PRODUCT NAME
or CATALOG #

NUMBER OF
SAMPLES
PER EVENT

NUMBER OF
EVENTS
PER YEAR

NUMBER OF
VIALS
PER EVENT

PRICE
PER VIAL

1.

Sample material must be a minimum of 1.0 mL liquid human urine matrix with human source material.

2.

The Contractor's sample material must be stable at refrigerated temperature for 60 days  and/or frozen stability of 1 year.  Opened stability must be at least 30 days after the WSLH Ship date.

3.

Samples must be compatible with all hCG and methods and not cause invalid results due to interfering substances, such as bovine serum or other preservatives.

4.

Samples must contain the following analyte:.Urine hCG – qualitative.

5.

Samples must be compatible with all urine hCG methods and not cause invalid results due to interfering substances, such as bovine serum, fibrin or other preservatives.

6.

Ten sample formulations with hCG at levels appropriate for positives with all urine hCG methods and samples negative for hCG (0-8000 mIU/mL) are needed per calendar year. 

7.

Contractor must be able to provide samples to accommodate a five sample program that ships two times a year.

8.

WSLH PT will have the ability to select from the levels of material offered and will determine the labeling order for each sample. The number of shipments and sample quantities needed is listed below. 

9.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2012 event ship dates:

2012 Event 1 = January 23, 2012
2012 Event 2 = August 6, 2012

PRODUCT NAME
or CATALOG #

NUMBER OF
SAMPLES
PER EVENT

NUMBER OF
EVENTS
PER YEAR

NUMBER OF
VIALS
PER EVENT

PRICE
PER VIAL

1.

Sample material must be a minimum of 3.0 mL liquid protein matrix and contain stabilized human red and white blood cells.

2.

The Contractor's sample material must be stable at room temperature for 60 days under normal storage conditions.

3.

Samples must contain the following analyte:. Red Blood Cells and White Blood Cells

4.

A minimum of six sample formulations for red and white blood cell testing are needed for a calendar year

5.

Samples must be compatible with total cell counts performed by automated methods including Abbott CELL-DYN 3200, Sapphire and Ruby; Beckman Coulter LH700 series and UniCel DxH 800; and Sysmex XE-2100, XE-5000, XT-1800i, XT-2000i, and XT-4000i, for quantification of red and white blood cells in body fluid samples including pleural, pericardial, peritoneal, synovial and cerebrospinal fluid.

6.

Contractor must be able to provide samples to accommodate a three sample program that ships two times a year.

7.

WSLH PT will have the ability to select from the levels of material offered and will determine the labeling order for each sample.

8.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2012 event ship dates:

2012 Event 1 = April 2, 2012
2012 Event 2 = September 17, 2012

A.

Sample Specifications

A.1

Samples must be human based.

A.2

Samples must test non- reactive for HIV, Hepatitis B, and Hepatitis C except where pools are intended to be reactive for Hepatitis and HIV.  Documentation of testing by techniques approved by the US Food and Drug Administration must be provided on the Certificate of Analysis (COA).

A.3

For each lot shipment, COA including expiration dates, results of sample sterility testing and sample storage requirements must accompany the shipment and/or be provided electronically.

A.4

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

A.5

No preservative additives are to be added, unless pre-approved.

A.6

Samples must be free from fibrin and other particulate matter which might interfere with sample processing or analysis.

A.7

Contractor must be able to meet all parameters/characteristics for each lot bid.

A.8

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

A.9

The samples produced must react adequately with most diagnostic kits/instruments currently on the market and upon request from WSLH PT produce written confirmation.

A.10

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

A.11

Contractor must be ISO certified and provide documentation.

A.12

Upon request, Contractor must supply representative test samples prior to acceptance of the lot. 

A.13

Contractor must ensure sample production schedule is in agreement with WSLH PT shipping schedule.

A.14

On an annual basis, WSLH PT and Contractor  will collaborate to establish analyte specifications/ targets for all levels of samples and allow WSLH PT final approval.

A.15

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

A.16

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

A.17

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

A.18

Contractor must maintain at least 3%-5% overage (based on WSLH PT sample order) of labeled samples and must be made available upon WSLH PT request.

B.

Vial Packaging and Labeling Specifications

B1.

All sample aliquots must be labeled by the Contractor.

1. Labels must be printed using black ink
2. Label stock must: 

* be white
* be void of any manufacturer’s name, trademark or lot number
* be able to adhere when samples are stored according to manufacturer’s
specifications until expiration date 
* be able to accommodate the following information:

• *Product specialty name
• WWW- Product code (SS)
• XX- Last two digits of year (11)
• YY- Event number (1-12)
• Z- Bottle number (1, 2, 3, 4, or 5)

3. Labels must be approved by WSLH PT on an annual basis.
4. Labels must adhere to the sample container at the storage temperature required (may vary by product storage requirements).

B.2

Sample material must be dispensed (volume varies by product) in leak resistant, labeled, capped vials.

B.3

Sample containers and tops must be void of any manufacturer’s name, trademark, lot number or product/item number.

B.4

Contractor must be willing to work with WSLH PT to rectify any sample vial types/configuration issues based on WSLH PT client feedback.

B.5

Indicate if any “kitting” of individual sample sets into a secondary container (box or bag) is available for any lots being bid by Contractor.  If able to provide “kitting” service, the Contractor must satisfy the following specifications:

Acceptable label example:

d. Kit labels must be approved by WSLH PT on an annual basis.

C.

Shipping/Billing Requirements

C.1

The Contractor must bulk ship the samples consistent with recommended closed vial storage conditions listed on COA to WSLH PT or contract shipper by overnight delivery carrier at no extra charge (sample cost includes shipping).

WSLH PT Shipping Address:                               Contract Shipper Address:
Wisconsin State Laboratory of Hygiene                  To be determined
Proficiency Testing
465 Henry Mall, Room 109
Madison, WI 53706-1578
ATTN: (specific coordinator name)
Product Enclosed: (……..)

C.2

The bid prices for samples must include all shipping costs.

C.3

All shipments must conform to all appropriate hazardous material handling regulations (such as IATA and DOT).

C.4

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

C.5

Multiple box shipments must indicate the total number of boxes. Example for labeling: 1 of  5, 2 of 5, etc.

C.6

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

C.7

Contractor must accept the costs to re-ship unsatisfactory samples to WSLH PT/contract shipper due to leaking vials, insufficient volume, broken vials and/or courier/shipping handling errors.

C.8

Sample stability and integrity must be maintained during WSLH PT’s standard 2 day shipping timeframe to clients.

C.9

Upon request, tracking and proof of delivery of shipments must be provided to WSLH PT.

C.10

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

C.11

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.

PRODUCT NAME
or CATALOG #

NUMBER OF
SAMPLES
PER EVENT

NUMBER OF
EVENTS
PER YEAR

NUMBER OF
VIALS
PER EVENT

PRICE
PER VIAL

1.

Sample material must be a minimum of 8 mL liquid human urine matrix with human source material.

2.

The sample vessel must have enough depth to allow common urinalysis reagent dipsticks to be totally submerged in the sample.

3.

The Contractor's sample material must be stable at room temperature for 30 days proven by clearly positive or negative reactions when using all common urinalysis analyte dipstick reagent products read visually or by instrument.  Refrigerated stability should be at least 60 days after WSLH ship date.

4.

Samples must be compatible with all hCG and urinalysis methods and not cause invalid results due to interfering substances, such as bovine serum or other preservatives.

5.

Samples must contain the following analytes: bilirubin, glucose, blood/hemoglobin, ketones, leukocyte esterase, nitrite, pH, protein, specific gravity, urine hCG (qualitative, waived methods), urobilinogen, acetone, creatinine, ictotest and reducing substances.

6.

A minimum of six sample formulations for semi-quantitative and qualitative testing are needed for a calendar year

7.

Contractor must be able to provide samples to accommodate a three sample program that ships two times a year.

8.

WSLH PT will have the ability to select from the levels of material offered and will determine the labeling order for each sample. The number of shipments and sample quantities needed is listed below. 

9.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2012 event ship dates:

2012 Event 1 = January 23, 2012
2012 Event 2 = August 6, 2012

PRODUCT NAME
or CATALOG #

NUMBER OF
SAMPLES
PER EVENT

NUMBER OF
EVENTS
PER YEAR

NUMBER OF
VIALS
PER EVENT

PRICE
PER VIAL

1.

Sample material must be a minimum of 1.0 mL simulated fecal material and must contain human stabilized hemoglobin. 

2.

The Contractor 's sample material must be stable at room temperature for 60 days under normal storage conditions.

3.

Samples must be compatible with all fecal occult blood kits or methods including guiaic and iFOB methods and not cause invalid results due to interfering substances.  The consistency of the samples must be compatible with ALL of the above listed methodologies and testing systems.

4.

Samples must contain the following analyte:.fecal occult blood

5.

A minimum of six sample formulations for fecal occult blood testing are needed for a calendar year.

6.

Samples must be compatible with all fecal occult blood kits or methods including guiaic and iFOB methods and not cause invalid results due to interfering substances.  The consistency of the samples must be compatible with ALL of the above listed methodologies and testing systems.

7.

Contractor must be able to provide samples to accommodate a three sample program that ships two times a year.

8.

WSLH PT will have the ability to select from the levels of material offered and will determine the labeling order for each sample.

9.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2012 event ship dates:

2012 Event 1 = April 2, 2012
2012 Event 2 = September 17, 2012

A.

Sample Specifications

A.1

Samples must be human based.

A.2

Samples must test non- reactive for HIV, Hepatitis B, and Hepatitis C except where pools are intended to be reactive for Hepatitis and HIV.  Documentation of testing by techniques approved by the US Food and Drug Administration must be provided on the Certificate of Analysis (COA).

A.3

For each lot shipment, COA including expiration dates, results of sample sterility testing and sample storage requirements must accompany the shipment and/or be provided electronically.

A.4

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

A.5

No preservative additives are to be added, unless pre-approved.

A.6

Samples must be free from fibrin and other particulate matter which might interfere with sample processing or analysis.

A.7

Contractor must be able to meet all parameters/characteristics for each lot bid.

A.8

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

A.9

The samples produced must react adequately with most diagnostic kits/instruments currently on the market and upon request from WSLH PT produce written confirmation.

A.10

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

A.11

Contractor must be ISO certified and provide documentation.

A.12

Upon request, Contractor must supply representative test samples prior to acceptance of the lot. 

A.13

Contractor must ensure sample production schedule is in agreement with WSLH PT shipping schedule.

A.14

On an annual basis, WSLH PT and Contractor  will collaborate to establish analyte specifications/ targets for all levels of samples and allow WSLH PT final approval.

A.15

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

A.16

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

A.17

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

A.18

Contractor must maintain at least 3%-5% overage (based on WSLH PT sample order) of labeled samples and must be made available upon WSLH PT request.

B.

Vial Packaging and Labeling Specifications

B1.

All sample aliquots must be labeled by the Contractor.

1. Labels must be printed using black ink
2. Label stock must: 

* be white
* be void of any manufacturer’s name, trademark or lot number
* be able to adhere when samples are stored according to manufacturer’s
specifications until expiration date 
* be able to accommodate the following information:

• *Product specialty name
• WWW- Product code (SS)
• XX- Last two digits of year (11)
• YY- Event number (1-12)
• Z- Bottle number (1, 2, 3, 4, or 5)

3. Labels must be approved by WSLH PT on an annual basis.
4. Labels must adhere to the sample container at the storage temperature required (may vary by product storage requirements).

B.2

Sample material must be dispensed (volume varies by product) in leak resistant, labeled, capped vials.

B.3

Sample containers and tops must be void of any manufacturer’s name, trademark, lot number or product/item number.

B.4

Contractor must be willing to work with WSLH PT to rectify any sample vial types/configuration issues based on WSLH PT client feedback.

C.

Shipping/Billing Requirements

C.1

The Contractor must bulk ship the samples consistent with recommended closed vial storage conditions listed on COA to WSLH PT or contract shipper by overnight delivery carrier at no extra charge (sample cost includes shipping).

WSLH PT Shipping Address:                               Contract Shipper Address:
Wisconsin State Laboratory of Hygiene                  To be determined
Proficiency Testing
465 Henry Mall, Room 109
Madison, WI 53706-1578
ATTN: (specific coordinator name)
Product Enclosed: (……..)

C.2

The bid prices for samples must include all shipping costs.

C.3

All shipments must conform to all appropriate hazardous material handling regulations (such as IATA and DOT).

C.4

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

C.5

Multiple box shipments must indicate the total number of boxes. Example for labeling: 1 of  5, 2 of 5, etc.

C.6

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

C.7

Contractor must accept the costs to re-ship unsatisfactory samples to WSLH PT/contract shipper due to leaking vials, insufficient volume, broken vials and/or courier/shipping handling errors.

C.8

Sample stability and integrity must be maintained during WSLH PT’s standard 2 day shipping timeframe to clients.

C.9

Upon request, tracking and proof of delivery of shipments must be provided to WSLH PT.

C.10

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

C.11

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.