[Histonet] Disposal of blocks and slides

[Walter Benton]

Charles,

Not sure if you are CAP accredited or will be, but this is from our checklist for the last inspection period.

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 local, state and national 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 Notes 2 and 3, 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 4 and 5, 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 6, 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 extra-institutional 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 CAP
Commission on Laboratory Accreditation (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
period.
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 legitimate purposes.
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: Given that patient survival rates are increasing and the continued emergence of
treatment based on biomarker testing, which at times may be required on the original tissue, it
is recommended that, whenever feasible, tissue block retention from patients with diagnosed
malignancies be retained beyond the 10 year requirement.
NOTE 4: 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 5: 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 6: 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).
*The restriction on release of blocks does not prohibit release of blocks for purposes of
treatment, diagnosis, prognosis, etc., for patients on research protocols as long as release
is consistent with patient privacy regulations (e.g. HIPAA) and applicable state and local


Walter Benton HT(ASCP)QIHC
Lab Operations Manager
Chesapeake Urology Associates
806 Landmark Drive, Suite 127
Glen Burnie, MD 21061
443-471-5850 (Direct)
410-768-5961 (Lab)
410-768-5965 (Fax)
Chesapeakeurology.com

Voted a Best Place to Work by
Baltimore and Modern Healthcare
Magazines.



-----Original Message-----
From: Charles Riley via Histonet [mailto:histonet at lists.utsouthwestern.edu]
Sent: Tuesday, January 12, 2016 8:29 AM
To: histonet at lists.utsouthwestern.edu
Subject: [Histonet] Disposal of blocks and slides

Hello all,

 What are the guidelines for disposal of blocks and slides? This was never discussed in my program and I am now in charge of the department. No one who currently works here has been through the process. Any help will greatly be appreciated.

--

Charles Riley HT(ASCP)CM

Histopathology Coordinator/ Mohs

Doctors Pathology Services, Dover DE
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