What is the Process?

Instructions to Contributors

1. Identify potential specimen
   
   The ACSR is looking for the following specimens:
   
   
   • Excisional biopsies of suspected lymphoma
   • Autopsy specimens which provide abundant tissue
   • Other tumors occurring in HIV-infected patients, such as breast, lung, colon, cancer, etc
   • Blood specimens obtained from newly diagnosed patients with lymphoma, prior to chemotherapy
   
   The most valuable specimens must at least one cm³ or greater in size. Please do not submit any skin biopsy specimens, especially biopsies of Kaposi's sarcoma, as this is a very prevalent disease and is not difficult for investigators to obtain.
   
   
2. Contact ACSR
   
   Institutions making donations to the ACSR should contact the Central Operations and Data Coordinating Center once potential specimen have been identified to ensure that the specimen are needed.
   
   
3. Submit specimen
   
   Prepare and ship the specimen according to the ACSR Pathology Tissue Handling Instructions. In every case where a specimen is submitted, the appropriate information needs to accompany the specimen. This includes a completed pink Specimen Submission Form and a copy of the pathology accession (submission) form from your institution (see instructions under ACSR Pathology Tissue Handling). The ACSR office must be notified on the day a specimen is shipped. Please fax copies of the Specimen Submission Form and the completed Federal Express airbill to the ACSR Pathology Unit. Friday shipments require special arrangements.
   
   
4. Clinical data
   
   Unless you have access to the patient's records, you will need to know the name of the referring clinician so that forms and requests for follow-up information can be sent to the appropriate individual. This information should be included in the Specimen Submission Form. The green Current Clinical Data form should be sent to the clinician to be completed and returned in a self- addressed, stamped envelope which you will provide.
   
   
5. Obtain blood specimen (newly diagnosed patients only)
   
   As mentioned above, blood specimens obtained from newly diagnosed patients with AIDS malignancies, prior to chemotherapy, would also be useful specimens to enter into the ACSR. Blood specimens (one yellow and one red top tube) should be processed according to the ACSR guidelines, stored and shipped in batches directly to the ACSR using the same packaging and shipping guidelines as tissue. Specimen Submission Forms for each case should be completed and included.
   
   
6. Follow up clinical data
   
   At one year intervals you should send a request for follow up clinical data on each patient with a specimen in the ACSR database. (See yellow Follow up Form attached.)

AIDS and Cancer Specimen Resource (ACSR) - Pathology Tissue Handling

1. Goals
   
   
   • To insure an accurate diagnosis for the patient
   • To procure adequate amounts of tissue for a national tissue bank for distribution to scientists
   
   
2. Statements
   
   The diagnosis will be ensured at two levels. We encourage the home pathologist to take a representative sample. (This is also a legal requirement at most hospitals.) Further diagnostic evaluation will be done at the ACSR site. The sample to be banked will be serial sectioned to produce more diagnostic slides and to accurately document the nature of "frozen tissue" to be banked. A surgical pathology report on the banked tissue will be generated at the ACSR site. An ACSR investigator will contact the referring pathologist by telephone with a preliminary diagnosis as soon as possible (next day in most cases). The purpose of this phone consultation is to ensure an accurate diagnosis for patient care purposes. We feel that the above procedures will accomplish the goals of the ACSR and will enable effective communication between participating pathologists.
   
   
3. State of the Tissue
   
   We have found that contrary to popular opinion, the best tissue preservative is humidity. Media such as saline and tissue culture medium compromise histology, are poorly buffered, and lead to a variety of freezing artifacts. Tissue is best shipped "stewing in its own juice" at room temperature. Cooling the tissue causes "metabolic damage" and hastens cell death. Thus the shipping containers should contain moistened gauze and should be sealed tightly during shipment and storage. The tissue will be divided (except for the home hospital section) and frozen at the ACSR site.
   
   
4. Documentation required for ACSR specimens processed
   
   Specimens sent to the ACSR require a patient name and "short history". The simplest way to supply this information is to photocopy a pathology accession (submission) form from your institution. This information is critical for several reasons:
   
   
   1. We will produce a pathology report at the ACSR site and these reports require the patient's name.
      
      
   2. We will provide real-time consultation to the home institution pathologists and/or clinicians. Such communication is best done with a name, otherwise medical errors in communication tend to occur. For example, a telephone consultation involving an 8 digit hospital accession number can produce problems.
      
      
   3. The home pathology accession form usually supplies minimal history such as "site" and "previous cancer". This history ultimately makes diagnosis more precise.
      
      
   ACSR records are confidential. The Pathology Department handles many internal and external cases regarding AIDS patients every day. See statement on patient confidentiality under Office of Human Research Protections, subsection Human Subjects.
   
   
5. Shipping
   
   Standard shipping containers and Federal Express airbills will be provided by the ACSR. We suggest these be put in a convenient and visible location in your cutting room. Please call Federal Express for pickup as soon as possible; the best samples obviously are the ones that do not stand around. All shipping charges will be covered by the ACSR.
   
   
6. ACSR Philosophy
   
   We have attempted to make the procedures as easy as possible for the referring pathologist. Tissue acquisition not only benifits future patients but in some circumstances the present patient may be eligible for innovative protocols depending upon the analysis. of the tissue. The critical shortage is fresh tissue for scientific studies. Our goals are to meet the needs of real time diagnoses and to optimize tissue volume for banking purposes.

OFFICE OF HUMAN RESEARCH PROTECTIONS Approval

1. OHRP approval
   
   Contributing institutions must have the Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) assurance of compliance before submitting tissue to the ACSR. Safeguarding the rights and welfare of human research subjects in activities supported by DHHS is a responsibility shared by the ACSR and any collaborating performance sites. If you are not sure whether your institution has either single or multiple assurance for conducting human research, please contact your Internal Review Board (IRB).
   
   
2. Informed consent
   
   You are advised to have your patient complete a consent form at the time a specimen is obtained.
   
   
3. Patient confidentiality
   
   A specimen submitted to the ACSR is processed as a regular pathology specimen. In other words, it is entered into the pathology department just like all other specimens submitted to the department. A patient identifier and patient name must be provided so that the ACSR pathologist can consult with the pathologist submitting the specimen about the diagnosis. According to standards observed by all pathology departments, specimens submitted as pathologic specimens and the patient's identification are kept absolutely confidential.
   
   The next step, submitting the specimen to the ACSR, will also be performed in a confidential manner. After the tissue donation is processed as a pathologic specimen, any remaining tissue will be considered for submission to the ACSR. There will be no patient identifier on the specimen when it is entered into the ACSR database.
   
   

   Shipping Instructions

   The ACSR Central Operations and Data Coordinating Office will provide each contributing pathology department with pre-addressed mailers and Federal Express airbills for shipping specimens to the ACSR. Shipment of infectious material is strictly regulated. Please adhere to the following instructions when shipping material to us.
   
   Although the majority of you have plenty of experience with the correct shipping of specimens, we will go over the process one more time. We want to be very specific and detailed so that there are no misunderstandings.
   
   According to the San Francisco area FedEx Dangerous Goods shipping resource person, 2002 brings no relevant changes in terms of the regulations for the shipping of such goods as those for the ACSR.
   
   This information will come to you in three distinct parts:
   
   
   1. General Information
   2. The Shipping Container
   3. The Paperwork
   
   
   

   General Information

   1. Packaging: Even though the specimen you send is at room temperature, please send it in the packaging for a dry ice shipment, but without the dry ice. There are practical reasons for this. First, Federal Express can be EXTREMELY particular about how a specimen is packaged. If one of the labels has a corner partly wrapped around the side of a box, it will be returned. If one label covers even the smallest amount of another label, the package will be returned. If the labels are crowded close together, and as a result you have to print very small (for example, the "To... From...") they will return the package. If they do not have easy access to the mailing paperwork, they will return the package.
      
      The small Infectious Substance mailer is too small to label with confidence. The plastic pouch that holds the Federal Express paperwork is larger than any one side of the box, and no one side is big enough to hold all the labels without some degree of overlap. The result, in our experience, is a small but significant and regular return rate of irreplaceable specimens. The dry ice mailer has plenty of surface area, and allows for everything to be well-spaced and legible. Thus, we feel it is worth the small amount of extra time and cost to ensure specimen delivery.
      
      A second reason for the double package is that the specimens should be shipped at room temperature; the packaging of the small shipping container is sometimes not enough to protect the specimens from hot or cold extremes.
      
      
   2. The recommended specimen mailers are available from the ACSR. You will be sent two types of mailers: the small boxes which come with the plastic jar, and the large dry ice shipper with Styrofoam lining.
      
      
   3. You will need to fill out Federal Express labels addressed to the ACSR contact person. The method for properly filling out the labels will be covered separately.
      
      
   4. On the day a specimen is sent to the ACSR site, fax a copy of the ACSR Specimen Submission Form to 415/206-3765, and please write the airbill number on your cover sheet; this will allow us to track the package.
   
   
   

   The Shipping Container

   On one side the shipping container, Saf-T-Pak provides outlines for where to place the various labels. You are free to use them; however we recommend using the layout suggested by Federal Express.
   
   Labeling the box:
   
   
   1. "To... From..." label. You will be responsible for creating your own "To... From..." labels (upper left corner). The label must include the names, complete addresses, and phone numbers of the persons responsible for both the shipping and receiving of the specific specimen.
      
      It might be easiest to pre-print the information on Avery labels.
      
      Note: If the specimen you send is more than 50 ml, you must use a the red "Danger!" label and center it in the upper half of the package.
      
      
   2. "Inside Packages Comply..." label should be placed on the lower left hand corner of the box.
      
      
   3. "Infectious Substance" label, the one with the interlocking symbol, should be placed on the lower-right hand corner of the box.
      
      
   4. Small "Infectious Substances..." label. This is the top of two small labels placed between labels # b and c above. If you are shipping more than 50 ml, be sure to cross out the bottom line and write in the correct amount. A sample of this is included on the sheet with the "Danger!" label.
      
      
   5. "UN" label should be placed underneath the "Infectious Substances..." label in #d.
   
   
   Packing the box:
   
   Secure the specimen inside the plastic container using bubble wrap or other appropriate material. After screwing on the lid of the plastic container, slide the plastic container into the cardboard roll and seal the small box tightly with tape. Place the box into the Styrofoam container and secure the box with packing material. Put the appropriate paperwork in the box before sealing it (see below). Seal the box with packing tape, and affix the FedEx plastic pouch on the top. You are now ready to fill out the FedEx form.
   
   

   The Paperwork

   Inside the box, please enclose the following:
   
   
   1. The ACSR Specimen Submission Form
      
      
   2. For pathology specimens, include your institutional Pathology accession (submission) form
      
      If you wish your shippers mailed back to you, please include the following:
      
      
   3. A label with your address on it
      
      
   4. A postal label with the appropriate amount of postage metered on it
      
      
   
   
   On the FedEx Dangerous Goods form:
   
   
   1. Fill in the appropriate address information. The provided labels will already have one address completed, as well as the suitable account number.
      
      
   2. Under #4 (Services) please X in Priority Overnight.
      
      
   3. Fill in #6. This is the number of packages (This should be 1, as you should send us specimens packed separately, each with its own label and airbill #) and the total weight of the package. Be sure to fill in the total weight at the bottom of the column. For ACSR purposes, this will be the same as the numbers you entered above.
      
      
   4. Next to the airbill number in the middle of the page, fill in "Page 1 of 1 Pages"
      
      
   5. Transport Details. If the specimen is less than 50 ml, then cross out the box that says "Cargo Aircraft Only." If the shipment is more (and uses the red "Danger!" label outside) then cross out the "Passenger & Cargo Aircraft" box. To the left, write in the departure airport. Write in the receiving airport below. To the right, scratch out the box which reads "radioactive," as you shouldn't be sending us anything radioactive.
      
      
   6. Nature and Quantity of Goods: Please write the following in the appropriate column:
      
      

      "Proper Shipping Name"	=	Infectious Substance Affecting Humans (HIV) or (HCV)
      "Class or Division"	=	6.2
      "UN or ID #"	=	UN 2814
      "Quantity & Type..."	=	1 Box, Fiberboard, x.30ml each
      "Packing Inst,"	=	602

      
      Under "Additional Handling Information" write: "Prior arrangements as required by the IATA Dangerous Goods Regulations 1.3.3.1. have been made."
      
      
   7. Please remember to put an emergency contact number at the bottom of the page, and to add your name, date, and signature in the bottom right hand corner.
      
      
   8. Keep the sender page for yourself. Fold the remaining paperwork, and place it in the plastic pouch, address side up.
   
   Any questions regarding shipping should be addressed to:
   
         Debbie Garcia
         SFGH Building 3, Room 207
         1001 Potrero Avenue
         San Francisco, CA 94110
   
         Phone: 415/206-3858
         Fax: 415/206-3765
         Email: dgarcia@acsr.ucsf.edu