SOW - FY26 Cleanroom Certification and Maintenance - signed.pdf

Department of Health and Human Services Indian Health Service

Statement of Work (SOW) USP-797 Cleanroom Certifications and Equipment Maintenance

1. PURPOSE OF THE PROJECT

The Indian Health Service (IHS), a federal agency within the Department of Health and Human Services, is responsible for providing federal health services to American Indians and Alaska Natives. The mission of IHS is to raise the physical, mental, social, and spiritual health of American Indians and Alaska Natives to the highest level and assure that comprehensive, culturally acceptable personal and public health services are available and accessible to members of the 574 federally recognized Tribes across the United States.

The Lawton Service Unit is a Joint Commission accredited federal facility in Oklahoma. To meet our mission, USP-797 cleanroom certifications and equipment maintenance is medical modality that has been deemed necessary to augment the services as such are necessary to support and supplement health care within the hospital. The mission of the Lawton Service Unit is to deliver quality care in order to attain positive health outcomes for all our valued patients with emphasis on cultural sensitivity and human dignity.

The Lawton Service Unit (LSU), specifically Lawton Indian Hospital (LIH), has a requirement for cleanroom certifications and equipment maintenance. Cleanroom certifications, sampling, and required testing are required every 6 months per USP Chapter <797> in order to compound category 2 compounded sterile products.

Proprietary equipment maintenance is required for biological safety cabinet (BSC) and laminar airflow workstation (LAFW).

2. DETAILED DESCRIPTION OF THE TECHNICAL REQUIREMENTS

2.1. The contractor shall provide biannual re-certification of ante room, buffer room, and hazardous drug buffer room. Certification for the BSC and LAFW workbench shall be provided.

2.1.1. Contractor shall provide re-certification for at least one additional instance for HVAC (heating, ventilation, and air conditioning) unit possible installation of new equipment.

2.2. The contractor shall perform HEPA filter integrity testing, airborne non-viable particle counting, microbiology sampling and assistance with any USP-797 required additional testing during biannual re-certification.

2.3. The contractor shall perform equipment maintenance when required and ceiling HEPA filter changes.

2.4. The contractor shall perform diagnostic, troubleshooting, and repair services for LAFW, BSC, or cleanrooms when requested by LSU. Resolution expectations include minimal equipment downtime.

2.5. The contractor shall perform tests in accordance with manufacturer specifications, USP Chapter <797>, USP Chapter <800>, ISO14644-1:2015, ISO14644-3:2019(E) CETA CAG-008-2010, CAG-009-2011v3, - 003-2022

2.6. The contractor shall perform preventative maintenance review and report recommended services.

3. PERIOD OF PERFORMANCE

The base year Period of Performance will be 12 months from date of award with four (4) twelve (12) month option years.

4. LEVEL OF EFFORT

4.1. The contractor shall provide reports that note findings, recommendations, and corrective actions.

4.2. Certificate of analysis and any USP-797 required additional documents

4.3. The contractor shall include microbiology sampling map and trending report in compliance with facility required testing locations.

5. SPECIAL REQUIREMENTS

5.1. In accordance with HHSAR 304.1300(b) non-routine contractor employees shall comply with OPDIV

DHHS/SE Region – Human Resources, Security Clearance Guidance – Visitors (3/29/12) policy for contract performance period. Contractor employees will be required to obtain a visitor’s pass upon arrival for services from Facilities Management. - (Security Clearance for on-site human services)

5.2. The USPHS Lawton Service Unit is a tobacco/smoke free environment (buildings and grounds). No tobacco/smoking use will be tolerated during service.

5.3. Security Requirements: Contractor personnel will be required to contact the government designated point of contact upon arrival when reporting for service calls or delivery supplies. The contractor shall be responsible for the security of all organizational information. Current rules and regulations applicable to the premises, where the work shall be performed shall apply to the contractor and its employees while working on the premises. These regulations include but are not limited to, escort by Lawton Service Unit official, presenting valid identification, smoking restriction and any safety procedures.

5.4. The contractor shall not disclose or cause to disseminate any information concerning operations of Lawton

Service Unit. Such action(s) could result in violation of the contract and possible legal actions.

5.4.1. All inquiries, comments, or complaints arising from any matter observed, experienced or learned of as a result of or in connection with the performance of the contract, the resolution of which may require the dissemination of official information, shall be directed to the government’s designated representative.

6. DELIVERABLES AND REPORTING REQUIREMENTS

6.1. Delivery: The contractor will coordinate the delivery, installation and training date with the designated government employee. The contractor shall deliver to Lawton Indian Hospital at 1515 Lawrie Tatum Rd, Lawton OK 73507 with all installation instructions, warranty documents, and specifications. No deliveries can be made after 4:15pm. Driver needs a valid ID.

6.2. Contractor Point of Contact: The contractor shall furnish one designated point of contact (POC) to the government’s designated representative for coordination of supplies, delivery, and/or maintenance. The

POC will be empowered to make daily decisions to ensure that the contract implementation and day-to-day maintenance meets the terms and conditions of this contract.

6.3. Contractor’s Phone Numbers: The contractor shall provide a toll-free telephone number for service calls, which must be answered during at least eight working hours, between 8:00 am and 4:30 pm, Monday through Friday.

6.4. Personnel Qualifications:

Company must service Oklahoma in a timely manner in instances where equipment needs urgent attention when requested.

7. GOVERNMENT FURNISHED PROPERTY, FACILITIES AND SERVICES

7.1. The Government shall supply the facilities, supplies and the equipment of the Pharmacy Department and all hospital specialty/support staff. Use of government furnished facility space, equipment, supplies, and personnel are for the provision of services set forth in this contract only.

8. CONTRACTOR FURNISHED PROPERTY, FACILITIES AND SERVICES

8.1. Required personnel, materials, supplies and equipment: The contractor shall furnish all personnel, materials, supplies and equipment required to perform work under the contract, to include but not limited to:

8.1.1. Equipment required to complete certification testing, tryptic soy agar plates, air sampling equipment, sampling materials

9. CHANGES TO THE STATEMENT OF WORK (SOW)

9.1. Any changes to this SOW shall be authorized and approved only through written correspondence from the

Contracting Officer. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

10. DELIVERABLES/PERFORMANCE MATRIX

Services delivered and completed within time frame as set forth in contract Yes or No Contractor was professional Yes or No Item delivered meets specifications of this SOW Yes or No Contractor provided a POC Yes or No

Department Supervisor Signature:_________________________

Department Director Signature:_________________________