The purpose of this sources sought notice is to conduct market research to determine if responsible sources exist by ascertaining if this effort can be successfully competed and/or set-aside for Small Businesses. The proposed North American Industry Classification System (NAICS) Code is 325413 - In-vitro Diagnostics Substance manufacturing with a corresponding size standard of 1,250 employees. The Government will use this information to determine the best acquisition strategy for this procurement. The Government is interested in all large and small businesses to include 8(a), Service-Disabled Veteran- Owned, HubZone, and Women-Owned small business concerns.
The Regional Health Contracting Office - Central, JBSA, Fort Sam Houston, Texas, is seeking potential sources to provide Immunoassay Control Kits for precision of Immunoassay reagents, Department of Pathology and Area Laboratory Services, San Antonio Military Medical Center, JBSA - Fort Sam Houston, TX. Immunoassay reagents measure the concentration of molecules in a solution through the use of an antibody/immunoglobin.
1) Organization name, address, e-mail address, Web site address, telephone number, and size (small versus large business, and any other socio-economic categories) and type of ownership for the organization;
2) Tailored capability statements addressing the salient characteristics listed, with appropriate documentation supporting capability.
The Vendor shall be able to provide material to cover all analytes listed. The Vendor shall be able to supply a local or internet based expert quality control program which can utilize data as provided by the Roche instruments via the Data Innovations Instrument Manager middleware. The Quality Control program shall be able to provide a report comparing the affiliated hospitals and clinics. The Quality Control Program shall provide interlaboratory peer group comparisons. The Quality Control program shall be able to load the latest peer comparisons that can be compared to labs values on Levy Jennings Charts.
The Vendor agrees to supply the customer with the following control material. All material must meet or exceed the following specifications.
1. Liquichek Cardiac Marker Plus Control LT Level 1(Product No. 146) or equivalent: Shall be liquid, human serum based, ready to use. Shall have 20 day open vial stability at 2-8C for most analytes. Package of 6 x 3 mL. Shall have the following analytes:
CK (Total), Digitoxin, NT-proBNP CKMB, Homocysteine, Troponin I, CRP, Myoglobin, Troponin T
2. Liquichek Cardiac Marker Plus Control LT Level 3(Product No. 148) or equivalent: Shall be liquid, human serum based, ready to use. Shall have 20 day open vial stability at 2-8C for most analytes. Package of 6 x 3 mL. Shall have the following analytes:
CK (Total), Digitoxin, NT-proBNP CKMB, Homocysteine, Troponin I, CRP, Myoglobin, Troponin T
3. Liquichek Diabetes Control Level 1(Product No. 171) or equivalent: Shall be liquid, human whole blood based, ready to use. Shall have 6 month shelf life and 14 day open vial stability at 2-8C. Package of 6 x 1 mL. Shall have the following analytes:
Hemoglobin A1C, Hemoglobin (Total)
4. Liquichek Diabetes Control Level 3(Product No. 173) or equivalent: Shall be liquid, human whole blood based, ready to use. Shall have 6 month shelf life and 14 day open vial stability at 2-8C. Package of 6 x 1 mL. Shall have the following analytes:
Hemoglobin A1C, Hemoglobin (Total)
5. Liquichek Pediatric Control Level 2(Product No. 355) or equivalent: Shall be human serum based, liquid, ready to use. Shall have at least 14 day open vial stability. Package of 6 x 4 mL. Shall contain bilirubin in the elevated neonatal range and the following analytes:
Bilirubin (Direct), Calcium, Phenylalanine, Bilirubin (Indirect), Chloride, Potassium Bilirubin (Neonatal), Glucose, Sodium Caffeine, Magnesium, Theophylline
6. Liquichek Immunoassay Plus Level 1(Product No. 361) or equivalent: Human serum use. Shall have 14 day open vial stability at 2-8C except Folate which shall have 7 day stability. Package of 12 x 5 mL. Shall have the following analytes:
Acetaminophen, hCG-Beta, Phenytoin, Testosterone AFP, Imipramine, Phenytoin (Free), Theophylline Amikacin, IgA, Procainamide, Tobramycin, Amitriptyline, IgE, Progesterone, TSH, Caffeine, IgG, Prolactin, Valproic Acid, Carbamazepine, IgM, PSA, Vancomycin, Digoxin, Lithium, T3 (Free), CEA, Iron, PSA (Free), Vitamin, B12, Cortisol, LH, Salicylate, Desipramine, Lidocaine, SHBG, Ferritin, NAPA, T3 (Total), Folate, Nortriptyline, T4 (Free), FSH, Phenobarbital, T4 (Total), Gentamicin
7. Liquichek Immunoassay Plus Level 3(Product No. 363) or equivalent: Human serum based, liquid, ready to use. Shall have 14 day open vial stability at 2-8C except Folate which shall have 7 day stability. Package of 12 x 5 mL. Shall have the following analytes:
Acetaminophen, hCG-Beta, Phenytoin, Testosterone AFP, Imipramine, Phenytoin (Free), Theophylline, Amikacin, IgA, Procainamide, Tobramycin, Amitriptyline, IgE, Progesterone, TSH, Caffeine, IgG, Prolactin, Valproic Acid, Carbamazepine, IgM, PSA, Vancomycin, Digoxin, Lithium, T3 (Free), CEA, Iron, PSA (Free), Vitamin, B12, Cortisol, LH, Salicylate, Desipramine, Lidocaine, SHBG, Ferritin, NAPA, T3 (Total), Folate, Nortriptyline, T4 (Free), FSH, Phenobarbital, T4 (Total), Gentamicin
8. Liquichek Specialty Immunoassay Level 1(Product No. 364) or equivalent: Human serum based, liquid, ready to use. Shall have 30 day open vial stability at 2-8C for Intact PTH. Package of 6 x 5 mL. Shall have the following analytes:
Anti-Tg, Erythropoietin, 25-Hydroxy Vitamin D Anti-TPO, Insuline Growth Factor, Osteocalcin, C-Peptide, Intact PTH
9. Liquichek Specialty Immunoassay Level 3(Product No. 366) or equivalent: Human serum based, liquid, ready to use. Shall have 30 day open vial stability at 2-8C for Intact PTH. Package of 6 x 5 mL. Shall have the following analytes:
Anti-Tg, Erythropoietin, 25-Hydroxy Vitamin D Anti-TPO, Insuline Growth Factor, Osteocalcin, C-Peptide, Intact PTH
10. Lyphochek Quantitative Urine Control Level 1, Normal (Product No. 376) or equivalent: Shall be human urine based. Shall have 28 month shelf life at 2-8C. Package 12 x 10 mL. Shall contain the following analytes:
3-Methoxytyramine, Cystine, Phosphorus, Dopamine, Potassium, 11-B-Hydroxy-Etiocholanolone, 5-Aminolevulinic Acid (ALA) Dehydroepiandrosterone Porphyrins (Total) 5-HIAA, Epinephrine, 11-B-Hydroxy-Androsterone Estriol (Total) Pregnanetriol 11-Ketoetiocholanolone Etiocholanolone, Protein (Total), 11-Ketoandrosterone, Pregnancy (Qual), Glucose, Sodium, 17-Hydroxycorticosteroids, HVA, Specific Gravity 17-Ketosteroids, Hydroxyproline (Free), Urea, 17-Ketogenic Steroids, Hydroxyproline (Total), Urea Nitrogen Aldosterone, Iron, Uric Acid, AMP (Cyclic), Lead, Uroporphyrins, Androsterone, Magnesium, VMA, Arsenic, Mercury, Zinc, Barbiturate, Metanephrine, Creatinine, Calcium, Metanephrine (Total), Chloride, Microalbumin, Copper, Norepinephrine, Coproporphyrin, Cortisol, Osmolality, Normetanephrine, Creatine, pH
11. Lyphochek Quantitative Urine Control Level 2, Normal (Product No. 377) or equivalent: Shall be human urine based. Shall have 28 month shelf life at 2-8C. Package 12 x 10 mL. Shall contain the following analytes:
3-Methoxytyramine, Cystine, Phosphorus, Dopamine, Potassium, 11-B-Hydroxy-Etiocholanolone, 5-Aminolevulinic Acid (ALA) Dehydroepiandrosterone Porphyrins (Total) 5-HIAA, Epinephrine, 11-B-Hydroxy-Androsterone Estriol (Total) Pregnanetriol 11-Ketoetiocholanolone Etiocholanolone, Protein (Total), 11-Ketoandrosterone, Pregnancy (Qual), Glucose, Sodium, 17-Hydroxycorticosteroids, HVA, Specific Gravity 17-Ketosteroids, Hydroxyproline (Free), Urea, 17-Ketogenic Steroids, Hydroxyproline (Total), Urea Nitrogen Aldosterone, Iron, Uric Acid, AMP (Cyclic), Lead, Uroporphyrins, Androsterone, Magnesium, VMA, Arsenic, Mercury, Zinc, Barbiturate, Metanephrine, Creatinine, Calcium, Metanephrine (Total), Chloride, Microalbumin, Copper, Norepinephrine, Coproporphyrin, Cortisol, Osmolality, Normetanephrine, Creatine, pH
12. Liquichek Serum Volatiles Control Level 1(Product No. 383) or equivalent: Shall be human serum based. Shall have 10 day open vial-stability at 2-8C. Shall have 3 year shelf life at 2-8C. Package 6 x 5mL. Shall contain the following analytes;
Acetone, Ethylene Glycol, Methanol (Methy Alcohol), Ethanol, Isopropanol (Isopropyl Alcohol)
13. Liquichek Serum Volatiles Control Level 2(Product No. 384) or equivalent: Shall be Shall be human serum based. Shall have 10 day open vial-stability at 2-8C. Shall have 3 year shelf life at 2-8C. Package 6 x 5mL. Shall contain the following analytes;
Acetone, Ethylene Glycol, Methanol (Methy Alcohol), Ethanol, Isopropanol (Isopropyl Alcohol)
14. Liquichek Urine Chemistry Control Level 1(Product No. 397) or equivalent: Shall be human urine based, liquid, ready to use. Shall have at least 30 day open vial stability at 2-8C. Package of 12 x 10 mL. Shall contain the following analytes:
Amylase, Microalbumin, Sodium Calcium, Osmolality, Specific Gravity Chloride, pH, Urea, Protein (Total), Cortisol, Phosphorus, Urea Nitrogen, Creatinine, Potassium, Magnesium, Uric Acid, Glucose, Pregnancy (Qualitative)
15. Liquichek Urine Chemistry Control Level 2(Product No. 398) or equivalent: Shall be human urine based, liquid, ready to use. Shall have at least 30 day open vial stability at 2-8C. Package of 12 x 10 mL. Shall contain the following analytes:
Amylase, Microalbumin, Sodium Calcium, Osmolality, Specific Gravity Chloride, pH, Urea, Protein (Total), Cortisol, Phosphorus, Urea Nitrogen, Creatinine, Potassium, Magnesium, Uric Acid, Glucose, Pregancy (Qualitative)
16. Lyphochek Urine Metal Control Level 1 (Product No. 400) or equivalent: Shall be human urine based. Shall have 5 day reconstituted stability at 2-8C. Shall have 3 year shelf life at 2-8C. Package 10 x 25 mL. Shall contain the following analytes:
5-Aminolevulinic Acid (ALA), Copper, Mercury, Pentachlorophenol, Aluminum, Fluoride, Nickel, Antimony, Hippuric Acid, Arsenic, Lead, Phenol, Cadmium, Magnesium, Phenylglyoxylic Acid, Chromium, Mandelic Acid, Selenium, Cobalt, Manganese, Thallium, Trichloroacetic Acid, Zinc
17. Lyphochek Urine Metal Control Level 2 (Product No. 405) or equivalent: Shall be human urine based. Shall have 5 day reconstituted stability at 2-8C. Shall have 3 year shelf life at 2-8C. Package 10 x 25 mL. Shall contain the following analytes:
5-Aminolevulinic Acid (ALA), Copper, Mercury, Pentachlorophenol, Aluminum, Fluoride, Nicke, Antimony, Hippuric Acid, Arsenic, Lead, Phenol, Cadmium, Magnesium, Phenylglyoxylic Acid, Chromium, Mandelic Acid, Selenium, Cobalt, Manganese, Thallium, Trichloroacetic Acid, Zinc
18. Lyphochek Urine Bone Marker Control Bilevel (Product No. 406) or equivalent: Shall be human urine based. Shall have 5 day reconstituted stability at 2-8C. Shall have 3 year shelf life at 2-8C. Package 6 x 2 mL (3 of each level). Shall contain the following analytes:
B-2-Microglobulin, Deoxypyridinoline (DPD), Pyridinoline (PYD), C-Telopeptide (CTx), N-Telopeptide (NTx), Creatinine, Pyridinium Corsslinks (DPD + PYD)
19. Lyphochek Whole Blood Metals Control Level 1 (Product No. 527) or equivalent: Shall be human whole blood based. Shall have 14 day reconstituted stability at 2-8C. Shall have at least 3 year shelf life at 2-8C. Package 6 x 2 mL. Shall contain the following analytes:
Arsenic, Cadmium, Mercury, Lead, Thallium
20. Lyphochek Whole Blood Metals Control Level 2 (Product No. 528) or equivalent: Shall be human whole blood based. Shall have 14 day reconstituted stability at 2-8C. Shall have at least 3 year shelf life at 2-8C. Package 6 x 2 mL. Shall contain the following analytes:
Arsenic, Cadmium, Mercury, Lead, Thallium
21. Lyphochek Whole Blood Metals Control Level 3 (Product No. 529) or equivalent: Shall be human whole blood based. Shall have 14 day reconstituted stability at 2-8C. Shall have at least 3 year shelf life at 2-8C. Package 6 x 2 mL. Shall contain the following analytes:
Arsenic, Cadmium, Mercury, Lead, Thallium
22. Liquichek Ethanol/Ammonia Control Level 1(Product No. 544) or equivalent: Shall be liquid, ready to use. Ammonia concentration in level 1 must be within the normal reference range. Shall have at least a 2 year shelf life and 20 day open vial stability at 2-8C. Package of 6 x 3 mL. Shall have the following analytes:
Ammonia, Ethanol
23. Liquichek Ethanol/Ammonia Control Level 3(Product No. 546) or equivalent: Shall be liquid, ready to use. Ammonia concentration in level 1 must be within the normal reference range. Shall have at least a 2 year shelf life and 20 day open vial stability at 2-8C . Package of 6 x 3 mL. Shall have the following analytes:
Ammonia, Ethanol
24. Liquichek Tumor Marker Level 1(Product No. 547) or equivalent: Human serum based, liquid, ready to use. Shall have 30 day open vial stability at 2-8C for most analytes. Package of 6 x 2 mL. Shall have the following analytes:
AFP, Ferritin, PSA, CA 15-3, hCG, PSA (Free), CA 19-9, hCG-Beta Subunit, Thyroglobulin, CEA, Prolactin, CA 27.29, IGF-1, CA 125, PAP
25. Liquichek Tumor Marker Level 2(Product No. 548) or equivalent: Human serum based, liquid, ready to use. Shall have 30 day open vial stability at 2-8C for most analytes. Package of 6 x 2 mL. Shall have the following analytes:
AFP, Ferritin, PSA, CA 15-3, hCG, PSA (Free), CA 19-9, hCG-Beta Subunit, Thyroglobulin, CEA, Prolactin, CA 27.29, IGF-1, CA 125, PAP
26. Liquichek Tumor Marker Level 3(Product No. 549) or equivalent: Human serum based, liquid, ready to use. Shall have 30 day open vial stability at 2-8C for most analytes. Package of 6 x 2 mL. Shall have the following analytes:
AFP, Ferritin, PSA, CA 15-3, hCG, PSA (Free), CA 19-9, hCG-Beta Subunit, Thyroglobulin, CEA, Prolactin, CA 27.29, IGF-1, CA 125, PAP
27. Liquichek Immunology Control Level 1(Product No. 594) or equivalent: Shall be human serum based, liquid and ready to use. Shall have at least 30 day open vial stability at 2-8C. Package of 6 x 3 mL. Shall contain the following analytes:
Albumin, Complement C3, IgM, Apolipoprotein B, IgE, Rheumatoid Factor, Ceruloplasmin, IgG, Alpha-1-Antitrypsin Complement C4 Kappa Light Chain Antistreptolysin O, CRP, Lambda, IgA, Light Chain Antithrombin III, Haptoglobin, Prealbumin Apolipoprotein A-1, Protein (Total), Transferrin
28. Liquichek Immunology Control Level 3(Product No. 596) or equivalent: Shall be human serum based, liquid and ready to use. Shall have at least 30 day open vial stability at 2-8C. Package of 6 x 3 mL. Shall contain the following analytes:
Albumin, Complement C3, IgM, Apolipoprotein B, IgE, Rheumatoid Factor, Ceruloplasmin, IgG, Alpha-1-Antitrypsin Complement C4 Kappa Light Chain Antistreptolysin O, CRP, Lambda, IgA, Light Chain Antithrombin III, Haptoglobin, Prealbumin Apolipoprotein A-1, Protein (Total), Transferrin
29. Multiqual Level 1(Product No. 697) or equivalent: Human serum based, liquid, ready to use. Shall have 30 day unopened stability at 2-8C. Shall have 14 day open vial stability at 2-8C. Shall have low osmolality value in level 1. Package of 12 x 10 mL. Shall have the following analytes:
Acid Phosphatase, Calcium (Total), Glucose, Potassium Albumin, Carbon, UIBC, Sodium, Dioxide, TIBC, Protein (Total), Alkaline Phosphatase, Chloride, Phosphorus Bilirubin (Total), ALT, Cholesterol (HDL), LDH, Triglycerides, Amylase, Iron, Bilirubin (Direct), Creatinine, Osmolality, Cholesterol (LDL), Lactic Acid, Urea, Nitrogen, Amylase (Pancreatic), Cholesterol (Total), GGT, Lipase, Uric Acid, AST, Cholinesterase, Magnesium, Bilirubin (Neonatal), CK
30. Multiqual Level 3 (Product No. 699) or equivalent: Human serum based, liquid, ready to use. Shall have 30 day unopened stability at 2-8C. Shall have 14 day open vial stability at 2-8C. Shall have low osmolality value in level 1. Package of 12 x 10 mL. Shall have the following analytes:
Acid Phosphatase, Calcium (Total), Glucose, Potassium Albumin, Carbon, UIBC, Sodium, Dioxide, TIBC, Protein (Total), Alkaline Phosphatase, Chloride, Phosphorus Bilirubin (Total), ALT, Cholesterol (HDL), LDH, Triglycerides, Amylase, Iron, Bilirubin (Direct), Creatinine, Osmolality, Cholesterol (LDL), Lactic Acid, Urea, Nitrogen, Amylase (Pancreatic), Cholesterol (Total), GGT, Lipase, Uric Acid, AST, Cholinesterase, Magnesium, Bilirubin (Neonatal), CK
31. Liquichek Spinal Fluid Control Level 1(Product No. 751) or equivalent: Shall be human based, liquid and ready to use. Shall have at least 30 day open vial stability at 2-8C. Package of 6 x 3 mL. Shall contain the following analytes:
Albumin, IgG, Protein electrophoresis, Chloride, IgM, Protein (Total), Glucose, Lactate, Sodium, IgA, LDH
32. Liquichek Spinal Fluid Control Level 2(Product No. 752) or equivalent: Shall be human based, liquid and ready to use. Shall have at least 30 day open vial stability at 2-8C. Package of 6 x 3 mL. Shall contain the following analytes:
Albumin, IgG, Protein electrophoresis, Chloride, IgM, Protein (Total), Glucose, Lactate, Sodium, IgA, LDH
33. Lyphochek Whole Blood Level 1, 6x2mL (Product No. 274) or equivalent:
34. Lyphochek Whole Blood Level 3, 6x2mL (Product No. 276) or equivalent:
35. Lyphochek Whole Blood Level 4, 6x2mL (Product No. 277) or equivalent:
36. Liquichek Assayed Multiqual Premium (Product No. 284) or equivalent:
37. Liquichek Assayed Multiqual Premium (Product No. 286) or equivalent:
38. TDM QC Level 1, 12x5mL (Product No. 725) or equivalent:
39. TDM QC Level 2, 12x5mL (Product No. 726) or equivalent:
40. TDM QC Level 3, 12x5mL (Product No. 727) or equivalent:
41. Utox QC S1E Low Opiate, 10x10mL (Product No. 423) or equivalent:
42. Utox QC S2E Low Opiate, 10x10 mL (Product No. 424) or equivalent:
43. Utox QC Negative, 10x20 mL (Product No. 460) or equivalent:
44. Unity Real Time Annual Subscription
45. Connectivity Support Annual Subscription
46. Unity Real Time Additional Database
This is not a solicitation. This information is for planning purposes only and is not to be construed as a commitment by the Government, implied or otherwise, to issue a solicitation or award a contract.
Vendors responding to this sources sought notice are advised their response does not ensure participation in future solicitations or contract awards. The Government will not reimburse any company or individual for any expense associated with preparation or participation in this research. Interested parties should e-mail responses to [email protected] by the date identified below. Hard copies of the responses are not required and will not be accepted.
Vendor responses should include:
1. The size of your business with regard to North American Industry Classification System (NAICS) code 325413 per the standard described in Federal Acquisition Regulation (FAR) Part 19.102 (FAR available at https://acquisition.gov).
2. Company name, DUNS, CAGE, Contact information including phone number and email.
3. Specifically identify whether your company is capable of providing immunoassay control kits to include all supplies listed above.
4. Submit your response no later than 26 July 2019 by 12:00 noon CST.