PWS-Blood (003).docx

Performance Work Statement Cheyenne River Health Center Blood Services

I. GENERAL

This performance-based work statement describes the requirements for non-personal services for delivery and supply of blood and blood components, for the Laboratory Department, to support the mission of the Indian Health Service (IHS)/Cheyenne River Health Center (CRHC).

The mission of the CRHC is to provide the best possible health care services to the Native American population served on the Cheyenne River Sioux Indian Reservation, in South Dakota.

II. BACKGROUND

The Indian Health Service (IHS) an agency within the Department of Health & Human Services is responsible for providing federal health services to American Indians and Alaska Natives. The Indian Health Service provides a comprehensive health service delivery system for approximately 1.9 million American Indians and Alaska Natives who belong to 567 federally recognized tribes, in 35 states. The Indian Health Service Headquarters is located in Rockville, MD and then divided into twelve physical areas: Alaska, Albuquerque, Bemidji, Billings, California, Great Plains, Nashville, Navajo, Oklahoma, Phoenix, Portland and Tucson.

The Great Plains Area Office (GPAO) works in conjunction with its 19 Indian Health Service Units and Tribal Managed Service Units to provide health care to approximately 122,000 Native American located in North Dakota, South Dakota, Nebraska, and Iowa. The GPAO facilities include: seven hospitals, eight health centers, and several smaller health stations and satellite clinics.

Our facility, the CRHC, falls under the GPAO. CRHC provides medical care for approximately 9,000 tribal members living on the CRST Reservation. Serving a rural area, many of our patients travel 100 miles’ round trip to receive care. The CRHC provides an expanded level of health care services specifically designed to meet the needs of the CRHC population served. Services include: Emergency Room Department, Pharmacy, Physical Therapy, Public Health Nursing, Radiology Services, Inpatient Care, Laboratory, MRI, Dental, Community Health, Contract Health Services, Dietitians, Audiology, Eye Care, and Specialist Clinics: OB/GYN, ENT, Audiology & Podiatry.

The CRHC is in need of blood services to provide all blood components needed for patient care at the facility.

ACROYMNYS: To be used throughout this document.

CRHC – Cheyenne River Health Center BU/BC – Blood Units/Blood Components TPOC – Technical Point of Contact

III. PURPOSE OF CONTRACT

The primary purpose of this contract is to provide BU/BC to the CRHC for direct patient care, to include, but not limited to the following: all blood components needed for transfusion (fresh frozen plasma, apheresis platelets, irradiated blood products, RhoGam, CMV negative packed red blood cells units, AS-3 red blood cell units, AS-C red blood cells leukocytes reduced), reference laboratory and apheresis products. The contractor will be the primary supplier of BU/BC to the CRHC. The secondary purpose is to provide higher level laboratory service to the CRHC for specialized blood banking.

IV. PERIOD OF PERFORMANCE

Base Year: 9/1/2024 – 8/31/2025 Option Year 1: 9/1/2025 – 8/31/2026 Option Year 2: 9/1/2026 – 8/31/2027

V. SCOPE OF WORK

A. Blood Stock Level: The blood stock level, determined and adjusted by mutual agreement, will be maintained at the CRHC, to meet routine and potential emergency needs. It will be rotated on scheduled basis as agreed upon. When possible, the request of the use of shorter dated units be used first, and the timely release of un-transfused/cross-matched blood for other patient use or return to the blood center.

B. Ordering Blood Components: BU/BC shall be ordered by an agreed scheduled shipping, calling Service for STAT, ASAP, or Non-Scheduled, or by on-line processes. Vendor shall maintain service 7 days a week and twenty-four (24) hours a day.

Blood components shall include, but not limited to:

i. Red blood cells leukocytes reduced

ii. Fresh frozen plasma

iii. Platelets that have been apheresis and leukocytes reduced, pathogen reduction technology, and/or large volume delayed sampling.

C. Receiving/Shipment of Blood: The contractor shall ship the, agreed order of BU/BC to the facility, meeting all standard required for the delivery of blood. The contractor will be the primary supplier of BU/BC and shall have the ability to meet STAT ad ASAP shipments within a short period of time. The contractor shall pay for delivery expenses of BU/BC to and from the facility using the agreed-upon method of delivery or shipment appropriate to the urgency of the shipment. The contractor shall guarantee all required packaging and temperature requirements, are meant to properly store and ship the BU/BC items.

BU/BC will be accompanied by appropriate documentation when shipped/delivered. BU/BC shall be transported to the CRHC in a validated manner so that the BU/BC remain within required specifications throughout the transport period. Upon delivery to the CRHC, the CRHC shall be responsible for any loss, destruction, or damage to the BC/BC.

D. Storage of Blood: Blood products are stored in a refrigerator capable of maintaining the required storage temperatures as specified in Title 21 of the Code of Federal Regulations, Standards of the American Association of Blood Banks and BSI policies and procedures, which are equipped with a continuous temperature monitoring system.

E. Return of BU/BC: The contract shall allow the option to return BU/BC, within an agreed upon time frame and conditions. The contractor and government shall agree upon an acceptable restocking and/or credit fee for any returned BU/BC.

VI. CONTRACTOR’S QUALITY CONTROL

The Contractor shall establish a quality control program to incorporate an inspection system covering all the services to be performed under the contract. It must specify areas to be inspected on either a schedule or unscheduled basis and the title of individual(s) who will do the Inspections. In additions, the quality control program shall address a method for identifying deficiencies in the quality of services performed before the level of performance becomes unacceptable. The Contractor shall maintain a file for all inspections conducted and of all corrective actions to be taken. This document shall be made available to the CRHC Service Unity upon request.

VII. ADDITIONAL REQUIREMENTS

Contractor Shall:

· Be a Blood Center, accredited by U.S. Food and Drug Administration

· Provide Proof and Maintain American Association of Blood Banks Accreditation

· Adhere to Title 21 of Code of Regulations, Standards of the American Association of Blood Banks, and BSI policies and procedures

· Hold Clinical Laboratory Improvement (CLIA) certification.

Contractor, when become aware, shall immediately notify the CRHC, if BU/BC is potentially infections, in compliance with the requirement of IHS and FDA.

Assisting the Contractor in the resolution of technical problems encountered during performance of this contract.

VIII. CONTRACTOR RESPONSIBILITY

Maintain quality and controls, supply, delivery, storage, restock, for the service and supply of BU/BC.

Allow agreed inspections by the government.

Report infectious BU/BC to the government.

Supply containers, labels, refrigeration, for shipping and storage of BU/BC.

Communicate openly and timely with the government to meet the needs of the requirement.

IX. GOVERNMENT RESPONSIBILITY

Responsible for proper inspection all BU/BC upon delivery and shall notify contractor immediately of any BU/BC found to be damaged, abnormal in appearance, received at unacceptable temperatures, or if there appear to be any testing, labeling, or shipping errors.

Storage of BU/BC received in accordance with IHS and Federal Regulations. Contractor requirements for storage should be submitted and agreed upon at the beginning of each contract period of performance.

Allow agreed inspection by the contractor.

Report transfusion adverse reactions to contractor.

Communicate openly and timely with the contractor to meet the needs of the requirement.

X. TECHNICAL POINT OF CONTACT

The Technical Point of Contact (TPOC) designated for this project is:

Danette Hoffman, Laboratory Supervisor Cheyenne River Health Center 24276 166th Street Eagle Butte, SD 57625 Office: 605-964-7724

The TPOC is responsible for the following:

a. Monitoring the contractor’s technical progress

b. Interpreting the statement of work

XI. CONTRACTING OFFICER REPRESENTATIVE

The Contracting Officer Representative (COR) designated for this Project is:

Stephanie Red Elk, COR Cheyenne River Health Center 24276 166th Street Eagle Butte, SD 57625 Office: 605-964-7724 Fax: 605-964-0522 The COR is responsible for:

a. Technical evaluation as required;

b. Assisting the Contractor and TPOC in the resolution of technical problems encountered during performance of this contract.

XII. INVOICE SUBMISSION

Invoices shall be submitted through Invoice Processing Platform (IPP).

The IPP website address is: https://www.ipp.gov

In compliance with the Office of Management and Budget (OMB) M-15-19 memorandum “Improving Government Efficiency and Saving Taxpayer Dollars Through Electronic Invoicing” directing Federal agencies to adopt electronic invoicing as the primary means to disburse payment to vendors. Invoices submitted under any award will be required to utilize the Invoice Processing Platform (IPP) in accordance with HHSAR 352.232-71, Electronic Submission and Processing of Payment Requests” IPP is a secure, web-based electronic invoicing system provided by the U.S. Department of the Treasury’s Bureau of the Fiscal Service, in partnership with the Federal Reserve Bank of St. Louis (FRSTL).

Contractors are encouraged to register an account with IPP if they have not already done so. If your organization is already registered to use IPP, you will not be required to re-register- however, we encourage you make sure your organization and designated IPP user accounts are valid and up to date. It will be the responsibility of the contractor to keep active and maintain there SAM.gov account, in order to keep there IPP account active. Payment is sent via E.F.T., through the account registered in SAM.gov.

If you require assistance registering or IPP account access, please contact the IPP Helpdesk at (866) 973-3131 (M-F 8AM to 6PM ET), or IPPCustomerSupport@fiscal.treasury.gov or ihse-invoicingteam@ihs.gov

Should the contractor feel that use of the IPP would be unduly burdensome, their response to the solicitation should include an explanation of this position, for a determination by the contracting officer to allow non-IPP invoicing.

The contractor shall submit a signed, invoice by the TPOC, verifying the items and services listed on the invoice were received by the government. The contractor will attached this signed invoices in IPP and submit for payment. Contractor shall invoice at least biweekly, unless another agreed upon time is established.

The Contractor shall include the following information on each invoice in accordance with the Prompt Payment Act (5 CFR Part 1315.9(b):

1. Contractor's name;

2. Invoice number and date;

3. Entire award number/Contract number or other authorization number for delivery of goods or services; and task order number.

4. Description (including dates of service), price, and quantity of goods and services rendered;

5. Shipping and payment terms;

6. UEI number and Taxpayer Identifying Number (TIN); and

7. Contact name (where practicable), title and telephone number.

XIII. PERFORMANCE-BASED SERVICE DELIVERY SUMMARY.

The contractor’s performance will be measured based on the following Performance Requirements. The Performance Requirements will be measured against Government Performance Standards and monitored in accordance with the following Methods of Government Surveillance or what is known as a Quality Assurance Surveillance Plan (QASP) to determine compliance.

Performance Standards

Quality Assurance Incentive

Performance Evaluation. If the contractor fails to perform required services at the acceptable quality level, the COR will provide written notice of such to the Contracting Specialist and CCO and the contractor. The Contracting Office will issue the contractor a Contract Discrepancy Report (CDR). The contractor shall have seven (7) calendar days to provide the Contracting Office with their response to the CDR.