Requirement Description.pdf

B.1 DESCRIPTION OF AGREEMENT

Under this agreement, the IDIQ holder Contractor shall provide all labor, personnel, supervision, tools, and materials necessary to perform testing, certification, and decontamination of primary engineering controls such as chemical fume hoods, laminar flow hoods, biological safety cabinets, and other related specialized rooms (such as Cleanrooms) or equipment ventilation systems requiring clean air certifications per CETA Guidelines, USP 797, USP 800, ANSI/ASHRAE 110, ISO 14644, and NSF/ANSI 49 standards. The contractor shall also provide personnel competency assessments and testing for sterile compounding personnel. Emergency calls are included in this requirement.

The Contractor shall furnish services in accordance with most recent version(s) of:

• United States Pharmacopeia (USP) Chapter <797> guidelines

• United States Pharmacopeia (USP) Chapter <800> guidelines

• Controlled Environment Testing Association (CETA) Application Guide for Certification of

Sterile Compounding Facilities for USP Compliance (CAG-003)

• CETA Application Guide for Compounding Isolator Testing (CAG-002)

• CETA Application Guide for the Exhaust System Requirements of Class II Biosafety Cabinets

(CAG-007)

• CETA Application Guide Matrix for Sterile Compounding Facilities (CAG-008)

• National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49

Biosafety Cabinetry

• ISO 14644

• VHA Directive 1108.12. (for Pharmacy)

• VHA Directive 1200.08 (for Research)

• ANSI-ASHRAE 110

• Testing and certification for conformance with applicable standards in accordance with specified

VA engineering design criteria for hazardous waste and material storage areas, and engineering controls (Primary PECs and Secondary PECs).

• Center for Disease Control’s NIH Microbiological and Biomedical Laboratories

• National Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number

49 [NSF 49].

• SAMA Standard LF10-1980 Laboratory Fume Hoods and USP 797/USP 800

• Institute of Environmental Sciences and Technology (IEST) RP-CC-034

• IEST-RP-CC013

• IEST-RP-CC002

All VHA facilities within the Western States Network Consortium are authorized to order any options listed on the Price/Cost Schedule at the listed price. No options may be ordered off this IDIQ unless they are listed on the Price/Cost Schedule. Additional, related items may be added without further competition to the Price/Cost Schedule with the award of a Modification by the administering Contracting Officer (CO). The administering CO is the only VHA employee authorized to Modify this IDIQ.

B.2 OBLIGATION OF FUNDS

This IDIQ does not obligate any funds. The Government is only obligated to the extent of authorized Task Orders issued under this IDIQ.

B.3 PRICE/COST SCHEDULE

The Contractor shall provide pricing for each orderable item on the Price/Cost Schedule spreadsheet

B.4 TERM OF IDIQ

This IDIQ is effective from the date of award for a period of 5 years (5 1-year ordering periods). An annual review will be conducted by the CO, to determine if it is in the best interest of the Government to continue with performance of this IDIQ.

B.5 AUTHORIZED USERS

All properly warranted COs in the (WSNC) are authorized to place orders under this IDIQ.

With delegation by the administering CO, Ordering Officers (OOs) may be authorized to place orders under this IDIQ. The Contractor shall not accept or perform any purported order that does not contain a Delivery Order number from a CO or designated OO.

B.6 ORDERING

Task and Delivery Orders will be placed against this IDIQ using Outlook Email Messages, Electronic Data Interchange (EDI), FAX Internet portal, paper or oral communications.

B.7 PURCHASE LIMITATIONS

Individual Task Orders (TO) may not exceed $200,000 each. The Price Ceiling is $8,500,000 over the life of the IDIQ.

B.8 REPORTING TO THE CONTRACTING OFFICER

An annual contract utilization report by VHA Facility per Task Order number, CLIN, hours rendered, and final costs shall be sent to the WSNC Acquisition and Utilization Specialist (AUS) and the administering CO that shows usage per facility and pricing generated during the reporting period. The report will be due 45 days after the closure of each government fiscal year.

B.9 PERFORMANCE WORK STATEMENT/SCOPE

B.9.1. Testing Requirements – Pharmacy On-site certifications of BSCs and LAFWs shall be accomplished in accordance with the most recent version of NSF/ANSI Standard 49 Biosafety Cabinetry. The contractor shall test and certify all CAIs and CACIs in accordance with CAG-002. The contractor shall test and certify all PECs in accordance with the most current version of The Institute of Environmental Sciences and Technology (IEST)-RP-CC002 (Unidirectional Flow Clean-Air Devices), CETA CAG-003, and the manufacturer's specifications.

All equipment used to certify PECs must be calibrated in accordance with IEST-RP-CC013 or manufacturer's recommendation and be NIST traceable where possible.

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 unit that fails to meet specifications shall be clearly marked with a sign that will notify the compounder 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 and within a mutually agreed timeframe.

The list of tests for PECs includes:

Air flow velocity profile

Air flow visualization profile HEPA/ULPA filter leak test

Induction leak test

Lighting intensity test

Ultraviolet (UV) lamp test

Vibration test Noise level test

Electrical leakage and ground circuit resistance and polarity tests

Preparation ingress and egress test

Chamber pressure test

Total particle count testing For each PEC passing the required certification tests, the contractor supplies each unit with a certification sticker displaying the following information:

Company name and contact information.

Unit make, model and serial number.

Report number Location (e.g., building, room number, area identification)

Certification date

Recertification date

Technician name and signature

B.9.2 Viable and Non-viable Particle Counts Viable and non-viable particle counts samples will be collected within the interiors of each clean room classified area and each PEC. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP <797>.

B.9.3 USP<797> Testing for Pharmacy Clean Rooms The contractor will provide comprehensive cleanroom testing and certification services every 6 months, in the event of an environmental or engineering control excursion/exceedance or sooner if there are changes to the area such as redesign, construction, replacement or relocation of any PEC, or alteration in the configuration of the room that could affect airflow or air quality or if a cleanroom(s) did not meet compliance. Certification tests for clean rooms include:

HEPA filter integrity testing

Airflow testing: Airflow testing is performed to determine acceptability of the air velocity, the room 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.

Total particle count testing

Room pressurization monitoring

Temperature and humidity monitoring Air pattern analysis

Dynamic airflow smoke pattern test for each PEC and SEC if air returns in the cleanroom suite are not low on the wall (contractor to leave video of smoke test on site prior to completion of certification process).

Written Report

Based upon findings noted in certification testing, or as necessary after an environmental excursion or physical change to the spaces or PECs occurs, additional applicable re-certification tests will be completed to reassess applicable areas and are included within this contract.

In the event that a room does not meet USP<797> or the VHA HVAC Design Manual requirements, the site identified POC(s) shall be informed immediately.

B.9.4 Air Changes per Hour The contractor shall calculate the total room volume for each buffer room, anteroom, 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 and anteroom and include their findings in the report. Comparison of ACPH will be completed both for USP <797> standards as well as those referenced in the VHA HVAC Design Manual, which are more stringent than USP <797>.

B.9.5 Pressure Requirements The contractor shall include in their report differential pressure readings from each buffer/anteroom to all surrounding areas. The report shall indicate whether the room is required to be a negative or positive pressure room per USP<797>. All readings and acceptance criteria shall be documented to at least one thousandths of an inch water column (e.g., 0.020” w.g. and not 0.02” w.g.) or one tenth of a pascal (e.g.,

5.0 Pa). Pressure differentials will be reflected on a report showing the sketch of the room(s).

B.9.6 Viable Environmental Sampling

Control plates are implicit in these analyses and shall not be listed out separately.

Air sampling: The contractor shall perform viable environmental sampling every 6 months, or every 3 months if a facility prefers more frequent monitoring. Viable environmental air sampling for fungi and bacteria will utilize high volume impaction samplers to conduct the sampling. Air samples will be collected in each room, the interior of each PEC, and each passthrough chamber connecting to classified areas. While it is acceptable per USP <797> standards to utilize Tryptic Soy Agar (TSA) media for bacteria, and another media specific for fungi, VISN 22 requires all air samples to utilize TSA media which supports growth of both bacteria and fungi. A sufficient volume of air (1000 liters) shall be tested at each location to maximize sensitivity. Samples of less than 1000 liters will not be acceptable. Air sampling must be conducted during dynamic operating conditions.

Surface Sampling: Surface sampling will be performed no less than monthly. Surface samples will be collected in each room, the interior of each PEC, passthrough chambers connecting to classified areas, and frequently touched surfaces. Surface sampling will be performed at the end of the largest CSP activity of the day but before area has been cleaned and disinfected. TSA media supplemented with neutralizing additives (e.g., lecithin and polysorbate 80) to neutralize the effects of any residual disinfecting agents that will be used for surface sampling.

Any laboratory results equal to or greater than the action level will require notification of the

POC(s) immediately upon receipt of results.

Reports to include at a minimum:

o Date and time sampling was taken.

o All environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown to the genus level.

o Media lots and expirations used for samples.

o Comments indicating when dynamic conditions were used.

o Certificates of analysis of media used.

o Sketch identifying location of each sample obtained.

B.9.7 Monthly Surface Sampling, Personnel Competency Assessment, and Gloved Fingertip (GFT) and Media Fill Test (MFT)

Monthly Surface Sampling:

o Surface samples will be taken from each of the following classified areas:

PEC

Pass through chambers connecting to classified areas.

Equipment contained within PEC.

Staging or work area(s) near the PEC.

Frequently touched surfaces- to be identified by pharmacy staff.

o Contractor will ensure that surface sample locations and quantity are reviewed with and verified by site identified POC(s) for each location.

o Surface samples will be collected, sent through the same laboratory used for viable environmental sampling, incubated with appropriate temperature and storage time, and analyzed all in accordance with USP <797> 2022 (or more recent) requirements.

Personnel Competency Assessment o Contractor shall offer service to complete and document assessment of competency of compounding personnel including gowning/garbing observation, gloved fingertip, and thumb testing (GFT), media fill testing (MFT), and post-test surface sample. Facilities will have the option to utilize contractor to complete competency assessment during scheduled monthly contractor onsite visits. If facilities elect to utilize this service, they will clearly communicate with the contractor at the time of visit scheduling of this need, as well as the number of staff requiring competency assessment.

Gloved Fingertip and Thumb Testing (GFT) and Media Fill Testing (MFT)

If facility elects for contractor to complete competency assessment, contractor will include materials and assessment of GFT/MFT results in accordance with USP <797> 2022 (or more recent) requirements.

If facility elects to complete competency assessment internally, facility will capture GFT/MFT samples after being instructed by certifier/contractor on proper collection, storage, and shipping methods. Facility collected samples will be sent through contractor to the same laboratory used for environmental sampling to ensure consistency. Contractor and laboratory will ensure incubation temperatures, and storage times comply with USP <797> 2022 (or more recent) requirements.

GFT/MFT results will be reported as the number of cfu per hand (left hand, right hand), and indicate if the cfu action level has been exceeded by counting the total number of cfu from both hands.

o Competency assessment and documentation will be in accordance with most recent version of USP <797> requirements.

B.9.8 Environmental Wipe Sampling for Hazardous Drug Residue The contractor will perform environmental wipe sampling for hazardous drug surface residue semiannually, or more frequently as needed to verify containment. The kits used to complete wipe sampling must be verified prior to use to ensure the sensitivity and validity of the methods and reagents used to recover a specific percentage of known marker drugs.

The drugs to be tested will be determined by the facility and may include, but are not limited to:

Cyclophosphamide

Ifosfamide

Methotrexate Fluorouracil

Platinum-containing drugs

A minimum of 6 surface environmental wipe samples will be completed per certification. Facilities can elect to expand beyond the minimum number of samples, but coordination with the contractor will be required prior to the certification visit. Environmental wipe sampling will include, at minimum, the following areas:

Interior of containment primary engineering control (C-PEC) and any equipment contained inside the C-PEC.

Pass-through chambers.

Surfaces in staging or work areas near C-PEC.

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

Areas immediately outside the hazardous drug buffer room or C-SCA

Areas designated for pharmacist end product verification (checking) / workstations.

Hazardous drug storage areas (including refrigerators).

Hazardous drug receiving areas.

Patient administration areas.

B.9.9 Nonviable Particle Testing The contractor shall perform environmental nonviable particle testing semiannually for all clean room classified areas and PECs. The contractor shall derive the minimum number of sampling locations using ISO 14644-1 and ISO 14644-2 standards. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment during dynamic operating conditions (equipment and references utilized will be stipulated within the report) with results reported relative to the following thresholds:

ISO Class 5: not more than 3520 particles of 0.5 µm and larger size per cubic meter of air.

ISO Class 7: not more than 352,000 particles of 0.5 µm and larger size per cubic meter of air.

ISO Class 8: not more than 3,520,000 particles of 0.5 µm and larger size per cubic meter of air.

B.9.10 Testing Requirements – All Other Areas (including but not limited to Laboratory, Dental, Research) The contractor shall perform annual or semi-annual certifications in accordance with, CETA guidelines ANSI/ASHRAE Standard 110 for fume hoods and NSF/ANSI 49 standards for biosafety cabinets.

B.9.11 HEPA Filter Replacement and Minor Repairs HEPA filters are dependent on type of equipment, and it shall be the facilities option to either purchase and provide the filter outside of this contract or have the contractor provide a quote to the COR/POC for the type of filter required prior to installation/certification. The contractor shall complete any HEPA filter replacement during the certification visit in instances where a need is identified, and a replacement HEPA filter is available on site. If HEPA filter changes must be postponed until a filter can be obtained, the contractor will install the new HEPA filter and conduct leak testing at a time agreed upon with the site identified POC(s).

The contractor shall provide a quote to complete additional minor repairs associated with clean room certifications and operations that are identified during the certification visit, and within the contractor's ability to resolve which may include, but are not limited to, the following:

CAI, CACI or LAFW filter or blower replacement

BSC filter or blower replacement

Minor repairs shall be made during inspections, such as sealing a hepa filter, speed control adjustments, damper adjustments for airflow, minor pressure adjustments. Other repairs could require decontamination prior, such as a hepa filter replacement, blower replacement, or a speed controller replacement and would require ordering parts and contractor revisit.

B.10 CONTRACTOR QUALIFICATIONS

The Contractor shall provide all equipment, supplies, management, supervision, personnel, and transportation necessary to assure that all services rendered are in accordance with this contract and all applicable federal and state laws and regulations. The contractor shall ensure all work meets performance standards specified in this Performance Work Statement (PWS) and referenced documents to include all notes, explanatory material, and appendixes.

The contractor’s testing personnel must have at least 2 years of experience and training on the subject matter outlined in this PWS as well as fundamental practices and precautions within current USP <797> and <800> standards and operations within ISO 5 and 7 environments (donning/doffing personal protective equipment and hand-washing procedures).

All testing and certifications must be reviewed and signed by a NSF/ANSI-49 and Controlled

Environment Testing Association (CETA) Certified National Board of Testing (CNBT) Registered Certified Professional (RCP) for Sterile Compounding Facility (SCF) as required by VA Directive 1108.12 to ensure consistent certification procedures using the Certification Application Guide (CAG-003-2006) for Sterile Compounding Facilities or current standards.

Copies of pertinent certifications, accreditations, and/or licenses must be provided if requested.

All testing outlined in this PWS must either be completed by or supervised by a technician with a

CETA National Board of Testing (CNBT) certification.

The laboratory used must be American Industrial Hygiene Association (AIHA) or A2LA

(American Association for Laboratory Accreditation), accredited for all viable sampling and hazardous drug wipe sampling analysis and ISO/IEC 17025 certified by an external accrediting body for surface sample, gloved fingertip testing (GFT) and media fill testing (MFT).

B.11 TESTING FREQUENCY:

Certification procedures defined in CETA CAG-003 shall be performed by a CETA National

Board of Testing (CNBT) certified testing individual/company no less than every 6 months or whenever the PEC or room is relocated or altered, or when major service to the sterile compounding facility is performed.

Environmental air sampling will be completed no less than every 6 months, or more frequently if a facility prefers more frequent monitoring or requires assessment of corrective actions associated with prior non-compliant results.

Surface sampling will be completed monthly by the contractor unless the facility prefers to conduct surface sampling independent of the contractor between scheduled contractor visits.

Recertification procedures may be required in between scheduled certifications based upon certification findings which may include any applicable certification test, environmental sampling, or personnel competency assessment. Recertification visits will be scheduled and completed as soon as possible and within 1 week of the request from the facility.

Newly assigned pharmacy personnel may require immediate personnel competency assessments that will be completed as soon as possible and within 1 week of the request from the facility.

Environmental wipe sampling for hazardous drug residue will be performed every 6 months, or more frequently if required to verify containment.

All other areas in facility as requested (either quarterly, semi-annually, or annually)

B.12 REPORTING REQUIREMENTS TO THE FACILITY

The contractor will immediately notify site identified POC(s) with any results indicating failure.

A formalized written report in PDF format, including all required aspects specified in this PWS will be provided in a timely manner with receipt by site identified POC(s) no more than 14 days from the certification evaluation date to the POCs identified in the Task Order.

Clean room certification reports must include all the following information. Pass/Fail notifications (in addition to actual findings) will be included on a per-test basis where applicable.

Executive summary or summary of findings Name & Credentials of Field Technician/Sampler Recommendations to resolve any identified discrepancies Room number and/or location Room type (e.g., oncology prep room) Identification information for PECs Date of testing Date of next required certification Standards or references used Pertinent notes regarding the certification testing Room schematic to include location of supply/exhaust diffusers, equipment, room dimensions Total room area and volume Humidity and temperature of each room assessed for certification.

Air changes per hour with assessment based upon both USP <797> standards as well as those referenced within the VHA HVAC Design Manual Pressure differentials Particle count tests o Nonviable particle counts.

o Viable particle count analysis o Picture of viable particle test locations in rooms o Number of personnel present in each PEC and SEC during total particle-count tests

Environmental viable sample results Environmental wipe sampling for hazardous drug residue results Dynamic airflow smoke-pattern test results o Smoke test video must be provided via a link to the video o Number of personnel present in each PEC and SEC during smoke test o Confirm/distinguish dynamic and static conditions, if applicable

B.13 PERFORMANCE MONITORING:

The facility COR shall monitor Contractor work based on the following criteria but not limited to:

1. Knowledge and regulatory compliance of Primary/Secondary Engineering Controls, chemical fume hoods, laminar flow hoods, biological safety cabinets, clean benches, clean rooms, buffer rooms, anterooms, storage rooms, specialized room ventilation systems, exhaust and slotted wall vents inspection procedures.

2. Ability to respond to and resolve emergency requests in a timely manner.

3. Informs COR/VA Representative of all failed device testing at time of discovery.

4. Provides report of all findings within 14 business days.

5. Follows OSHA safety protocols in work performance.

6. Provides required certification(s) to perform work prior to beginning inspection(s).

7. Informs COR/VA Representative when on VA grounds.

8. Utilizes appropriate PPE and has appropriate tools at time of work.

9. Conduct is professional and courteous at all times.

10. Quality of services and repairs.

11. Quality and clarity of reports.

12. Performs cost control.

13. Business and Management Relations.

B.14 HOURS/DAYS OF PERFORMANCE

Unless otherwise specified and/or directed by the Contracting Officer (CO) or the Contracting Officer’s Representative (COR), all contract work shall be performed during the hours of 8:00 a.m. to 4:30 p.m.

Monday through Friday, except federal holidays. Contractor may have to work outside normal business hours without additional charge to the government due to clinical requirements in some areas such as surgery, recovery, GI Clinic, and the Emergency Department.

B.15 EMERGENCIES

The Contractor shall have the capability to respond within 24 hours of contact or emergency repairs.

Contractor shall furnish the COR or VA POC with a written estimate of cost to make necessary repairs and receive Contracting Officer (CO) approval prior to initiating repairs.

B.16 FEDERAL HOLIDAYS

The 11 holidays set by law (5 U.S.C. 6103) that are observed by the VA, i.e., New Year’s Day, Birthday of Martin Luther King, Jr., Washington’s Birthday, Memorial Day, Juneteenth National Independence Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day and any other day declared by Executive order to be a federal holiday.

B.17 SECURITY REQUIREMENTS

1. The C&A requirements do not apply, and a Security Accreditation Package is not required.