile microbial growth media used for the media fill testing

4.6.4.3. Media Fill Testing shall occur initially and every 6 months.

4.6.4.4. Media Fill Testing will occur prior to gloved fingertip and thumb testing for aseptic manipulation competency.

4.6.4.5. The Contractor shall incubate media fill tests in controlled temperature environments in accordance with USP <797> and <800>.

4.6.4.6. Documentation of the media fill test will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the results.

4.6.4.7. If an employee does not pass, the Contractor will return for retesting no later than one week after results have been reported.

4.6.5. Gloved Fingertip and Thumb Testing

4.6.5.1. The Contractor shall perform three separate gloved fingertip and thumb tests post hand hygiene and garbing during initial qualification testing (one sampling device per hand) for each designated employee.

4.6.5.2. The Contractor shall perform one gloved fingertip and thumb tests post hand hygiene and garbing for requalification testing (one sampling device per hand) for each designated employee.

4.6.5.3. Requalification gloved fingertip testing shall occur every 6 months.

4.6.5.4. Immediately following the media fill test, the contractor shall perform gloved fingertip and thumb tests (one sampling device per hand) for each designated employee.

4.6.5.5. A certificate of analysis (COA) must be provided for commercial sterile microbial growth media used for the media fill testing.

4.6.5.6. Gloved fingertip and thumb samples shall be performed in controlled temperature environments and incubated in accordance with USP <797> and

<800>.

4.6.5.7. Each sample shall be labeled with a personnel identifier, whether it was from the right or left hand, and the date and time of sampling.

4.6.5.8. Documentation results for gloved fingertip and thumb sampling will include the name of the person evaluated, evaluation date/time, media and components used, including manufacturer, expiration date and lot number, starting temperature for each interval of incubation, dates of incubation, the results, and the identification of the observer and the person who reads and documents the number of colony forming units (CFU) for the left and right hand.

4.6.5.9. If an employee does not pass, the Contractor will return for retesting no later than one week after results have been reported.

4.6.6. Surface Sampling of the Direct Compounding Area in conjunction with Media Fill

Testing

4.6.6.1. The contractor shall perform surface sampling of the direct compounding area after the employee completes the media fill test but before the area has been cleaned and disinfected.

4.6.6.2. If an employee does not pass, the Contractor will return for retesting no later than one week after results have been reported.

5. REPORTING REQUIREMENTS: The results of each sampling and testing shall be recorded and submitted as a comprehensive report, along with a statement of compliance or non-compliance with the specified tests. A written report of certification for all primary engineering controls, with statement of Pass/Fail, will be furnished on the day of certification. The

Contractor must provide the full report, to include all items as listed above in Section 3, to the

Chief of Pharmacy Service and other designated facility staff timely upon completion of all analyses, including identification of viable microorganisms, fungi, etc. not to exceed two weeks from the certification date.

5.1. The following information should be included in the report for clean room certification.

Pass/Fail notifications should be included on a per-test basis where applicable.

5.1.1. Executive summary or summary of findings.

5.1.2. Room number and/or location

5.1.3. Room type (e.g. non-hazardous buffer room)

5.1.4. Date of testing

5.1.5. Date of next required certification

5.1.6. Standards used to test room

5.1.7. Notes

5.1.8. Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

5.1.9. Total room area and volume

5.1.10. Room humidity and temp

5.1.11. Air changes per hour

5.1.12. Pressure differential

5.1.13. Nonviable particle counts

5.1.14. Viable particle count analysis

5.1.15. Picture of viable particle test location in room

6. Deliverables

PWS Deliverable Due Date Frequency/Remarks

4.1.6 Certification sticker for

PECs

Within 24 hours of certification

As needed/Affix sticker to PECs

4.6 Personnel Reports Within 21 days of

completion of the visit.

As needed/Submit to POCs

5 Certification Reports for PECs and SECs

Within 14 days of completion of the visit.

As needed/Submit to POCs

8.2 Proof of National

Safety Foundation

Prior to Starting Work

As needed/ COR approval required

(NSF) accredited NSF- 49 Biosafety Cabinet Field Certifier credential

8.3 Proof of facility related

certifications and testing experience as evidenced by submitting primary and secondary engineering control certification reports

Prior to Starting Work

As needed/ Submit to COR

8.4 Proof of personnel

related samplings, assessments, and testing experience

Prior to Starting Work

As needed/ Submit to COR

8.5 Provide names of

CETA-certified technicians

Prior to Starting Work

As needed/Submit to

COR

9.3 Certificate copies of

CETA National Board of Testing (CNBT) and Registered Certified Professionals for Sterile Compounding Facilities (RCP SCF)

Prior to Starting Work

As needed/ COR approval required

9.4 Proof of Current

certification for an NSF-accredited certifier

Prior to Starting Work

As needed/Submit to

COR

9.5 Current certification of

ISO/IEC 17025

Accredited/Certified Environmental Microbiology Laboratory

Within 15 days after contract award effective date and annually

Annually/Submit to

COR

9.6 Competencies

documentation for technicians to perform testing and any technicians who read media tests

Prior to Performing Work

Annually/Submit to

COR

9.8 Standard operating

procedures (SOPs) for testing, troubleshooting, repair, and certification

Prior to Starting Work

Annually/Submit to

COR

9.9 SOP for changing out

biologically contaminated HEPA

Prior to Performing Work

Annually/Submit to

COR

filters in Class II BSCs and SOP for changing out HEPA filters contaminated with hazardous drugs in Class II BSCs

11 Certification reports Within 14 days of completion of the visit.

As needed/Submit to POCs

13 Sampling reports that include viable sampling and environmental monitoring

Within 14 days following sampling collection.

As needed/Submit to POCs

7. Performance Requirements Summary

Discrepancy Definitions

*Discrepancy is defined as anytime a required task is not accomplished in accordance with the

PWS.

Critical Discrepancy:

A failure to perform a task that directly impacts product sterility, correct dosing or ingredient integrity, posing a risk of patient harm or serious contamination.

Minor Discrepancy:

A failure that does not impact patient safety, sterility, or product efficacy. Minor discrepancies are typically cosmetic or administrative in nature, such as incomplete documentation, format errors in logs, or missing noncritical signatures, and do not pose a health or contamination risk.

Acceptable Quality Levels (AQL):

AQLs represent the maximum number of minor discrepancies allowed during the evaluation period. All critical discrepancies have a zero-tolerance standard.

PWS Tasks Performance

Standards

Acceptable Quality

Levels

4.1 Primary Engineering

Controls (PECs)

Certification

At Minimum Every 6 months

No more than 1 minor discrepancy with each certification; 0 critical allowed

4.1.6 Certification sticker

for PECs

At Minimum Every 6 months

No more than 1 minor discrepancy with each certification ; 0 critical allowed

4.2 Secondary

Engineering

Controls (SECs)

Certification

At Minimum Every 6 months

No more than 1 minor discrepancy with each certification ; 0 critical allowed

4.6 Personnel Reports At Minimum Every 6

months

No more than 1 minor discrepancy with each personnel report issuance ; 0 critical allowed

5 Certification Reports for PECs and SECs

At Minimum Every 6 months

No more than 1 minor discrepancy with each certification report issuance ; 0 critical allowed

11 Certification reports At Minimum Every 6 months

No more than 1 minor discrepancy with each certification report issuance ; 0 critical allowed

13 Sampling reports that include viable sampling and environmental monitoring

Monthly for surface sampling

At minimum Every 6 months for environmental wipe sampling

No more than 1 minor discrepancy monthly for monthly surface sampling; 0 critical allowed

No more than 1 minor discrepancy environmental wipe sampling report issuance; 0 critical allowed

8. CONTRACTOR QUALIFICATIONS: The contractor shall provide experienced employee(s) to perform all required onsite services. The contract and requisite employees who will perform services onsite for this requirement also shall possess the following qualifications:

8.1. Certification as a Controlled Environment Testing Association (CETA) National Board of Testing (CNBT) accredited Registered Cleanroom Certification Professional for Sterile Compounding Facilities is required by VA for all primary and secondary engineering control certifications/assessments under VHA Directive 1108.12. The contractor shall provide this certification at the time of bidding. All pharmacy equipment and rooms shall be tested to current USP <797> and USP <800> standards using CETA testing protocols. This testing shall be performed by a CETA-certified technician.

8.2. Certification as a National Safety Foundation (NSF) accredited NSF-49 Biosafety Cabinet Field Certifier. The contractor shall provide this certification at the time of bidding.

8.3. Employees who are to perform the work shall provide proof of facility related certifications and testing experience as evidenced by submitting primary and secondary engineering control certification reports from at least 2 separate state/federal government medical facility contracts within the last 5 years. Reports may be redacted where necessary. The contractor shall provide copies of this report at the time of quote submission and prior to work being performed.

8.4. Employees who are to perform the work shall provide proof of personnel related samplings, assessments, and testing experience as evidenced by submitting personnel validation reports from at least 2 separate state/federal government medical facility contracts within the last 5 years. Reports may be redacted where necessary. The contractor shall provide this documentations at the time of bidding and prior to work being performed.

8.5. Due to the critical nature of the testing required within the classified spaces within the STVHCS Pharmacy cleanroom, each technician to perform onsite services shall be a CETA-certified technician. The contractor shall provide the names of their CETA-certified technicians at the time of quote submission and prior to work completion.

9. The Contractor will provide all parts, labor, equipment, material, travel expenses to test and certify the operation and performance of equipment systems and personnel per the Statement of Work. All inspections, testing and certifications must be performed by properly trained and appropriately accredited on-site field certification technicians. Certified technicians must be trained on all types of equipment listed in this SOW. Documentation shall be provided to the

VA certifying that each field certification technician has been trained and certified in the work required by this SOW as follows:

9.1. Contractor must have a working knowledge of most recent publications of USP<797>

Pharmaceutical Compounding-Sterile Preparations and USP Chapter <800> Hazardous

Drugs-Handling in Healthcare Settings.

9.2. Contractor must have a working knowledge of NSF/ANSI 49-2024 Biosafety Cabinetry:

Design, Construction, Performance and Field Certification.

9.3. Contractor must be able to provide a technician with current certification as a

Registered Cleanroom Certified Professional for Sterile Compounding Facilities by the

CNBT for cleanroom certification. Proof of current CETA-accredited certification for a specific individual must be provided to facility’s POC prior to performing any work.

9.4. Contractor must provide a technician with current certification as an NSF Class II

Biosafety Cabinet Field Certifier for Class II BSC testing and certification. Proof of current certification for an NSF-accredited certifier must be provided to facility’s POC prior to performing any work.

9.5. Contractor must provide current certification and utilize an ISO/IEC 17025

Accredited/Certified Environmental Microbiology Laboratory.

9.6. Contractor must have documented competencies for any technicians sent to perform testing and for any technicians who read the media tests. Copies of each technician’s current competencies must be provided to facility’s POC prior to performing any work.

9.7. Note: A Certified Industrial Hygienist (CIH) credential does not waive any of the above certification requirements.

9.8. Contractor must have standard operating procedures (SOPs) for testing, troubleshooting, repair, and certification including documentation of certification equipment calibration to National Institute of Standards and Technology (NIST)-traceable primary standards, a safety plan to include job hazard analysis, respiratory protection program, hazard communication and safety data sheets (SDS) for all chemical products that will be used during the course of this contract. Copies of the

SOPs must be provided to facility’s POC prior to performing any work.

9.9. Contractor must have a specific SOP for changing out biologically contaminated HEPA filters in Class II BSCs, and a specific SOP for changing out HEPA filters contaminated with hazardous drugs in Class II BSCs. Copies of the SOPs must be provided to facility’s POC prior to performing any work.

9.10. Technicians must successfully demonstrate competency in garbing and hand hygiene when performing work in classified areas.

9.11. Due to the sensitive nature of the work area, prior to entering sterile compounding areas (i.e., buffer room, ante room, segregated compounding area, and containment-segregated compounding area), the Contractor will maintain a clean work area at all times by wearing appropriate personal protective equipment (set forth by USP <797> and USP <800> standards) and cleaning any equipment with 70% sterile isopropyl alcohol.

9.12. Contractor must have working knowledge of the following CETA Documents referenced by USP <797> and USP <800>, current version or higher:

9.12.1. CAG-001: CETA Applications Guide For the Use Of Compounding Isolators In

Compounding Sterile Preparations In Healthcare Facilities (Revised 2008)

9.12.2. CAG-002: CETA Compounding Isolator Testing Guide (Revised 2026)

9.12.3. CAG-003: Certification of Sterile Compounding Facilities for USP Compliance

(Revised 2022)

9.12.4. CAG-004: Biological Decontamination and Disinfection of Accessible Surfaces in

Biosafety Cabinets (Revised 2020)

9.12.5. CAG-005 Servicing Hazardous Drug Compounding Primary Engineering

Controls (Revised 2025)

9.12.6. CAG-006: Procurement, Utilization, and Disposal of HEPA and ULPA Filters

(Revised 2023)

9.12.7. CAG-007: Exhaust System Requirements of Class II Biosafety Cabinets

(Revised 2020)

9.12.8. CAG-008: Certification Matrix for Sterile & Nonsterile USP Compounding

Facilities (Revised 2022)

9.12.9. CAG-009: Viable Environmental Monitoring for Sterile Compounding Facilities

(Revised 2023)

9.12.10. CAG-010: CETA Application Guide for Informational Notes to Meet the

NSF/ANSI 49:2010a Standard Requirements (Revised 2011)

9.12.11. CAG-013: Media Fill Testing for Sterile Compounding Personnel (Revised

2023)

9.12.12. CAG-014: Airflow Visualization Study (New 2022)

9.12.13. CAG-015: Testing of Pass-Throughs (New 2025)

9.13. Contractor must have working knowledge of the following ISO standards:

9.13.1. 14644-1:2015 Cleanrooms and associated controlled environments -- Part 1:

Classification of air cleanliness by particle concentration

9.13.2. 14644-2:2015 - Cleanrooms and associated controlled environments -- Part 2:

Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

9.13.3. 14644-3:2019 Cleanrooms and associated controlled environments -- Part 3:

Test methods

9.13.4. 14644-9:2022 Cleanrooms and associated controlled environments -- Part 9:

Assessment of surface cleanliness for particle concentration.

10. CONTRACTOR PERSONNEL BADGES AND PARKING: The contractor technician shall acquire an access badge upon entrance into the STVHCS buildings. Contractor shall safeguard the access badge and report any lost, stolen, or destroyed badges to the COR.

Contractor shall ensure technicians properly display their access badges. Access badges shall be worn at or above the waist (facing forward). Access badges shall be returned to the COR at the end of each site visit. Contractor shall ensure technician parks in the appropriate designated parking areas. Parking information shall be coordinated with the COR. Contractor shall be aware that STVHCS does not validate or make reimbursement for parking violations of the contractor technician under any circumstance.

11. CERTIFICATION REPORTS: The contractor shall provide the PM or COR with a report for each cleanroom, LAFW, and BSC that is certified within 2 weeks of completion of the visit.

Any cleanroom, LAFW, and BSC that is not certifiable shall be immediately brought to the attention of the PM, or COR by the contractor before leaving the facility. In addition, the cleanroom, LAFW, and BSC in question will be marked as such with clear signage that the unit is “OUT OF SERVICE” until further notice. Failure to follow these procedures may result in delay of payment or nonpayment. Each certification report from the contractor shall contain, at a minimum, the following information:

11.1. Contractor name, address and contact information also listing contract personnel with appropriate accreditations and credentials.

11.2. Confirming remark that the most current version of this CAG was referenced for this certification and the actual date the certification was completed.

11.3. Simple and clear method of identification of the approximate location of the collected data in relation to the physical layout of the equipment or facility tested, including specific and clear nomenclature for the data locations.

11.4. Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process.

11.5. Comparison of data recorded against expected values or specific equipment performance criteria established in the STVHCS Pharmacy Service Standard Operating Procedures (SOP). In the absence of a current STVHCS Pharmacy Service SOP; the contractor’s SOP, USP 797, recommended practices, and manufacturer’s specifications will be used.

11.6. Safety data sheets (SDS) for all chemical products that will be used during certification procedures.

11.7. A list of equipment utilized in data collection to include make, model, serial number, and calibration date.

11.8. A copy of the current calibration documentation for each piece of equipment utilized in data collection, when applicable.

11.9. A written report detailing the airflow patterns from the airflow visualization test must be provided. The report shall contain a definitive statement of acceptability for the intended purpose. The documentation shall clearly identify the area or equipment being assessed along with the appropriate aseptic technique performed by the compounding personnel.

A video recording shall be used to support this written statement and sent to the facility to support personnel training. The plan for recording and transmitting this video to STVHCS shall be established and mutually agreed upon prior to scheduled testing.

11.10. Pass/Fail notifications, where applicable.

11.11. Listing of replacement parts provided, when applicable.

11.12. Hyperlinks within the report (such as a table of contents) that will allow the PM to quickly navigate through the report to view areas that have issues.

12. ASSESSMENT REPORTS: The contractor shall ensure that the PM, or COR is aware of any personnel assessment failures before the contractor leaves the facility. Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable.

13. SAMPLING REPORTS: The contractor shall contact the PM, or COR upon completion of work to verbally report any issues which occurred that may adversely affect the sampling results before the contractor leaves the facility. Large formal reports as required for the pharmacy clean rooms that include viable sampling and environmental sampling kits for hazardous drug detection shall be submitted to the COR within 2 weeks following the collection of the viable sampling and /or surface sampling kit. An informal report of the results of viable sampling and/or surface sampling kits shall be submitted to the PM, or COR within two (2) business days of the receipt of the results from a properly accredited laboratory. All microbiological samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Environmental Microbiology Lab Accreditation Program (EMLAP). All environmental wipe samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Industrial Hygiene Laboratory Accreditation Program (IHLAP). Failure to follow these procedures may result in delay of payment or nonpayment. Pass/Fail notifications should be included where applicable. Each sampling report from the contractor shall contain, at a minimum, the following information:

13.1. An SOP or protocol that describes the procedures used for sampling along with the volume, ISO classification, method of collection, frequency, activity level, action levels, response to exceeded concerns levels, media types, risk level, laboratory analysis, incubation time and temperature.

13.2. A sampling map of the cleanroom, LAFW, and BSC noting the locations and types of samples to be taken where applicable. Photographs should be taken if possible.

13.3. Growth and Sterility Control Reports (where applicable)

14. EXCLUDED SERVICES: The contractor shall not be obligated to provide services under this contract for damage to or destruction of instrument(s) covered where such damage or destruction is a result of or caused by:

14.1. Fire or explosion of any origin, riot, civil commotion, aircraft, war

14.2. Act of God or other force of nature including but not limited to lightning, windstorm, hail, flood, earthquake

14.3. VAMC misuse or abuse of such instrument

14.4. Decontamination due to spillage by VA personnel due to their own negligence

14.5. Installation of unauthorized field modifications.

15. ENVIRONMENT OF CARE: The contractor shall maintain a clean and safe environment at all times.

16. CONTRACTING WITH PARTIES LISTED ON THE OIG LIST OF EXCLUDED

INDIVIDUALS/ENTITIES: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal payments due to fraud and/or abuse of the Medicare and Medicaid programs.

The list of excluded individuals/entities can be found on the OIG web site at www.hhs.gov/oig.

With submittal of proposal, the contractor shall provide evidence that none of the contractor’s employees are on the Excluded Parties list.

17. INVOICES/PAYMENTS: This provision shall survive the termination or ending of the contract. Payment for services rendered by the Contractor under the terms of this contract will be made upon receipt of a properly executed invoice. Invoice to be submitted within fourteen

(14) workdays following completion of the Contractors rendered services. VA will verify services performed and certify invoices for payment within thirty (30) days following date of receipt of sampling reports. Any identified discrepancy(s) in billings shall be cause for extending provisions of this paragraph until the discrepancy or other identified problem with the billing invoice has been resolved. Invoices shall:

17.1. Be electronically prepared and submitted in accordance with FAR 52.212-4(g)

17.2. Clearly state the terms of any discounts offered

17.3. Include the current fiscal year and purchase order number

17.4. Include the period of performance covered by the invoice

17.5. Accept payment for services rendered under this contract as payment in full. This provision shall survive the termination or ending of the contract.

18. GENERAL: Contractors, contractor personnel, subcontractors and subcontractor personnel will be…