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MICROBIOLOGY, SPECIAL MICROBIOLOGY, PARASITOLOGY & VIROLOGY PROFICIENCY TESTING (PT) SAMPLES

(contract last updated 11/18/2011)

SCOPE: Contract for the Wisconsin State Laboratory of Hygiene – Proficiency Testing (WSLH-PT) for Microbiology, Special Microbiology, Parasitology and Virology Proficiency Testing (PT) Samples. PT ships various types of sample material containing specified amounts of organisms, antigens and toxins to program participants two or more times per calendar year based on lot.  Orders will be placed with the manufacturer at least two months prior to the WSLH PT need date unless a longer lead time is requested by the manufacturer.  No sample item quantity overages will be accepted without expressed permission from WSLH PT.

CONTRACT # DESCRIPTION
12-5345 MICROBIOLOGY, SPECIAL MICROBIOLOGY, PARASITOLOGY & VIROLOGY PROFICIENCY TESTING (PT) SAMPLES
CONTRACT ORIGIN: ADDITIONAL INFORMATION:
UW-Madison
Purchasing Services
21 N Park St, Ste 6101
Madison, WI 53715-1218
UW-Madison users contact:
Susanne Matschull
(608) 262-3198 / FAX (608) 262-4467
smatschull@bussvc.wisc.edu
  Non-UW-Madison users contact: Vendor Representative
SPECIAL APPROVAL REQUIRED FROM: Wisconsin State Lab of Hygiene
Becky Briggs, Special Microbiology PT Coordinator
465 Henry Mall
Madison, WI 53706
608-265-1100
COOPERATIVE PURCHASING: YES
CONTRACT TERM: November 1, 2011 through October 31, 2012, with automatic renewal extensions to October 31, 2014, unless amended, cancelled or rebid.

Manufacturer(s) MERIDIAN BIOSCIENCE
Vendor(s)
018791
Meridian Bioscience
3471 River Hills Dr
Cincinnati  OH  45244
     
Sales Representative: PHONE # FAX #
Fred Rachford 513-271-3700 513-272-5271
E-mail fred.rachford@meridianbioscience.com
  PHONE # FAX #
Ordering/Expediting: 513-271-3700 513-272-5271
Invoice Information: 513-271-3700 513-272-5271
Returns: 513-271-3700 513-272-5271
Supplier Diversity Reporting: 513-271-3700 513-272-5271
Website: www.meridianbioscience.com
Commodity Code 115-05
115-10
115-12
115-90
193-08
271-92
495-28
Federal Employee ID # (FEIN) 31-1508032
F.O.B. “D” FOB DESTINATION, FREIGHT PREPAID AND ALLOWED
Terms: N/30
Delivery: As specified
Invoicing: Invoices will show net pricing
Orders: E-mail, Fax, Phone
Back Orders: Will notify ordering department within 24 hours of order/release.
Pricing Information: SEE BELOW

LOT 5 - PARASITOLOGY MATERIAL

 

DESCRIPTION

PRICE/EACH

5-1.

Giardia/Cryptosporidium Antigen (4)

$13.85

5-2.

Stool Wet Mount  (5)

$12.00

5-3.

PVA Smears (6)

$10.65

5-4.

Blood Parasite Smears (7)

$14.80

LOT 5
SPECIFIC SPECIFICATIONS
PARASITOLOGY MATERIAL

1.

Contractor must validate stool and blood parasitology samples upon manufacturing and also 45 days prior to shipment.  Three percent of random samples must be tested, and documentation of validation must be included in the COA.

2.

Material must have an expiration date of at least 12 months from production date when refrigerated.  NO REFRIGERATION IS REQUIRED FOR PARASITOLOGY SPECIMENS.

3.

Liquid stool samples must be packaged in ampules and be at least 1.0 ml or greater.

4.

Giardia lamblia and Cryptosporidium antigen samples must consist of 10% formalin preserved stool suspensions containing a mixture of Giardia lamblia, Cryptosporidium spp. and negative sample bases.  Samples must be compatible with EIA and DFA testing.

5.

Stool wet mount samples must consist of 10% formalin preserved stool suspensions containing a mixture of intestinal parasites. Samples must be compatible with modified acid fast stain methods.

6.

Permanent stain samples for intestinal parasites must consist of unstained Polyvinyl alcohol (PVA) fixed stool smears.  Smears must be on labeled slides or have frosted ends for labeling.

7.

Blood parasite samples must consist of unstained and/or Giemsa stained thin blood smears containing a mixture of Babesia, Trypanosoma, Plasmodium, Anaplasma and/or Ehrlichia species and filarial worms. Smears must be on labeled slides or have frosted ends for labeling.

8.

Slide samples must be individually packaged in a way that protects slides from damage and must be fully labeled on the outside of the packaging.

10.

Contractor must ensure sample production schedule is compatible with the following tentative 2012 WSLH PT shipping dates: 

2012 Event 1 = January 10, 2012
2012 Event 2 = May 7, 2012             
2012 Event 3 = September 17, 2012


Manufacturer(s) MICROBIX BIOSYSTEMS INC
Vendor(s)
137309
Microbix Biosystems Inc
265 Watline Ave
Mississauga On L4Z 1P3
Canada
     
Sales Representative: PHONE # FAX #
Kevin Koole 905-361-8910 X228 905-361-8911
E-mail fred.rachford@meridianbioscience.com
  PHONE # FAX #
Ordering/Expediting: 905-361-8910 X249 905-361-8911
Invoice Information: 905-361-8910 X249 905-361-8911
Returns: 905-361-8910 X249 905-361-8911
Supplier Diversity Reporting: 905-361-8910 X249 905-361-8911
Website: www.microbix.com/antigens
Commodity Code 115-05
115-10
115-12
115-90
193-08
271-92
495-28
Federal Employee ID # (FEIN) 98-0101052
F.O.B. “D” FOB DESTINATION, FREIGHT PREPAID AND ALLOWED
Terms: N/30
Delivery: As specified
Invoicing: Invoices will show net pricing
Orders: E-mail, Fax, Mail
Back Orders: Will notify ordering department within 24 hours of order/release.
Pricing Information: Contact agent at (608) 262-3198 or e-mail smatschull@bussvc.wisc.edu for pricing.

GENERAL SPECIFICATIONS

A.

Sample Specifications

A.1

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

A.2

Contractor must manufacture all material in conformance with the current Good Manufacturing Practice (cGMP) as defined by the Food and Drug Administration (FDA).

A.3

For each sample, the Contractor must provide, at least one week prior to WSLH PT shipment, a Certificate of Analysis (COA) for evaluation.  For purposes of this specification, production or internal quality control data are also acceptable.    This must be provided with each shipment and must include the expiration date and storage requirements of the material.

A.4

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

A.5

Within any defined lot, Contractor must be able to supply all organisms or mixtures of organisms and antigens or toxins required by WSLH PT.

A.6

Contractor must be capable of providing samples specified in this contract on a regular basis beginning no later than November 1, 2011.  Specific sample content and program label information will be divulged upon award of this contract.

A.7

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.8

A preliminary list of annual samples/organisms will be provided by WSLH PT to facilitate sample production.  Contractor accepts that sample content for events 2 and 3 are preliminary and pending approval by Centers for Medicare and Medicaid Services (CMS).  Contractor must accommodate, at no additional cost to WSLH PT, adjustments required by CMS.

A.9

Contractor must supply appropriate type and amount of diluents or hydration broth with all preserved samples.

A.10

Vials for liquid samples must be leak proof, labeled, and capped. 

A.11

Contractor must not charge WSLH PT for replacement and/or shipping costs of liquid samples, diluents and/or hydration broths due to product leakage during transport.

A.12

The shelf life of the material must be at least six months from the shipment date to participants. 

A.13

Material supplied must be free from known interferences and suitable for use on methodologies routinely used for testing by WSLH PT customers.  False positive or false negative reactions are not acceptable.  Cost of samples will be reimbursed to WSLH PT when samples exhibit matrix effects, sample preparation errors as documented by WSLH PT, or contain organisms not approved by WSLH PT.

A.14

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

A.15

Prior to awarding the lot, Contractor must provide WSLH PT with samples of product being bid for independent evaluation and verification of instrument/method compatibility upon request by WSLH PT.

A.16

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

A.17

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

A.18

Contractor, at no cost to WSLH PT, must replace any material found not suitable for analysis including insufficient sample or diluents due to leaking vials, unreadable slides/smear/stains or circumstances due to a Contractor error.

A.19

Material Safety and Data Sheet (MSDS) must be available for all supplied material when requested by WSLH PT.

A.20

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

A.21

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

B.

Packaging and Labeling

B.1

All sample vials must be labeled by the Contractor.

  • Labels must be printed using water-resistant black ink.
  • Label stock must

            * be white
            * remain adhered to when samples are stored according to Contractor’s specifications until expiration date 
           * be able to accommodate the following information:

●  *Product specialty name
●  WW- Product code (2 or 3 characters)
●  YY- Last two digits of year
●  EE- Event number or month code (2 or 3 characters)
●  N- Sample number

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

B.2

Organisms/antigens contained in samples must not be identified by name or code on any sample labels.

B.3

Overage samples defined in General Specifications A.16 must be labeled 30 days in advance of the WSLH PT ship date and be made available in a timely manner.

B.

Packaging and Labeling

 

B.4

Contractor may kit samples.

 

B.5

If Contractor meets General Specification B.4, the Contractor must meet the following specifications:
a. The 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.
e. Organisms/antigens contained in samples must not be identified by name or code on any kit labels.

C.

Bulk Shipping/Billing Specifications

C.1

Contractor must be able to bulk ship samples to a shipper specified by WSLH PT.

C.2

The bid prices for samples must include all bulk shipping/handling costs if shipped to a WSLH PT specified location.

C.3

Samples must arrive at least 3 weeks prior to the WSLH PT ship date or by the date specified with the order.  Shipping schedule must be pre-approved by WSLH PT.

C.4

Contractor must enclose a printed copy of the packing slip(s) in each bulk shipment.  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 for bulk sample shipment.

C.8

Contractor must assume the sample destruction costs associated with broken, damaged, or leaking vials due to inadequate protective packaging, and costs associated with lost samples during bulk shipment.

C.9

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


Manufacturer(s) REMEL
Vendor(s)
019756
Remel Inc
12076 Santa Fe Dr
Lenexa KS 66215
     
Sales Representative: PHONE # FAX #
Katie Merrill 913-895-4060 800-447-5750
E-mail katie.merrill@thermofisher.com
  PHONE # FAX #
Ordering/Expediting: 337-479-1000 337-474-7404
Invoice Information: 337-479-1000 337-474-7404
Returns: 337-479-1000 337-474-7404
Supplier Diversity Reporting: 913-895-4060 800-447-5750
Website: www.remel.com
Commodity Code 115-05
115-12
193-08
193-36
271-92
495-28
495-75
Federal Employee ID # (FEIN) 74-2826694
F.O.B. “D” F.O.B. DESTINATION, FREIGHT PREPAID AND ALLOWED
FOR LOTS 1, 3 and 4
“E” F.O.B. DESTINATION, FREIGHT PREPAID AND ADDED
FOR LOTS 10 AND 11
Terms: N/30
Delivery: As specified
Delivery: As specifified.
Invoicing: Invoices will show net pricing
Return Policy: Product returns must be coordinated by Customer Service at 800-255-6730. Request for returns must be made on the day of receipt. A Return Authorization Number is required and must accompany returned products. For returns due to customer error, a 20% restocking charge will apply. Perishable or temperature sensitive products cannot be returned for any reason. These items include but are not limited to:Animal Blood, Diagnostic Tests, Prepared Culture Media, Quality Control Organisms: Reagents, Susceptibility and Differentiation Disk.

Returns of products ordered through an authorized Remel Product distributor must be coordinated directly with your distributor.   

Orders: E-mail, Fax, Mail or Phone
Back Orders: Will notify ordering department within 24 hours of order/release.
Pricing Information: SEE BELOW

LOT 1
SPECIFIC SPECIFICATIONS
BACTERIOLOGY MATERIAL

 

SPECIFICATIONS

1.

Organisms for culture must be in a preserved form not requiring refrigeration during shipping.

2.

All liquid samples must be a minimum of 0.5 mL.

3.

Bacterial antigens and toxins must be in an inactivated form.  Cerebral Spinal Fluid (CSF) Bacterial Antigen is not available in active form.

4.

Contractor must validate culture samples upon manufacturing QC sampling rate for manufacture of specimens are per ANSI/ASQC Z1.4-193.

5.

Samples must have 95% accuracy by clinical methods appropriate to the organism or antigen/toxin tested. Documentation of validation, biochemical profiles, and susceptibility patterns must be included in the Certificate of Analysis (COA).

6.

Strep A Antigen Samples:  Samples must consist of swab samples of group A streptococcus, normal mouth flora and negative sample bases.  Contractor must be able to manufacture group A strep antigen samples using plastic, solid shafted, and rayon tipped swabs.  Samples must be compatible for group A strep antigen samples using kits manufactured/distributed by Alere, Quidel, and/or Fisher. Contractor will verify compatibility for group A strep antigen samples using kits manufactured/distributed by Alere, Quidel, and/or Fisher, if kits are provided to Contractor.

7.

Strep A Culture Samples:  Samples must consist of cultures for group A streptococcus and normal mouth flora.

8.

Strep B Culture Samples:  Samples must consist of cultures for group B streptococcus and normal flora.

9.

Neisseria gonorrhoeae Samples:  Samples must consist of cultures for N. gonorrhoeae and normal flora.

10.

Miscellaneous Bacteriology Culture Samples:  Samples must consist of aerobic and anaerobic bacteria cultures for throat, urine, blood, stool, eye, ear, genital and wound pathogens and/or normal flora and negative sample bases.

11.

Methicillin Resistant Staphylococcus Aureus (MRSA) and Vancomycin Resistant Enterococcus (VRE) Samples:  Samples must consist of cultures for MRSA, VRE, Enterococcus spp., Staphylococcus spp., normal respiratory flora and/or negative sample bases.  Samples must be compatible with BD GeneOhm VanR, and Cepheid Xpert vanA.

12.

Enteric Pathogen Samples:  Samples must consist of cultures for stool pathogens, to include: several serotypes of Salmonella enterica subspecies enterica (including at least S. Typhimurium and S. Enteritidis), Shigella flexneri, Shigella boydii, Shigella sonnei, Campylobacter jejuni, Yersinia enterocolitica, Escherichia coli O157:H7, Aeromonas hydrophila, Plesiomonas shigelloides, Vibrio parahaemolyticus and/or normal stool flora and negative sample base.  Samples must be compatible for Campylobacter samples using Meridian Bioscience immunoassay kits.  Contractor will verify compatibility for Campylobacter samples using Meridian Bioscience immunoassay kits, if kits are provided to Contractor.

13.

Gram Stain Samples:  Samples must consist of unstained smears made from culture on labeled glass slides.  Contractor must be able to supply air dried, fixed organisms on a glass slide.  Slide samples must have a frosted end for labeling, or labeled prior to shipping.  For all slide samples, Contractor must provide protective slide holders that protect samples from damage during transport.

14.

CT/GC Detection Samples:  Samples must consist of Chlamydia trachomatis, Neisseria gonorrhoeae and negative sample base swabs for molecular testing. Samples must be compatible with Gen-Probe Aptima II, and Gen-Probe Pace 2, Roche Cobas Amplicor and BD ProbeTec ET.

15.

Chlamydia Samples:  Samples must consist of Chlamydia trachomatis, and negative sample base swabs for Enzyme Immunoassay (EIA) testing.

16.

Vaginal Pathogens Samples:  Samples must consist of Gardnerella vaginalis, Candida spp., Trichomonas vaginalis, normal flora and negative sample base swabs.  Samples must be compatible with BD Affirm VPIII and OSOM Trichomonas Rapid Test.

17.

Cerebral Spinal Fluid (CSF) Bacterial Antigen Samples:  Samples must consist of Group B streptococcus, Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitidis group B, Neisseria meningitidis group A, C, or W135. Samples must be compatible with BD Directigen and Wellcogen kits.  Samples containing S. pneumoniae must be compatible with Alere BinaxNOW.  Item is not inactivated as specified in Lot 1 number 3.

18.

Clostridium difficile toxin/antigen Samples:  Samples must consist of inactivated Clostridium difficile antigen/toxin samples and negative sample base.  Samples must be compatible for Clostridium Difficile samples for kits manufactured by Meridian Bioscience and Alere.  Contractor will verify compatibility for Clostridium difficile samples using kits manufactured by Meridian Bioscience and Alere, if kits are provided to Contractor. 

19.

Bioterrorism Preparedness Exercise Samples:  Samples are selected from the APHL list of surrogate organisms.  WSLH PT may provide stock cultures for use in the production process.  Contractor must subculture and quality control the selected organisms to verify “characteristic” reactions are obtainable by culture and biochemical means.

20.

Contractor must include any American Type Culture Collection (ATCC) or other royalty fees that WSLH PT will be charged.

21.

Contractor must not charge WSLH PT any ATCC or other royalty fee for organisms that are supplied to the Contractor by WSLH PT.

22.

Contractor must ensure sample production schedule is compatible with the following tentative 2012 WSLH PT shipping dates for samples identified in Lot 1 specifications 6-18:
2012 Event 1 = March 9, 2012
2012 Event 2 = July 6, 2012             
2012 Event 3 = October 19, 2012
Orders must be placed with the manufacture at least 3 months prior to the WSLH PT date for shipment unless longer lead time is requested by the manufacture.

23.

Contractor must ensure sample production schedule is compatible with the following tentative 2012 WSLH PT shipping dates for samples identified in Lot 1 specification 19:
2012 Event 1 = April 16, 2012
2012 Event 2 = September 4, 2012
Orders must be placed with the manufacture at least 3 months prior to the WSLH PT date for shipment unless longer lead time is requested by the manufacture.

LOT 1
PRICING
BACTERIOLOGY MATERIAL

Prices include the cost of bulk shipping.

ITEM NUMBER

DESCRIPTION
(LOT 1 SPECIFICATION NUMBER THAT ITEM RELATES TO)

CATALOG #

PRICE/
EACH

1-1.

Strep A antigen (6)

R482000011, R482020011, R482030013, R482040011, R482050011

$4.04

1-2.

Strep A culture (7)

R481960011, R4C1960011

$5.33

1-3.

Strep B culture (8)

R481940011, R4C1940011

$5.33

1-4.

N. gonorrhoeae culture (9)

R481910011, R4C1910011

$5.33

1-5.

Miscellaneous bacteriology cultures (10)

R481900012, R3C1900012

$5.33

1-6.

MRSA/VRE culture (11)

R481920011, R4C1920011

$5.33

1-7.

Enteric pathogen culture (12)

R481930011, R4C1930011

$5.33

1-8.

Gram stain (13)

R48210011, R4C210011

$4.27

1-9.

CT/GC detection (14)

R480500211, R4C0500213, R4P0500212

$6.86

1-10.

Chlamydia antigen (15)

R480500311, R4P0500312

$6.86

1-11.

Vaginal pathogens (16)

R4805004, R4C05004, R4P05004

$6.86

1-12.

CSF bacterial antigen (17)

R481800011, R4P1800011

$9.15

1-13.

Clostridium difficile toxin/antigen (18)

R4818700, R4C1800013

$9.15

1-14.

Bioterrorism preparedness exercise (19)

R481730021, R4C1730021

$6.48

1-15

ATCC or equivalent royalty fees (20)

 

$0.30

LOT 3
SPECIFIC SPECIFICATIONS
MYCOBACTERIOLOGY MATERIAL

 

SPECIFICATIONS

1.

Organisms for culture must be in a preserved form not requiring refrigeration during shipping.

2.

Contractor must validate culture samples upon manufacturing.  QC sampling rate for manufacture of specimens are per ANSI/ASQC Z1.4-1993

3.

Samples must have 95% accuracy by clinical methods appropriate to the organism or antigen/toxin tested. Documentation of validation, biochemical profiles, and susceptibility patterns must be included in the Certificate of Analysis (COA).

4.

Mycobacteriology samples for AFB stain must consist of at least 0.5 mL inactivated liquid suspensions of Mycobacteria and other respiratory pathogens and normal flora.

5.

Mycobacteriology samples for culture must consist of 5.0 mL simulated sputum for concentration and culture.  Samples must contain a fully sensitive strain of Mycobacterium tuberculosis and other respiratory pathogens and normal flora.

6.

Contractor must include any American Type Culture Collection (ATCC) or other royalty fees that WSLH PT will be charged.

7.

Contractor must ensure sample production schedule is compatible with the following tentative 2012 WSLH PT shipping dates: 

2012 Event 1 = February 27, 2012
2012 Event 2 = September 17, 2012    
Orders are to be placed with the manufacture at least 5 months prior to the WSLPT date for shipment unless a longer lead time is requested by the manufacture.        

LOT 3
PRICING
MYCOBACTERIOLOGY MATERIAL

Prices must include the cost of bulk shipping.

Item Number

Description (Lot 3 Specification Number that item relates to)

Catalog #
(if available)

Price/
Each

3-1.

AFB stains (4)

R482800011, R4C2800011

$7.41

3-2.

Mycobacteriology culture (5)

R481900111, R4C1900111

$9.15

3-3.

ATCC or equivalent royalty  fees (6)

 

$0.30

LOT 4
SPECIFIC SPECIFICATIONS
MYCOLOGY MATERIAL

# SPECIFICATIONS

1.

Organisms for culture must be in a preserved form not requiring refrigeration during shipping.

2.

Contractor must validate culture samples upon manufacturing.  QC sampling rate for manufacture of specimens are per ANSI/ASQC Z1.4-1993

3.

Samples must have 95% accuracy by clinical methods appropriate to the organism or antigen/toxin tested. Documentation of validation, biochemical profiles, and susceptibility patterns must be included in the Certificate of Analysis (COA).

4.

Mycology culture samples must consist of fungus and fungus-like organisms for culture including yeast and dermatophytes.

5.

Dermatophyte culture samples must consist of a mix of dermatophytes, non-dermatophyte mold forms, yeast, bacteria, and negative sample bases.  Samples must be compatible with Dermatophyte Test Media and selective and non-selective mycology media.

6.

Yeast culture samples must contain yeast and yeast-like organisms.  Samples must be compatible with full yeast culture and rapid yeast ID systems as well as germ tube and agar screening methods in use by WSLH PT participants.

7.

Cryptococcal antigen samples must consist of Cryptococcus neoformans (heat killed) and negative sample base in 1.0 – 2.0 mL suspension in leak proof vials.

8.

Contractor must include any American Type Culture Collection (ATCC) or other royalty fees that WSLH PT will be charged.

9.

Contractor must ensure sample production schedule is compatible with the following tentative 2012 WSLH PT shipping dates: 

2012 Event 1 = January 10, 2012
2012 Event 2 = May 7, 2012
2012 Event 3 = September 17, 2012  
Orders must be placed with manufacture at least 4 months prior to the WSLPT date for shipment unless a longer lead time is requested by the manufacture.

LOT 4
PRICING
MYCOLOGY MATERIAL

Prices must include the cost of bulk shipping.

Item Number

Description (Lot 4 Specification Number that item relates to)

Catalog #
(if available)

Price/
Each

4-1.

Mycology culture (4)

R481700011,  R4C1700011

$6.41

4-2.

Dermatophyte culture (5)

R481710011, R4C1700011

$6.41

4-3.

Yeast culture (6)

R481720011, R4C1720011

$6.41

4-4.

Cryptococcal antigen (7)

R4818100, R4C18100

$9.15

4-5.

ATCC or equivalent royalty fees (8)

 

$0.30

LOT 10
SPECIFIC SPECIFICATIONS
HANDLING AND SHIPPING SERVICES FOR LOTS 1, 2 , 3, 4 from 12-5345-R1
and LOTS 5 and 7 from 12-5345

# SPECIFICATIONS

Handling and Shipping Services to WSLH PT Customers

1.

Contractor must be able to ship samples to WSLH PT customers according to WSLH PT shipping schedules (listed in individual lot specifications).                         

2.

Contractor must package, address and ship samples to clients at room temperature.

3.

Contractor must not divulge WSLH PT participant lists without prior WSLH PT approval.

4.

Contractor must be able to receive samples from outside sources and ship all samples listed in lots 1 through 7 to WSLH PT customers.  With the exception of shiga toxin lot #2.

5.

Contractor must be able to kit samples received from outside sources following General Specification B.5 upon request by WSLH PT.

6.

Contractor must combine orders into 1 shipment if customer receives more than one product per shipment.

7.

Contractor must ship WSLH PT participant forms/paperwork, samples, and /or diluents in the same package by express courier for 2nd day delivery.  Collated instructions/result forms must be received no later than 2 weeks prior to ship date. 

8.

Packaging must be able to accommodate photomicrographs, when requested by WSLH PT.

9.

Shipment boxes must be labeled with standard sample storage requirements (e.g., Refrigerate, stable at room temperature).

10.

Organisms/antigens contained in samples must not be identified by name or code on any external package labeling or packing lists included in the container sent to the participants, nor can sample information be released without prior approval from WSLH PT.

11.

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

12.

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

13.

Contractor must include all packing material and hazardous shipping charges.

14.

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.  List the price that would be charged to relabel one sample: $4.55

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

15.

Contractor must be capable of processing international shipments. (see below under Shipments to Foreign Countries).

16.

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 troubleshooting.

17.

Contractor must be able to accept electronic files of demographic information for clients.

18.

Contractor must provide adequate protective packaging and accept all costs associated with re-shipment due to packing or kitting errors by Contractor, or samples that are lost or damaged in transport to WSLH PT customers.

LOT 10
PRICING
HANDLING AND SHIPPING SERVICES FOR LOTS 1, 2, 3, 4 from RFB 12-5345-R1
and Lots 5 and 7 from 12-5345

Lot #

Description

Cost per
package

1.

Bacteriology Regulated

Bacteriology QA

$15.75

$15.75

3.

Mycobacteriology

$17.82

4.

Mycology

$15.75

5.

Parasitology

$15.75

CUSTOMS:  Shipments to Foreign Countries:
The WSLH PT may enroll some participants from Canada, the Virgin Islands, Europe and possibly Mexico. 

Canada:

$115.50 

Virgin Islands:

Fed-X $126.00
Freight Forwarder $262.50

Europe:

Minimum $262.50
Maximum $472.50

Mexico:

Fed-X $126.00
Freight Forwarder $472.50

LOT 11
SPECIFIC SPECIFICATIONS
HANDLING AND SHIPPING SERVICES FOR
MYCOBACTERIOLOGY MOLECULAR SAMPLES 

#

SPECIFICATIONS

Handling and Shipping Services to WSLH PT Customers

1.

Contractor must be able to ship samples to WSLH PT customers according to WSLH PT shipping schedules.

Tentative 2012 shipping schedule:
2012 Event 1 = February 27, 2012
2012 Event 2 = September 17, 2012             

2.

Contractor must be able to receive, package, address and ship samples consisting of frozen Mycobacterium tuberculosis cell suspensions.

3.

Samples must be stored at -20 ºC and remain frozen during all kitting and/or packaging procedures performed by Contractor.

4.

Contractor must not divulge WSLH PT participant lists without prior WSLH PT approval.

5.

Contractor must be able to kit samples received from outside sources following General Specification B.5 upon request by WSLH PT.

6.

Contractor must combine orders into 1 shipment if customer receives more than one product per shipment.

7.

Contractor must ship WSLH PT participant forms/paperwork and samples in the same package by express courier for overnight delivery.  Collated instructions/result forms must be received no later than 2 weeks prior to ship date.

8.

Contractor must provide adequate coolant to keep samples frozen during shipment to WSLH PT customers.

9.

Shipment boxes must be labeled with standard sample storage requirements (e.g., Freeze upon arrival).

10.

Organisms/antigens contained in samples must not be identified by name or code on any external package labeling or packing lists included in the container sent to the participants, nor can sample information be released without prior approval from WSLH PT.

11.

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

12.

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

13.

Contractor must include all packing material and hazardous shipping charges in the bid price.

14

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.  List the price that would be charged to relabel one sample: $4.55

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

15.

Contractor must be capable of processing international shipments. Bid price does not include international shipments (see below under Shipments to Foreign Countries).

16.

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 troubleshooting.

17.

Contractor must be able to accept electronic files of demographic information for WSLH PT customers.

18.

Contractor must provide adequate protective packaging and accept all costs associated with re-shipment due to packing or kitting errors by Contractor, or samples that are lost or damaged in transport to WSLH PT customers.

LOT 11
PRICING
HANDLING AND SHIPPING SERVICES FOR
MYCOBACTERIOLOGY MOLECULAR SAMPLES 

Description

Cost per package

Mycobacterium tuberculosis

 $17.82

CUSTOMS:  Shipments to Foreign Countries;
The WSLH PT may enroll some participants from Canada, the Virgin Islands, Europe and possibly Mexico.  Please respond to the questions contained in the Bidders Response Sheet pertaining to the handing of this possibility.

Please identify the extra costs per shipment that you would charge to ship to these places:

Canada:

$115.50 

Virgin Islands:

Fed-X $126.00
Freight Forwarder $262.50

Europe:

Minimum $262.50
Maximum $472.50 

Mexico:

Fed-X $126.00
Freight Forwarder $472.50

SCOPE:  The Wisconsin State Lab of Hygiene Proficiency Testing (WSLH PT) Department through the Purchasing Department requests bids to supply and ship bacteriology, mycobacteriology, mycology, parasitology and virology proficiency testing (PT) samples.  PT ships various types of sample material containing specified amounts of organisms, antigens and toxins to program participants two or more times per calendar year based on lot.  This request for bid includes 4 Lots for samples and 2 Lots for shipping.  Each lot will be awarded separately.  Quantities are estimates based upon anticipated WSLH PT program enrollments.  Actual usage may vary.  Orders will be placed with the manufacturer at least two months prior to the WSLH PT need date unless a longer lead time is requested by the manufacturer.  No sample item quantity overages will be accepted without expressed permission from WSLH PT.

Lot 1     Bacteriology Material
Lot 3     Mycobacteriology Material
Lot 4     Mycology Material
Lot 10  Shipping for Lots 1-9
Lot 11   Shipping for Mycobacteriology Molecular Samples

GENERAL SPECIFICATIONS

 

Sample Specifications

 

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

 

Contractor must manufacture all material in conformance with the current Good Manufacturing Practice (cGMP) as defined by the Food and Drug Administration (FDA).

 

For each sample, the Contractor must provide, at least one week prior to WSLH PT shipment, a Certificate of Analysis (COA) for evaluation.  For purposes of this specification, production or internal quality control data are also acceptable.    This must be provided with each shipment and must include the expiration date and storage requirements of the material.

 

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

 

Within any defined lot, Contractor must be able to supply all organisms or mixtures of organisms and antigens or toxins required by WSLH PT.

 

Contractor must be capable of providing samples specified in this contract on a regular basis beginning no later than November 1, 2011.  Specific sample content and program label information will be divulged upon award of this contract.

 

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 preliminary list of annual samples/organisms will be provided by WSLH PT to facilitate sample production.  Contractor accepts that sample content for events 2 and 3 are preliminary and pending approval by Centers for Medicare and Medicaid Services (CMS).  Contractor must accommodate, at no additional cost to WSLH PT, adjustments required by CMS.

 

Contractor must supply appropriate type and amount of diluents or hydration broth with all preserved samples.

 

Vials for liquid samples must be leak proof, labeled, and capped. 

 

Contractor  must not charge WSLH PT for replacement and/or shipping costs of liquid samples, diluents and/or hydration broths due to product leakage during transport.

 

The shelf life of the material must be at least six months from the date of manufacture. 

 

Material supplied must be free from known interferences and suitable for use on methodologies routinely used for testing by WSLH PT customers.  False positive or false negative reactions are not acceptable.  Cost of samples will be reimbursed to WSLH PT when samples exhibit matrix effects, sample preparation errors as documented by WSLH PT, or contain organisms not approved by WSLH PT.

 

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

Prior to awarding the lot, Contractor must provide WSLH PT with samples of product being bid for independent evaluation and verification of instrument/method compatibility upon request by WSLH PT.

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

Contractor  must ship only for the items ordered by WSLH PT.  Contractor will invoice for the number of samples ordered by WSLH PT plus 50% of the contracted price for the unused 3% overage. 

Contractor, at no cost to WSLH PT, must replace any material found not suitable for analysis including insufficient sample or diluents due to leaking vials, unreadable slides/smear/stains or circumstances due to a Contractor error.

Material Safety and Data Sheet (MSDS) must be available for all supplied material when requested by WSLH PT.

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

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

 

Packaging and Labeling

Contractor may kit samples.

If Contractor meets General Specification B.4, the Contractor must meet the following specifications:
a. The 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. ls must be approved by WSLH PT staff on an annual basis.
e. Organisms/antigens contained in samples must not be identified by name or code on any kit labels.

 

Bulk Shipping/Billing Specifications

Bidding on lot 10 as itemized list.


Revision History

AMENDMENT #1 (11/18/11): issued as a partial rebid for Lots 1, 3, 4, 10 and 11 only to Remel Inc.
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