LOT

ITEM

PRODUCT NAME OR
CATALOG #

PRICE
PER VIAL

4

LOT 4 - 5-part Differential Product-Abbott (AF-1)

CBC-4K

$8.25

5

LOT 5 - 5-Part Automated Differential Hematology Product-ABX Pentra/AcT 5 diff (AF-2)

Pentra-5D

$8.25

7

LOT 7 - 5-Part Automated Differential Hematology Product-Sysmex X Series (AF-5)

CBC-XE

$8.25

8

LOT 8 - 5-Part Automated Differential Hematology Product-Advia (AF-6)

CBC-Tech

$8.25

12

LOT 12 - Sedimentation Rate for Sedimat 15 (SRA)

Sedrite 111

$7.25

15

LOT 15 - Whole Blood Glucose for HemoCue (HWG)

GLU/HGB

$7.00

1.

Material must be whole blood, from human source material, as needed by lot, containing human erythrocytes, mammalian or human white blood cells and simulated platelets in a human-like base.

2.

Material must be non-reactive for Hepatitis B, Hepatitis C and HIV, using techniques specified by the U.S. Food and Drug Administration.  Documentation of testing must be provided on the COA or alternate form.

3.

Sample vials and tops must be void of any manufacturer’s name, trademark or lot number.

4.

Material must be supplied in liquid form.

5.

Samples must be of different levels (normal and abnormal) spanning the analytical range representative of clinical human samples.

6.

On an annual basis, the Contractor must provide analyte specifications for all levels of a product and allow WSLH PT to select levels for each event samples are needed.  If not provided by the contractor, WSLH PT will assign target levels for each sample needed and submit to contractor.

7.

All sample vials must be labeled by the Contractor.

• Labels must be printed using water-resistant black ink
• Label stock must:
• Be void of any manufacturer’s name, trademark or lot number
• Be able to adhere when samples are stored according to contractor’s specifications until expiration date
• Be able to accommodate the following information:
• Sample Label:

                                                                                       Color sequence:


• *Program specialty name                                               Sample #1 = blue
• **WWW- Program code (HE)                                         Sample #2 = yellow
• XX- Last two digits of year (11)                                      Sample #3 = pink
• EE- Event number (1-12)                                               Sample #4 = green
• Z- Bottle number (1, 2, 3, 4, or 5)                                  Sample #5 = purple

 
c.    Labels must be approved by WSLH PT staff on an annual basis.

LOT 4

5-PART DIFFERENTIAL PRODUCT-ABBOTT (AF-1) SPECIFICATIONS

LOT

ITEM

PRODUCT NAME OR
CATALOG #

PRICE
PER VIAL

1

LOT 1 - Basic Hematology Product (HE)

Para 12

$3.77

2

LOT 2 - 3-Part Automated Differential Hematology Product-Sysmex (AS)

Para+Check

$5.82

3

LOT 3 - 3-Part Automated Differential Hematology Product (AT)

Para 12

$3.77

6

LOT 6 - 5-Part Automated Differential Hematology Product- Beckman Coulter (AF-3)

Stak-Chex

$6.98

9

LOT 9 -Hematology-Waived Product (HW)

Para 12

$3.77

10

LOT 10 - Reticulocytes (RT)

Retec-Chex II

$6.47

11

LOT 11 - Sedimentation Rate (SR)

ESR-Chex

$5.04

13

LOT 13 - Sickle Cell Screening (SK)

Sickle-Chex

$6.87

14

LOT 14 - Whole Blood Glucose (SW/WB)

Glucose

$3.19

1.

Material must be whole blood, from human source material, as needed by lot, containing human erythrocytes, mammalian or human white blood cells and simulated platelets in a human-like base.

2.

Material must be non-reactive for Hepatitis B, Hepatitis C and HIV, using techniques specified by the U.S. Food and Drug Administration.  Documentation of testing must be provided on the COA or alternate form.

3.

Sample vials and tops must be void of any manufacturer’s name, trademark or lot number.

4.

Material must be supplied in liquid form.

5.

Samples must be of different levels (normal and abnormal) spanning the analytical range representative of clinical human samples.

6.

On an annual basis, the Contractor must provide analyte specifications for all levels of a product and allow WSLH PT to select levels for each event samples are needed.  If not provided by the Contractor, WSLH PT will assign target levels for each sample needed and submit to Contractor.

7.

All sample vials must be labeled by the Contractor.

• Labels must be printed using water-resistant black ink
• Label stock must:
• Be void of any manufacturer’s name, trademark or lot number
• Be able to adhere when samples are stored according to contractor’s specifications until expiration date
• Be able to accommodate the following information:
• Sample Label:

                                                                                       Color sequence:

• *Program specialty name                                               Sample #1 = blue
• **WWW- Program code (HE)                                         Sample #2 = yellow
• XX- Last two digits of year (11)                                      Sample #3 = pink
• EE- Event number (1-12)                                               Sample #4 = green
• Z- Bottle number (1, 2, 3, 4, or 5)                                  Sample #5 = purple

 
c.    Labels must be approved by WSLH PT staff on an annual basis.

 8.

9.

Prior to each event, the Contractor must provide WSLH PT an order deadline date for needed product.

10.

Contractor upon request must provide WSLH PT samples of product being bid for independent evaluation and verification of instrument/method compatibility.

11.

Contractor, at no cost to WSLH PT, must replace any material found not suitable for analysis.

12.

Contractor must submit for each sample, material description (product insert), specifications indicating levels available for each analyte available, material safety data sheet (MSDS), and results from any other testing required by WSLH PT as indicated in the applicable lot specifications.  

13.

Materials must be shipped overnight courier by means consistent with recommended storage conditions.

14.

Contractor must ship product to WSLH PT in accordance with their closed vial storage recommendations stated on their Certificate of Analysis (COA).

15.

For each lot bid, Contractor must provide product name, number of levels available, projected annual production schedule(s), product insert and assay sheet.

16.

The prices quotes for materials must include all shipping costs

17.

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

18.

Contractor must maintain at least 5% overage of each sample to be kept sequestered and available for WSLH-PT request.

1.

Material must have an expiration date of at least 60 days when refrigerated, longer expiration date preferred.

2.

Material must be available in at least 3 different levels, prefer 5 different levels.

Number of levels material has:  5

3.

Material must be packaged in plastic or glass vials with cap-piercable tops. 

4.

Total volume must be at least 2.0 mL.

5.

Each sample must be suitable for testing all hematology analyzers and manual methods.

6.

Samples must arrive at WSLH PT at least 10 days prior to WSLH PT ship date.
Approximate 2011 WSLH PT event/ship dates: 

February 21
May 2
October 17

1.

Material must have an expiration date of at least 60 days when refrigerated, longer expiration date preferred

2.

Material must be available in at least 3 different levels, prefer 5 different levels.

Number of levels material has:

3.

Material must be packaged in plastic or glass vials with cap-piercable tops. 

4.

Total volume must be at least 2.0 mL.

5.

Each sample must be suitable for testing on hematology instruments performing 1, 2 or 3 part automated differentials.

6.

Samples must arrive at WSLH PT at least 10 days prior to WSLH PT ship date.
Approximate 2011 WSLH PT event/ship dates: 

February 21
May 2
October 17

1.

Material must have an expiration date of at least 60 days when refrigerated, longer expiration date preferred

2.

Material must be available in at least 3 different levels, prefer 5 different levels.

Number of levels material has:  5

3.

Material must be packaged in plastic or glass vials with cap-piercable tops. 

4.

Total volume must be at least 2.0 mL.

5.

Each sample must be suitable for testing on the Beckman Coulter MAXM, HMX and LH Series instruments. 

6.

Bar coded labels must be available for these samples. 

7.

Samples must arrive at WSLH PT at least 10 days prior to WSLH PT ship date.
Approximate 2011 WSLH PT event/ship dates: 

February 21
May 2
October 17

1.

Material must have a closed vial expiration date of at least 60 days when refrigerated.

2.

Material must be available in at least 3 different levels.

Number of levels material has:  3 levels

3.

Material must be packaged in plastic or glass vials. Total volume must be at least 1.0 mL.

4.

Each sample must be suitable for all automated methods and manual reticulocyte counts using New Methylene Blue stain.

5.

Samples must arrive at WSLH PT at least 10 days prior to WSLH PT ship date.
Approximate 2011 WSLH PT event/ship dates: 

April 4
September 12

1.

Material must have a closed vial expiration date of at least 60 days when refrigerated.

2.

Material must be available in at least 3 different levels.

Number of levels material has:  3 levels

3.

Material must be packaged in plastic or glass vials.   Total volume must be at least 5.0 mL.

4.

Each sample must be suitable for all manual and automated sedimentation rate methods.

5.

Material must be ready to use and not require the removal of sodium citrate or sodium chloride prior to testing.

6.

Samples must arrive at WSLH PT at least 10 days prior to WSLH PT ship date.
Approximate 2011 WSLH PT event/ship dates: 

April 4
September 12

1.

Material must have a closed vial expiration date of at least 60 days when refrigerated.

2.

Material must be available in at least 2 different levels.

Number of levels material has:  2 levels

3.

Material must be packaged in plastic or glass vials.  Total volume must be at least 1.5 mL.

4.

Each sample must be compatible with solubility tests and hemoglobin electrophoresis to detect the presence of Hemoglobin S.

5.

Samples must arrive at WSLH PT at least 10 days prior to WSLH PT ship date.
Approximate 2011 WSLH PT event/ship dates: 

April 4
September 12

1.

Material must have a closed vial expiration date of at least 60 days from contractor ship date to WSLH PT, when material is kept refrigerated.  Open vial stability must be no less than 30 days.

2.

Material must be available in at least 5 different levels, with glucose concentrations within the reportable range for most whole blood glucose monitors.  Documentation of glucose concentration target levels (mg/dL) for each sample must be provided for each shipment.

Number of levels material has:  5 levels

3.

Material must be packaged in plastic vials with dropper tip.  Non-leaking, threaded twist-on caps preferred.

4.

Total fill volume must be at least 2.0 mL.

5.

Each sample must be suitable for testing on most whole blood glucose monitors.  Contractor must be able to confirm that their product has been tested for compatibility with several different glucose meters from different manufacturers, and multiple system appropriate strip lots.  Contractor must indicate each whole blood monitor system/point-of-care analyzer for which their product is known to be incompatible.  Examples of different manufacturers of whole blood glucose monitors for which compatibility is desired includes, but is not limited to, Abbott (Precision Systems, FreeStyle Systems), Accu-Chek (AccuData, Advantage Systems, Aviva, Complete Systems, Inform Systems), Bayer (Ascensia Systems), LifeScan (One Touch Systems, SureStep Systems), Nova (StatStrip).

6.

Material must be assayed for finished product contamination (Tested to show finished product does not contain actively growing yeasts, molds, gram negative, or gram positive microorganisms).  Contractor must provide this information with each shipment.

7.

Five different levels of materials offered will be selected for each of two shipments to accommodate both a three-sample and a five-sample program each shipment.  WSLH PT will determine labeling order for each concentration selected.

8.

Samples must arrive at WSLH PT at least 10 days prior to WSLH PT ship date.
Approximate 2011 WSLH PT event/ship dates: 

March 14
September 19