[Histonet] Block release
Harrison, Sandra C.
Sandra.Harrison3 <@t> va.gov
Fri Oct 22 14:54:53 CDT 2010
Here's what the recently revised CAP checklist says about releasing blocks; scroll down to Note 2:
ANP.12500 Record Retention Phase II
Surgical pathology records and materials are retained for an appropriate period.
NOTE 1: Minimum requirements for surgical pathology, providing these are not less stringent than
state and federal regulations, are:
1. Accession log records - 2 years
2. Wet tissue (stock bottle) - 2 weeks after final report
3. Paraffin blocks - 10 years (subject to Note 2, below)
4. Glass slides (including control slides) and reports - 10 years (slides must remain
readable for this period)
5. Surgical pathology reports - 10 years (see Notes 3 and 4, below)
6. Fluorochrome-stained slides - at the discretion of the laboratory director
7. Fine needle aspiration slides - 10 years
8. Images of FISH studies - 10 years (see Note 5, below)
There must be a documented policy for protecting and preserving the integrity and retrieval of
surgical pathology materials and records.The retention period should be extended, when appropriate,
to provide documentation for adequate quality control and medical care.
NOTE 2: Regarding release of blocks for research purposes: Federal regulations require that a
laboratory retain paraffin blocks for two years. The CLA requires, however, that they must be kept
for at least 10 years. Nevertheless, blocks may be released for research purposes after the two-year
regulatory requirement if all of the following criteria are met:
1. The written consent of the patient is obtained. For laboratories subject to U.S.
regulations, the consent must include formal authorization in accordance with the
requirements of HIPAA, if identifiable patient information is released.
2. The laboratory retains sufficient blocks to support the diagnosis for the full 10-year
3. Provision is made for retrieval by the laboratory of any blocks or material that remain
after use in research, if the blocks or material are needed for diagnostic, legal, or other
4. The laboratory meets other relevant requirements including but not limited to the
requirements of the institution, the directives of any applicable institutional review board
(IRB) or similar entity; and state and local laws and regulations.
NOTE 3: Pathology reports may be retained in either paper or electronic format. If retained in
electronic format alone, however, the electronic reports must include a secure pathologist electronic
signature. Images of paper reports--such as microfiche or PDF files--are acceptable.
NOTE 4: Reports of outside consultations performed on cases from the laboratory (whether or not
such consultation was requested by the laboratory) must be retained for 10 years after the date on
which the original report was issued.
NOTE 5: There is no retention requirement for images when the source slides remain readable for
the required 10-year retention period. The 10-year retention requirement applies to images of slide
preparations that are not readable for the 10-year period (e.g. FISH studies).
22 of 44
VA Med Ctr - Minneapolis
Path & Lab Med Service 113
Anatomic Pathology Checklist 06.17.2010
Evidence of Compliance:
✓ Written record and specimen retention policy(ies)
From: histonet-bounces <@t> lists.utsouthwestern.edu [mailto:histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of Bernice Frederick
Sent: Monday, October 18, 2010 10:04 AM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Block release
I have been asked to post a query as to what your institution does in terms
of releasing blocks for oncology clinical trials. Please respond as it is
important to us as we receive a lot of those blocks here at Northwestern
(policies, procedures, alternative submissions etc) If you are in Australia,
Ireland, Canada, Puerto Rico or Peru please also answer (though I sort of
know already) as we do get blocks from you also.
Bernice Frederick HTL (ASCP)
Pathology Core Facility
710 N Fairbanks Court
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