SOW.docx

STATEMENT OF WORK Comment by Powers, Jeffrey: To MOMMC- Please review the redlines within the SOW. To maintain operational standards, I have referenced an additional document named “Attachment 1” that we will add adjacent to the SOW and the final contract. If we can agree on the updates in the SOW document, please “accept all” and return for approval.

FOR

BLOOD PRODUCT SUPPLIER AND IMMUNOHEMATOLOGY REFERENCE LABORATORY SERVICES

AT

MIKE O’CALLAGHAN MILITARY MEDICAL CENTER, NELLIS AFB, NV

14 APR 2021

TABLE OF CONTENTS

Contents

1.0. DESCRIPTION OF SERVICES

1.1. SCOPE OF WORK. This requirement is for a blood supplier and services contract for Mike O’Callaghan Military Medical Center (MOMMC) and outlines the procedures and conditions under which the blood supplier will: (a) distribute blood/blood components to the Installation, and (b) provide immunohematology reference laboratory services to the installation according to an agreed upon price list in Attachment 1.

2.0. GENERAL OPERATIONAL REQUIREMENTS

2.1. WORK REQUIREMENTS. Outlines the procedures and conditions under which the blood supplier will distribute blood/blood products to the Installation and provide immunohematology reference laboratory services to the installation according to an agreed upon price list.

2.2. BLOOD RELATED CHARGES: Blood center product service (processing) fees should be listed on patient bills separately from hospital blood related charges. All fees shall be in accordance with current approved fee schedule.

3.0. MANAGEMENT AND SAFETY REQUIREMENTS

3.1. IAW HA Policy 04-019:

3.1.1. Installation access may be suspended, limited or denied at any time by the Installation Commander. Installation access changes may be based on the failure to comply with the terms of the agreement. Suspension may also apply for military contingencies or wartime requirements, or if it is determined that the overall local/regional peacetime MHS blood needs are not being met due to competition by the civilian agency.

3.1.2. At all times during the term of this contract, the blood supplier will remain licensed by the Food and Drug Administration (FDA) and follow the standards of the AABB.

4.0. BLOOD SUPPLY

4.1. Blood Stock Level: A blood component stock level, determined and adjusted by mutual agreement, will be maintained at MOMMC to meet routine and potential emergency needs. It will be rotated on a scheduled basis as agreed upon. When possible, shorter dated units will be used first and MOMMC will release in a timely manner untransfused, crossmatched blood for other patients use or return to the blood supplier.

4.2. Delivery Shipment of Blood: Unless other arrangements are made, the blood supplier shall pay routine delivery and pickup expenses of blood products and patient samples to and from MOMMC, using the agreed upon method of delivery or shipment appropriate to the urgency of the shipment. Emergent STAT or ASAP orders will be charged accordingly and outlined in the fee schedule. Comment by Powers, Jeffrey: To MOMMC- Vitalant will charge for emergent STAT and ASAP orders accordingly and

4.2.1. STAT delivery of orders should be processed and ready to ship within one (1) hour of order. Comment by Powers, Jeffrey: To MOMMC- Language updated to reflect Vitalant delivery procedures for STAT, ASAP and Routine orders.

4.2.2. ASAP delivery of orders should be processed and ready to ship within four (4) hours of order.

4.2.3. Routine delivery of orders should be processed and ready to ship within twenty-four (24) hours of order.

4.2.4. Blood components may be ordered for a scheduled delivery.

4.3. Ordering Blood: Blood products and services may be ordered by phone, fax, or online portal. The blood supplier shall maintain service 24 hours a day, 7 days a week.

4.4. Platelet Orders: Platelets must be available to order 24/7/365 with STAT delivery to be processed and ready to ship within 1 hour of order. Comment by Powers, Jeffrey: To MOMMC- Same as STAT definition above.

5.0. STORAGE OF BLOOD

5.1. MOMMC will furnish blood component storage equipment restricted to the storage of blood and other biologicals, capable of maintaining appropriate storage temperatures according to the component type and equipped with a suitable alarm system and continuous temperature recording mechanism. MOMMC shall verify continuous storage temperature of the equipment and shall maintain such documentation according to requirements set forth by the FDA and AABB.

5.2. MOMMC agrees to provide blood product storage temperature records to the blood supplier upon request. These documents may be required during inspections by regulatory agencies. MOMMC will notify the blood supplier of any temperature deficiencies regarding consigned products within 24 hours of the occurrence and agrees not to return blood products subjected to temperatures outside the appropriate range unless approved for return by the blood supplier.

5.3. Return of Blood: MOMMC may return unmodified, unused units of red blood cell products provided the following considerations are met: proper temperature requirements have been maintained; the integrity of the unit container has been maintained and the label has not been defaced; at least one crossmatch segment remains (unless the blood supplier has approved the use of the last crossmatch segment); requirements for return shipment are followed; and each return shipment is accompanied by a properly completed return request. Returned red blood cells must have greater (>) than fifteen (15) days until expiration to be accepted. Please reference Attachment 1 for full return policy.

5.4. Upon request by the Installation, the blood supplier will use reasonable efforts to provide blood components subject to availability and adequate voluntary donations. The Installation will keep complete and accurate records of patients supplied with the blood (including product names, lot identifications, and quantities), any therapeutic adverse effects, complaints, or other pertinent information relating to the blood.

5.5. Upon discovery, the Installation will ensure that possible transfusion-transmitted infections or other serious complications associated with transfusion which may have resulted from the blood products supplied by the blood supplier are reported to the blood supplier (an “Adverse Event”). The Installation will cooperate with the blood supplier’s investigation of any Adverse Event and supply information concerning the recipient of the blood to the blood supplier using forms provided by the blood supplier.

5.6. There are risks, side effects, and hazards associated with human blood products that cannot be prevented, even through careful blood donor screening and testing. These risks, side effects, and hazards are set forth in the Circular of Information for the use of human blood and blood components as prepared by the AABB, America’s Blood Centers, and the American Red Cross, and are recognized as acceptable by the US FDA. It therefore follows that the region cannot guarantee or warrant the blood in any way. The region is not responsible for any loss or damage arising out of the blood unless and to the extent caused by the blood supplier’s negligence or misconduct.

5.7. Notwithstanding anything herein to the contrary, neither party will be liable for any loss or damage of any kind arising out of delay or failure in performance of any obligation hereunder beyond that Party’s reasonable control, including but not limited to any delay or failure caused by failure, unavailability or shortage of power, materials or supplies, flood, fire, storm, other abnormally inclement weather, other act of God, act of war, riot, act or omission of government or governmental agency (including FDA withdrawal and recall recommendations), strike, work stoppage, other labor unrest, inadequate voluntary donations required for the rendering of the Blood, other act or omission in the process of manufacture, production or supply under the control of third parties, or any other emergency.

5.8. With respect to manufactured blood, the blood supplier will provide the following notifications to the Installation: (a) within three (3) calendar days of blood collected from a donor who tested negative at the time of donation but tests reactive for evidence of HIV or HCV infection on a later donation or who is determined to be at increased risk for transmitting HIV or HCV infection; (b) within forty-five (45) days of the test, of the results of the supplemental (additional, more specific) test for HIV or HCV, as relevant, or other follow-up testing required by the FDA; and (c) as set forth in 21 C.F.R 610.48(b)(3). Under no circumstances will the blood supplier ever reveal the identity of the blood donor.

6.0. TRAINING AND SURVELLIANCE REQUIREMENTS

6.1. GOVERNMENT SUPERVISOR. The Government will periodically evaluate the blood supplier’s performance by appointing a representative(s) to monitor performance to ensure services are received. The Government representative will evaluate the blood supplier’s performance through inspections of invoices/reports and receive and investigate all complaints from base personnel. The Government may inspect each task as completed or increase the number of quality control inspections if deemed appropriate because of repeated failures discovered during quality control inspections or because of repeated customer complaints. Likewise, the Government may decrease the number of quality control inspections if performance dictates. The Government representative shall make final determination of the validity of customer complaint(s). The CO or designee will notify the blood supplier of any noncompliance with the foregoing provisions and advice the contractor of the action to be taken. After receipt of such notice, the blood supplier shall immediately initiate corrective action. If the blood supplier fails or refuses to comply promptly, the CO may issue a stop-work order for all or any part of the work and hold the blood supplier in default as provided elsewhere in this contract.

7.0. REGULATORY

7.1. Regulations. The Parties will comply with applicable laws and industry standards, including without limitation, requirements, regulations, standards, recommendations, specifications, guidelines and directives of the FDA and ARC; DoD HA Policies 04-015 and 04-019; the standards of the Joint Commission and the AABB; U.S. economic sanctions; anti-terrorism and anti-money laundering laws; the USA PATRIOT Act; laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control; and Executive Order 13224 (“Regulations”). In the event it is determined that blood supplier policy conflicts with an HA Policy, the Parties will meet to discuss a mutually agreeable resolution.

7.2. POINT OF CONTACT. The point of contact will be the 99th Medical Group, Pathology Flight Commander at (702) 653-2811, the Transfusion Services Technical Supervisor at (702) 653-2805, or designee. The military medical authority point of contact will be the 99th Medical Group Commander at (702) 653-2000.

7.3. PENALITIES AND FINES. The Contractor shall satisfy all applicable regulatory agency requirements. In the event a regulatory agency assesses a monetary fine against the Government for violations caused by the Contractor, the contractor shall reimburse the Government for the amount of the fine.

8.0. HOURS OF OPERATION

8.1. COLLECTION/ PICK-UP SCHEDULE. NORMAL HOURS: Contractor shall normally provide collection and pickup service on regular business days; as needed; between 8:00 a.m. until 4:00 p.m. In the event a pick-up falls on a holiday, the pick-up will take place no later than the very next business day. The Government reserves the right to increase and/or adjust the frequency of pickup and/or drop off to meet the needs of 99 MDG operations. The contractor shall perform the work at Bldg 1300, Mike O’Callaghan Military Medical Center, 4700 Las Vegas Blvd (North), Nellis Air Force Base, Nevada 89191.

NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT:

If a holiday falls on Sunday, the following Monday will be observed as the National Holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National Holiday by U.S. Government agencies. Also included would be any day specifically declared by the President of the United States.

9.0. GOVERNMENT FURNISHED PROPERTY AND SERVICES

9.1. FURNISHED PROPERTY. The Government will provide the following property and services in connection with the Contractor performance.

9.2. STORAGE AREAS. MOMMC will provide proper storage for all blood components.

9.3. EMEGENCY MEDICAL CARE. The 99 MDG Emergency Department is available for emergency treatment of jobsite injuries. If any employee is injured, the person may be taken directly to the Emergency Department, but the COR must be notified by the end of the following weekday and an injury report must be filed with the Hospital Safety Office. Care will be rendered at the rates established by local procedures.

9.4. BASE ACCESS. Contractor Personnel Access to Air Force Installations: The Contractor shall follow the provisions listed in FARS, Chapter 53, Sec 5352.242-9000 in order to enable contractor employees gain unescorted entry access to Nellis AFB.

10.0. PERSONNEL REQUIREMENTS

10.1. CONTRACTOR EMPLOYEES. The Contractor is responsible for providing fully knowledgeable, trained technicians that are competent to meet the contract requirements. Contractor employees shall enroll his/her employees in a medical surveillance program that meets the standards of 29 CFR 1910 at the expense of the Contractor. Contractor furnishes and ensures good condition of all PPE for contractor employees.

10.2. IDENTIFICATION BADGE. Contractor personnel are required to wear a company badge during the entire time they are on Nellis AFB grounds. ID Badges must have an identification picture and state the name of the individual and company represented.

10.3. PARKING. Park only in areas designated by the Facility Management Office. The Contractor shall display on each of its vehicles the company name in a manner and size that is clearly visible. The Contractor shall conform to the posted speed limits and parking restrictions set at Nellis AFB.

10.4. INDEMNIFICATION. It is expressly agreed and understood by the Contractor and the 99 MDG that the Contractor agrees to indemnify the 99 MDG against all liabilities, claims, penalties incident to death, bodily injuries, destruction or damage to property, contamination of adverse effects on the environment or any violation of government laws, regulations or orders, caused in whole or part by the Contractor’s breach of any term of this agreement or any negligent or willful act or omission of the Contractor, its employees or subcontractors in the performance of this contract.

10.5. AUTHORIZED SERVICES. Only those services specified herein are authorized under this contract. Prior to performing any service or repair on a non-contract nature, the CO and the COR must be advised of the reasons for this additional work. The CO or his/her designee in consultation with the COR may authorize the additional services or repairs under a separate purchase authorization. Reimbursement will not be made unless prior authorization is obtained.

10.6. SMOKING POLICY. The 99 MDG maintains a no smoking policy within all of its facilities in the medical campus. All tobacco products are prohibited from use to include electronic cigarettes of any variation, cigarettes, cigars, pipes, and chewing tobacco. Smoking is permitted only in designated tobacco area.

11.0 DEFINITIONS

11.1. CO: Contract Officer

11.2. COR: Contract Officer Representative

11.3. MDG: Medical Group