Attachment 1 - BSC SOW.pdf

Statement of Work

SECTION 1 – BACKGROUND

The Contractor shall provide a trained Field Certifier(s) who shall provide and perform all services, materials/supplies, and equipment necessary to conduct maintenance, field tests and certification for the equipment items and equipment requirements listed in this Statement of Work (SOW) for locations in

Defense Health Networks Pacific Rim, Indo-Pacific, and Central. The Contractor will provide labor, all supplies, and transportation for technicians to perform the services per the Original Equipment

Manufacturer (OEM) specifications, Department of Defense Manual (DoDM) 6055.18 Safety Standards for Microbiological and Biomedical Laboratories, local command instructions, and the Joint Commission

Hospital Accreditation Program requirements. The Contractor shall allow only Field Certifiers who are accredited through the NSF® Biosafety Cabinet Field Certification – Enhanced Accreditation Program, as required by the DoDM 6055.18. All Class II biosafety cabinet certifications must be performed at least annually in accordance with the requirements in NSF/American National Standards Institute (ANSI) 49-

2022 Biosafety Cabinetry: Design, Construction, Performance, and Field Certification (Normative Annex

5: Field Tests). Certification of biosafety cabinets and other primary engineering controls (i.e. Laminar airflow workbench, compounding aseptic isolator, mobile isolation chamber, etc.) in pharmacy settings used for compounded sterile preparations must be performed at least semi-annually in accordance with the guidelines of Unites States Pharmacopeia (USP) General Chapter 797 Pharmaceutical Compounding –

Sterile Preparations (USP 797 Section 5: Certification and Recertification) in addition to the NSF/ANSI

49-2022 requirements specifically for Class II biosafety cabinets.

SECTION 2 – SCOPE OF WORK

The Contractor shall provide the following support:

2.1 Calibration

Provide on-site equipment calibration (including any parts required to compete the calibration) for the equipment listed in Section 4 of this SOW. Calibration shall be per the OEM’s specifications, every 6 months for pharmacy compounding controls, or at least annually for class II biosafety cabinets. This activity involves the OEM required mechanical and electronic adjustments to ensure consistent, standardized performance or output.

2.2 Preventive Maintenance

The Contractor shall provide preventive maintenance (including any parts required to complete the preventive maintenance) for the equipment listed in Section 4 of this SOW. Preventive maintenance shall be performed in a manner which will minimize corrective maintenance and will include but is not limited to: calibration, adjustment, lubrication, updating software for security, safety, or system functionality issues, testing required to maintain a safe environment of care, electrical safety testing, output testing, replacement of batteries and other shelf life components on a scheduled basis (which becomes corrective maintenance if the component fails due to lack of preventive maintenance). Preventive maintenance shall be performed per the OEM specifications, once every 6 months for pharmacy compounding controls, or at least annually for class II biosafety cabinets.

2.3 Repairs Not Included (for the purposes of this SOW, calibrations and preventive maintenance are not considered “repairs”)

The Contractor shall not repair any unit(s) in Section 4 of this SOW without the express, written permission of the Contracting Officer. For any repair necessary to return a unit to the OEM specified working condition, the Contractor must submit a written breakdown of the problem encountered, the work required to fix the problem, and an estimated price for the repair work, including all parts and labor, to points of contact identified for each piece of equipment. The Contracting Office will decide whether or not to proceed with the repair work and inform the contractor of this decision.

2.4 Certification

Provide on-site equipment certification for the equipment listed in Section 4 of this SOW. Certification shall be performed at least annually for Class II biosafety cabinets and semi-annually for primary engineering controls in pharmacy settings used for compounded sterile preparations. In addition, certification must occur after high efficiency particulate air (HEPA) or ultra-low particulate air (ULPA) filters are changed, maintenance repairs are made to internal parts, biosafety cabinets/primary engineering controls are moved, or changes are made to the heating, ventilating, and air conditioning system;

equipment; or room geometry that could affect the biosafety cabinet/primary engineering controls’ performance.

2.5 Class II Biosafety Cabinet Certification

Equipment listed in Section 4.1 must be certified using procedures in NSF/ANSI 49-2022. These field certification procedures are intended to confirm that an installed cabinet evaluated under the current version of the standard has met all design criteria contained in NSF/ANSI 49 and currently meets all criteria contained in Normative Annex F: Field Tests.

All preconditions, certification intervals, and field tests required for certification can be found in

Normative Annex 5: Field Tests. In addition to the annual certification requirement of Class II Biosafety

Cabinets, they must also be certified:

• At the time of installation

• Whenever HEPA/ULPA filters are changed

• Maintenance repairs are made to internal parts

• Cabinets are moved

• Changes are made to the heating, ventilating, and air conditioning system; equipment; or room geometry that could affect the cabinets’ performance.

The following physical tests shall be conducted on-site for a certification to be considered for the statement "Field Certified in accordance with NSF/ANSI 49":

• Downflow velocity profile test

• Inflow velocity test

• Airflow patterns test

• HEPA/ULPA filter leak test

• Site installation assessment tests o alarm functions as required by this standard o blower interlock o exhaust system performance (proper exhaust duct negative pressure and canopy performance)

• Cabinet integrity test (positive pressure plenum cabinets only)

For Type A cabinets with exposed biologically contaminated positive pressure plenums, either a pressure decay or soap bubble leak test is mandatory. The tests shall be performed at the time of installation, when positive pressure containment panels are removed, and after relocation of the biosafety cabinet.

The site installation assessment tests shall include:

• Alarm functions as required by NSF/ANSI 49

• Blower interlock; and

• Exhaust system performance (proper exhaust duct negative pressure and canopy performance)

The following tests are for worker comfort and safety and are performed at the request of the customer or at the discretion of the field certification provider:

• Lighting intensity

• Vibration

• Noise level; and

• Electrical leakage, ground circuit resistance, and polarity tests

2.6 Pharmacy Biosafety Cabinet and other Primary Engineering Control Certification

Equipment listed in Section 4.2 must be certified using procedures in the USP General Chapter 797. The

USP General Chapter 797 requires compounding areas including biosafety cabinets and other laminar airflow systems (i.e. Laminar airflow workbench, compounding aseptic isolator, mobile isolation chamber, etc.) used as primary engineering controls in compounding areas for either Category 1, Category 2, or Category 3 compounded sterile preparations be certified initially, and recertification performed at least every 6 months. Tests required can be found in USP 797 Section 5: Certification and

Recertification and include:

• Airflow testing

• HEPA filter integrity testing

• Total particle count testing

• Dynamic airflow smoke pattern test

Compounding areas and primary engineering controls must be recertified if there are changes to the area such as redesign, construction, replacement or relocation of any primary engineering control, or altercation in the configuration of the room that could affect airflow or air quality.

For class II biosafety cabinets the testing required by USP 797 is an adjunct to, and not a substitute for, the minimum testing required to consider a biosafety cabinet field tested and certified in accordance with

NSF/ANSI 49.

2.7 Qualification and Field Certifier Accreditation Requirements

Ensure that only fully qualified field engineers and/or technicians who have gone through OEM or equivalent third-party service schools for the equipment shall be employed in the performance of any and all work performed under this contract. Service personnel shall have sufficient experience to demonstrate proficiency in maintenance of the product. The Contractor shall allow only Field Certifiers who are accredited through the NSF Biosafety Cabinet Field Certification – Enhanced Accreditation Program to perform class II biosafety cabinet certification. Upon request, Contractor shall provide written assurance of the competency their personnel as well as a list of credentials for approved field service personnel.

The Contracting Officer (KO), Contracting Officer’s Representative (COR) and/or Technical

Representative (TR) may authenticate the training requirements and request training certificates or credentials from the service vendors at any time.

2.8 Test Equipment

The contractor shall provide all required tools, equipment, and media/supplies, and is responsible for ensuring that all materials meet the required standards and specifications, thereby guaranteeing the accuracy and reliability of the testing and certification results.

Test equipment calibration shall be traceable to National Institutes of Standards and Technology (NIST traceable). Any efforts conducted without equipment within the calibration intervals is not performance in accordance with this contract. Upon request by TR, the Contractor and/or service vendors shall provide a copy of the current calibration certification of all test equipment to be used, or which has been used, on Defense Health Agency equipment.

2.9 Field Service Reports

The Contractor shall develop and submit to the Government an itemized list of all certification work upon completion of service. Reports shall be submitted to the locally identified technical point of contact. The field service report should include, at a minimum:

• Model number

• Serial number

• Location

• Venting information (ducted or not ducted)

• Type of connection (canopy, direct, or none)

• Type of biosafety cabinet or primary engineering control

• Test equipment used for each field test including:

o Manufacturer o Model o Serial number o Calibration date

• Specific field test data

• Acceptance criteria for each field test

• Printed name of field certification technician

• Field test date

• Field retest date

2.10 Recalls

When product recall or upgrades are necessary to maintain the equipment in service within the original manufacture’s specification, the Contractor shall obtain and install equivalent. The Contractor shall schedule with points of contact identified for each piece of equipment for recall services prior to performing any recall maintenance, to avoid disrupting patient care and to notify the department of arrival, services and maintenance required.

2.11 Travel and Accommodations

The Contractor shall be responsible for all travel and travel related costs (lodging, airfare, per diem, and transportation) and accommodations shall be arranged by the Contractor.

SECTION 3 – PERIOD OF PERFORMANCE

The initial period of performance will be for one year, starting from the day of contract award. The contract will include 4 one-year options, and a six (6) month extension. Preventive Maintenance, Calibrations, Certifications and Repairs shall be provided every 6 months or annually, according to OEM specifications and NSF/ANSI 49 and USP 797 requirements.

SECTION 4 – DELIVERY LOCATION

4.1 Equipment requiring annual certification (at a minimum):

See the attached excel document titled “Biosafety Cabinet Equipment Laboratory Operations” for equipment that requires, at a minimum, annual certification.

4.2 Equipment requiring semi-annual certification (at a minimum):

See the attached excel document titled “Biosafety Cabinet Equipment Pharmacy Operations” for equipment that requires, at a minimum, semi-annual certification.

4.3 Unscheduled and Additional Maintenance/Certification Requirements

The Contractor will be notified of additional equipment and their locations that require maintenance, field tests for certification or if an additional certification is required due to:

• HEPA/ULPA filters are changed

• Maintenance repairs are made to internal parts

• Cabinets/primary engineering controls are moved

• Changes are made to the heating, ventilating, and air conditioning system; equipment; or room geometry that could affect the cabinets’ performance

SECTION 5 – DELIVERABLES/REPORTING SCHEDULE

5.1 Service Event Documentation

The Contractor shall develop and submit to the Government an itemized list of all certification work upon completion of service. Reports shall be submitted to the locally identified technical point of contact. The field service report should include, at a minimum:

• Model number

• Serial number

• Location

• Venting information (ducted or not ducted)

• Type of connection (canopy, direct, or none)

• Type of biosafety cabinet or primary engineering control

• Test equipment used for each field test including:

o Manufacturer o Model o Serial number o Calibration date

• Specific field test data

• Acceptance criteria for each field test

• Printed name of field certification technician

• Field test date

• Field retest date

5.2 Formal Acceptance or rejection of Documents

The Government will have 5 business days to review each document and provide feedback/comments.

The Contractor shall have 5 business days to incorporate any required comments. The Contractors’ delivery of the final document to the Government shall constitute acceptance by the Government.

SECTION 6 – SPECIAL REQUIREMENTS

6.1 Minimum Qualifications

Only fully qualified field engineers, technicians and/or field certifiers who have gone thorough original manufacturer (OEM) Training or equivalent and are accredited through the NSF Biosafety Cabinet Field

Certification – Enhanced Accreditation Program to perform class II biosafety cabinet certification are to be employed in the performance of any and all work under this contract.

6.2 Utilities

The Contractor may use Government utilities (e.g., electrical power, compressed air, water) that are available and required for any service performed under this contract while at Government facilities. The facilities engineer however must approve of any Contractor equipment which would connect to these utilities in order to ensure compatibility with local installation utilities.

6.3 Outage Requirements

Any outages required in order to perform services must be approved by local installation

Facilities Management prior to initiation of work and shall be performed per Facilities' instruction. Contractor may request Facilities assistance in performing these outages if required.

6.4 Hazardous Materials

Ensure that all use, storage, transport of any materials regulated by OSHA as "hazardous", required for the performance of this contract, is in in compliance with all federal, state, and local regulations. Contractor shall have available Safety Data Sheet’s for any such materials on-site.

6.5 On-site Requirements

The Contractor shall protect all facilities from damage caused by the Contractor and shall repair, at no additional cost to the Government, all damages caused by the Contractor's activities. During performance of services, Contractor shall keep the site safe, neat, clean and orderly. Contractor shall be responsible for all means, methods, materials/supplies, techniques, sequences, and procedures of the services.

6.6 Access to Equipment

Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to do the service. The Contractor shall be free to start/stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on-duty personnel responsible for such equipment.

6.7 Normal Working Hours

Work required in the performance of this contract shall be performed between the hours of

0800 and 1700, local installation standard time. Contractor may be permitted to arrange for the performance outside of these hours via coordination with KO, COR, and/or TR at no additional cost to the

Government.

6.8 Work Attire

All Contractor personnel shall dress in casual business attire when at the work site. Casual business attire excludes short pants, tee shirts, open toe shoes, and other dress considered not to be appropriate.

Notwithstanding any other terms or conditions of the contract, Contractor wearing inappropriate dress to the work site may be immediately removed from the project, or at the discretion of local installation personnel. Contractor personnel may be requested by local installation personnel to leave the work site and return with appropriate attire. Travel/lost work time to return with appropriate dress is not chargeable.

6.9 Communication Courtesy

Contractor personnel shall be courteous and respectful to the customer and all other onsite personnel at all times. The Contractor shall follow the direction provided by KO, COR, TR, and local management personnel, or their designee(s), regarding the level of communication with the naval base personnel and conflict resolution escalation procedures.

6.10 Contractor Performance Evaluation

If performance does not meet the specifications stated in this SOW the Contractor shall be notified of substandard performance. The Contractor shall be given a specified amount of time by the Contracting

Officer to correct the deficiencies. If deficiencies are not corrected, appropriate action will be taken in conformance with laws and regulation.

6.11 Delays

The KO, COR, and TR will review any Contractor delay or failure to perform and determine if the delay was caused by technical factors beyond the Contractor’s control and without fault or negligence of the

Contractor. If the review indicates performance deficiency is not the result of factors beyond the

Contractor’s control, the Contractor will be notified by the Contracting Officer. The Contractor shall respond within 24 hours with receipt of notification and provide remedies to correct the deficiencies.

6.12 General Safety Requirements

The Contractor shall exercise safety precautions as the TR may determine to be reasonably necessary to protect the lives and health of occupants of buildings in which work is being performed. The KO or COR will notify the Contractor of any noncompliance with the foregoing conditions and the action(s) to be taken. Service vendors shall, after receipt of such notice, immediately correct the conditions to which attention has been directed. If field service engineer refuses to comply promptly, the TR may issue an order stopping all or any part of the work. Under such circumstances, the KO or COR with notify the

Contractor and hold the service vendor in contract default. Nothing in this section will be construed so as to limit the Contractor or their sub-contractor’s responsibilities to comply with any existing law, nor to switch jurisdictions.

6.13 Government Right of Refusal

The KO, COR, TR, and/or local management personnel reserves the right to reject any of the Contractor's personnel and refuse them permission to enter the premises or work on identified equipment. This right may be exercised at any time. The reasons for rejections may include lack of training and experience, but may also include but not be limited to: behavior, attire, security concerns, and immigration status.

6.14 Compliance with Applicable Laws

The Contractor shall be knowledgeable of and comply with all applicable Federal, State, and local laws, regulations, and requirements regarding the conduct of his business. The Contractors personnel shall comply with the Department of Defense Information Assurance Policies applicable. Contract shall require wage determinations and comply with applicable Federal and State worker's compensation and occupational disease statutes.

6.15 Modifications to Contract

Only the KO has the authority to obligate the government, and then only in writing. No modification or instruction from any party shall be construed to authorize the Contractor to take any action for which they expect compensation without written authorization from the KO.

6.16 Invoicing

All invoicing shall be done in accordance with this SOW and in accordance with contract. Failure to do so may delay or interfere with payment for services rendered.