ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 8(b) Not Kitted

1

IE12-MMM-1

$5.95

2

IE12-MMM-2

$5.95

3

IE12-MMM-3

$5.95

4

IE12-MMM-4

$5.95

5

IE12-MMM-5

$5.95

1.

Sample material must be liquid, human heparinized plasma or human serum based. 

2.

Sample volume must be a minimum of 2.0 mL.

3.

Fifteen formulations must be provided per calendar year. 

4.

Contractor must provide three events with five samples per event for product IE and two events with 3 samples per event for product TM.  The three sample TM product must be the same lot numbers and sample vial numbers as three of the samples from the five sample IE program.  Labeling instructions and sample numbers will be provided by WSLH PT. 

5.

Samples must contain the following analytes:  Total CK, CK-MB, high sensitivity-CRP, Myoglobin, Troponin-I, Troponin-T.  CK-BB must be “not detectable”.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with current instrumentation/methods supported by various manufacturers including: ABBOTT, Beckman Coulter, Siemens, Ortho Clinical Diagnostics, Roche Diagnostics, TOSOH Biosciences. 

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.  Vials must be rated to withstand frozen storage range -15 to -25 °C. 

10.

Minimum sample stability must be one year frozen.

11.

Samples must remain stable through one freeze thaw cycle.

12.

Open vial stability must be at least 1 day at refrigerated temperatures.

13.

Contractor must provide WSLH PT with shipping requirements for product upon request.

14.

Sample stability and integrity must be maintained during WSLH PT shipping to participants (specimens must not be labile under shipping conditions).

15.

COAs must display quantitative values and the instrumentation used for testing.

16.

Tentative 2012 WSLH PT shipping dates: 
January 10, 2012 (IE only)
April 24, 2012 (IE & TM)
November 13, 2012 (IE & TM)

 ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 10(b) Not Kitted

1

CHF12-e-1

$8.50 

2

CHF12-e-2

 $8.50

3

CHF12-e-3

$8.50 

1.

Sample material must be liquid, human EDTA plasma based.

2.

Sample volume must be a minimum of 1.0 mL.

3.

Contractor must prepare six sample formulations per calendar year. 

4.

Contractor must provide two events per calendar year with three samples per event.

5.

Samples must contain the following analytes:  BNP and NT-proBNP.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with Alere Triage meters and automated laboratory instrument platforms by manufacturers such as: ABBOTT, Beckman Coulter, Siemens, Roche Diagnostics.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.  Vials must be rated to withstand frozen storage range -15 to -25 °C. 

10.

Minimum sample stability must be one year frozen.

11.

Samples must remain stable through one freeze thaw cycle.

12.

Open vial stability must be at least 1 day at refrigerated temperatures.

13.

Contractor must provide WSLH PT with shipping requirements for product upon request.

14.

Sample stability and integrity must be maintained during WSLH PT shipping to participants (specimens must not be labile under shipping conditions).

15.

COAs must display quantitative values and the instrumentation used for testing.

16.

Tentative 2012 WSLH PT shipping dates:
2012 Event 1 = April 24, 2012
2012 Event 2 = November 13, 2012

 ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 12(b) Not Kitted

1

CP12-e-1

 $9.30

2

CP12-e-2

 $9.30

3

CP12-e-3

 $9.30

4

CP12-e-4

 $9.30

5

CP12-e-5

 $9.30

1.

Samples must be liquid, human EDTA plasma based.

2.

Sample volume must be a minimum of 1.5 mL.

3.

Contractor must prepare 15 formulations per calendar year. 

4.

Contractor must provide three events per calendar year with five samples per event.

5.

Samples must contain the following analytes:  BNP, CKMB, Myoglobin, Troponin-I and d-dimer.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with Alere Triage meters.

8.

Samples must be free of fibrin, particulate matter and lipemia which might interfere with sample processing or analysis.

9.

Samples must be packaged in leak resistant, labeled, capped vials.  Vials must be rated to withstand frozen storage range -15 to -25 °C. 

10.

Minimum sample stability must be one year frozen.

11.

Samples must remain stable through one freeze thaw cycle.

12.

Open vial stability must be at least 1 day at refrigerated temperatures.

13.

Contractor must provide WSLH PT with shipping requirements for product upon request.

14.

Sample stability and integrity must be maintained during WSLH PT shipping to participants (specimens must not be labile under shipping conditions).

15.

COA’s must display quantitative values as determined with the Alere Triage instrument.

16.

No more than two samples per event may have target values intended for detection outside detectable range-low, or outside detectable range-high. 

17.

Tentative 2012 WSLH PT shipping dates:
2012 Event 3 = January 10, 2012
2012 Event 2 = April 24, 2012               
2012 Event 3 = November 13, 2012

 ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 15(b) Not Kitted

1

NB12-e-1

$3.20

2

NB12-e-2

$3.20

3

NB12-e-3

$3.20

4

NB12-e-4

$3.20

5

NB12-e-5

$3.20

1.

Sample material must liquid, human be human serum based.

2.

Sample volume must be a minimum of 1.0 mL.

3.

Contractor must prepare fifteen sample formulations per calendar year. 

4.

Contractor must provide three events per calendar year with five samples per event.

5.

Samples must contain following analytes: Total bilirubun, direct bilirubin, neonatal bilirubin.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Analyte concentrations must be representative of those seen in neonates and liver disease.

8.

Direct bilirubin and total bilirubin must be compatible with instrumentation by various manufacturers. Manufacturers include: ABBOTT, Beckman Coulter, Siemens, Ortho Clinical Diagnostics, TOSOH Biosciences, Roche Diagnostics. 

9.

Neonatal bilirubin must be compatible with Ortho Clinical Diagnostics VITROS systems.

10.

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

11.

Samples must be packaged in leak resistant, labeled, capped, amber colored vials.  Vials must be rated to withstand frozen storage range -15 to -25 °C. 

12.

Refrigerated storage, unopened, must be at least 60 days and/or frozen stability of 1 yr.

13.

Open vial stability must be at least 3 days at refrigerated temperatures.

14.

Contractor must provide WSLH PT with shipping requirements for product upon request.

15.

Sample stability and integrity must be maintained during WSLH PT shipping to participants (specimens must not be labile under shipping conditions).

16.

COA’s must display quantitative values and the instrumentation used for testing.

17.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = January 10, 2012         
2012 Event 2 = April 24, 2012
2012 Event 3 = November 13, 2012

 ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 17(b) Kitted

1

GH12-e-1

$3.95 

2

GH12-e-2

$3.95 

3

GH12-e-3

$3.95 

4

Beta Hydroxybutyrate Material

$40.00/vial

1.

Samples must be liquid, human whole blood based.

2.

Sample volume must be a minimum of 1.0 mL.

3.

Six sample formulations are required for a calendar year.

4.

Three-sample product, ships two times per year. 

5.

Samples must contain the following analyte: glycohemoglobin (hemoglobin A1c).

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with both chromatographic and immunochemical methods which test for hemoglobin A1c.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Refrigerated storage, unopened, must be at least 60 days and/or frozen stability of 1 yr.

11.

Opened vial stability must be at least 5 days at 2-8° C.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

13.

COAs must display quantitative values and the instrumentation used for testing.

14.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = March 27, 2012
2012 Event 2 = October 22, 2012

Beta Hydroxybutyrate Specifications 

15.

The sample labels must be BHB[YY]-[Event]-[sample number]. 

16.

The samples are liquid 1 mL samples in a crimp seal container. 

17.

The Specimens must have a shelf life of a minimum of 12 months at 2-8 °C and 7 days open vial stability at  2-8°C.

18.

The specimens must be able to be shipped on Cold packs or dry ice. 

19.

The lab is planning on two shipments per year with three levels each shipment. 

GENERAL SPECIFICATIONS

A.

Sample Specifications

A.1

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

A.2

Contractor must be International Standardization Organization (ISO) certified and provide documentation of certification.

A.3

Contractor must provide a Certificate of Analysis (COA) for every sample with each shipment.  COA must be provided by mail or electronically at least one week prior to WSLH PT scheduled ship date.

A.4

Samples must test non-reactive for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C.  Documentation of testing by techniques approved by the FDA must be provided on the COA.

A.5

Testing of product sterility ( 0 CFU/ML microbials ) must be documented and provided on the COA.

A.6

COA must include expiration dates and sample storage requirements.

A.7

Product performance documented on each COA must be from the final product shipped to WSLH PT. 

A.8

Analyzer(s) mfg/model(s) used in testing for COA documentation must be recorded on COA.

A.9

Contractor must be capable of providing samples specified in this contract on a regular basis beginning no later than November 1, 2011.

A.10

Analytes identified by the Contractor as “endogenous” or “as found” must be identified and listed as such on the COA.

A.11

Upon request, Contractors must supply a representative test sample and/or COA prior to acceptance of the bid. 

A.12

The Contractor must maintain at least 3% overage of each item manufactured to be kept sequestered and available for WSLH PT upon request. 

A.13

Contractor must ship and invoice only for the number of samples ordered by WSLH PT. 

A.14

Contractor must notify WSLH PT of any changes to additives and/or preservatives made to the product after the original bid acceptance.

A.15

Cost of samples must be reimbursed to WSLH PT when samples exhibit matrix effects, exhibit preparation errors as documented by WSLH PT, or contain analyte levels not approved by WSLH PT.

A.16

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

A.17

Samples must be of different levels (normal and abnormal) which span the analytical range for most analyzers, representative of clinical human samples.

A.18

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

A.19

For each non-custom product the Contractor must submit a product insert and potential analyte concentrations from which to choose.

A.20

Material supplied must be free from known interferences and suitable for use on methodologies routinely used for testing by WSLH PT customers (must be compatible with most instruments/diagnostic kits currently on the market) and written documentation of compatibility tests must be available to WSLH PT on request.

A.21

Samples must be void of any manufacturer’s name, trademark, lot number, or product/item number. 

A.22

Contractor must collaborate with WSLH PT on an annual basis to establish analyte specifications/targets for all levels of product and must allow WSLH PT final approval.

A.23

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

A.24

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

B.

Vial Packaging and Labeling

B.1

All sample vials must be labeled by the Contractor.

            * be white
            * remain adhered to samples when stored according to Contractor’s specifications until the expiration date
            * remain adhered to samples over several freeze thaw cycles
            * be able to accommodate the following information:

●  Product specialty name
●  WWW- Product code (2 or 3 characters)
●  YY- Last two digits of year
●  EE- Event number or month code (2 or 3 characters)
●  N- Bottle number
c.  Labels must be approved by WSLH PT staff on an annual basis.

B.2

Overage samples defined in General Specifications A.11 must be labeled 30 days in advance of the WSLH PT ship date and be made available in a timely manner.

B.3

Sample material must be dispensed in leak resistant, labeled, capped vials.

B.4

Contractor must provide temperature rating of sample container upon WSLH PT request.

B.5

Contractor may kit samples.

C.

Bulk Shipping/Billing Specifications

C.1

The Contractor must bulk ship the samples to WSLH PT by overnight delivery carrier at no extra charge (sample cost includes shipping) to the following address which must include:
Proficiency Testing
Wisconsin State Laboratory of Hygiene
465 Henry Mall, Room 109
Madison, WI 53706-1578
ATTN: (specific coordinator name)

C.2

The bid prices for samples must include all shipping costs.

C.3

Samples must arrive at least three weeks prior to the WSLH PT ship date or by the date specified with the order.  Shipping schedule must be preapproved by WSLH PT.

C.4

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

C.5

Each box in the shipment must indicate the box number and the total number of boxes.  Example for labeling: 1 of 5, 2 of 5, etc.  This information must be provided on the outside of the box next to the shipping label.

C.6

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

C.7

Contractor must provide adequate protective packaging.

C.8

Contractor must assume all costs associated with the replacement of lost, broken, damaged, or leaking samples during shipment to WSLH PT.

C.9

Contractor must agree that mixed product shipment boxes/containers will have each specific product segregated and self contained.

C.10

Dry ice must be segregated and self contained from bulk sample shipments in all boxes requiring dry ice.

C.11

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

C.12

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

C.13

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

C.14

Contractor must provide tracking and proof of delivery of shipments to WSLH PT.

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 1(b) Not Kitted

1

CET12-e-1

$3.60

2

CET12-e-2

$3.60

3

CET12-e-3

$3.60

4

CET12-e-4

$3.60

5

CET12-e-5

$3.60

CHEMISTRY/ENDOCRINOLOGY/THERAPEUTIC DRUGS (CET)

1.

Sample material must be human serum based.

2.

Sample volume must be a minimum of 5.0 mL.

3.

Contractor must prepare fifteen sample formulations are needed per calendar year.

4.

Contractor must provide three events per calendar year with five samples per event.

5.

Samples must contain the following analytes:  ALT, albumin, alkaline phosphatase, amylase, AST, direct bilirubin, total bilirubin, is endogenous, CO2, chloride, total cholesterol, HDL cholesterol, LDL cholesterol, creatine kinase, creatinine, GGT, glucose,  human chorionic gonadotropin, total iron, total iron binding capacity, lactate, LD, lipase, magnesium, osmolality, phosphorus, potassium, sodium, total protein, triglycerides, BUN, uric acid, acetaminophen, carbamazepine, digoxin, gentamicin, lithium, N-acetylprocainamide, phenobarbital, phenytoin, procainamide, quinidine, salicylate, theophylline, tobramycin, valproic acid (VPA), vancomycin, alpha fetoprotein, cortisol, free thyroxine , free Triiodothryonine, T3U/T-Uptake, thyroid stimulating hormone, thyroxine, triiodothryonine.

6.

Samples may contain analytes:  Unsaturated iron binding capacity.  25-hydroxyvitamin D.  (endogenous)

7.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

8.

Samples must be compatible with instrumentation from various manufacturers.  Manufacturers include: ABBOTT, Beckman Coulter, Siemens, Ortho Clinical Diagnostics, TOSOH Biosciences, Roche Diagnostics, Alfa Wassermann.

9.

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

10.

Samples must be packaged in leak resistant, labeled, capped, amber colored vials.  Vials must be rated to withstand frozen storage range -15 to -25 °C. 

11.

Refrigerated storage, unopened, must be at least 60 days and/or frozen stability of 1 yr. Unopened refrigerated storage 30 days)

12.

Open vial stability must be at least 5 days at refrigerated temperatures.

13.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

14.

COAs must display quantitative values and the instrumentation used for testing.

15.

Analytes listed for which levels are targeted as “endogenous” must be indicated as endogenous on the COA.

16.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = February 7, 2012
2012 Event 2 = May 29, 2012
2012 Event 3 = September 10, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 3(b) Not Kitted

1

IBC12-e-1

 $4.50

2

IBC12-e-2

  $4.50

1.

Sample volume must be a minimum of 2.0 mL. (sample is dried)

2.

Contractor must prepare six sample formulations per calendar year.

3.

Contractor must provide three events per calendar year with two samples per event.

4.

Samples must contain the following analytes:  Unsaturated iron binding capacity, total iron binding capacity.

5.

Samples may contain analytes:  Transferrin and iron.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with direct measurement by instrumentation from various manufacturers.  Manufacturers include: ABBOTT, Beckman Coulter, Siemens, Ortho Clinical Diagnostics, TOSOH Biosciences, Roche Diagnostics.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Refrigerated storage, unopened, must be at least 60 days and/or frozen stability of 1 yr.

11.

Open vial stability must be at least 5 days at refrigerated temperatures.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

13.

COAs must display quantitative values and the instrumentation used for testing.

14.

Analytes listed for which levels are targeted as “endogenous” must be indicated as endogenous on the COA.

15.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1= February 7, 2012
2012 Event 2= May 29, 2012
2012 Event 3= September 10, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 4(b) Not Kitted

1

CS12-e-1

$6.00 

2

CS12-e-2

$6.00 

3

CS12-e-3

$6.00 

1.

Samples must be liquid, human serum based.

2.

Sample volume must be a minimum of 5.0 mL.

3.

Six sample formulations are needed per calendar year. 

4.

Three-sample product, ships two times per year.

5.

Samples must contain the following analytes: DHEA sulfate, estradiol, ferritin, folate, FSH, homocysteine, endogenous, prealbumin, progesterone, prolactin, total testosterone, transferrin, vitamin B12.

6.

Contractor must disclose all additional analytes not included in the list of required analytes.

7.

Sample must be compatible with instrumentation from various manufacturers.  Manufacturers include: ABBOTT, Bayer Diagnostics, Beckman Coulter, Ortho Clinical Diagnostics, Roche Diagnostics, Siemens, TOSOH Biosciences.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Refrigerated storage, unopened, must be at least 60 days and/or frozen stability of 1 yr.  2-8° unopened Stability 30 days

11.

Opened vial stability must be at least 5 days at 2-8° C.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

14.

COAs must display quantitative values and the instrumentation used for testing.

15.

 Tentative 2012 WSLH PT shipping dates:
2012 Event 1 = March 27, 2012
2012 Event 2 = October 22, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 5 (b) Not Kitted

1

CSB12-e-1

$8.50 

2

CSB12-e-2

$8.50 

3

CSB12-e-3

$8.50 

1.

Samples must be human serum based.

2.

Sample volume must be a minimum of 2.0 mL.

3.

Six sample formulations are needed per calendar year. 

4.

Three-sample product, ships two times per year. 

5.

Sample must contain the following analytes: C-Peptide, Insulin, PTH (whole molecule), 25-OH Vitamin-D, total.

6.

Contractor must disclose all additional analytes not included in the list of required analytes.

7.

Sample must be compatible with instrumentation from various manufacturers.  Manufacturers include: Bayer Diagnostics, Beckman Coulter, DiaSorin, IMMULITE, Roche Diagnostics, TOSOH Biosciences.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Refrigerated storage, unopened, must be at least 1 yr. stability.

11.

Opened vial stability must be at least 2 days at 2-8° C.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

14.

COAs must display quantitative values and the instrumentation used for testing.

15.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = March 27, 2012
2012 Event 2 = October 22, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 7(b) Not Kitted

1

WC12-e-1

$3.60 

2

WC12-e-2

$3.60 

3

WC12-e-3

$3.60 

1.

Sample material must be human based whole blood or serum.

2.

Sample volume must be a minimum of 2.0 mL.

3.

Six sample formulations are needed per calendar year.  Three-sample product, ships two times per year.

4.

Samples must contain the following analytes:  ALT, AST, albumin, alkaline phosphatase, amylase, total bilirubin, calcium, total cholesterol, CO2, chloride, creatinine, GGT, glucose, HDL cholesterol, LDL cholesterol, potassium, sodium, total protein, triglycerides, BUN, uric acid.

5.

For each shipment, target value ranges must represent clinical low, mid, elevated analyte concentrations. 

6.

Target value for HDL cholesterol should not exceed 100mg/dL.

7.

Contractor must disclose all additional analytes present in sample base but not included in the list of required analytes (Item #4).

8.

Analytes listed as “endogenous” or “as found” must be indicated and identified as such on the COAs.

9.

COAs must display quantitative values and the instrumentation used for testing.

10.

Samples must be compatible with, but not limited to, the following waived chemistry systems: Abaxis Piccolo, Cholestech LDX.

11.

Contractor must disclose all methods with which the product offered is known to be incompatible.

12.

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

13.

Samples must be packaged in leak resistant, labeled, capped, amber colored vials.

14.

Samples are stable 1 year @ 20; 30 days @ 2-8° unopened 

15.

Open vial stability must be at least 5 days at refrigerated temperatures.

16.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

17.

Tentative 2012 WSLH PT shipping dates:
2012 Event 1 = April 2, 2012
2012 Event 2 = September 17, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 13(b) Not Kitted

1

MT12-e-1

$8.65 

2

MT12-e-2

$8.65 

3

MT12-e-3

$8.65 

1.

Samples must be liquid, human serum based.

2.

Sample volume must be a minimum of 2.0 mL.

3.

Six sample formulations are required per calendar year.

4.

Three-sample product, ships two times per year.

5.

Samples must contain the following analytes; CA 125, CA 15-3, CA 19-9, CA 27/29, CEA, free PSA, total PSA.

6.

Contractor must disclose all additional analytes not included in the list of required analytes.

7.

Sample must be compatible with instrumentation from various manufacturers.  Manufacturers include: ABBOTT, Bayer Diagnostics, Beckman Coulter, Ortho Clinical Diagnostics, Roche Diagnostics, Siemens, TOSOH Biosciences.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Refrigerated storage, unopened, must be at least 60 days and/or frozen stability of 1 yr.2-8° unopened, 30 days.

11.

Opened vial stability must be at least 5 days at  2-8° C.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

14.

COAs must display quantitative values and the instrumentation used for testing.

15.

 Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = March 27, 2012
2012 Event 2 = October 22, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 14(b) Not Kitted

1

AM12-e-1

$3.35

2

AM12-e-2

$3.35

3

AM12-e-3

$3.35

4

AM12-e-4

$3.35

5

AM12-e-5

$3.35

1.

Samples must be liquid, human serum based.

2.

Sample volume must be a minimum of 2.0 mL.

3.

Fifteen sample formulations are needed per calendar year. 

4.

Samples must contain the following analytes:  ethanol, acetone spiked with acetoacetate.

5.

COA’s must include semi-quantitative and qualitative values for acetone/acetoacetate and quantitative values for ethanol, and list the test method(s) and/or instrumentation used to determine these values.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Sample must be compatible with instrumentation and kits in use by WSLH PT customers.  Manufacturers include: Bayer (Acetest), ABBOTT, Beckman Coulter, Siemens, and Roche Diagnostics.

8.

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

9.

Unopened samples must be stable for at least 60 days when stored refrigerated and/or at least one year when stored frozen.

10.

Opened vial stability must be at least 5 days at 2-8° C.

11.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

12.

Contractor must provide samples in the following format: 5 samples per shipment, shipping 3 times per year.  Contractor must ensure sample production schedule is compatible with the following tentative 2012 WSLH PT shipping dates: 

2012 Event 1 = February 7, 2012
2012 Event 2 = May 29, 2012             
2012 Event 3 = September 10, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 16(b) Not Kitted

1

HCG12-e-1

$2.15

2

HCG12-e-2

$2.15

3

HCG12-e-3

$2.15

4

HCG12-e-4

$2.15

5

HCG12-e-5

$2.15

1.

Sample material must be liquid, human serum based.

2.

Sample volume must be a minimum of 1.0 mL. 

3.

Contractor must prepare fifteen formulations per calendar year.

4.

Contractor must provide three events per calendar year with five samples each event.

5.

Samples must contain the following analytes:  serum hCG, qualitative.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be suitable for analysis on commonly used qualitative serum pregnancy kits including products manufactured/distributed by:  Quidel, Fisher Scientific and Alere.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.  Vials must be rated to withstand frozen storage range -15 to -25 °C. 

10.

Refrigerated storage, unopened, must be at least 60 days and/or frozen stability of 1 yr.

11.

Open vial stability must be at least 5 days at refrigerated temperature.

12.

Contractor must provide WSLH PT with shipping requirements for product upon request.

13.

Sample stability and integrity must be maintained during WSLH PT shipping to participants (specimens must not be labile under shipping conditions).

14.

No more than three samples per event may have target values intended for negative qualitative interpretation.

15.

COAs must display quantitative values and the instrumentation used for testing.

16.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = February 7, 2012
2012 Event 2 = May 29, 2012
2012 Event 3 = September 10, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 19(b) Not Kitted

1

NH12-e-1

$4.15

2

NH12-e-2

$4.15

3

NH12-e-3

$4.15

1.

Samples must be liquid human serum based.

2.

Sample volume must be a minimum of 2.0 mL.

3.

Six sample formulations are required for a calendar year.

4.

Three-sample product, ships two times per year. 

5.

Samples must contain the following analyte: Ammonia.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with instrumentation from various manufacturers.  Manufacturers include: ABBOTT, Bayer Diagnostics, Beckman Coulter, Ortho Clinical Diagnostics, Roche Diagnostics, Siemens, TOSOH Biosciences.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Refrigerated storage, unopened, must be at least 60 days and/or frozen stability of 1 yr.  2-8° unopened storage = 30 days

11.

Opened vial stability must be at least 5 days at 2-8° C.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be liable under normal shipping conditions).

13.

COAs must display quantitative values and the instrumentation used for testing.

14.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = March 27, 2012
2012 Event 2 = October 22, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 20(b) Not Kitted

1

CU12-e-1

$3.40

2

CU12-e-2

$3.40

3

CU12-e-3

$3.40

1.

Samples must be liquid, simulated human urine or human urine based.

2.

Sample volume must be a minimum of 10.0 mL.

3.

Six sample formulations are needed per calendar year.

4.

Three-sample product, ships two times per year. 

5.

Samples must contain the following analytes:  amylase, calcium, chloride, creatinine, glucose, microalbumin, magnesium, osmolality, phosphorous, potassium, sodium, protein, urea nitrogen, uric acid.

6.

Upon request, Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with instrumentation from various manufacturers such as Abbott, Beckman Coulter, Siemens, Ortho Clinical Diagnostics, and Roche Diagnostics.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Sample refrigerated storage, unopened, must be at least 60 days after the WSLH PT ship date and/or have an unopened frozen stability of 1 yr.  FROZEN STORAGE NOT RECOMMENDED.

11.

Open vial stability must be at least 5 days at refrigerated temperature.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

13.

COAs must display quantitative values and the instrumentation used for testing.

14.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = April 16, 2012
2012 Event 2 = November 5, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 21(b) Not Kitted

1

UD12-e-1

$5.35

2

UD12-e-2

$5.35

1.

Samples must be liquid, human urine based.

2.

Sample volume must be a minimum of 10.0 mL.

3.

Six sample formulations are needed per calendar year. 

4.

Samples must contain the following analytes:  acetaminophen, amphetamines, barbiturates, benzodiazepines, buprenorphine, cannabinoids, cocaine metabolites, EDDP, ethanol (alcohol), LSD, MDMA, methadone, methamphetamines, methaqualone, morphine, opiates, oxycodone, phencyclidine, propoxyphene, tricyclic antidepressants.

5.

COA’s must include quantitative values for the above listed analytes, and list the test method(s) and/or the instrumentation used to determine analyte values.

6.

Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Sample must be compatible with instrumentation and kits in use by WSLH PT customers.  Manufacturers include: ABBOTT, Beckman Coulter, Biosite, Bio-Rad, Siemens, Medtox, and Roche Diagnostics.

8.

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

9.

Unopened samples must be stable for at least 60 days when stored refrigerated and/or at least one year when stored frozen.  FROZEN STORAGE NOT RECOMMENDED; 2-8° good for 1 year.

10.

Opened vial stability must be at least 5 days at 2-8° C.

11.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

12.

Contractor must provide samples in the following format: 2 samples per shipment, shipping 3 times per year.  Contractor must ensure sample production schedule is compatible with the following tentative 2012 WSLH PT shipping dates: 

2012 Event 1 = February 7, 2012
2012 Event 2 = May 29, 2012             
2012 Event 3 = September 10, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 22(b) Not Kitted

1

SF12-e-1

$3.60 

2

SF12-e-2

$3.60 

3

SF12-e-3

$3.60 

1.

Samples must be liquid, simulated human spinal fluid.

2.

Sample volume must be a minimum of 2.0 mL. 

3.

Six sample formulations are needed per calendar year.

4.

Three-sample product, ships two times per year. 

5.

Samples must contain the following analytes:  protein, glucose, LD, sodium, potassium, chloride, lactic acid.

6.

Upon request, Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with instrumentation from various manufacturers such as Abbott, Beckman Coulter, Siemens, Ortho Clinical Diagnostics, and Roche Diagnostics.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Refrigerated storage, unopened, must be at least 60 days after the WSLH PT ship date and/or have an unopened frozen stability of 1 yr.

11.

Open vial stability must be at least 5 days at refrigerated temperature.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

13.

COAs must display quantitative values and the instrumentation used for testing.

14.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = April 16, 2012
2012 Event 2 = November 5, 2012

ITEM

PT SAMPLE DESCRIPTION

PRICE PER VIAL

LOT 23(b) Not Kitted

1

PC12-e-1

$5.15 

2

PC12-e-2

$5.15  

3

PC12-e-3

$5.15  

1.

Samples must be liquid, human serum based.

2.

Sample volume must be a minimum of 3.0 mL.

3.

Six sample formulations are needed per calendar year. 

4.

Three-sample product, ships two times per year. 

5.

Samples must contain the following analytes: albumin, amylase, cholesterol, creatinine, glucose, LD, pH, protein and triglycerides.

6.

Upon request, Contractor must disclose all additional analytes present but not included in the list of required analytes.

7.

Samples must be compatible with instrumentation from various manufacturers such as Abbott, Beckman Coulter, Siemens, Ortho Clinical Diagnostics, and Roche Diagnostics.

8.

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

9.

Samples must be packaged in leak resistant, labeled, capped vials.

10.

Refrigerated storage, unopened, must be at least 60 days after the WSLH PT ship date and/or have an unopened frozen stability of 1 yr.

11.

Open vial stability must be at least 5 days at refrigerated temperature.

12.

Sample stability and integrity must be maintainable during WSLH PT 2 day shipping to participants (specimens must not be labile under normal shipping conditions).

13.

COAs must display quantitative values and the instrumentation used for testing.

14.

Tentative 2012 WSLH PT shipping dates: 
2012 Event 1 = April 16, 2012
2012 Event 2 = November 5, 2012

GENERAL SPECIFICATIONS

A.

Sample Specifications

A.1

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

A.2

Contractor must be International Standardization Organization (ISO) certified and provide documentation of certification.

A.3

Contractor must provide a Certificate of Analysis (COA) for every sample with each shipment.  COA must be provided by mail or electronically at least one week prior to WSLH PT scheduled ship date.

A.4

Samples must test non-reactive for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C.  Documentation of testing by techniques approved by the FDA must be provided on the COA.

A.5

Testing of product sterility ( 0 CFU/ML microbials ) must be documented and provided on the COA.

A.6

COA must include expiration dates and sample storage requirements.

A.7

Product performance documented on each COA must be from the final product shipped to WSLH PT. 

A.8

Analyzer(s) mfg/model(s) used in testing for COA documentation must be recorded on COA.

A.9

Contractor must be capable of providing samples specified in this contract on a regular basis beginning no later than November 1, 2011.

A.10

Analytes identified by the Contractor as “endogenous” or “as found” must be identified and listed as such on the COA.

A.11

Upon request, Contractors must supply a representative test sample and/or COA prior to acceptance of the bid. 

A.12

The Contractor must maintain at least 3% overage of each item manufactured to be kept sequestered and available for WSLH PT upon request. 

A.13

Contractor must ship and invoice only for the number of samples ordered by WSLH PT. 

A.14

Contractor must notify WSLH PT of any changes to additives and/or preservatives made to the product after the original bid acceptance.

A.15

Cost of samples must be reimbursed to WSLH PT when samples exhibit matrix effects, exhibit preparation errors as documented by WSLH PT, or contain analyte levels not approved by WSLH PT.

A.16

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

A.17

Samples must be of different levels (normal and abnormal) which span the analytical range for most analyzers, representative of clinical human samples.

A.18

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

A.19

For each non-custom product the Contractor must submit a product insert and potential analyte concentrations from which to choose.

A.20

Material supplied must be free from known interferences and suitable for use on methodologies routinely used for testing by WSLH PT customers (must be compatible with most instruments/diagnostic kits currently on the market) and written documentation of compatibility tests must be available to WSLH PT on request.

A.21

Samples must be void of any manufacturer’s name, trademark, lot number, or product/item number. 

A.22

Contractor must collaborate with WSLH PT on an annual basis to establish analyte specifications/targets for all levels of product and must allow WSLH PT final approval.

A.23

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

A.24

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

B.

Vial Packaging and Labeling

B.1

All sample vials must be labeled by the Contractor.

●  Product specialty name
●  WWW- Product code (2 or 3 characters)
●  YY- Last two digits of year
●  EE- Event number or month code (2 or 3 characters)
●  N- Bottle number
c.  Labels must be approved by WSLH PT staff on an annual basis.

B.2

Overage samples defined in General Specifications A.11 must be labeled 30 days in advance of the WSLH PT ship date and be made available in a timely manner.

B.3

Sample material must be dispensed in leak resistant, labeled, capped vials.

B.4

Contractor must provide temperature rating of sample container upon WSLH PT request.

B.6

If Contractor meets General Specification B.5, the Contractor must meet the following specifications:
a. Box/bag must be labeled with the WSLH PT logo, product, 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
            * remain adhered to box/bag when stored according to sample Contractor specifications until expiration date.
d. Kit labels must be approved by WSLH PT staff on an annual basis.

C.

Bulk Shipping/Billing Specifications

C.1

The Contractor must bulk ship the samples to WSLH PT by overnight delivery carrier at no extra charge (sample cost includes shipping) to the following address which must include:
Proficiency Testing
Wisconsin State Laboratory of Hygiene
465 Henry Mall, Room 109
Madison, WI 53706-1578
ATTN: (specific coordinator name)

C.2

The bid prices for samples must include all shipping costs.

C.3

Samples must arrive at least three weeks prior to the WSLH PT ship date or by the date specified with the order.  Shipping schedule must be preapproved by WSLH PT.

C.4

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

C.5

Each box in the shipment must indicate the box number and the total number of boxes.  Example for labeling: 1 of 5, 2 of 5, etc.  This information must be provided on the outside of the box next to the shipping label.

C.6

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

C.7

Contractor must provide adequate protective packaging.

C.8

Contractor must assume all costs associated with the replacement of lost, broken, damaged, or leaking samples during shipment to WSLH PT.

C.9

Contractor must agree that mixed product shipment boxes/containers will have each specific product segregated and self contained.

C.10

Dry ice must be segregated and self contained from bulk sample shipments in all boxes requiring dry ice.

C.11

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

C.12

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

C.13

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

C.14

Contractor must provide tracking and proof of delivery of shipments to WSLH PT.