Attachment 5 - TE 5 - DoDSR Req.doc

TECHNICAL EXHIBIT 5

AFHSC DoDSR Technical Requirements for HIV Contract

1. Specimen Preparation

1.1. The contractor shall, within four hours of the conclusion of all specimen testing, ensure transfer of the residual serum (approximately 2.5cc) into a tube (“parent tube”) suitable for permanent archival storage, and shall freeze the parent tube and the residual serum to a temperature of -25C or below and shall maintain the parent tubes at this temperature or lower during all subsequent operations.

1.2. The contractor shall utilize parent tubes of translucent polypropylene. Acceptable parent tubes shall have an external width of approximately 11.5mm, a hemispheric base approximately 6.25mm tall, a straight vertical rise of approximately 75mm, an internal diameter of approximately 9.5mm, and shall be externally threaded to receive screw caps.

1.3. The contractor shall utilize low profile parent tube screw caps. Acceptable caps shall not have a diameter greater than 15mm, a height approximately 13mm, and shall not permit unintentional dislodging through frequent handling or shipment. The contractor shall ensure that caps can be removed with reasonable manual effort.

1.4. The contractor shall ensure the parent tubes are tightly capped to form a seal at or prior to the time of parent tube freezing.

2. Specimen Identification

2.1. The contractor shall ensure the unique identification of each specimen through the assignment of a uniquely generated alpha-numeric specimen identifier (serum number) 10-14 characters in length. The contractor may employ uppercase letters (A-Z), numbers (0-9), spaces, and hyphens (“-“) to construct appropriate serum numbers.

2.2. The contractor shall ensure that all specimen numbers generated are unique regardless of the specimen source or the specimen source’s specimen identification mechanism. If the contractor employs a specimen accession number generated by the specimen source to base construction of a serum number, the contractor shall append the accession number with a combination of prefix, suffix or check digit such that a unique serum numbers shall result regardless of possible duplication in specimen source accession number. In addition to any prefix, suffix and check digit used by the contractor for internal uniqueness, the addition of a dash (“-“) followed by the calendar year (“YY”) should be used to maintain uniqueness over time and across previous contracts.

2.3. The contractor shall provide a technical point of contact for staff at the Armed Forces Health Surveillance Center to contact to alert to the presence of duplicated serum numbers from among the existing inventory, and upon notification, modify the appended prefix or suffix to ensure that newly created serum numbers do not duplicate serum numbers from among the existing inventory.

3. Parent Tube Labeling

3.1. The contractor shall provide appropriate human-readable labeling and barcoding of parent tubes with a permanent adhesive label suitable for long-term archival storage at -30C.

3.2. The contractor shall utilize labels of approximate width 3.15cm, and shall affix the label such that the width runs parallel to the length on the parent tube. The contractor shall affix the label such that no text or portion of the barcode is obscured or covered by another portions of the label.

3.3. The contractor shall ensure that the label includes a machine-readable one-dimensional barcode of approximate width 2.35cm, oriented with the reading frame parallel to the length of the parent tube.

3.4. The contractor shall ensure that the label includes human-readable text to include, at a minimum, serum number, date of specimen, family member prefix (FMP) and social security number (SSN) of the subject.

3.5. The contractor shall utilize a font on the label which distinguishes zero (“0”) from the letter O (“O”), which distinguishes one (“1”) from the letter I (“I”), and shall utilize capital letters in all labeling.

4. Parent Tube Packaging

4.1. The contractor shall ensure the packaging parent of tubes into appropriate cardboard boxes (“trays”) to facilitate shipment of specimens and their long-term archival storage under standardized conditions.

4.2. The contractor shall package parent tubes into trays holding 308 specimens each, York Container Company file number # 147256 or equivalent. Acceptable trays shall be made of sturdy cardboard, be of internal dimensions 43.5 x 17.4 x 9.3 cm, external dimensions 45.0 x 18.0 x 9.9 cm, and shall have a cardboard lid that opens hinged along the length of the tray, and which closes snugly with cardboard flaps to form square edges .The contractor shall separate specimens from each other in each tray through the use of a cardboard partition holding 11 x 28 specimens, one per well, General Partition / York Container Company file number #147621. Acceptable partitions shall be made of sturdy cardboard, be of dimensions 43.0 x 16.5 x 6.6 cm, with square wells of side length 1.5 cm.

4.3. The contractor shall label the rows (A-K) and columns (01-28) formed by the partitions in each tray such that when the cardboard lid is opened away from the operator and hinged along the distant length, the rows run lengthwise and the columns run widthwise, beginning from the left most distant corner.

A

B

C

D

E

F

G

H

I

J

K

4.4. The contractor shall write or print on each tray a sequential six digit numeric sequence uniquely identifying the tray (“source box”) number. The contractor shall ensure that source box numbers are sequential within contract task orders, and that each sequence is further prefixed by a unique two character alphanumeric sequence (“source box type”) unique to each subcontract, such that the location of each unique parent tube can be identified by source box type, source box number, row, and column.

5. Specimen Transfer

5.1. The contractor shall provide for the efficient and timely transfer of specimens to the custody of the Armed Forces Health Surveillance Center Department of Defense Serum Repository (DoDSR) via truck pickup. Unless otherwise arranged by mutual agreement between the contractor and the Armed Forces Health Surveillance Center, transfer shall occur via truck pickup at a frequency of approximately every 6-8 weeks.

5.2. If transfer is via truck pickup, the contractor shall make specimens available for pickup at a location no greater than 1600 road miles distant from the current location of the DoDSR, 11800 Tech Road, Silver Spring, MD. Truck pickup may occur anytime during normal contractor operating hours (0800-1500hrs local time, Monday through Friday) at a schedule no greater than once weekly.

5.3. If transfer is via truck pickup, the contractor shall ensure that trays are prepared and ready for pickup by ensuring adequate aisle space in their freezers for loading of 18" wide custom tray carriers. The contractor shall provide for a standard loading dock or lifting device to enable the transfer of specimens to the receiving truck.

5.4. The contractor shall ensure that specimens testing HIV negative or which have undergone no HIV testing are available and prepared for pickup no more than 7 days following completion of all testing. The contractor shall only prepare and make available trays for transfers which are at least 90% full.

5.5. The contractor shall provide the Armed Forces Health Surveillance Center at the time of pickup a shipment manifest listing the source box types and numbers included in a given shipment.

5.6. The contractor shall ensure that specimens are maintained at a temperature –25°C or below during all operations prior to their acceptance by staff at the DoDSR. The contractor’s responsibilities for specimen management shall end upon completion of pickup operations or upon a shipment’s acceptance by staff at the Department of Defense Serum Repository.

6. Specimen Data

6.1. The contractor shall produce at regular intervals one or more data files for the Armed Forces Health Surveillance Center containing pertinent information on specimens whose testing has concluded in the previous interval. The contractor may produce separate data files for separate testing contract task orders, but shall ensure that data on specimens of only a single source box type are included in each data file, and shall ensure that data for a given source box number are complete in a single data file.

6.2. The contractor shall ensure the data files are formatted in plain text, and contain the minimum necessary information to identify a specimen, including: serum number, FMP and SSN of the subject, and date of specimen collection, as well as the minimum necessary information to identify a specimen’s location: source box number, row and column, and status code. The contractor shall include additional data in the data files, including specimen collection reason (i.e. the specific reason or indication for HIV testing or otherwise), HIV test result and other pertinent data, subject to establishment of an acceptable Interface Control Document (ICD) between the contractor and the Armed Forces Health Surveillance Center and subject to the contract task order official’s approval for release of this additional data.

6.3. The contractor shall make the new data files available at a schedule outlined in the ICD ranging between every business day or weekly via secure FTP to secure servers at the Armed Forces Health Surveillance Center, and shall ensure the data files are named according to a standard convention outlined in the ICD.

6.4. The contractor shall provide a technical point of contact for staff at the Armed Forces Health Surveillance Center to establish, maintain, and modify the testing subcontract-specific ICDs, and to report problems or request assistance with transfer of data files.