Attachment 1_PWS_Rev. 1.pdf

Performance Work Statement (PWS) Veterans Affairs Connecticut Healthcare System ( VACTHCS)

Service of Primary and Secondary Engineering Controls

1. SCOPE OF WORK:

The Contractor shall furnish all labor, equipment, materials (including replacement parts), supplies, tools, transportation and travel, tools, and equipment necessary to perform all inspections, testing, repair and internal HEPA filter replacement, as required throughout the contract period at the VA Connecticut Healthcare System: West Haven and Newington divisions. The Contractor shall perform routine service within seventy-two (72) hours of a request for service from the Contracting Officer’s Representative (COR) outside of the scheduled service, and within four (4) hours of an emergency request for service from the COR. No additional funding will be provided for travel or travel related expenses to the VAMC for service.

Places of Performance:

West Haven VAMC - 950 Campbell Avenue, West Haven, CT 06516

Newington VAMC - 555 Willard Avenue, Newington, CT 06111

The VAMC uses a variety of engineering ventilation controls to maintain employee exposures to airborne biologic, chemical and radiological hazardous air contaminants below applicable regulatory limits. These include biological safety cabinets (Class 1 BSCs, Class II BSCs), transfer stations, dump stations, grossing stations, ducted and ductless chemical fume hoods, HEPA carts, and custom local exhaust ventilation devices (“capture hoods”). In addition, the In-Patient Pharmacy USP 797 Sterile Cleanroom Facilities also uses Class I and Class II BSCs, Compounding Aseptic Isolators (CAIs) for non-hazardous drugs, Compounding Aseptic Containment Isolators(CACIs) for hazardous drugs (as defined by NIOSH and OSHA), and Laminar Airflow Work Benches (LAFW) to maintain I.V. sterility during preparation.

For a list of the relevant items, see Attachment A. The number of items in service may change throughout the contract period. The numbers and types of devices in Attachment A are the Government's best estimate of the number and type expected to be serviced by the contract. The Government reserves the right to delete or add units as required.

Equipment that needs to be retested due to repairs or filter change out shall be covered under this contract at the contract rate.

Viable organism sampling that needs to be repeated due to failures shall be covered under his contract at the contract rate.

If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it. Work items or services not already included in this PWS, but relevant to it, may be ordered by the CO without further competition. Only the CO has the right to obligate funding or order work not expressly detailed in this PWS. The Government shall not be held responsible for payment for any work performed by the contractor that is outside the scope of this contract or without the prior approval of the CO.

2. CONTRACTOR QUALIFICATIONS:

All inspections, testing and certifications must be performed by properly trained and appropriately accredited on-site field certification technicians. These certified technicians must be trained on all of the types of equipment listed in Attachment A of this PWS. Documentation shall be provided to the VA certifying that each field certification technician has been trained and certified in the work required by this PWS as follows:

For BSC testing and certification, each on-site field certification technician must hold a current certification as a NSF Class II Biosafety Cabinet Field Certifier. Current certification for a specific individual can be confirmed at: http://info.nsf.org/Certified/Biosafety-Certifier/ [NSF-accredited certifier]

For fume hood testing and certification, within twelve (12) months of award of the base year of this contract, each on-site certification technician must hold a current certification as a Registered Fume Hood Certified Professional [note: actual name may change] by the Controlled Environmental Testing Association (CETA) National Board of Testing (CNBT).

For USP 797 Clean Room testing and certification, each on-site certification technician must hold a current certification as a Registered Cleanroom Certified Professional for Sterile Compounding Facilities by the CETA CNBT. Current certification for a specific individual can be confirmed at:

https://www.cetainternational.org/ceta-cnbt-credentialed-professionals-directory-main#/[CETA-accredited certifier / certifier accreditation program]

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

The Contractor shall submit their 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.

Special requirement: The Contractor shall submit a specific SOP for changing out biologically contaminated HEPA filters in Class I and Class II BSCs, and a specific SOP for changing out HEPA filters contaminated with hazardous drugs in In-Patient Pharmacy Class I and Class II BSCs, CAIs, CACIs, C-SCAs, and laminar flow hood

3. PERFORMANCE REQUIREMENTS:

The VA Connecticut Healthcare System has Class I and Class II BSCs) in Pathology & Laboratory Medicine Service (P&LMS) and Research & Development (R&D) Service, that require NSF/ANSI 49 certification; Class II BSCs, compounding aseptic isolators (CAIs), compounding aseptic containment isolators (CACIs), laminar airflow workbenches (LAFWs) and containment segregated compounding areas (C-SCAs) in Pharmacy Service areas that require CETA CAG-003 certification. , , ducted and ductless chemical fume hoods in P&LMS and R&D Service that require ASHRE 110 certification, custom local exhaust ventilation devices (“capture hoods”) in the P&LMS Histology Lab and a downdraft autopsy table in the P&LMS Morgue that require certification per manufacturers specifications, In-Patient Pharmacy USP 797 clean rooms (hazardous drugs (“chemo”)/ nonhazardous drugs/soft wall), IV Rooms (nonhazardous drugs), and ante rooms that require USP 797 and/or USP 800 testing and certification.

The contractor shall certify BSCs, ducted and ductless fume hoods, CAIs, CACIs C-SCAs, LAFW and other equipment in accordance with the most current versions of the following reference standards:

- American Society of Heating, Refrigeration and Air-Conditioning Engineers (ASHRAE) 110-2016 Methods of Testing Performance of Laboratory Fume Hoods

- Controlled Environmental Testing Association (CETA) Documents Referenced by USP <797> :

•CAG-001-2005 Applications Guide For The Use Of Compounding Isolators In Compounding Sterile Preparations In Healthcare Facilities (Revised December 2008) •CAG-002-2006 Compounding Isolator Testing Guide (Revised December 2008) •CAG-003-2006 Sterile Compounding Facilities (Revised May 2015) •CAG-004-2007 Application Guide for the use of Surface Decontaminants in Biosafety Cabinets •CAG-005-2007 Servicing Hazardous Drug Compounding Primary Engineering Controls •CAG-006-2010 CETA High Efficiency Filter Application Guide •CAG-007-2010 Application Guide for Exhaust System Requirements of Class II, Type B Biosafety Cabinets •CAG-008-2010 CETA Certification Matrix for Sterile Compounding Facilities (Updated January 2012) •CAG-009-2011v3 CETA Certification Application Guide USP <797> Viable Environmental Sampling & Gowning Evaluation

Additional CETA Guidance:

•CAG-000-2007 Application Guide Publication Flowchart

- ISO (International Organization for Standardization) 14644-1:2015 Cleanrooms and associated controlled environments -- Part 1: Classification of air cleanliness by particle concentration

- ISO 14644-2:2015 - Cleanrooms and associated controlled environments -- Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

- ISO 14644-3:2005 Cleanrooms and associated controlled environments -- Part 3: Test methods

- ISO 14644-9:2012 Cleanrooms and associated controlled environments -- Part 9: Classification of surface cleanliness by particle concentration

- ISO 14698-2:2003 - Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2:

Evaluation and interpretation of biocontamination data

-Manufacturer performance requirements.-NSF (National Sanitation Foundation International)/American National Standards Institute (ANSI) 49-2016 Biosafety Cabinetry: Design, Construction, Performance and Field Certification

- USP (United States Pharmacopeia Convention) Chapter <797> Pharmaceutical Compounding – Sterile Preparations (June 1, 2008)

- USP Chapter <800> Hazardous Drugs – Handling in Healthcare Settings (February 1, 2016) -OSHA (Occupational Safety and Health Administration) -EPA (Environmental Protection Agency) -CTDEEP (Connecticut Department of Energy, and Environmental Protection)

The Contractor shall furnish all labor, equipment, materials, replacement parts, supplies (under $25.00), transportation, travel, permits, testing, equipment certificates and incidentals necessary for the performance of the work specified in this PWS.

During the inspection, the contractor shall perform routine maintenance to correct any equipment malfunctions and assure that the equipment meets manufacturer's factory specifications.

Any calibration procedures or adjustments necessary to assure accurate and reliable equipment operation will be performed at this time.

Replacement of Class II BSC internal supply and exhaust HEPA filters and chemical sorbent filters (e.g., for ductless fume hoods) as needed to maintain equipment certification and other replacement parts for the repair will be paid at the actual vendor cost plus the percentage markup quoted on this contract.

All deficiencies and defects shall be itemized and reported as cost of repairs in the contractor’s monthly inspection/maintenance statement. The Contractor shall submit supplier quotes with each invoice request. Repair, replacement of parts or materials shall be performed on an as-needed basis to maintain equipment certification, determined by the servicing technician and approved by the CO and within 2 calendar days of the approval.

WORKING HOURS

All Certifications service shall be performed during normal VA Medical Center working hours of 8:00 a.m. to 4:30 p.m. Monday through Friday, except Federal Holidays, unless no additional labor charges would apply, or if they do, without advance approval by the CO.

Certain patient care support areas such as the pharmacies will need to be completed from 6:00 am to 8:00 am or after 2:30 pm so as not to interfere with drug preparation for units and clinics. The contractor shall include pricing for standard working hour labor rates and non-standard working hour labor rates in the Price/Cost Schedule. It is an estimated that there will be 24 hours per year outside normal working hours.

All work must be arranged in advance with the COR.

All equipment (Class I BSCs, Class II BSCs, CAI, CACIs, ducted and ductless fume hoods, custom containment devices) and Pharmacy USP 797 Clean Room certifications shall be accomplished using industry standard scientific measurement equipment each calibrated to an applicable NIST-traceable primary

3.1.1 standard provided by the Certification contractor.

TESTING AND CERTIFICATION PROCEDURES:

The contractor shall supply every unit that passes the required certification specifications with a certification sticker on the same day of the service with the following information:

- Class I and Class II BSCs and LAFWs: Contractor’s Company name, address and phone number; unit make, model and serial number, report number, location (room number), applicable certification standard, certification date, recertification date, and certification technician’s signature/printed name, pass/fail status.

- CAI and CACI: Contractor’s Company name, address and phone number; unit make, model and serial number; applicable certification standard, certification date, recertification date, report number, technician’s signature/printed name, pass/fail status of the material ingress/ egress test, recovery time of the main chamber, indication that the operator has to wait at least the recovery time before initiating operations after material transfer, and ventilation appropriate for use with volatile / non-volatile hazardous drugs.

- Fume Hood: Contractor’s Company name and address and phone number; unit make, model and serial number; applicable certification standard certification date, recertification date, report number, average face velocity, sash height, and certification technician’s signature/printed name, pass/fail status.

- Capture hoods in P&LM Histology and downdraft autopsy table in P&LM Autopsy Suite – [add the certification criteria]

Any unit that does not pass required certification specifications will be marked as such with clear signage that states this unit is out of service until further notice. Notify the COR and the supervisor of the service immediately if any units fail for the certification, so a contingency plan can be initiated and a repair can be scheduled.

USP 797 and USP 800 TESTING FOR PHARMACY CLEAN ROOMS

Primary Engineering Controls (PECs) - All primary engineering controls (PECs) including Class I BSCs, Class II BSCs, LAFWs, CAls and CACls shall be tested to NSF 49/ANSI (BSCs), CETA CAG- 002-2006 (isolators) specifications and/or manufacturer specifications to include any additional USP 797 or 800 nonviable particle testing.

Room Supply HEPA Filter Leak Test - The contractor shall perform an in-line HEPA filter leak test of each terminal supply diffuser using [insert method].

Air Changes per Hour (ACH) - The contractor shall measure the volumetric supply and exhaust for each room using a properly calibrated balometer hood, and then using the total room volume for each room, calculate the room air exchange rate. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The contractor shall calculate air changes per hour (ACPH) for each buffer and ante room and include their findings in the report. In the event that a room does not meet USP 797 or USP 800 requirements for ACPH, the contractor shall immediately notify the COR and the pharmacy point of contact.

Pressure Requirements - The contractor shall include in their report differential pressure reading from each buffer/ante 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.

Nonviable Particle Testing The contractor shall perform environmental · nonviable particle testing semiannually (e.g. every 6 months) and whenever the units are serviced. The contractor shall' derive the minimum number of sampling locations using Annex A in the ISO/DIS 14644 1.2 standard.

Testing shall be performed by qualified operators using current, electronic equipment with results of the following:

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

LAFVV, BSC, CAI and CACI. , ISO Class 7: not more than 352,000 particles 0.5 µm and larger size per 'cubic meter of air for any buffer area -ISO-class--8: not more than 3,520,000 particles 0.5 µm and larger size per cubic meter of air for any ante area.

Report Requirements - All of 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.

Room number and/or location

- Room type (e.g. oncology prep room)

- Date of testing

- Date of next required certification

- Standards used to test room

- Notes

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

· - Total room area and volume

- Room humidity and temp

- Air changes per hour

- Pressure differential

- Nonviable particle counts

- Viable particle count analysis and interpretation

- Picture of viable particle test locations in room

OTHER REPORTING REQUIREMENTS:

The Contractor shall contact the COR to schedule work, prior to beginning work and at the conclusion of all work. For services performed during normal working hours, the contractor's technician is to report to the COR to report/sign-in and obtain an identification badge, which shall be worn at all times while the technician is on station.

After work is completed, the contractor's technician(s) are 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. Contractor shall also contact Safety Office nd the service’s supervisor or person in charge upon completion of work to verbally report the status of the unit and any deficiencies identified. The COR, or designee, must sign the service report before the technician(s) leave the facility. Failure to follow these procedures may result in delay of payment or nonpayment.

The service report from the contractor must contain, at a minimum, the following information:

1. Date and time of the contractor's arrival on station

2. Service report of actions performed

3. Technician(s) name

4. Class II BSCs, CAIs, CACIs, ducted and ductless fume hoods and specialty local exhaust ventilation devices (e.g., P&LM Histology custom capture hoods, Morgue downdraft autopsy table) reports shall include the following as applicable to type of hood certification:

a. List of equipment used; to include manufacturer make, model, serial number, and date calibrated.

b. Velocity profile and average

c. Direct inflow CFM profile and average

d. HEPA filter leak test

e. Smoke Intrusion test

f. Sash alarm system test

g. Pressure gage reading

h. Light intensity

i. Sound Level

j. Ground polarity

5. Clean Room Test Reports for IV Room, Clean Room, and Ante

Room shall include:

a. List of equipment used to include manufacturer make, model, serial number, and date calibrated.

b. Particle Counts

c. Room Air Changes per Hour

d. Room pressurization test

e. Temperature

f. Humidity

g. Differential pressure between all rooms

A formal certificate and report for each unit serviced must be submitted to the COR within three (3) business days.

Courtesy copies of certificate and written reports, for units within the pharmacies, shall be issued to the Pharmacy Service within three (3) business days.

Larger formal reports as required for the pharmacy clean rooms, CAIs, CACIs, etc. that include viable sampling shall be submitted to the COR within ten (10) business days following the receipt of the viable sampling. Results of viable samples shall be submitted to the COR within one (1) business day of the receipt of the results from the laboratory.

EXCLUDED SERVICES: The contractor shall not be obligated to provide services under this agreement for damage to or destruction of instrument(s) covered where such damage or destruction is:

a. A result of or caused by fire or explosion of any origin, riot, civil commotion, aircraft, war, or any Act of God or other force majure including but not limited to lightning, windstorm, hail, flood, earthquake, or

b. Caused by the VAMC misuse or abuse of such instrument

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

d. Installation of unauthorized field modifications.

4. PERFORMANCE REQUIREMENT SUMMARY: The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective Standard Performance Threshold Method of

Surveillance

The contractor shall ISO 14644-1:2015 Zero Deviation from the Periodic perform all Class I BSC, Class II BSC, ducted and ductless fume hoods, Pharmacy CAI and CACI

USP 797, 800

NSF49, OSHA

Standard Surveillance inspections, testing, repair and certifications.

EPA

5. SECURITY:

The contractor shall be liable for security of all areas accessed by the service technician(s). All doors, passageways, windows and accesses to equipment and service areas, must be locked and/or secured after passage. In no instance will any door, window or access be rendered unlocked, propped open, mechanism taped open or .rendered to prevent securing. The contractor shall be responsible to physically ensure such accesses are secured to prevent unauthorized entry.

Contractor Personnel Badges and Parking:

An access badge will be given to the contractor's employee upon entrance into the VA Connecticut Healthcare System's (VA) buildings. The contractor employee must safeguard the access badge and immediately report any lost, stolen, or destroyed badges to the facility Point of Contact (POC). All contract personnel must properly display their access badges. Access badges must be worn at or above the waist (facing forward). The contractor's employees must return the access badge(s) to the facility POC or designee at the end of each pickup process.

It is the responsibility of the contractor's personnel to park in the appropriate designated parking· areas. Parking information shall be coordinated with each facility POC.

The VA does not validate or make reimbursement for parking violations of the contractor's personnel under and circumstance.

Interference to Normal Function:

Contractor may be required to interrupt their work at any time so as not to interfere with the normal functioning of the facility, including utility services, fire protection (detection and suppression) systems, passage of facility patients, personnel, equipment and carts and patient care activities (e.g. preparing sterile compounds)..

In the event of an emergency, contractor services may be stopped by the VA and rescheduled at no additional cost to the government.

Contractor personnel shall inform the facility POC or the designee of the need to gain access to secured areas. If access is required to secure areas, prearranged scheduling will be made with the facility POC or designee.