DOCUMENT

06-Hood Cert-DRAFT SOW.docx

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Contract Opportunity
Date Originally Posted
Oct. 4, 2022, 5:51 p.m.
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.docx
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SCOPE OF WORK FOR SERVICE & SUPPORT:

Pharmacy and Laboratory Hoods: Area Wide Contract

C-1PURPOSE:

The purpose of this contract is to provide a comprehensive service and support agreement for pharmacy and laboratory hoods equipment manufactured by various manufacturers and in accordance with USP 797 and UPS 800 pharmacy compounding units located within the IHS operated facilities in the Great Plains Area (ND, SD, IA, NE). The award of a contract will be a requirements (Indefinite Delivery/Indefinite Quantity) type.

C-2SCOPE OF WORK:

Contractor shall provide to the Great Plains Area Indian Health Service, hereafter referred to as the Government, with the services described in this statement of work for the period specified.

Testing & Certification: Services to be performed by the contractor under this contract is to provide the assessments to determine USP 797 and UPS 800 compliance. Each assessment will review the existing site conditions and list any recommendations to achieve USP 797 and USP 800 compliance. Assessments shall also include staff interviews to determine existing compounding practices Upon compliance, complete calibration / preventive maintenance, mechanical / electrical safety testing, certification and filter replacement as recommended by the original equipment manufacturer (OEM) and required by the Center for Medicare and Medicaid Services and various accrediting/regulating bodies. Additional services include decontamination of decommissioned devices prior to disposal, and testing of ante-and compounding rooms as needed.

Removal: At no time shall the contractor remove, or cause to be removed any device, operation option or accessory from the healthcare clinic, hospital, or health station without express written consent from the Contracting Officer Representative or Clinical Engineering.

Response Period and Hours of Performance:

A maximum of five (5) business days to be on site at the facility after the initiation request. Unless otherwise agreed upon, work shall be performed Monday through Friday, 8am to 5 pm excluding weekends and holidays.

Performance Period: The performance period for this contract is 12 months from PO issuance with 4 option years:

C-3EQUIPMENT:

See attached listing. Note: equipment list is subject to add/remove/replace throughout the contract life

C-4EXCLUSIONS:

Contractor is not responsible for damage caused by failure to operate the equipment in accordance with manufacturer’s instructions, abuse, misuse, or neglect, or damage by fire, lightning, flood, tornado, windstorm, hail, earthquake, explosion, smoke, aircraft accident, motor vehicle accident, collapse of building, strike, riot, vandalism, power failure or fluctuations, heating or air conditioning failure..

In the event that the Contractor determines that there is probable cause to believe that an operator or equipment user is abusing, neglecting, or mishandling an item of equipment, the Contractor shall be bound by the terms of this contract to notify, in writing, the Chief, Division of Clinical Engineering, 115 4th Ave SE Room 309, Aberdeen, SD 57401 all facts or specifics of said abuse.

The following are, specifically excluded from this contract:

Operating supplies or accessories not furnished by Contractor during the course of normal Inspection and Services, such as expendable items including recording charts, paper, ink, pens, ribbons, pen arms, etc. This does not include filters, etc. that are required to be periodically replaced which will be covered as preventive maintenance parts under this contract.

Work external to the equipment or maintenance of accessories, alterations, attachments or other devices not specifically covered under this contract unless noted in writing, and agreed to by both parties.

Equipment which has been modified, altered, added to, improperly repaired, improperly installed, or used in violation of the manufacturer’s instructions or damages resulting from other than ordinary use.

Any questions regarding the applicability of any or all determinations and/or findings that are subject to protest and/or disputes will be adjudicated by the Great Plains Area, Indian Health Service, Senior Contracting Officer.

C-5DOCUMENTATION:

The Contractor shall provide all inspection forms and labels necessary to perform services as specified.

The Contractor is required to present (2) two copies of the service tickets/calibration record with the P.O. number of the service contract on them for each time a service is performed on the equipment. Lack of service tickets being presented will be cause for non-payment by the Government. One copy of the service ticket (together with the calibration certificate) shall be left with the Department Supervisor and one copy (together with the calibration certificate) shall be mailed to the Chief, Division of Clinical Engineering, 115 4th Ave SE Room 309, Aberdeen, SD, 57401 within one week of the service. Service tickets may be also be submitted via email to ABR_OEHBiomed@ihs.gov .

Contractor will provide a “statement of competency”, or certification of training for each Service Technician who will provide services under this contract. The specific documents shall be mailed to the Chief, Division of Clinical Engineering, 115 4th Ave SE Room 309, Aberdeen, SD 57401 or emailed to ABR_OEHBiomed@ihs.gov following award of the contract, but prior to beginning any work under the contract.

All labels, forms, documentation, certificates, or reports left at the inspected facility or sent to the Contracting Officer or his/her representative evidencing performance of services shall become the permanent property of the U.S. Government and may not be removed from the Facility.

C-6QUALITY CONTROL:

The Contractor shall have a prior successful history in providing services that demonstrates and ability to provide these services to the Government.

The Contractor shall investigate all complaints or potential problems involving services performed that do not conform to Government expectations.

C-7BASIS OF PAYMENT:

All payments are due and payable upon receipt of complete and accurate invoices and in accordance with the Prompt Payment Act. Invoices shall be submitted with all information and supporting documentation as described in C-5 Documentation. A complete and accurate invoice is substantially correct in that all aspects of the required information are clearly evident on the invoice. If items such as invoice number, date, dates of service, contract/purchase/task order number, etc., are not on the invoice, it will be returned to the Contractor for resubmission. The Prompt Payment Act Clause will be provided by the Contracting Officer at the time of award and will further clarify the requirements. Finance charges for late payment of charges due to problems not of the Contractor’s making shall be paid according to the regulations and amount determined by the Great Plains Area Indian Health Service Financial Management Branch. If the Government fails to pay an amount when properly due, the Contractor has the option of suspending all services provided by this contract after providing a detailed explanation to the Contracting Officer. The Contracting Officer is responsible for assuring that direct patient care is not compromised by frivolous or unlawful suspension of services. Disputes will be handled according to the Disputes Clause and shall not violate any rule or regulation or law.

The steps for authorizing work, and approving payments are as follows:

Contractor shall submit, on as frequent a basis as in necessary to the Area Clinical Engineering Program:

A schedule showing which hoods are due at which facility

An estimated cost for performing the preventive maintenance/calibration/certification tasks for each hood/facility

A "Task Order" or "Delivery Order" will be issued to the Contractor authorizing the work to be performed and agreeing to the estimated costs

Contractor shall submit an invoice and all supporting documentation as described in C-5 and C-7 for payment.

The Area Clinical Engineering Program will validate the invoice and supporting documentation in order to approve payment.

C-8LIABILITY:

In no event shall the Government release the Contractor from liability arising from acts of omission, improper repair, negligence, or deliberate or non-deliberate acts that jeopardize the health and safety of patients and/or Government employees. The rules of law governing such incidents or actions shall prevail.

C-9RELEASES:

No information, findings, or determinations generated in pursuit of this contract may be released outside of the contractors’ immediate possession without the concurrence of the Contracting Officer.

C-10CONTRACTOR’S TERMS & CONDITIONS:

The contractor’s terms and conditions shall be incorporated into the contract by reference. Where conflicts arise, the Federal Acquisition Regulations, and other Federal Regulations, Laws and Rules shall take precedence.