[Histonet] Block retention?
wbenton <@t> cua.md
Thu Jan 10 11:43:17 CST 2013
Who inspects you? That is what you should follow unless your management wants to be more cautious and follow the CAP guidelines which you have listed. Entire procedure listed below.
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 unless the tissue is blocked specifically for research
and not used for patient diagnostic purposes.* The CLA requires, however, that paraffin blocks
used for patient diagnostic purposes must be kept for at least 10 years. Nevertheless, such blocks
may be released for research purposes after the two-year regulatory requirement if all of the following
criteria are met:
1. For laboratories subject to US regulations, formal written authorization is obtained 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).
Walter Benton HT(ASCP)QIHC
Chesapeake Urology Associates
806 Landmark Drive, Suite 126
(All Deliveries to Suite 127)
Glen Burnie, MD 21061
wbenton <@t> cua.md
From: histonet-bounces <@t> lists.utsouthwestern.edu [histonet-bounces <@t> lists.utsouthwestern.edu] On Behalf Of JMaslanka <@t> stpetes.org [JMaslanka <@t> stpetes.org]
Sent: Thursday, January 10, 2013 12:21 PM
To: histonet <@t> lists.utsouthwestern.edu
Subject: [Histonet] Block retention?
I searched for retention policies and found what seems to be an 8 year
difference in keeping blocks. How long do you retain your blocks?
CDC website CLIA
Sec. 493.1105 Standard: Retention requirements
(7) Slide, block, and tissue retention--
(ii) Blocks. Retain pathology specimen blocks for at least 2 years
from the date of examination.
CAP website states using CLIA as guide
Surgical Pathology (including bone marrows)
2 weeks after final report
Joe Maslanka BS, CT,HT (ASCP)
Anatomical Pathology Technical Supervisor
St Peter's Hospital,MT 59601
Give thanks for ALL things.....
"Kindness is the language the blind can see & the deaf can hear- Mark
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