ITEM #

ITEM DESCRIPTION

NUMBER OF
UNITS PER EVENT

NUMBER OF EVENTS PER YEAR

PRICE PER UNIT

1a-1

Red Cell Units
(~550 mL at 3.5%-4.0% suspension)

5

3

$1,185.00

1a-2

Corresponding Defibrinated Serum/Plasma Units (~850 mL per unit)

5

3

$824.00

1a-3

Red Cell Donor Unit (~1000mL at a 3.5%-4.0% suspension)

1

3

$1,185.00

GENERAL SPECIFICATIONS

A

Material Specifications

1.

Red cells, defibrinated serum/plasma & whole blood materials must be human based.

2.

For each sample, the Contractor must provide, at least one week prior to WSLH PT shipment, a Certificate of Analysis (COA) for evaluation. CoAs must be provided with each shipment and must include the expiration dates, test results and storage requirements of the material.  Testing of samples must be done on the final product to be shipped to WSLH PT.

3.

Methods and/or instruments used in testing for COA documentation must be recorded on COA.

4.

Samples must test non-reactive for HIV, Hepatitis B and Hepatitis C.  Documentation of this testing must be provided on the COA.

5.

Contractor must provide material safety data sheets (MSDS) for all applicable material.

6.

Contractor must manufacture their product(s) in conformance with the current Good Manufacturing Practice (cGMP) as defined by the Food and Drug Administration.

7.

Contractor should be ISO certified and provide documentation or in the process of obtaining ISO certification.

8.

Material supplied must be free from known interferences including, but not limited to, hemolysis, lipemia, fibrin, clots, and signs of contamination.

9.

Contractor must disclose all methods with which the samples offered are known to be incompatible.

10.

Upon request, Contractor must supply WSLH PT a representative test sample(s) prior to acceptance of the lot. Collaboration between WSLH PT and the Contractor will be necessary to establish the appropriate volume of representative material needed for testing prior to lot acceptance.

11.

Upon request, Contractor must supply WSLH PT with the reaction strengths of all testing performed.

12.

Contractor must notify WSLH PT in a reasonable time frame prior to the event ship date of any quality control issues related to the material manufacturing that may delay shipment.

13.

Contractor, at no cost to WSLH PT, must replace any material found to exhibit performance less than stated on the COA and/or exhibit constituents not approved by WSLH PT.

14.

WSLH PT will supply shipment dates for each calendar year to the Contractor by October 1st of the previous year.  Prior to each event, Contractor must provide WSLH PT an order deadline for needed material. 

15.

On an annual basis, WSLH PT will supply the Contractor with suggested targets for each event up the upcoming year by October 1st of the previous year.  Due to the sourcing complexity of this material, adjustments to the suggested targets can be made by collaboration between WSLH PT and the Contractor prior to each event (scheduled WSLH PT ship date) to establish workable targets that will still meet the needs of WSLH PT.

B

Shipping/Billing Specifications

1.

The bid prices for materials must include all shipping costs.

2.

Contractor must ship and invoice only for materials ordered by WSLH PT.

3.

Contractor must accept the costs to re-ship unsatisfactory material due to previously mentioned conditions in General Specification A.8 and/or their courier/shipping handling errors.

4.

Contractor must not charge WSLH PT for replacement and/or shipping costs of material due to product leakage during transport. 

5.

Contractor must provide adequate protective packaging, with special care taken for shipments during extreme cold and extreme hot conditions.

6.

Contractor must enclose a printed copy of the packing slip(s) in each shipment to WSLH PT.  Packing slip(s) must be enclosed in box #1 of multiple box shipments.

7.

Multiple box shipments must indicate the total number of boxes. Example for labeling: 1 of 3, 2 of 3, etc. This information must be provided on the outside of the box next to the shipping label.

8.

Total weight of each sealed shipment box/container must be less than 50 lbs.

9.

Contractor should have process in place to have original shipping container(s) and/or packaging material(s) returned to Contractor at no cost to WSLH PT.

10.

All shipments must conform to all appropriate hazardous material handling regulations such as the International Air Transport Association (IATA) and Department of Transportation (DOT).

Specific Material Specifications

A

1.

Five units of 3.5% - 4.0% red cell suspensions are needed per event for ABO forward typing and Rh typing (1 unit of red cell suspension for each of 5 samples x 3 events = 15 units needed per year).

2.

Red cells must be washed by Contractor and resuspended in a 3.5% - 4.0% cell suspension with Alsever solution. 

3.

The volume needed per unit must be a minimum of 550 mL.

4.

Each of the standard ABO groups (A, B, AB, and O) must be represented in at least one of the three events per year.

5.

Each Rh type (Rh positive and Rh negative) must be represented in each of the three events per year.  Units with weak representations of the D antigen (weak D) must not be provided unless approval is given by WSLH PT.

6.

Type A and Type AB units must be tested for A1 and A2 subgroups and the results of this testing must be displayed on the COA.

7.

Forward and back typing must match unless pre-approval is given by WSLH PT for Contractor to supply an ABO discrepancy as a challenge.

8.

At least one of the five units per event must be DAT positive.  The red cells can be sensitized with IgG, complement or both.

9.

Red cells must be tested for ABO forward typing, Rh typing, DAT polyspecific and DAT IgG by both tube and gel methods within one week of shipment to WSLH PT and the results must be stated on the COA.  Red cells must be tested for DAT complement by tube method within one week of shipment to WSLH PT and the results must be stated on COA. 

B

1.

Five units of corresponding defibrinated serum/plasma are needed per event for ABO reverse typing, unexpected antibody screening and antibody identification (1 unit of defibrinated serum/plasma for each of 5 samples x 3 events = 15 units needed per year).

2.

Each defibrinated serum/plasma unit must contain a minimum of 850 mL.

3.

Two of the five units per event must contain one unexpected antibody. The Contractor must incorporate a full range of clinically significant antibody identification interpretations expected in patient samples within the annual events.  Multiple antibodies in the same sample are acceptable.  Collaboration between WSLH PT and the Contractor will be necessary to appropriate antibodies in terms of their characterizations (reaction phases, reaction strengths, availability).

4.

Back typing reaction strengths for each unit must be strong enough to be picked up by both tube and gel methods (i.e., ABO discrepancies due to unexpected weak or missing back typing reactions must be avoided unless pre-approval is given by WSLH PT). 

5.

Positive reactions for the antibody screens and antibody identifications for each unit (regardless of technique/reagent used: gel, tube-saline-AHG, tube-albumin-AHG, tube-LISS-AHG, tube-PEG-AHG, solid phase, IgG AHG or polyspecific AHG) must be detected in the 37°C and/or AHG phase at a strength of 2+ or stronger. Antibodies only reacting at room temperature/immediate spin must be avoided unless pre-approval is given by WSLH PT.

6.

Each unit must be tested for ABO back typing, unexpected antibodies and antibody identifications using both tube and gel methods within one week of shipment to WSLH PT and the results must be stated on the COA.

C

1.

One unit of a 3.5% - 4.0% red cell suspension is needed per event to serve as the donor cell for compatibility testing (1 unit of 3.5% - 4.0% red cell suspension per event x 3 events = 3 units needed per year).

2.

Donor cell unit must be washed by Contractor and resuspended in a 3.5% - 4.0% cell suspension with Alsever solution. 

3.

The volume needed per donor cell unit must be a minimum of 1000mL

4.

Donor unit must be DAT negative.

5.

Selected donor cell suspension must present one or more antigens which when combined with the selected defibrinated serum/plasma units, results in at least two incompatible crossmatches per event.

6.

Incompatibility must not be strictly due to ABO/Rh incompatibility. There must be instances where incompatibility is due to the presence of unexpected clinically significant antibodies.

7.

Positive reactions for incompatible crossmatces other than ABO incompatibilities (regardless of technique/reagent used: gel, tube-saline-AHG, tube-albumin-AHG, tube-LISS-AHG, tube-PEG-AHG, solid phase, IgG AHG or polyspecific AHG) must be detected in the 37°C and/or AHG phase at a strength of 2+ or stronger.

8.

Positive reactions for incompatible crossmatches due to ABO incompatibilities only must be detected at a strength of 2+ or stronger at immediate spin.

D

1.

Material must be suitable to test manual tube, gel, slide and solid phase methods. 

2.

Contractor must ensure sample production schedule is compatible with the following tentative 2013 WSLH PT shipping dates:

2013 Event 1 = March 11, 2013
2013 Event 2 = June 17, 2013             
2013 Event 3 = September 30, 2013

3.

Expiration of material must exceed the WSLH PT customer result due date. 
Tentative WSLH PT customer result due dates are listed below:

Due Dates:       
Event 2013-1 March 27, 2013                      
Event 2013-2 July 3, 2013
Event 2013-3 October 16, 2013

Lot 1a Specifications

1.

The Contractor will bulk produce Lot 1 material and must bulk ship this material to WSLH PT by overnight delivery carrier at no extra charge to the following address:

Proficiency Testing
Attn: (specific coordinator name)
Wisconsin State Laboratory of Hygiene
465 Henry Mall, Room 109
Madison, WI 53706-1578

2.

Material must be shipped in leak resistant containers labeled with the sample identification.

3.

WSLH PT must receive the material at least six working days prior to the WSLH PT ship date. Tentative WSLH PT 2013 shipping dates:

2013 Event 1 = March 11, 2013
2013 Event 2 = June 17, 2013             
2013 Event 3 = September 30, 2013

Any changes must be pre-approved by WSLH PT.