Call for revision of College of American Pathologists--mandated requirements for retention of laboratory records and materials.
|Article Type:||Letter to the editor|
Medical laboratories (Information management)
Khoury, Joseph D.
Vogelzang, Nicholas J.
|Publication:||Name: Archives of Pathology & Laboratory Medicine Publisher: College of American Pathologists Audience: Academic; Professional Format: Magazine/Journal Subject: Health Copyright: COPYRIGHT 2008 College of American Pathologists ISSN: 1543-2165|
|Issue:||Date: Nov, 2008 Source Volume: 132 Source Issue: 11|
|Topic:||Event Code: 260 General services; 200 Management dynamics Computer Subject: Company systems management; Company business management|
|Product:||Product Code: 7397030 Biomedical Testing Labs NAICS Code: 54138 Testing Laboratories SIC Code: 8071 Medical laboratories; 8731 Commercial physical research|
|Organization:||Organization: College of American Pathologists|
|Geographic:||Geographic Scope: United States Geographic Code: 1USA United States|
To the Editor.--The existing requirement by the College of American
Pathologists (CAP) mandating laboratories to retain pathology reports,
slides, and paraffin-embedded tissue blocks for a minimum of 10 years is
outmoded. (1) This is also true for many state regulations governing
this matter. The indefinite retention of tissue from patients is
standard at many major academic institutions, but this is not the case
at many hospitals and laboratories. In the present era of significant
advances in the management of certain cancer types, this recommended
timeframe falls short of the survival some patients enjoy.
Having a relatively short retention time for laboratory records and material is impacting patient enrollment on clinical trials. We have noted that some patients who relapse several years after initial diagnosis are being denied enrollment in clinical trials because their initial pathology was unobtainable from the hospital where the initial surgery was performed. In fact, in 1 clinical trial that is currently open at our institution, several patients were not eligible for enrollment solely because their initial diagnostic material had been discarded. The trial is a phase I vaccine study that requires the patient to be positive for HLA-A2 and the tumor to express prostate-specific membrane antigen, preferentially expressed antigen on melanomas, and p2-microglobulin. There are no restrictions with regard to the type of cancer. To date, 40 patients have consented to be screened for the trial, of which 28 patients had a diagnosis of prostate cancer. Five of the prostate cancer patients were denied enrollment in this trial because pathology material could not be obtained from the corresponding original pathology facilities, which stated to our clinical trials office that the materials were discarded in view of the length of time that had elapsed since diagnosis (Table). On the basis of these data showing that all 5 prostate cancer patients who could not enter the trial had been diagnosed more than 10 years prior to consideration of entry in the trial, that the median survival after diagnosis of localized prostate cancer is more than 15 years, that in many cases the only tissue ever available for prostate cancer patients is the original biopsy, and that valuable genetic and pathologic data are available only from such tissue, we recommend that tissue blocks on cancer patients be maintained longer than currently mandated.
We suggest that there be a major revision of the CAP-mandated requirements for retention of laboratory records and materials both to increase the retention time and to institute mechanisms by which patients are involved in the decision to discard their material. We propose changing the mandated requirement to retain tissue from 10 years to at least 20 years, applicable at a minimum to all diagnostic material on patients with cancer. Thereafter, if the cost of increased retention times is a major concern at a particular facility, there should be an effort to find the patient and ask whether he or she would like to assume ownership of the material so that the patient can provide the specimens if they are subsequently needed. This is particularly important as predictive biomarkers are developed for personalized medicine.
The call for change in the requirements for retention of records and materials should be endorsed by the professional organizations including the CAP and should be endorsed by state legislation. We hope that this communication will serve as an impetus to initiate the needed changes.
(1.) College of American Pathologists Laboratory Accreditation Program Inspection Checklists. Available at: www.cap.org. Accessed May 13,2008.
The authors have no relevant financial interest in the products or companies described in this article.
Joseph D. Khoury, MD
Louis M. Fink, MD
Department of Pathology
Nicholas J. Vogelzang, MD
Department of Hematology/
Nevada Cancer Institute
Las Vegas, NV 89135
In Reply.--Drs Khoury, Vogelzang, and Fink state that the College of American Pathologists 10-year retention period for tissue (presumably paraffin blocks) is insufficient and propose changing it to 20 years. Although the current retention period is already much longer than the 2 years required by the Clinical Laboratory Improvement Amendments of 1988 (42 CFR 493.1105), the authors argue that this is still "relatively short" and that patients would benefit from a longer period. Institutions can always choose to keep blocks longer than the minimum retention period, but before the College can mandate a longer period for all laboratories, the value of that change must be balanced with the added burden it represents.
The authors base their proposal on 5 patients who were ineligible for a small phase I trial because their blocks were no longer available. As most clinical trials enroll patients within 10 years of diagnosis, this situation would seem to be very uncommon. Changing the retention period to 20 years on this basis would result in a substantial incremental increase in the cost of storage for all laboratories that would likely benefit only a few patients.
The authors do not address the issue of storage conditions, but the quality of paraffin-embedded material stored under routine conditions for more than 10 years is often unknown. The quality of RNA, for instance, has been shown to decrease significantly after 10 years. (1) If prolonged storage of paraffin blocks reduces their value for some types of testing, the relative benefit of this proposed change is diminished even further.
Anticipating objections to a blanket requirement to store all blocks for 20 years, the authors offer 2 alternatives, neither of which is realistic. The first--a separate 20-year storage interval for cancer cases--is impractical. Busy histology laboratories must have an efficient daily work flow process to ensure that patient care needs are met and that errors are avoided. Having to establish a process to sort through and segregate blocks sometime after the pathologist has determined which ones contain cancer would be an enormous (and new) burden on histology laboratories. The second alternative--requiring institutions to locate every patient after 10 years and involve them in the decision to discard their material--is simply not credible.
Before mandating changes as significant as the ones proposed, a much clearer demonstration of value is needed. If, as seems most likely, very few patients would benefit from the proposed change, the substantial increase in resources needed would merely represent another unfunded mandate for laboratories without sufficient justification.
(1.) Cronin M, Pho M, Dutta D, et al. Measurement of gene expression in archival paraffin-embedded tissues: development and performance of a 92-gene reverse transcriptase-polymerase chain reaction assay. Am J Pathol. 2004;164:35 42.
The author has no relevant financial interest in the products or companies described in this article.
Patrick L. Fitzgibbons,MD
Past Chair, College of
Department of Pathology
St Jude Medical Center
Fullerton, CA 92835
Summary of the Time Intervals Between Diagnosis and Enrollment in Phase I Vaccine Study Patient Interval, y 1 14 2 12 3 15 4 12 5 15
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