PWS Blood and Blood Products.docx

Performance Work Statement (PWS) for the Blood and Blood Products

The mission of the Quentin N Burdick Memorial Health Care Facility and the Belcourt IHS Laboratory is to provide the best possible health care services to the Native American people. This acquisition establishes the performance requirements for furnishing blood and blood products to the Belcourt IHS Laboratory. This firm-fixed-price Purchase Order will be for one base year and 4 option years.

1.2 Objective

The Contractor shall furnish blood and blood products that comply with all applicable Federal laws, regulations, licensing requirements, and accreditation standards. Services shall be performed in a manner that ensures uninterrupted support to patient care operations.

A Blood stock level, determined and adjusted by mutual agreement, will be maintained at the Quentin N Burdick Memorial Health Care Facility Laboratory to meet routine and potential emergency needs. It will be rotated on a scheduled basis as agreed upon.

Delivery Shipment of Blood Unless other arrangements are made, the Contractor shall pay delivery expenses of blood to and from the Quentin N Burdick Memorial Health Care Facility laboratory using the agreed-upon method of delivery or shipment appropriate to the urgency of the shipment.

1.4 Background

The Indian Health Service (IHS) is an agency within the Department of Health and Human Services (HHS) responsible for providing comprehensive health services to eligible 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.

The Quentin N Burdick Memorial Health Care Facility is an IHS-operated healthcare facility that provides emergency, inpatient, outpatient, surgical, obstetrical, and ancillary healthcare services to its patient population. Timely access to safe and reliable blood and blood products is essential to support patient care, emergency response, trauma stabilization, surgical procedures, transfusion therapy, and other medically necessary treatments.

To ensure continuity of clinical operations and compliance with applicable federal regulations and accreditation standards, the Government requires a qualified contractor to furnish blood and blood products on a routine and emergency basis. The contractor shall maintain the capability to provide products that meet all applicable Food and Drug Administration (FDA) requirements, American Association of Blood Banks (AABB) standards, and other governing regulatory requirements.

This acquisition is intended to establish a performance-based contract that ensures the availability, quality, traceability, and timely delivery of blood and blood products necessary to support the healthcare mission of the Indian Health Service.

1.5 Type of Contract Contemplated

The Government contemplates the award of a single-award Firm-Fixed-Price (FFP) Indefinite-Delivery/Indefinite-Quantity (IDIQ) contract resulting from this solicitation. Individual orders shall be issued for blood and blood products as requirements arise during the period of performance.

The Government anticipates establishing fixed unit prices for the blood and blood products identified in the Schedule. Orders will be placed on an as-needed basis, and the Contractor shall furnish the supplies and related services in accordance with the terms and conditions of the contract.

The contract shall include a Base Period and, if determined to be in the Government's best interest, option periods that may be exercised in accordance with FAR Part 17. The Government does not guarantee orders in excess of the stated minimum guarantee.

The contemplated contract type is consistent with FAR Part 12, Acquisition of Commercial Products and Commercial Services, and FAR Part 16, Types of Contracts, utilizing firm-fixed-price arrangements that place maximum risk and full responsibility for costs and resulting profit or loss upon the Contractor while providing incentives for efficient and economical performance.

1.6 Period of Performance

The period of performance of this contract consists of a base year and four option years, beginning from the date of award.

1.7 Place of Performance

The place of performance shall be the Contractor's facility(ies) and the designated Indian Health Service (IHS) delivery location(s).

The Contractor shall perform all collection (if applicable), testing, processing, storage, inventory management, packaging, transportation, and quality assurance activities at its own facilities. The Contractor shall be responsible for ensuring that all blood and blood products are maintained under required environmental conditions throughout storage and transportation until delivery and acceptance by the Government.

The primary delivery location is:

Quentin N Burdick Memorial Health Care Facility 1300 Hospital Loop Belcourt, ND 58316 The Government reserves the right to designate additional delivery locations within the service area during the period of performance. Any changes to delivery locations shall be made by the Contracting Officer.

Deliveries shall be made to the location(s) identified on individual orders during the days and hours established by the Government, except for emergency or after-hours deliveries, which shall be made as requested by authorized Government personnel.

Title and risk of loss shall remain with the Contractor until delivery is completed and the supplies are accepted by the Government at the designated delivery location.

1.1. Applicable Documents

The Contractor shall perform under this contract in accordance with the applicable editions of the following statutes, regulations, standards, and guidance in effect on the date of contract award.

The following documents establish minimum performance, quality, and regulatory requirements and are incorporated by reference for contract performance.

A. Documents for Contract Compliance The following documents establish minimum performance, quality, and regulatory requirements and are incorporated by reference for contract performance.

B. Government-Furnished Information (GFI) The Government will furnish the following information after contract award:

· Facility ordering procedures.

· Delivery schedules and receiving hours.

· Authorized ordering officials and Contracting Officer's Representative (COR) contact information.

· Facility-specific blood product inventory requirements, if applicable.

C. Order of Precedence In the event of any inconsistency between this Performance Work Statement and the documents referenced herein, the terms and conditions of the contract shall govern unless otherwise required by statute or regulation.

· Packed Red Blood Cells (PRBCs)

· Fresh Frozen Plasma (FFP)

· Platelets (when ordered)

· Irradiated Blood Products (when ordered)

· Leukocyte-reduced blood products (when ordered)

· CMV-negative blood products (when ordered)

· Washed blood products (when ordered)

· Antigen-negative blood products (when ordered)

· Pediatric blood products (when ordered)

· Other specialty blood components as ordered by the Government (when ordered)

· Accept routine and emergency orders twenty-four (24) hours per day, seven (7) days per week.

· Maintain a single point of contact for routine orders and customer service.

· Provide procedures for emergency and after-hours ordering.

· Deliver routine orders within the delivery timeframe established by the ordering activity.

· Deliver emergency orders within the timeframe specified by the ordering activity based on clinical need.

· Transport all blood products under validated temperature-controlled conditions.

· Deliver products to the Government-designated receiving location.

· All blood products are licensed for distribution in the United States

· Products are tested, labeled, and traceable in accordance with applicable regulations.

· Products are shipped before expiration dates sufficient to support clinical use.

· Products are free from damage or evidence of compromised storage conditions.

· Assist the Government in maintaining adequate blood inventory levels.

· Recommend appropriate inventory levels based on utilization needs.

· Replace eligible products approaching expiration in accordance with the Contractor’s replacement policy.

· Notify the Contracting Officer and the Contracting Officer’s Representative (COR) within twenty-four (24) hours of any FDA recall, biological deviation, market withdrawal, or safety notification affecting products provided under this contract.

· Provide replacement products as appropriate.

· Product identification information

· Blood Type

· Unit Number

· Expiration Date

· Shipping Documentation

· Temperature monitoring documentation, when applicable

· Monthly utilization report

· Delivery performance report

· Product replacement report

· Recall and corrective action report

· Quality performance report

2.9 Contractor Personnel

The Contractor shall ensure personnel performing under this contract are qualified, trained, and authorized to perform assigned duties and comply with all applicable regulatory requirements.

3.0 Contractor Quality Assurance

The Contractor shall maintain and implement a documented Quality Assurance (QA) Program throughout the period of performance to ensure that all blood and blood products furnished under this contract comply with the requirements of the contract, applicable federal regulations, and recognized industry standards.

The Contractor’s QA Program shall, at a minimum:

· Ensure compliance with applicable FDA regulations and current AABB Standards for Blood Banks and Transfusion Services.

· Maintain procedures for quality control, corrective and preventive actions (CAPA), process improvement, and management review.

· Ensure personnel are trained and qualified to perform assigned duties.

· Maintain records demonstrating compliance with applicable regulatory and accreditation requirements.

· Monitor contractor performance to ensure products consistently meet contract requirements.

3.1 Quality Assurance Plan

Withing fifteen (15) calendar days after the contract award, the Contractor shall submit a Quality Assurance Plan to the COR for review. The QAP shall describe the Contractor’s internal processes used to ensure compliance with the requirements of this contract.

At a minimum, the QAP shall address:

· Organizational responsibilities for quality management

· Procedures for receiving, processing, storing, packaging, transporting, and delivering blood products.

· Methods for monitoring compliance with contract requirements.

· Procedures for identifying, documenting, investigating, and correcting deficiencies.

· Recall and product notification procedures.

· Internal audit and continuous improvement processes.

· Training and competency requirements for personnel.

The Contractor may use its existing commercial quality management system, provided it meets the requirements of this contract.

3.2 Performance Monitoring

The Contractor shall routinely monitor its performance against the contract requirements and take timely corrective action when deficiencies are identified. Documentation supporting corrective actions shall be maintained and made available to the Government upon request.

The Contractor may propose alternative performance measures or inspection methods that provide substantially equivalent assurance of quality in accordance with FAR 46.201(b). Any proposed alternative shall be submitted to the Contracting Officer for approval before implementation.

3.3 Government Acceptance

The Government intends to rely on the Contractor's established quality assurance system consistent with FAR 46.202-1 for commercial products. Government review, inspection, or acceptance activities do not relieve the Contractor of responsibility for furnishing products and services that conform to all contract requirements.

The Government reserves the right to inspect, verify, or reject any product or service that does not conform to the requirements of this contract.

4.0 Delivery or Deliverables

Timely delivery of blood and blood products and associated documentation is essential to successful contract performance. The Contractor shall furnish all deliverables in accordance with the schedule established by this Performance Work Statement (PWS), individual delivery orders, and the terms and conditions of the contract.

Unless otherwise specified, all reports shall be submitted electronically in Adobe PDF or Microsoft Excel format to the Contracting Officer's Representative (COR). Product deliveries shall be made to the Government-designated delivery location identified in the applicable order.

Deliverable Schedule

a. Deliver all blood and blood products in accordance with the delivery schedule specified in the applicable order.

b. Ensure products are packaged and transported under validated temperature-controlled conditions to maintain product integrity throughout transit.

c. Deliver only products that meet the contract requirements for quality, labeling, shelf life, and regulatory compliance.

d. Notify the Contracting Officer and COR immediately of any anticipated deliver delays that might affect patient care.

e. Provide complete shipping documentations with each delivery.

Government Review The Government will inspect deliveries upon receipt to verify:

· Correct product type and quantity

· Product condition and expiration date

· Required shipping and traceability documentation.

· Compliance with applicable storage and transportation requirements Acceptance by the Government does not relieve the Contractor of responsibility for latent defects, fraud, or nonconformance discovered after acceptance.

Contractor Notice All information developed, generated, or provided under this contract shall be protected from unauthorized disclosure. The Contractor shall not release, publish, or otherwise disseminate information relating to this contract without the prior written approval of the Contracting Officer, except as required by law or regulation.

be easy to miss. Creating a centralized checklist facilitates timely, compliant delivery of all necessary data and reports. You can either include it in the body of the SOW document, or cross-reference here to a separate document, and list it in the attachments.

Where a written milestone deliverable is required in draft form, indicate a completion time for the agency’s review of the draft deliverable, e.g. within calendar days from date of receipt. The agency should also indicate the number of days the contractor has to deliver the final deliverable from date of receipt of the government’s comments.

Sample Text: Timely submission of deliverables and reports is essential to successfully completing this requirement. Schedules for deliverables are specified in the attached <reference the table or DD Form 1423s>. All deliverables shall be prepared and submitted according to media, content, and schedule described in the <insert table or CDRL> and SOW.

FAR 4.10 – Uniform Use of Line Items, provides the following guidance for line items and subline items:

· Each line item may be subdivided into separate unique subsets (called subline items) to ease administration. If a line item has deliverable subline items, the line item is informational. A line item with subline items will contain only the information that is common to all subline items under it.

· Subline items differentiate between or among certain characteristics of the line item, such as colors or sizes, dates of delivery, destinations, or places of performance.

· Subline items are established to define deliverables or organize information about deliverables.

· You may use informational subline items for administrative purposes. This type of subline item identifies information that relates directly to the line item and is an integral part of it (e.g., parts of an assembly or parts of a kit). Position informational subline items within the line item description, not in the quantity or price fields.

· Each line item:

· Must be separately identifiable. Services are separately identifiable if they have no more than one statement of work or performance work statement.

· Provide for a single unit price or total price

· Identify the accounting classification citation

· Identify the delivery schedule, destination, period of performance, or place of performance

· Use a single contract pricing type (e.g., fixed-price or cost-reimbursement – no combinations in a single line item).

· All subline items under one line item must be the same contract type as the line item.

· Note -- this does not prohibit using different contract types for different line items, only that an individual line item can use only a single contract type.

· If a contract contains a combination of fixed-price, time-and-materials, labor-hour, or cost-reimbursable line items, identify the contract type for each line item in the schedule (or a comparable section of the procurement instrument) to facilitate payment

· Table 1 at the end of this template provides a model covering the FAR required data elements. Elements denoted by an * in are recommended by VAO.

· Exceptions:

· Indefinite-delivery contracts. The following elements are not known at time of award but must be provided in each order issued: accounting classification, delivery date and destination, or period and place of performance

· IDIQ and requirements contracts. May omit the quantity at the line item level for the base award provided that the total contract minimum and maximum, or the estimate, respectively, is stated

· Single unit price or single total price. The requirement for a single unit price or single total price at the line item level does not apply if any of the following conditions are present:

· There are associated deliverable subline items that are priced

· The line item or subline item is not separately priced

· The supplies or services are being acquired on a cost-reimbursement, time-and-materials, or labor-hour basis.

· The procurement instrument is for services and firm prices have been established for elements of the total price, but the actual number of the elements is not known until performance (e.g., a labor-hour contract for maintenance/repair). The contracting officer may structure these procurement instruments to reflect a firm or estimated total amount for each line item.

· VAO recommends including the following notice to contractors:

Notice to contractors:

All information and data related to this project that the contractor gathers or obtains shall be both protected from unauthorized release and considered the property of the government. The contracting officer will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this contract. Press releases, marketing material, or any other printed or electronic documentation related to this project, must not be publicized without the written approval of the contracting officer.]

Contracting Administration Only the Contracting Officer (CO) has the authority to modify the terms and conditions of this contract. The Contractor shall not act upon any direction that changes the scope, price, or period of performance unless authorized in writing by the Contracting Officer.

The Contracting Officer's Representative (COR) is responsible for technical oversight of contract performance and may provide technical direction that is within the scope of the contract. The COR is not authorized to make contractual commitments or changes.

Communication The Contractor shall maintain current points of contact for routine business, emergency orders, recalls, and after-hours support throughout the period of performance. Changes to contact information shall be provided to the CO and COR within one (1) business day.

Delivery Coordination The Contractor shall coordinate deliveries with the Government-designated receiving activity and comply with facility receiving procedures and hours of operation unless otherwise directed for emergency deliveries.

Emergency Notifications The Contractor shall immediately notify the CO and COR of any event that could adversely affect the Contractor's ability to perform, including product shortages, supply chain disruptions, recalls, transportation delays, or other circumstances that may affect timely delivery or product availability.

Confidentiality The Contractor shall protect Government information obtained during contract performance from unauthorized disclosure and shall use such information only for purposes of performing this contract.

Order of Precedence In the event of a conflict between the requirements of this Performance Work Statement and other technical documents incorporated into the contract, the order of precedence established by the contract shall apply.

Source Selection Information—See FAR 2.101 and 3.104 [This footer applies during internal development of the PWS. Remove the footer when officially releasing the PWS to vendors as a draft for comment or in the formal solicitation] Source Selection Information—See FAR 2.101 and 3.104 Developed by Virtual Acquisition Office™ for federal government use and customization.

Table 1: Model for List of Deliverables For fixed-price line items:

OR

Period of performance Destination

OR

Place of performance SOW reference*

Typically one, but If multiple accounting classifications for a single deliverable apply, include the dollar amount for each

Due date or frequency

Not required in the line item if there are associated deliverable subline items that include the actual detailed identification

002-01

002-02

For informational (administrative) subline items, an accounting classification citation is not required

Add rows as needed

For cost-reimbursement line items:

OR

Period of performance Destination

OR

Place of performance SOW reference*

Typically one, but if multiple accounting classifications for a single deliverable apply, include the dollar amount for each

Due date or frequency

002-01

002-01

Add rows as needed