National Institutes of Health, National Heart, Lung, and Blood Institute, Contracts Operations Branch, 6701 Rockledge Drive, Room 6100, MSC 7902, Bethesda, MD 20892

R -- DATA MONITORING OF THE U.S. BLOOD SUPPLY SOL NHLBI-PS-2000-531 DUE 113099 POC Ms. Cecilia Morales, (301) 435-0369 E-MAIL: moralesc@gwgate.nhlbi.nih.gov, moralesc@gwgate.nhlbi.nih.gov. The National Heart, Lung, and Blood Institute (NHLBI), intends to negotiate on a sole source basis with the National Blood Data Resource Center, 8101 Glen Brook Road, Bethesda, Maryland 20814, to monitor and collect blood data of the U.S. Blood Supply from selected blood centers around the country. The National Blood Data Resource Center, a not-for-profit subsidiary of the American Association of Blood Banks, is the only current organization that has experience in collecting the data needed to monitor the adequacy of the blood supply, beginning now and in real time, both Pubic Health Service requirements. The Board and Advisory group for the National Blood Data Resource Center contains the expertise that did what blood monitoring has been done in this country over the past 30 years; in the past 2 years, the National Blood Data Resource Center has conducted two surveys, one a broad review of all blood centers and transfusion services in the U.S. and one a "QuiKount" survey of collection centers. Although there are other groups that collect data from segments of the whole blood industry, none of them have the capability of rapidly expanding to what the National Blood Data Resource Center is already doing. The National Blood Data and Resource Center will begin in December to collect November data. In order to obtain the blood data within the federally mandated time frame, an award to any other source could not be made. The Statement of Work to monitor and collect blood data of the U.S. Blood Supply from selected blood centers around the country is a follows: I. Background & General Information There has never been a systematic monitoring of the US blood supply, although as far back as the 60s this deficiency was decried and suggestions made that it should be done. In the middle 70s, the American Blood Commission made an attempt to establish data collection and a monitoring function. This failed because it was too cumbersome and not timely and the data were of little use. The American Blood Commission, founded to bring order into what was a diverse and unmanaged US blood supply, was unable to solve some of the most contentious issues and was disbanded. Supported by several grants, Dr. Douglas Surgenor and colleagues assessed the collection and utilization of blood in the US on a number of occasions, but these were irregular and the results untimely (published in the peer reviewed literature as research papers). More recently, the American Association of Blood Banks created and partially funded a National Blood Data Resource Center to follow up in more regular fashion the surveys done by Surgenor by collecting data from all blood collecting centers and all transfusion services every two years. Much of the funding for this endeavor was to come from NBDRC "members" who paid fees for which they had access to the data. Aside from some public summaries, the data were unavailable to those who didn't pay for it. The first survey was done in 1998 for 1997 data; the next will be done in 2000 for 1999 data. In the past 17 years, great strides have been taken in improving the safety of blood transfusion, but at the expense of increasing the reasons for deferring donors. This loss of donors has threatened the adequacy of the blood supply, although true, prolonged and widespread shortages have not occurred. Recently, it has been believed necessary to defer as donors individuals who had spent an aggregate of 6 months or more in the United Kingdom between 1980 and 1996. This was to prevent the theoretical transmission of variant Creutzfeldt-Jakob Disease via blood transfusion, but it was predicted to cost 2% of the blood supply. In considering the effects of this deferral, the Public Health Service (PHS) determined that it was essential that the nation's blood supply be monitored in real time and sufficiently closely to predict (or at least detect promptly) a blood shortage of sufficient severity to affect patient care very adversely. The NHLBI accepted the challenge and is establishing methods to do this. II. Contractor Requirements Specifically, the Contractor shall collect blood data on a monthly basis from selected blood centers around the country. The time frame for monthly reports are from midnight between last day of the preceding month and first day of the current month to midnight on the last day of the current month. Reports are to be made by 10 working days after the end of the month. The following are the blood data elements to be collected: A. RELEASED FOR DISTRIBUTION: Have successfully fulfilled all processing requirements, (including satisfactorily completing all testing) and are released for distribution to hospitals or other customers (Collections minus all losses prior to release for distribution). 1. Whole Blood and Packed Red Cell Family' of Products Group together if desired. Indicate if grouping was employed. *Report by ABO and Rh type. 2. Platelet Concentrate Family' of Products, Prepared from whole blood donations (random, donor platelets), Prepared by platelet-pheresis procedure. A platelet-pheresis product is what is obtained at one sitting from one donor, even if split into two or more products for distribution. These are "released for distribution" just as for red cell products. Do NOT report apheresis products in equivalency for random donor pooled products. B. IMPORTED BLOOD PRODUCTS: Imported from other blood centers within or outside the U.S. Report the following products separately: 1. Whole blood (ABO and Rh), 2. Packed red cells (ABO and Rh), 3. Random-donor platelets; and 4. Apheresis platelets. C. DISTRIBUTION OF RED CELL PRODUCTS: Report total distribution of red cell products. Group whole blood and packed red cells together if so desired. Indicate if grouping was employed. 1. Within region, 2. Outside of region. D. DELAYED PROVISION OF BLOOD: Where limited supplies of red cell products resulted in postponement of elective surgery or delayed provision of blood for medically indicated transfusions. Indicate on form if no delays or postponements occurred in a given month. Also indicate on form if thisinformation is not generally obtained. Report any information, even if it is likely incomplete. 1. Number of patients categorized by blood group and type (ABO and Rh). 2. Number of units per patient. E. UNITS ORDERED VERSUS UNITS SHIPPED: Report difference between the number of units ordered and the number of units shipped. 1. Whole blood (ABO and Rh), 2. Packed red cells (ABO and Rh), 3. Random donor platelets, 4. Apheresis platelets. If there is a "back order" that is filled by the end of the day (midnight), a discrepancy need not be recorded and reported. If back orders are not used or if a back order is not filled by midnight, report it as a discrepancy between what was ordered and what was shipped. A "satisfactory" substitute need not be regarded as "failing to fill as ordered." Satisfactory substitutions include: whole blood or red cells of the same blood group and type; group A for AB (match Rh); an apheresis unit for a multi-unit "dose" of random platelet units; and reducing a platelet order from more than 6 to 6 for a given patient (unless there are medically extenuating circumstances). F. BLOOD CENTER INVENTORY: Report total inventory of in date products. 1. Whole Blood (ABO and Rh), 2. Packed red cells (ABO and Rh), 3. Random donor platelets, and 4. Apheresis platelets. Lump whole blood and packed red cells together if so desired. Indicate if grouping was employed. The inventory should be provided twice monthly at the same time of day (designate) and on the same respective days each month (suggest the first and third Wednesday of each month). If the Center is accustomed to working with a computer print-out "inventory," this approach will be acceptable. The source (computer or physical count) should be designated. Reports are to be sent to the Data Center at any time, but no later than when the monthly report is due (by the tenth working day of the new month). If a computer inventory is given, it would be useful to know how often the computer inventory is reconciled to a physical one. Up to 10 additional generally available data elements may be added if they will likely provide a clearer picture of the blood supply. III. Government Responsibilities- The National Blood Data and Resource Center will validate their data by comparing it to previous national surveys (e.g., 1997 Survey and the 1999 QuiKount Survey). Acceptance of the data will be based on reasonableness, accuracy and consistency of the data compared to the data obtained in previous national surveys as well as from previous months of this program's collection activities. The data will be reviewed by the project officer on a monthly basis for reasonableness, accuracy and consistency. It will also be reviewed on a quarterly basis by a select committee of PHS personnel from the FDA, CDC, and NIH (NHLBI project officer). IV. Deliverables and Reporting Requirements The contractor shall deliver monthly & quarterly reports of the blood data elements listed above. The time frame for monthly reports are from midnight between the last day of the preceding month and first day of the current month to midnight on the last day of the current month. Reports are to be delivered not later than ten (10) business days after the end of the month. The Monthly reports shall be in raw data in an Excel spreadsheet with blood center identifying information removed, to be provided on or before the 24th day of the following month. The quarterly summary data reports to be provided within 30 days of the end of the Quarter. V. Program Management and Control Requirements The National Blood Data and Resource Center will validate their data by comparing it to previous surveys (e.g., 1997 Survey and the 1999 QuiKount Survey). Acceptance of the data will be based on reasonableness, accuracy and consistency of the data compared to the data obtained in previous national surveys as well as from previous months of this program's collection activities. The data will be reviewed by the project officer on a monthly basis for reasonableness, accuracy and consistency. It will also be reviewed on a quarterly basis by a select committee of PHS personnel from the FDA, CDC, and NIH (NHLBI project officer). PERIOD OF PERFORMANCE: Period of Performance: December 1, 1999 thru December 31, 2002. This acquisition if being conducted under simplified acquisition procedures and is exempt for the requirement of FAR Part 6. The Standard Industrial Classification (SIC) Code 8733, Size Standard $5.0 Million. This notice of intent is not a request for competitive proposals. Interested parties may identify their interest and capabilities in response to this requirement. The determination by the Government not to compete the proposed contract based upon responses to this notice is solely for the purpose of determining whether to conduct a future competitive procurement. Responses to this announcement, referencing synopsis number NHLBI-PS-2000-531, may be submitted to the National Heart, Lung, and Blood Institute, Contracts Operations Branch, Procurement Section, Building RKL2, Room 6149, 6701 Rockledge Drive, Bethesda, Maryland 20892-7902, Attention Cecilia D. Morales, Purchasing Agent. All responsible sources may submit a response, which if timely received, shall be considered by the Agency. Posted 11/19/99 (W-SN402452). (0323)

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