Attachment 1 - Statement of Work.pdf

STATEMENT OF WORK

WHOLE BLOOD COLLECTION BAGS

AT MADIGAN ARMY MEDICAL CENTER/JBLM, WA

1. GENERAL REQUIREMENTS

1.1. SCOPE OF WORK:

1.1.1. The Contractor shall provide whole blood collection bags and consumables at The Armed Services Blood Bank Center-Pacific Northwest (ASBBC-PNW), Madigan Army Medical Center, JBLM WA which shall contribute with providing quality blood and blood products to beneficiaries and in support of health care delivery.

1.1.2. The Contractor shall provide whole blood collection bags and consumables in accordance with established standards, principles and ethics of the profession and applicable professional specialty organizations, The Food and Drug Administration (FDA), the Association for the Advancement of Blood and Biotherapies (AABB), The Clinical Laboratory Improvement Act (CLIA), applicable Department of Defense (DoD) and Army specific regulations, directives, and policies, and military treatment facility (MTF) specific policies, procedures, and job descriptions.

1.1.3. The Contractor shall perform to the standards of this Statement of Work (SOW).

1.2. ADMINISTRATIVE:

1.2.1. Contractor Representative. The Contractor shall designate, in writing, a primary point of contact for contract coordination and implementation not later than five business days after receiving notice of contract award.

Changes in the primary point of contact (POC), at any time, shall require the Contractor to notify the Contracting Officer (KO) of the new representative at least five working days prior to the change. This notification shall be in writing and shall state the name and contact information for the new point of contact.

1.2.2. Problems experienced by the Government with the Contractor’s performance will be discussed and resolved. Unresolved problems will be referred to the KO for resolution.

1.3. HOURS OF OPERATIONS:

1.3.1. Monday – Friday: 0800-1400 (for collections) and 0700-1830 (for processing and shipping). ASBBC- PNW is closed on Federal Holidays.

1.3.2. Holidays. The following is a list of legal federal holidays. Any of the federal holidays falling on a Saturday will be observed on the preceding Friday, holidays falling on a Sunday will be observed on the following Monday.

New Year’s Day, January 1st Martin Luther King’s Birthday, 3rd Monday in January President’s Day, 3rd Monday in February Memorial Day, Last Monday in May Juneteenth Independence Day, June 19th Independence Day, July 4th Labor Day, 1st Monday in September Columbus Day, 2nd Monday in October Veteran’s Day, November 11th Thanksgiving Day, 4th Thursday in November Christmas Day, December 25th

NOTE 1: Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If the area in which a contract employee is scheduled to work is closed due to the holiday and the employee is not required to report in, payment will not be made for those hours. Closures of the installation due to inclement weather or other such acts of God shall be handled in the same manner.

1.3.3. Closures. During anticipated closure of the facility due to Command declared training holidays or during unplanned closure of the facility due to natural disasters, military emergencies, severe weather, or otherwise, the contractor shall not invoice the Government for services not performed and the Government will not be liable to the contractors for any such closures.

1.4. RECORDS. The Contractor shall maintain all records necessary to comply with regulatory requirements and Food and Drug Administration (FDA) standards. The Contractor shall be responsible for creating, maintaining, and disposing of only those Government required records that are specifically cited in this SOW or required by the provisions of a mandatory directive, Applicable Publications and Forms. If requested by the Government, the Contractor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request.

2. DEFINITIONS/ACRONYMS:

2.1 DEFINITIONS. Following is a list of basic definitions.

2.1.1 CONTRACTING OFFICER: The ONLY person with the authority to enter into, administer, change, and/or terminate contracts and make related determinations and findings.

2.1.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR): A Government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract. NOTE: The COR is not authorized to make any changes to the terms and conditions of the contract.

2.1.3. QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the Government to check services to determine if they meet the requirements of the CLIA/DoD CLIP ’88 & ’03, CAP, JCAHO, U.S. Army Medical Command and U.S. Navy Bureau of Medicine quality assurance and risk management programs and ensure compliance with the terms and conditions of the contract.

2.1.4. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, in accordance with MAMC DPALS Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the

SOW.

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

AABB - Association for the Advancement of Blood and Biotherapies AR - Army Regulation ASBBC-PNW Armed Services Blood Bank Center-Pacific Northwest BUMED U.S. Navy Bureau of Medicine and Surgery CAP - College of American Pathologists COR - Contracting Officer's Representative DA - Department of the Army DN - Department of the Navy DoD CLIP Department of Defense Clinical Laboratory Improvement Program FDA - Food and Drug Administration HIPAA - Health Insurance Portability & Accountability Act of 1996 MAS - Minimum Acceptable Standards MEDCOM- U.S. Army Medical Command JC - Joint Commission OSHA - Occupational Safety and Health Administration PMS - Preventive Maintenance Services PRS - Performance Requirements Summary QA - Quality Assurance QA&I - Quality Assessment & Improvement QC - Quality Control SOW - Statement of Work

3. GOVERNMENT FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES:

3.1. The Government will provide, without additional cost to the Contractor, the facilities, equipment, materials, and services listed below.

3.2. GENERAL. None.

4. SPECIFIC TASKS

4.1. DESCRIPTION.

4.1.1. The contract is a request for whole blood collection bags including consumables required in order to provide quality blood and blood products to beneficiaries and in support of healthcare delivery.

4.1.2. The Contractor shall provide the consumables and a shall coordinate exact quantities and shipment schedule with the COR prior to shipment IAW with Paragraph 4.2.1.6., Deliveries (below).

4.1.3. All consumables must be FDA approved.

4.2. CONSUMABLE MATERIAL

4.2.1. The Contractor will provide the consumables listed in Table 4.1.

Table 4.1 – Consumable Material Quantity Whole Blood Leukoreduction Collection Bags CPDA-1 500mL 6,600 Whole Blood Leukoreduction Collection Bag Adapters 8,500

4.2.1.1. The whole blood collection bags must have a primary container volume of 500mL, utilize CPDA-1 as an anticoagulant and have an in-line leukoreduction filter that meets or exceeds the AABB and FDA required residual WBC counts of <5.0x106 WBCs per unit.

4.2.1.2. Collection bags must also have at least two satellite containers that allow for the sterile separation of whole blood components (plasma and packed red blood cells).

4.2.1.3. Bags must be equipped with a sample diversion pouch that allows for collection of diagnostic and infectious disease testing.

4.2.1.4. Contractor must provide adapters for the collection of test specimens from sample diversion pouch.

4.2.1.5. Whole blood collection bags must also be FDA 510k cleared and be able to interface with existing collection and manufacturing equipment at the ASBBC-PNW (i.e. centrifuges, compomat, mixer/scales, leukoreduction stands etc.).

4.2.1.6. Deliveries. The Contractor shall make standing deliveries every month on business days between the hours of 0800-1400. If a federal holiday occurs on a scheduled delivery day, the delivery will be made the following business day between the hours of 0800 – 1400, unless directed differently by the ASBBC-PNW personnel.

Unscheduled deliveries due to anticipation of increased collections and/or emergency same day deliveries may be requested by the government if mission required.