SOW - Attachment 1 Redacted.pdf

CONFIDENTIAL

Attachment 1- Vitalant

Attachment 1

EXHIBIT A

Return Policy

VITALANT may permit Hospital to return unexpired Red Blood Cells to VITALANT for credit, subject to a fifty percent (50%) restocking fee, described below, provided Hospital complies with all of the following conditions:

(a) Hospital shall verify that proper temperature requirements have been satisfied and monitored during the storage period, in compliance with the regulatory requirements, including Title 21 of the Code of Federal Regulations and Standards of the AABB.

(b) Hospital shall verify that the integrity of the unit container has been maintained and neither the unit container nor the affixed label is damaged, broken, disturbed, defaced, tampered with, or otherwise manipulated.

(c) Hospital shall ensure that the original label is intact, unmarked and uncovered. Any labels or tags affixed by the Hospital to the unit must be removed prior to return.

(d) At least two (2) crossmatch segments must remain available for use, unless VITALANT has approved use of the last crossmatch segment.

(e) Hospital shall inspect blood products at the time of packing and shall pack products in accordance with VITALANT policies and in appropriate shipping containers. Hospital shall document that inspections have occurred in compliance with the regulatory requirements, and it shall not return blood products to VITALANT which appear unsuitable for re-issue.

(f) All requests to receive credit for unused blood products must be received by VITALANT no more than seven (7) days from the expiration date of any such blood products.

(g) All returned blood products must have a minimum of fourteen (14) days remaining prior to expiration at the time they are received by VITALANT.

(h) All requests to receive credit for returned blood products must comply with the VITALANT ordering and return instructions, billing protocols and, where applicable, the on-line product management system.

A restocking fee equal to fifty (50%) percent of the fee charged for the blood product will apply to any blood product returned to VITALANT in compliance with this policy. For example, if Hospital is charged $500 for a Red Blood Cell unit, the Hospital will pay a restocking fee of $250 per unit for a blood product returned pursuant to this policy.

In general, STAT and ASAP orders, platelets, and frozen, specialty, altered or modified blood products are not returnable. Examples include, but are not limited to, frozen plasma, cryoprecipitate, irradiated blood products, blood products with special testing or other modification, such as CMV-negative, antigen negative, sterile docking, divided units or HLA/HPA matched units. However, in limited circumstances where VITALANT agrees to accept return of altered or modified blood products or STAT/ASAP delivered blood products, the service fees associated with Hospital’s requested alteration or modification or STAT/ASAP delivery are not eligible for credit.

VITALANT may provide credit to Hospital for expired blood products received, not transfused and discarded by Hospital under the following circumstances:

(a) Red Blood Cells are provided to Hospital less than seven (7) days prior to expiration;

(b) Platelets are provided to Hospital less than twenty-four (24) hours prior to expiration; or

(c) AB Red Blood Cell products.

Hospital is responsible for appropriate disposal of any expired products.

VITALANT may modify this Return Policy, in its sole discretion, upon thirty (30) days’ advance written notice to Hospital.

Blood Service Products & Fees

Blood Service Fees.

VITALANT charges a blood service fee (the “Blood Service Fees”) to cover the costs associated with collecting, processing, testing, and delivering blood and blood components for patient use and to advance VITALANT's nonprofit mission so that it may continue to provide services. The Blood Service Fee Schedule is attached as Exhibit B and incorporated herein by reference.

Hospital agrees to pay to VITALANT the Blood Service Fees as set forth on Exhibit B. The fees set forth in Exhibit B are based on the annual volume projections for the Initial Term of this Agreement. VITALANT and Hospital agree that the Blood Service Fees set forth in Exhibit B shall remain fixed for the Initial Term, with the express exception of any fee increase made by VITALANT pursuant to subsections below. After the Initial Term of the Agreement, as defined herein, VITALANT may increase the Blood Service Fees upon ninety (90) days’ prior written notice to Hospital.

In consideration of additional expenses it may incur, VITALANT has the right to increase the Blood Service Fees and/or Lab Services Fees at any time during the Term of the Agreement, upon thirty

(30) days’ prior written notice to Hospital, in the event VITALANT implements a new laboratory test and/or process relating to collection and provision of blood and blood components intended to improve the safety or quality of blood or blood components provided to Hospital and as required by FDA or applicable state law or as advisable pursuant to professional standards, including standards, guidance or recommendations issued by or through the FDA, AABB or other professional organizations. Upon request of Hospital, VITALANT shall provide verification of any such requirement or recommendation of FDA, state law, and/or professional standards, including standards, guidance or recommendations issued by or through the AABB or other professional organizations, which lead to the fee increase.

Recognizing the common distribution of blood types among the blood donor population and the additional cost associated with acquiring Group O Red Blood Cells beyond the normal distribution, the fees referenced in Section 3 of the Agreement and Exhibit B are based upon a Group O Red Blood Cell utilization of fifty-two (52) percent or less of Hospital’s total Red Blood Cell utilization. To assist Hospital in optimizing Group O Red Blood Cell utilization, VITALANT will make its Medical Directors available to review and make recommendations for Hospital’s transfusion policies and practices based on an analysis of the Hospital’s complexity of services, and provide education and clinical support to Hospital physicians on an as-needed basis.

VITALANT reserves the right to increase fees upon ninety (90) days’ written notice to Hospital if Hospital fails, after written request by VITALANT, to reduce disproportionate usage of Group O Red Blood Cells, and Hospital’s Group O Red Blood Cell utilization repeatedly rises or remains above fifty-two (52) percent of Hospital’s total Red Blood Cell utilization.

Laboratory Tests & Service Fees

Lab Services Fees.

If Hospital requests that VITALANT provide Lab Services as described in Section 1.5, VITALANT shall invoice Hospital, and Hospital shall pay VITALANT, for Lab Services in accordance with the VITALANT Lab Services Fee Schedule set forth in Exhibit C, attached hereto. Hospital agrees that it has the right to bill and collect from patients or third-party payers for Lab Services performed under this Agreement. VITALANT agrees that it shall not bill any patient or third-party payer directly for any Lab Services performed under this Agreement. After the Initial Term of the Agreement, VITALANT may increase the Lab Services Fees upon ninety (90) days’ prior written notice to Hospital.

Primary Provider.

Subject to the other terms and conditions of the Agreement, VITALANT and Hospital acknowledge and agree that the Blood Service Fees are offered to Hospital in consideration of VITALANT being the primary provider of blood and blood components to Hospital. Hospital may during the Term of the Agreement obtain blood or blood components from a provider other than VITALANT only if:

(a) There is a medically emergent circumstance that VITALANT is not able to meet; or

(b) There is a Force Majeure Event; or

(c) An alternate supplier is needed to meet the needs of a particular patient, provided Hospital has first requested VITALANT to provide the necessary blood or blood components for the patient, and VITALANT is unable to do so;

or

(d) At the request or direction of a patient or the patient’s physician, Hospital is directed to use autologous blood which is only available through a provider other than VITALANT.

Except as stated above, Hospital shall utilize VITALANT as its primary source of blood and blood components to meet all routine and emergency needs for obtaining blood or blood components during the Term of the Agreement.

Titration Studies, per Titration LS230 Fee per titration tested.

Red Cell Separation Method LS235

Fee for each special method used to harvest patient autologous red cells i.e., Microhematocrit or Hypotonic RBC separations.

Red Cell Separation - Percoll LS240 Fee per Percoll treatment and red cell separation method.

Serum Neutralization/Inhibition Procedure

LS245 Fee per neutralization/inhibition serum/plasma set up.

Serum Treatment with Chemical Agents LS250 Fee per each serum/plasma chemical treatment (i.e., 0.01 M DTT treatment)

Thermal Amplitude Test LS255 Testing to determine cold antibodies optimal temperature of reactivity.

Polyagglutination Screen LS260 Screen test for polyagglutination.

Includes testing with human sera and lectins, if available.

Donath-Landsteiner Test LS265 Diagnostic test of Paroxysmal Cold Hemoglobinuria (PCH).

Drug Dependent Antibody Studies LS270 Test for identification of drug dependent antibodies.

Pathological Cold Agglutinin Screen LS275

Test to evaluate the clinical significance of cold reactive autoantibodies.

Cold Agglutinin Titer LS280 Titer of cold reactive autoantibodies (per titer).

Hemoglobin S LS285/41M Sickle cell screen test.

Kleihauer-Betke, Quantitative LS287

Kleihauer-Betke (KB)- is used to determine the volume of fetomaternal hemorrhage to estimate the amount of RhIg needed to prevent alloimmunization.

Rosette Test, Qualitative LS290 Screening test for fetomaternal hemorrhage.

Monocyte Monolayer Assay

(MMA) LS292

Monocyte Monolayer Assay used to better predict the transfusion risk of a clinically significant antibody. (Send out)

DAT NEG AIHA Evaluation LS295

DAT negative Hemolytic anemia investigation (other names) Immune Hemolytic Anemia Evaluation; Micro Coombs; Super Coombs. (Send out)

Platelet Crossmatch Test LS305 Platelet crossmatch by solid phase methods, per strip tested.

Platelet Antibody Screen Test LS310 Platelet Antibody Detection using

Capture-P Ready-Screen (CPRS).

Compatibility Screen LS410

Charge for each RBC unit is screened with patient plasma/serum.

Compatibility screen is not the crossmatch test of record and unit is not tagged.

Plasma Thawing LS435/57M Thawing of Plasma and Cryoprecipitate for transfusion

Blood Type Recheck LS445 Patient ABO/Rh(D) confirmation from a 2nd specimen for transfusion of blood products.

Molecular Extended Red Cell Genotype/Phenotype LS505

Molecular determination of allelic variants that determine common and rare red cell antigens using multiplex PCR and microarray analysis. (Send out)

Molecular Genotype- Platelet (HPA) LS510

Molecular determination of allelic variants that determine common Human Platelet Antigens, using multiplex PCR and microarray analysis. (Send out)

RHD Genotype Test LS515 RHD gene sequencing. Send out to a specialized genomics laboratory.

RHCE Genotype Test LS520 RHCE gene sequencing. Send out to a specialized genomics laboratory.

Molecular Sequencing Test LS525

Gene sequencing. Send out to a specialized genomics laboratory.

Covers all non-RH sequencing, i.e., sequencing for ABO, LU, JK and other genes.

Donor/Product Search Fee, per Search LS605

Fee is applied per search when donor recruitment is required to provide products or when searching outside the local lab inventory for:

• Antigen negative red cell units

• HPA selected platelets

• HLA selected platelets

Unconfirmed Antigen Request, per Component LS610/55M

Fee for requests of components with unconfirmed results for antigen typing or Hemoglobin S. Units are not labeled/tagged as antigen negative.

Rare Search Fee, per search LS615 Fee for rare product search outside the Vitalant inventory.

ARDP Fee, per unit LS620

Fee the American Rare Donor Program (ARDP) charges to the IRLs per unit they located and is shipped to requesting lab/center.

Import Fee, per unit LS625

Fee per each special typed product imported from a Non-Vitalant blood center.

Fee does NOT include the blood product or antigen typing charges.

Those will be charged when the units are shipped/issued.

Transfusion Reaction Investigation - Clerical LS705

Transfusion Reaction Investigation - Clerical. Charge in addition to the serological testing performed as part of the investigation of the reaction reported.

Transfusion Reaction Evaluation - Physician LS710

Transfusion Reaction investigation, interpretation and written report, Physician services.

HLA Selected Platelet Fee, per Component LS805/42M

Fee charged for each HLA selected or HLA antibody selected platelet shipped or issued.

Antigen Typing, Donor - Confirmed or Historical, per Antigen

LS810/23M Donor common red cell antigen typing, per antigen.

Antigen Typing, Donor, Rare - Confirmed or Historical, per Antigen

LS815/24M Donor rare red cell antigen typing, per antigen.

Crossmatched Platelet Tagging, per Component LS825/43M Fee per crossmatched platelet tagged issued or shipped.

Donor Antigen Screening, 1-10 Units Screened LS830

Fee for random unit screening to find antigen negative units per batch of 1 - 10 units screened.

Rare Unit Fee, per Component LS835/18M

Fee for each component issued or shipped that meets the ‘Rare’ definition.

Less than 5 days fresh, RBC LS855/62M Fee for less than 5 days fresh, RBC, per unit

Less than 10 days fresh, RBC LS860/63M Fee for less than 10 days fresh, RBC, per unit

Additional Wash, each LS865/17M Additional component wash performed, each

Aliquot Preparation, each LS870 Blood component aliquot preparation, each

Aliquot Preparation and Syringe, each LS875 Blood component aliquot preparation and syringe, each

On-Call Fee LS905

On-Call Fee. Apply to Patient Testing workup or Antigen negative request outside of regularly staffed business hours.

STAT Request LS910

STAT Patient Workup. Urgency for Patient Testing workup or Antigen negative request (move to front of the line) requested by client.

ASAP Request LS915

ASAP Patient Workup. Special Urgency for Patient Testing workup or Antigen negative request requested by client.

Sample/Material Handling Fee LS930/50M Fee for sample pick up or for delivery of consumables (i.e. armbands) Blood Bank Arm Bands, per Box LS965 Fee for supply of Blood Bank arm bands, per box.

Specimen Hold, each LS970 Fee for holding/storing patient sample pending testing orders.

NOTE: The item listings in The Laboratory Services Fee schedules are for tests or services.

The tests and services listed will be charged appropriately when performed upon request.

For prices of services not listed, please contact your Regional Account Director.