36C25818Q0263-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE (MM-DD-YYYY)

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Blood and Blood Products

PHX- ALB - PRS IDIQ

5 year IDIQ - 1 Oct 2018 to 30 Sept 2023 85014 36C25818Q0263 09-24-2018 N 621991 Department of Veterans Affairs NCO22-Gilbert Network Contracting 777 E. Missouri, Suite 300 Phoenix AZ 85014 Johanne Gingras, Contract Specialist NCO 22-Gilbert, Veterans Health Administration Phoenix, AZ johanne.gingras@va.gov Multiple Sites:

Carl T Hayden VAMC, Phoenix AZ New Mexico VAHCS, Albuquerque, NM Northern AZ VAHCS, Prescott, AZ 85012

USA

johanne.gingras@va.gov Johanne Gingras, Contract Specialist, Phoenix VA VISN _22_ Medical Centers 5 year order Period: 10/1/2018 through 09/30/2023 Anticipate Indefinite Delivery Indefinite Quantity - IDIQ Contract

Scope of Procurement

The Contractor shall provide Blood and Blood Products to the VA medical centers in VISN 22 East (as specified below) in accordance with the pricing, terms and conditions contained herein.

List of Facilities by Name, Address and COR

a. New Mexico VA Healthcare System

(NMVAHCS)

1501 San Pedro SE Building 41, Basement, Rm BA-102 Albuquerque, New Mexico 87108 COR: Ronalynn Engstrom 505-256-2881 Ronalynn.engstrom@va.gov

b. Phoenix VA Healthcare Systems

(PVAHCS)

Building 1, Room E215 650 East Indian School Rd Phoenix, AZ 85012 COR: Edward Yee 602-277-5551 x7510 Edward.yee@va.gov

c. Northern Arizona VA Healthcare System (NAVAHCS) Building 107, Room 106 500 US Highway 89 North Prescott, AZ 86313 COR: Eliza Carnley 928-445-4860 x6025 Eliza.carnley@va.gov

Statement of Work

A. Quality of the Product

1. All whole blood and blood components provided to patients in VA medical centers must meet the requirements of the American Association of Blood Banks (AABB) and/or the Food and Drug Administration (FDA), Department of Health and Human Services.

2. Allogeneic blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB.

a. All blood must be collected by the closed system under aseptic conditions, processed in appropriate solutions and the container so labeled. The label must also bear the expiration date of the contents, which must not exceed the Food and Drug Administration (FDA) allowable limit for the type of anticoagulant in which the blood component is drawn.

b. All blood supplied must be free of hemolysis, clots, and excessive chyle.

3. Autologous blood/blood components must be typed for ABO and Rho(D) in accordance with licensed methodologies, and must be tested for all transfusion transmitted disease markers currently required by the FDA.

4. The Contractor shall supply 100% “volunteer donor” blood as defined in 21CFR606.121(c)(5)(ii). All blood/blood components must be collected from donors in accordance with the requirements of the AABB and the FDA.

5. In the event of a recall, Contractor shall promptly send copies of the recall request to the Blood Bank Medical Director at the VA medical center where the blood product was issued.

6. Contractor shall make reference transfusion services available to all VA medical centers. The offeror must be capable of providing the blood components and specialized testing detailed in the Schedule of Supplies/Services and Prices/Costs (the Schedule) on a 24-hour per day, seven days per week basis.

B. Changes in Testing Requirements for Transfusion Transmitted Diseases

In the event that additional testing for transfusion transmitted diseases is nationally mandated by the FDA during the contract period, specific price adjustments may be requested by the supplier to address the cost for the additional testing. In the event that this should occur, a letter detailing the rationale for the price increase must be submitted to the Contracting Officer at least 30 days before the intended implementation date.

C. Donor Requirements

1. The contractor shall maintain readily available blood donor lists, including names, addresses, and social security numbers. Such lists must indicate whether, and on what date, blood of a particular donor was furnished to the VA under this contract.

Offeror’s donor identification numbers must be unique to the donor unit and must have a FDA-approved numbering schematic.

2. Donor selection must be in accordance with criteria established by the FDA and/or the AABB.

3. Each unit of blood collected through voluntary donation must minimally be tested for all transfusion transmitted disease markers currently required by both the FDA and AABB.

4. Each platelet component must be tested for bacterial contamination (sterility) in accordance with AABB standard 5.1.5. effective March 1, 2004.

D. Orders/Deliveries:

D.1. Schedules of Supplies:

Minimum guaranteed amount is $100,000.00 for the contract period. Funding shall be provided on a separate delivery order each fiscal year per facility.

DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND CLIN ORDER VALUE

There is no minimum quantity and order value for the given Delivery/Task Order issued for a given CLIN. The maximum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not exceed $6,750,000.00, the maximum contract ceiling.

See Attachment 1 schedule of supplies for blood and blood products available from the contractor.

1. Orders will be categorized into three types: stock, as soon as possible (ASAP) and STAT. These categories are defined as follows:

a. Routine-Shipments of blood products to maintain minimum inventory levels or blood products ordered to fulfill a standing request.

b. As Soon As Possible (ASAP) – Shipments of blood products to fill a request for a waiting outpatient, or a non-life threatening need within several hours, or to replenish a depleted inventory of a particular blood product which has been used since the previous routine delivery. ASAP orders must be delivered within 4 hours of request.

c. STAT – A need for blood products so acute that a patient’s life could be jeopardized if the request for blood products is unfulfilled. STAT orders must be delivered within 120 minutes of request to all sites.

2. Routine blood and blood component orders shall be delivered as specified within 24 hours following online, telephoned, or faxed orders or mutually agreed upon shipment of inventory. All online orders shall be followed up with a confirmation e-mail for facilities that use online orders. Telephone orders shall be confirmed at time of order. To facilitate service to the Facilities, the contractor shall maintain service 24 hours a day, seven days a week. Unless other arrangements are made, the contractor shall pay expenses for delivery of blood and blood components to and from each hospital using the method of delivery or shipment appropriate to the circumstances. Contractor will ensure that all blood and blood components supplied to the Facilities will be accompanied by appropriate documentation and will be transported in a validated manner to ensure that the blood and blood components remain within specification throughout the transfer period. Thereafter, the Facilities shall be responsible for any loss, destruction, or damage to the blood. The blood components provided to the Facilities may not be sold, exchanged, transferred without the prior authorization of the Contractor, except in the event of an emergency. The Facilities shall notify the Contractor in the event of such an emergency and retain records to track the disposition of the unit.

a. Phoenix VA Health Care System (PVAHCS) and Northern Arizona VA Health Care System (NAVAHCS) Orders marked “ASAP” shall be delivered within 8 hours.

b. New Mexico VA Health Care System (NMVAHCS) orders marked “ASAP” shall be delivered within 4 hours.

c. NMVAHCS and PVAHCS orders marked “STAT” shall be delivered within 1 hour.

d. NAVAHCS irradiated units shall be delivered within 8 hours.

e. PVAHCS irradiated units shall be delivered within 4 hours.

f. NMVAHCS irradiated units shall be delivered within 3 hours.

g. Antigen negative units shall be delivered within 8 hours for PVAHCS and NAVAHCS. Antigen negative units ordered by NMVAHCS shall be delivered within 8 hours except in the case of a rare source antigen negative unit. When an antigen negative unit of rare source is required, Contractor shall communicate within three (3) hours the anticipated timeframe of delivery.

h. Platelet antibody screens and cross-matches shall be completed within 72 hours.

i. STAT serological problem cases shall be resolved within 12 hours of receipt of sample at testing facility

j. All other serological problem cases shall be resolved within 48 hours.

k. PVAHCS and NAVAHCS preliminary case resolution shall be communicated within 12 hours of receipt of sample at testing facility.

l. NMVAHCS preliminary case resolution shall be communicated within 24 hours.

3. Autologous blood is fully tested before being sent out by Contractor. Contractor’s staff will have done preliminary group and screen. Units will be appropriately tagged, and limited to autologous use only. Autologous blood will be delivered to the VA blood bank designated by the patient's physician.

4. All blood and blood components will be ordered by the VA Medical Center on Delivery Orders issued to cover the estimated quantities of blood and blood components to be used during the specified period. VA reserves the right to use credit card to pay for services/supplies under this contract. Credit card payments may be subject to a processing fee not to exceed 3%.

5. Laboratory Tests: All laboratory tests must be performed by a laboratory accredited by AABB, certified by HCFA, or licensed and/or registered by FDA. In the event the vendor implements a new laboratory test intended to improve the safety or quality of blood or blood components provided to the Facilities and as required by FDA or as advisable pursuant to professional standards including standards or recommendations through the AABB or other professional organizations, the contract may be modified at the discretion of the Government to add the test to the price schedule, section B.2.

6. VA Personnel Authorized to Place Orders: VA personnel authorized to place orders will be identified at time of award.

7. Order of Precedence: The first order of precedence are the terms and conditions of this contract, then all applicable Federal Law or Regulation.

8. The specific volumes distributed in a routine order will be established by each VA medical center. However, the contractor shall submit a proposed delivery and route schedule for approval within ten days after contract award. Schedule may be adjusted periodically.

9. Either leukoreduced or non-leukoreduced blood will be ordered on a site-specific basis (Refer to Attachment D for volumes).

10. Once units are received by a VA medical center, those units become the property of the VA medical center, and payment will be made appropriately, based on contract terms and proper invoicing. They are not to be treated as though they are on consignment. However, for inventory control purposes, efforts will be made by each VA medical center to assist the contractor and other facilities in meeting patient transfusion needs.

11. The VA will be subject to and comply with all requirements and regulations associated with the recall and withdrawal of blood or blood components from its inventory due to health and safety risks.

12. Efforts will be made to assist the supplier in hosting blood donor drives at the VA medical center(s) in those cases where it can be reasonably accommodated by the hosting VA site, and where there are no previous commitments to other blood centers, including the Department of Defense. The annual number of blood donor drives will be negotiated between the contractor and the VA medical center.

E. NOTES

1. Inspection of Storage Facilities: Upon request by the FDA, CAP, AABB, or the Contractor, its agents and employees, the Facilities will allow reasonable on-site inspection of blood storage facilities during normal business hours. The Facilities will further allow the review and copying of their Standard Operating Procedure for blood component storage and quality assurance records throughout the term of this contract.

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

3. Storage of Blood: The Facilities will furnish specific storage units restricted to storage of blood and other biologicals capable of maintaining required storage temperatures as specified in Title 21 of the Code of Federal Regulations, Standards of the American Association of Blood Banks and Contractor policies and procedures which are equipped with a continuous temperature monitoring system that records temperatures at least once every four (4) hours. The Facilities will verify continuous blood storage temperature of the refrigerator and will maintain such documentation for five years. The Facilities agree to provide blood storage temperature records to the Contractor upon request. These documents may be required during inspections by regulatory agencies. Further, VA will maintain whole blood and red blood cells at the temperature of 1 to 6 degrees Centigrade as appropriate. VA will notify Contractor of any temperature deficiencies in the storage of blood and blood components within 24 hours of the occurrence and agrees not to return units of blood subjected to temperatures outside the required temperature range unless approved for return by the Contractor.

4. Return of Blood: The Facilities will return unused units of blood and blood components under the following conditions:

a. Proper temperature requirements have been maintained (for red blood cells and platelets).

b. The integrity of the unit container has been maintained and the label has not been defaced.

c. At least two crossmatch segments remain, unless the blood center laboratory has approved use of the last crossmatch segment.

d. Blood and blood components are inspected at the time of packing and packed in accordance with standard industrial practice. The Facilities shall document that proper inspections, to be defined as inspections performed by each hospital blood bank following its own existing procedures to confirm the viability of inspected units in accordance with applicable regulations and standards, have occurred and agree not to return blood or blood components which appear unsuitable for use.

e. At least 7 days expiration remaining for units of blood

5. Hospital Notification: If the Contractor becomes aware that any delivered blood or blood component are potentially infectious, including with HIV, HCV, or HTLV I/II, the Contractor shall notify the Facilities. The notification shall be consistent with requirements of FDA. Where required or allowed by law, notification may be provided through a state department of health or similar government agency. Upon of receipt of notice from the Contractor, the Facilities shall notify the recipient of the blood or blood component or the recipient’s physician.

1. Within three (3) calendar days after identifying blood or blood components previously collected from donors who have subsequently tested reactive for evidence of HCV or HIV infection or from donors who are determined to be at increased risk for transmitting HCV or HIV, the Contractor shall

(i) Quarantine all in-date blood and blood components identified from the donor intended for use in another person or for further maintenance into injectable products; and

(ii) Notify consignees to quarantine all in-date blood and blood components identified from the donor if intended for use in another person for further manufacture into injectable products.

2. Within forty-five (45) calendar days of a reactive test for evidence of HCV or HIV infection, the Contractor shall notify consignees of the donor’s test results.

E. Shelf Life

1. All blood/blood components must be labeled, stored, and shipped in accordance with the current regulations of both the FDA and the AABB. If these regulations change during the course of this contract, the contractor shall implement the necessary changes as directed/recommended by the regulatory and accrediting agencies.

2. For routine orders, allogeneic blood/blood components must be supplied with appropriate remaining shelf life, as detailed below.

3. For ASAP and STAT orders, the contractor shall provide units with the appropriate remaining shelf life IAW E.2 whenever possible; however, the VA understands that the urgency of the situation and the availability of the blood product may preclude this possibility.

4. When the VA returns units prior to expiration in accordance with the contractors return policy, the contractor shall credit the VA for units which are returned, as detailed in the Schedule.

F. Value Added Services

These services will be provided to the VISN 22 East VA medical centers at no charge.

1. Contractor shall provide physician consultative services to the VISN 22 East VA medical centers that are consistent with the services offered to other non-VA contracted customers. A description of the services must be included with the offeror’s proposal.

2. Contractor shall provide educational programs to the VISN 22 East VA medical centers that are consistent with the programs offered to other non-VA contracted customers. A description of the educational programs must be included with the offeror’s proposal.

G. Billing:

1. Statements shall be issued twice monthly, or as emergency products are ordered, with charges including line item entry for each blood product issued and/or used with details and chronologically listed.

2. NMVAHCS and PVAHCS shall receive a deduction on the invoices in accordance with the separate Memorandum of Understanding between Kirkland Air Force Base for NMVAHCS and Luke Air Force Base for PVAHCS from Contractor regarding military donor credits.

H. General and Miscellaneous Terms:

1. The Contractor awarded this contract shall be VISN 22 East VAs primary supply source for blood and blood components. The Facilities shall obtain blood and blood components from a provider other than the awarded Contractor only if:

(i) There is an emergent circumstance (as defined in the Facilities reasonable discretion, with an explanation to be provided to the Contractor if requested); or

(ii) There is a Force Majeure Event (as provided herein); or

(iii) The Contractor is unable to provide blood or blood components within a reasonable time of an order being placed; or

(iv) The Contractor refuses to provide blood or blood components; or

(v) At the request or direction of a patient or a patient’s physician, the facility is directed to use autologous blood which is available through a provider other than the awarded contractor.

2. To ensure that payments made to the Contractor are included to the extent appropriate in determining reasonable costs incurred by the Facilities as a provider of services under Medicare, in the event this contract is determined to be “a contract between the provider and any of its sub-contractors which is entered into after the date of enactment of Social Security Act, Section 1861 (V)(1)(I), and the value or cost of which is $10,000 or more over a 12 month period,” the contractor shall perform the obligations as may from time-to-time be applicable for subcontractors under the Social Security Act and the regulations promulgated thereunder.

3. Upon request by the Facilities, the Contractor shall review alternative methods for reducing costs relating to blood or blood components and will provide mutually agreed upon assistance for implementation of such alternative methods. Examples of the methods that may be considered include blood utilization review, transfusion service, best practice audits, and order, inventory, and delivery optimization.

4. Facilities agree to support Contractor’s volunteer blood donor program and to encourage blood donations among VA employees and others.

5. The Contractor agrees to indemnify the Government for any and all claims asserted against it based on allegations of negligence in collecting, testing, processing, packaging, or distributing blood or blood components provided under this contract such that the alleged negligence affects the quality or purity of the blood or blood components. Such indemnification is intended to cover the Government only in connection with allegations of negligence for the above described activities that the Contractor has agreed to perform under the terms of this contract. Such limited indemnification shall not apply to any claim asserted for alleged negligence in connection with any other activity or failure to act, whether or not such other activity or failure to act constitutes active or passive negligence. This limited indemnification is contingent upon the Government providing the Contractor with prompt, written notification of any and all occurrences which may result in a claim under this paragraph.

6. The Government agrees to indemnify the Contractor for all claims asserted against it based on allegations of negligence of the Facilities, their employees, agents, or medical staff. This limited indemnification is contingent upon the Contractor providing the Government with prompt, written notification or any and all occurrences which may result in a claim under this paragraph.

7. No laboratory tests or other procedures are presently available that can ensure that blood or blood components provided under this contract are free from all agents that may cause disease or illness, including but not limited to the presence of viruses and retroviruses. The Contractor shall not be held to make any warranties, express or implied, regarding the blood and blood components to be provided under this contract, and no provision of the contract creates any warranty of merchantability or fitness as to blood or blood components provided under this contract. Except with respect to instances of intentional misconduct, under no circumstances and under no theory of liability shall either party be liable to the other for any indirect, punitive, or consequential damages arising under or relating to this contract.

8. Force Majeure. Each party shall be excused from any delay in performance or from failure to perform in accordance with the terms of this contract to the extent that such delay or failure to perform results from any cause beyond the reasonable control of the party, including without limitation, fires, floods, epidemics, quarantine restrictions, strikes, war, earthquake, acts of God, labor difficulties, riot, failure of public utilities, freight embargoes, unusually severe weather, delay in delivery of goods or services by suppliers or subcontractors to such party, loss of goods in transit, and Government or court action (the ‘Force Majeure Event’). Such party shall give notice to the other party promptly in writing upon learning of the Force Majeure Event. Notwithstanding any provision to the contrary, the affected party shall not be liable for any damages arising out of the Force Majeure Event.

9. Confidentiality: Terms of the paragraph shall be observed except when disclosure is required by law. During the term of this contract and for a period of five (5) years after any termination or expiration hereof, the vendor and the Government acknowledge and agree that all information communicated by one party (the “Disclosing Party”) to the other (the “Receiving Party”) in connection with this contract shall be received in confidence, and shall be used only to carry out the terms of this contract. Confidential information shall not be disclosed by the Receiving Party or its agents or personnel without the prior written consent of the other party. The obligations under this paragraph do not apply to information that: (a) is or becomes generally available to the public other than as a result of disclosure by the Receiving Party, (b) was known to the Receiving Party or had been previously possessed by the Receiving Party without restriction against disclosure at the time of receipt thereof by the Receiving Party, or (c) was independently developed by the Receiving Party without violation of this contract. If either party receives a subpoena or other validly issued administrative or judicial demand requiring it to disclose the other party’s confidential information, such party shall provide prompt written notice to the other of such demand in order to permit it to seek a protective order. So long as the notifying party gives notice as provided herein, the notifying party shall be entitled to comply with such demand to the extent permitted by law, subject to any protective order or the like that may have been entered in the matter.

10. Severability. If any term, provision, covenant or condition of the contract is held by a court of competent jurisdiction to be invalid, void or unenforceable, the remainder of the provisions hereto shall remain in full force and effect and shall in no way be affected, impaired or invalidated as a result of such decision.

11. Assignment. Neither party may assign, delegate or transfer in any manner the obligations and rights set forth in the contract without the written consent of the other party.

12. Entire contract. The contract is the entire contract between the parties relating to the subject matter of the contract and shall supersede all prior arrangements, negotiations, and understandings between the parties, whether oral or written. No waiver of any term, provision or condition of the contract shall be deemed to be or shall constitute a waiver of any term, and no waiver of any present condition shall constitute a waiver of such condition occurring in the future.

13. Change in Law. In the event, a change in federal law, including applicable regulations, or enforcement of same materially affects the contract, the parties shall negotiate immediately, in good faith, any necessary or appropriate amendment(s) to the contract.

14. Third Parties. The contract is not intended and shall not be construed to create any rights or benefits for any person or entity not a party to the contract.

15. Exhibits. All Exhibits referred to in the contract are hereby incorporated herein. In the event, any provision of the contract conflicts with any Exhibit, the Exhibit shall control with respect to the subject matter of such Exhibit.

16. Counterparts. The contract may be executed in any number or counterparts, each of which shall be deemed an original. All such counterparts together shall constitute but one and the same instrument.

17. Ability to Enter Contract. Each party represents and warrants that it is free to enter into the contract and to perform each of the terms and conditions of the contract.

I. CONTRACTOR RESPONSIBILITIES

1. Contractor must be currently registered and/or licensed with the Food and Drug Administration (FDA), Department of Health and Human Services pursuant to Section 510 of the Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. Section 360, and shall maintain FDA, AABB, CLIA, CAP, and applicable State licensure and provide certificates to VA Clinical Lab(s) annually and upon request.

2. Contractor must submit proof that he holds an unrevoked U.S. License which is issued by the Center for Biologics Evaluation and Research (CBER), FDA under section 351 of the Public Health Service Act, as amended, 42 U.S.C. Section 262, as a source of supply for whole blood. Contractor shall ensure that all contract personnel have met qualifying criteria, including current and valid licenses and certifications. Ultimately, the decision to reject and accept contract staff rests with the Department of Veterans Affairs. Non-acceptance of contract personnel does not relieve Contractor from satisfying and fulfilling all requirements of this contract.

3. Upon contractor personnel entrance of government grounds, they shall adhere to the following VA Policies:

a. All Contractor personnel shall have ID badges worn at all times and displayed above the waist.

b. All Contractor personnel shall park in designated parking areas only. The VA will not invalidate or make reimbursement for parking violations of the Contractor’s personnel under any circumstances.

c. All Contractor personnel shall respect and adhere to the smoking area policy and only smoke in areas permitted by the Department of Veterans Affairs.

J. QUALITY CONTROL PROGRAM

Performance standards define desired services. The Government performs surveillance to determine Contractor and Contract exceeds, meets or does not meet the Performance Standards identified below. The Government reserves the right to monitor all aspects of Contractor performance as it pertains to the terms and conditions stated herein.

Performance Standards:

1. Contractor shall maintain current licensure in the field of Blood and autologous blood.

2. Contractor shall ensure proper temperature of blood products during shipping and storage.

3. Contractor shall adhere to schedule as outlined in B.3.9 of SOW for all deliveries.

4. Contractor shall ensure appropriate labeling of blood and blood products.

Methods of Quality Control Surveillance:

Various methods exist to monitor performance. The Contracting Officer’s Technical Representative (COTR) shall use the surveillance methods listed below in the administration of the Quality Control Program.

1. Direct observation – performed periodically through the life of the Contract.

2. Periodic inspection – evaluates outcomes on a periodic basis. Inspections may be scheduled or unscheduled as required.

3. User survey – combines elements of validated user complaints and random sampling. Random survey is conducted to solicit user satisfaction and may lead to sampling and inspections.

4. Period sampling – variation of random sampling. However, sample is only taken when problem/deficiency is suspected. Sample results are applicable only for the specific work inspected. Since sample is not entirely random, it cannot be applied to total activity performance.

Security: This requirement is for blood and blood products only the C&A requirements do not apply. Security Accreditation Package is not required.

Documenting of Quality Control Surveillance:

The Government shall document positive performance. Any report may become a part of the supporting documentation for any contractual action. Negative findings will be provided to Contracting Officer for resolution with Contractor.

PERFORMANCE PERIOD: October 1, 2018 through September 30, 2023

Definitions

ALLOGENEIC: Blood or blood components drawn from a non-related donor for subsequent transfusion to a patient (synonymous with homologous).

ANTIBODY WORK-UP: Serological work-up performed on potential transfusion recipients, per patient per episode (set of examples); may be defined as simple or complex.

AUTOLOGOUS: Blood drawn from a donor-patient for subsequent transfusion; in this case, restricted to pre-deposit units of blood, i.e., not including intra-operative or post-operative blood salvage.

BLOOD GROUP: ABO Blood group plus the Rho(D) type of the unit, specifically O+, O-, A+, A-, B+, B-, AB+, AB-.

CMV NEGATIVE: Unit from a donor who has been screened for antibody to Cytomegalovirus and deemed to be negative. Use of CMV negative blood components are indicated in those patients who are undergoing transplantation or are otherwise severely immunocompromised.

COMPONENT (BLOOD COMPONENT): Portion of a unit of whole blood which has been physically separated by some mechanical means, e.g., centrifugation.

CRYOPRECIPITATE: Plasma component which has been prepared to contain high concentrations of Factor VIII and fibrinogen. It is stored in the frozen state and thawed immediately prior to transfusion. Product is used for the treatment of specific coagulation factor deficiencies, such as von-Willebrand’s Disease, hypofibrinogenemia and uremic thrombocytopenia which have been shown to be irresponsive to DDAVP treatment.

DERIVATIVE: Portion of a unit of whole blood or blood component which has been chemically separated by some type of fractionation process. Examples include albumin, plasma protein fraction, intravenous gamma globulin, and various coagulation products.

FRESH FROZEN PLASMA (FFP): Plasma component that is stored in the frozen state and is thawed immediately prior to transfusion. Used for the treatment of significant multiple coagulation factor deficiencies or congenital factor deficiencies not treatable by cryoprecipitate. These may be associated with massive transfusion, severe liver disease, disseminated intravascular coagulation, hemolytic uremic syndrome, or thrombotic thrombocytopenia purpura, but not as a volume expander. Fresh frozen plasma 24 (FP24) is plasma frozen within 24 hours of collection and contains reduced levels of Factor VII and normal levels of Factor V. FP24 may be used interchangeably with FFP unless used to treat Factor VII deficiency.

HOMOLOGOUS: Blood or blood component drawn from a non-related donor for subsequent transfusion to a patient (synonymous with allogeneic).

IRRADIATED COMPONENT: Blood component that has been subject to a minimum central dose of 2500 cGy of irradiation.

LEUKOCYTE-REDUCED BLOOD COMPONENTS: Cellular products prepared by an approved filtration method.

PLATELETPHERESIS: Platelet component which is drawn from a donor using apheresis equipment, is stored in the liquid state, and is roughly equivalent to six to eight units of random platelets. Used for the treatment of significant thrombocytopenia as indicated for random platelets; however, it offers the advantage of minimizing donor exposures to prevent the patient from becoming refractory and/or contracting a transfusion transmitted disease.

PLATELETS (RANDOM): Platelet component that is prepared from a single unit of whole blood and is stored in the liquid state. Used for the treatment of significant thrombocytopenia associated with a variety of other clinical conditions, including active bleeding, massive transfusion, disseminated intravascular coagulation, and scheduled invasive procedures.

RECALL: A request from the supplier of blood component to return a specific unit(s) which was inadvertently issued to the VA medical center, regardless of the reason, or was issued to the VA medical center prior to the receipt of information about a donor which would have prevented such release.

RED BLOOD CELLS (RBC): Red cell components that remain in the liquid state, i.e., not frozen, regardless of anticoagulant. Used for the treatment of anemia which is not treated pharmacologically either due to etiology or time constraints.

ROUTINE ORDERS: Orders that are generally placed on a regular basis at a pre-established time to provide adequate inventory of specific blood components of specific blood groups.

SHELF LIFE: Number of days remaining prior to the expiration date from the date received in the facility.

SPECIAL TYPINGS: Typings for RBC antigens other than ABO and Rho(D); performed in order to find red blood cell units appropriate for patients who have developed unexpected antibodies.

STANDING ORDER: A type of routine order which allows for shipment of a specific volume of specific blood components according to an established delivery schedule; assists the supplier in projecting volumes of components required in order to improve recruitment and minimize waste.

VOLUNTEER DONOR: Person who does not receive monetary payment for blood donation. Benefits, such as monetary time off from work, membership in blood assurance programs, and cancellations on non-replacement fees that are not readily convertible to cash, do not constitute monetary payment.

SECTION D – ATTACHEMENT 1

D.1 Blood and Blood Products – on an as needed basis

New Mexico, Phoenix and Prescott VA Healthcare System, Pathology & Laboratory Medicine Service

BLOOD SERVICES

IMMUNOHEMATOLOGY REFERENCE LABORATORY TESTING

STAT DELIVERY CHARGED

RETURNED BLOOD CREDIT

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Observation and Audit

Page 1 of