A.1

Samples must be human based.

A.2

Serum pools 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.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 sample(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

Samples must be available in the following levels:  Level 1 must be negative; Level 2 must be positive; and Level 3 must be abnormal high positive.

A.15

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.16

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

A.17

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.18

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

A.19

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

B.1

All sample aliquots must be labeled by the Contractor .
a. Labels must be printed using black ink 
b. 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 Contractor ’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)

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 Specifications

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

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.

#

SPECIFIC SPECIFICATIONS

1.

Samples must be liquid, human serum that is not heat inactivated.

2.

Samples must contain the following analyte:  antibody to Treponema pallidum (Syphilis).

3.

Samples must have a minimum expiration date of 6 months after the WSLH PT ship date when refrigerated.

4.

Sample volume must be at least 1.0 mL.

5.

Samples must be suitable for testing nontreponemal test methods including RPR, VDRL, TRUST, USR, RST and treponemal test methods including FTA-ABS, FTA-ABS DS, MHA-TP, TP-PA, EIA and chemiluminescence.

6.

Samples must be tested by RPR and VDRL nontreponemal methods prior to shipping and the COA’s must include qualitative/quantitative (titers) results and methodology (kits/instruments) used for testing.

7.

Samples must be tested by a treponemal confirmatory method such as TP-PA and/or FTA-ABS prior to shipping and the COA’s must include the results and methodology (kits/instruments) used for testing.

8.

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

9.

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. 

10.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = May  16, 2011
2011 Event 3 = August  29, 2011
2012 Event 1 = February 6, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4988

(positive)  $3.00

(negative)  $2.00

(Average pos/neg)  $2.50

#

SPECIFIC SPECIFICATIONS

1.

Samples must be liquid, human serum based that is not heat inactivated.

2.

Analyte:  Anti-HIV

3.

Samples must have a minimum expiration date of 6 months after the WSLH PT ship date when refrigerated.

4.

Sample volume must be at least 1.0 mL.

5.

Samples must be suitable for testing rapid test kits on the market including Oraquick, MedMira Reveal, Trinity Uni-Gold, and Clearview.

6.

Samples must be suitable for testing traditional HIV test methods such as EIA and Western Blot.

7.

Samples must test definitely positive and definitely negative by Anti-HIV 1 only test methods.

8.

Samples must be tested by a common rapid Anti-HIV screening method and a common automated EIA screening method prior to shipment and found to be definitely positive and definitely negative.  The COA’s must include the methodology (kits/instruments) used for testing.

9.

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

10.

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. 

11.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = May  16, 2011
2011 Event 3 = August  29, 2011
2012 Event 1 = February 6, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-5420

(positive)  $3.25

(negative)  $2.90

(Average pos/neg)  $3.075

#

SPECIFIC SPECIFICATIONS

1.

Samples must be liquid, human serum based that is not heat inactivated.

2.

Analyte:  Anti-HIV

3.

Samples must have a minimum expiration date of 6 months after the WSLH PT ship date when refrigerated.

4.

Sample volume must be at least 1.0 mL.

5.

Samples must be suitable for testing rapid test kits on the market including Oraquick, MedMira Reveal, Trinity Uni-Gold, and Clearview.

7.

Samples must test definitely positive and definitely negative by Anti-HIV1 only test methods.

8.

Samples must be tested by a common rapid Anti-HIV screening method and a common automated EIA screening method prior to shipment and found to be definitely positive and definitely negative.  The COA’s must include the methodology (kits/instruments) used for testing.

9.

Contractor must be able to provide sample material to accommodate a three sample program that ships twice a year. 

10.

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. 

11.

COA’s must include methodology (kits/instruments) used for testing.

12.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = August  29, 2011
2012 Event 1 = February 6, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-5421

(positive)  $3.25

(negative)  $2.90

(Average pos/neg)  $3.075

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Samples must contain the following analytes:  C3, C4, IgG, IgM, IgA, IgE.

4.

Sample volume must be at least 1.0 mL.

5.

The following Normal ranges are intended to be used when interpreting the pool requirements (level of reactivity).
C3        83-177 mg/dl                 C4        12-42 mg/dl       IgM       56-352 mg/dl
IgG       740-1420 mg/dl             IgA       70-312 mg/dl     IgE       5-155 IU/ml

6.

Contractor must provide quantitative values using current diagnostic methods for each event.

7.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = May 17, 2011
2011 Event 3 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4983

$5.50

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  antibody to Borrelia Burgdorferi (IgG/IgM).

4.

Sample volume must be at least 0.5 mL.

5.

Upon request, WSLH PT must be provided quantitative values tested by current kits/instruments.

6.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4984

$4.75

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  antibody to Helicobacter pylori IgG/IgM.

4.

Sample volume must be a minimum of a 0.5 mL, but preferably 0.5 mL.

5.

WSLH PT must be provided values tested by current kits.

6.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4982

(positive)  $4.50

(negative)  $2.00

(Average pos/neg)  $3.25

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  CRP (qualitative and quantitative)

4.

WSLH PT must be provided quantitative/qualitative values tested by current kits/instruments.

5.

Sample volume must be at least 1.0 mL.

6.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4981

(positive)  $2.75

(negative)  $2.00

(Average pos/neg)  $2.375

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  infectious mononucleosis

4.

Sample volume must be a minimum of 0.7 mL.

5

WSLH PT must be provided values tested by current kits.

6.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4989

(positive)  $2.65

(negative)  $2.00

(Average pos/neg)  $2.325

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  Antinuclear antibody.

4.

Sample volume must be a minimum of 0.6 mL, but preferably 1.0 mL.

5.

Positive samples must consist of varying patterns such as centromere, homogeneous, rim, nucleolar speckled.

6.

Upon request, WSLH PT must be provided quantitative values tested by current kits/instruments.

7.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = May 17, 2011
2011 Event 3 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4979

(positive)  $4.25

(negative)  $2.00

(Average pos/neg)  $3.125

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  Antistreptolysin O (qualitative and quantitative).

4.

Sample volume must  be at least 1.0 mL.

5.

WSLH PT must be provided qualitative/quantitative values tested by current kits/instruments.

6.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.    Approximate 2011-2012 event ship dates:

2011 Event 2 = May 17, 2011
2011 Event 3 = September 6, 2011
2012 Event 1 = January 31, 2012           

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4980

(positive)  $3.25

(negative)  $2.00

(Average pos/neg)  $2.625

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  Rubella (IgG or total) qualitative and quantitative.

4.

Analyte:  Rubella (IgM) qualitative.

5.

Sample volume must be at least 1.0 mL.

6.

WSLH PT must be provided quantitative/qualitative values tested by current kits/instruments.

7.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = May 17, 2011
2011 Event 3 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4987

(positive)  $2.50

(negative)  $2.00

(Average pos/neg)  $2.25

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  Infectious mononucleosis (qualitative).

4.

Sample volume must be a minimum of 0.7 mL, but preferably 0.7 mL.

5.

Upon request, WSLH PT must be provided quantitative values tested by current kits/instruments.

6.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = May 17, 2011
2011 Event 3 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4985

(positive)  $2.65

(negative)  $2.00

(Average pos/neg)  $2.325

#

SPECIFIC SPECIFICATIONS

1.

Sample material must be liquid, human serum based.

2.

Samples must have a minimum expiration date of 6 months from WSLH PT ship date when refrigerated.

3.

Analyte:  Rheumatoid factor (qualitative and quantitative).

4.

Sample volume must be at least 1.0 mL.

5.

WSLH PT must be provided qualitative/quantitative values tested by current kits/instruments.

6.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = May 17, 2011
2011 Event 3 = September 6, 2011
2012 Event 1 = January 31, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

70-4986

(positive)  $3.45

(negative)  $2.00

(Average pos/neg)  $2.725

#

SPECIFIC SPECIFICATIONS

1.

Samples must be liquid, human serum based that is not heat inactivated.

2.

Samples must contain the following markers:  HBsAg, Anti-HBc, Anti-HBs, Anti-HCV and Anti-HAV.

3.

These markers must be targeted for:  HBsAg, Anti-HBc, Anti-HBs, Anti-HCV and Anti-HAV. The samples must be tested for these markers prior to shipment and the results must be listed on the COA (results must include the sample quantitative results versus the assay cut-off values).

4.

WSLH PT desires to have Anti-HAV IgM and Anti-HBc IgM positive material incorporated into at least one of the 15 samples per year because they have clients that test for these markers.  Contractor must disclose a proposal of how many positive samples, for each of these markers, will be supplied in the 15 challenges per year.

Anti-HAV IgM = ___________ (0-15)
Anti-HBc IgM = ___________  (0-15)

Note: Price quoted must include the cost for these markers. 

5.

Anti-HAV IgM and Anti-HBc IgM must be tested for prior to shipping and the results must be listed on the COA (results must include the sample quantitative results versus the assay cut-off values).

6.

Samples must have a minimum expiration date of 6 months after the WSLH PT ship date when refrigerated.

7.

Sample volume must be at least 1.5 mL.

8.

Samples must be suitable for testing common instrument systems on the market (e.g., Centaur, Immulite, Abbott, Vitros, Roche, Bio-Rad).

9.

Contractor must attempt to avoid the supply of hepatitis markers with borderline, equivocal, or gray zone results.

10.

Sodium azide cannot be present in the sample.

11.

The total protein concentration in the samples must be adequate enough to mimic a patient sample. 

12.

Samples must be received by contract shipper/WSLH PT at least 15 working days prior to event ship date.  Approximate 2011-2012 event ship dates:

2011 Event 2 = May  16, 2011
2011 Event 3 = August  29, 2011
2012 Event 1 = February 6, 2012

PRODUCT NAME or CATALOG #

PRICE PER VIAL

Anti-HAV

(positive)  $10.72

(negative)  $8.00

(Average pos/neg)  $6.86

#

SPECIFIC SPECIFICATIONS

1.

Contractor must combine orders into 1 shipment if WSLH PT client receives more than one lot.  Lots that require shipment are: 1, 2, 3 and 4b.

2.

Approximate WSLH PT 2011 event ship dates:

2011 Event 1 = February 7, 2011
2011 Event 2 = May  16, 2011
2011 Event 3 = August  29, 2011

3.

Handling, kitting and shipping price is to include all packing material and hazardous material charges within the United States.  Quoted Event price does not include international shipments (see below under Shipments to Foreign Countries).

4.

Contractor must satisfy the following specifications.
a. The primary box/bag must be labeled with the WSLH PT logo, product or shipping item, year and event.
b. Labels must be printed using water-resistant black ink 
c. Label stock must
¨ be white
¨ be void of any manufacturer’s name, trademark or lot number
¨ have adhesive capable of withstanding moisture and temperature fluctuations including refrigeration
¨ be able to accommodate the following information:

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

5.

Contractor must affix a label to the outside of shipping container that describes the contents (e.g.“WSLH PT material and paperwork enclosed”). 

6.

Samples must be packaged, addressed and shipped to clients.

7.

Contractor must include sufficient absorbent material with samples to avoid leakage from primary sample container should breakage occur in transit.

8.

Contractor must be able to accept text file of demographic information for clients.

9.

Contractor must be capable of processing international shipments.

10.

Contractor must provide a designated contact individual(s) in which to send demographic client text files and shipping requests to.  This individual(s) will also function as a source for shipping/tracking questions should they arise.

11.

WSLH PT will ship client paperwork (testing instructions, result forms, packing slips, etc.) to Contractor at least 3 weeks prior to event ship date.  Contractor must be able to collate WSLH PT client paperwork based on a unique account number assigned by WSLH PT.

12.

Contractor must accommodate shipping requests outside of the WSLH PT Event ship dates on an as needed basis. For example, WSLH PT clients may need a sample resent due to sample breakage, integrity compromised, late enrollment and/or post event troubleshooing.

13.

WSLH PT offers remedial and instrument/kit validation sample sets utilizing the left over samples from each event on an as needed individual client basis.  These sample sets may require unique labels and paperwork separate from the Event labels and paperwork.  Contractor must be able to accommodate these types of shipments.  Because unique labels must be affixed, relabeling of left over samples is required. 
Price to relabel one sample: $3.50

Note: the relabeling price should not be included in the quoted price for the Event shipments

14.

Contractor must use a courier service that provides trackable shipments.

15.

Contact individual(s) mentioned in item #10 must electronically forward tracking numbers to the WSLH PT contact that sent the shipping request once the shipment has been released.