MODIFICATION
66 -- Metabolites in Human Plasma
- Notice Date
- 5/26/2006
- Notice Type
- Modification
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- Department of Commerce, National Institute of Standards and Technology (NIST), Acquisition Management Division, 100 Bureau Drive, Building 301, Room B129, Mail Stop 1640, Gaithersburg, MD, 20899-1640
- ZIP Code
- 20899-1640
- Solicitation Number
- SB1341-06-Q-0341
- Response Due
- 6/5/2006
- Archive Date
- 6/20/2006
- Point of Contact
- Andrea Parekh, Contract Specialist, Phone (301)975-6984, Fax (301)975-8884,
- E-Mail Address
-
andrea.parekh@nist.gov
- Small Business Set-Aside
- Total Small Business
- Description
- The following are responses to questions received: Question # 1: NIST is requesting approximately 24,000 ml from approximately 100 donors. From our experience 24,000 ml will require at least 135 donors. Furthermore, not all donors can be relied upon to give a full unit of blood. Is a larger number of donors acceptable and will less than 200 ml plasma per individual donor be allowed (that is will short draws be allowed)? Answer # 1: Yes to both questions - more donors providing less than 200 mL/donor are okay as long as the demographic requirements are met. Question # 2: Is the glucose oxidase test requested to ascertain glucose levels with the assumption that a fasting normal donor will exhibit between 77 and 100 mg/dL glucose? It should be pointed out that this will not exclude a donor that had not fasted for 8-10 hours as a normal donor could return to this glucose level within 3-4 hours of breaking their fast. Would it not be better to just require that the donors exhibit glucose between 77 and 100 mg/dL? Answer # 2: The glucose 85-110 is acceptable for normal range. The low end can go down to 70. There is controversy for FPG between 100-110 being normal; however, as long as the total population average is below 100 and no individual is above 110 we should have a normal enough sample. While this does not necessary mean they were fasted, it will exclude diabetics and many pre-diabetics who would have greatly altered metabolism. Question # 3: Would it not be more cost effective to simply pool donors that are non-diabetic and meet the other health requirements and ignore age, sex, race and ethnicity? Given this cost, and the questionable value of these restrictions, would the NIST consider dropping the age, sex, ethnic and racial requirements? Answer # 3: These are restrictions imposed by NIH, and NIST is not at liberty to drop them. Questions # 4: Are vegetarians considered to be practicing extreme dietary regimens? Answer # 4: Yes. Question # 5: The paragraph describing the elimination of units containing RBCs is very confusing. If RBCs are observed, why not simply re-centrifuge? Is the purpose here to eliminate hemolyzed units? If so, why not so state and give a maximum hemoglobin requirement? Answer # 5: Yes, hemolyzed units are to be excluded, but this exclusion can be done by visual inspection as stated. Question # 6: The paragraph requiring the determination of plasticizers is similarly confusing and actually much too broad. In the first place, there are no blood drawing apparatuses in the market currently that will not contain soft plastic products (at least not to our knowledge) which means that all such materials (draw tubes, blood bags, etc.) will contain plasticizers and therefore all such commercially available materials will leach plasticizers into the blood and any products derived from the blood such as serum or plasma. Furthermore, there are literally dozens if not hundreds of plasticizers in use commercially. We would need to know a) what plasticizers does the NIST want screened and b) what level will they accept for each of these plasticizers? Answer # 6: The determination requirement is hereby omitted from the statement of work in section 6.3- Specific Requirement. The contractor shall provide NIST with 20 sets of equipment that contacted the plasma during processing (tubes, bags, etc.) so that qualified investigators can determine whether plasticizers and other contaminants provide a response on their own analytical platforms. Question # 7: ?Unavoidable, known contaminants must be documented to avoid misinterpretation of metabolites.? This statement is much too broad. What unavoidable known contaminants are being referred to here? Since we are not given a list of the metabolites, we have no idea what contaminants are being referred to. We would need a specific list of these ?known? contaminants? Answer # 7: Reference answer # 6 for the answer to question # 7. Question # 8: The method requested for filling the vials?that is numbered with the vials being sequentially filled in a Z pattern from 1-20,000 (with an additional 2000 plastic tubes) is much too slow. For example if there is a 3 second minimum time per specimen (which is probably too fast) it will take 20 hours to fill all of the specimens. We would strongly recommend that at least 2 and possible 3 separate filling devices be placed into the single 24 liter pooled plasma container and three sets of numbered vials be filled simultaneously which will reduce the filling time to under 8 hours. Answer # 8: The suggestion of 2 or 3 filling devices is acceptable as long as boxes are labeled to distinguish among the 3 devices ? e.g., label boxes from the devices as A,B,C, with each also labeled for fill order: 1A, 2A, 3A, etc. Questions # 9: The plastic vials requested in addition to the samples in the glass vials are requested at the end of the fill. Is this correct? Would it not be more appropriate to sample these within the sampling run? Answer # 9: The requirement is for one single plastic bottle containing 2 L of the same plasma that was provided in the 20,000 individual glass vials. Question # 10: Given the age, racial, sex and ethnic restrictions (as well as several health related restrictions) the 105 days requested for completion of this project is unrealistic. Can the project be given at least 6 months to complete if these requirements are insisted upon? Answer # 10: The total period of performance shall remain 105 days after receipt of order. Question # 11: When you ask for Asian American plasma, what exactly are you asking for? What countries do these donors originated from? What countries do you consider Asian? The Asian culture makes it difficult to obtain units of blood. Answer # 11: Census data, from which our demographic requirements were drawn, rely on self-identification. "Asian" could include: Afghanistan, Armenia, Azerbaijan, Bahrain, Bangladesh, Bhutan, Brunei, Cambodia, China, Cyprus, East Timor, Georgia, India, Indonesia, Iran, Iraq, Israel, Japan, Jordan, Kazakhstan, Kuwait, Kyrgyzstan, Laos, Lebanon, Malaysia, Maldives, Mongolia, Myanmar, Nepal, North Korea, Oman, Pakistan, Philippines, Qatar, Russia*, Saudi Arabia, Singapore, South Korea, Sri Lanka, Syria, Tajikistan, Thailand, Turkey, Turkmenistan, United Arab Emirates, Uzbekistan, Vietnam, and Yemen. Note: Russia and Turkey are located in both Asia and Europe. Question # 12: Alaskan donor- Is this a "Must have" or can something else be substituted? Answer # 12: American Indian can be substituted for the Alaskan
- Place of Performance
- Address: 100 Bureau Drive, Gaithersburg, MD, Mail Stop 1640
- Zip Code: 20899
- Country: USA
- Zip Code: 20899
- Record
- SN01057987-W 20060528/060526220256 (fbodaily.com)
- Source
-
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