Call for Revision of College of American Pathologists-Mandated Requirements for Retention of Laboratory Records and Materials/In Reply

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Call for Revision of College of American Pathologists-Mandated Requirements for Retention of Laboratory Records and Materials/In Reply Powered By Docstoc
					                                                           Letters to the Editor
                                                    thologists (CAP) mandating labora-               Summary of the Time Intervals
                                                    tories to retain pathology reports,                 Between Diagnosis and
                                                    slides, and paraffin-embedded tissue                  Enrollment in Phase I
                                                    blocks for a minimum of 10 years is                     Vaccine Study
                                                    outmoded.1 This is also true for many          Patient                Interval, y
                                                    state regulations governing this mat-
                                                                                                      1                       14
                                                    ter. The indefinite retention of tissue            2                       12
                                                    from patients is standard at many                 3                       15
                                                    major academic institutions, but this             4                       12
                                                    is not the case at many hospitals and             5                       15
                                                    laboratories. In the present era of sig-
A, Signature of Sir William Osler (courtesy of      nificant advances in the management
the Alan Mason Chesney Medical Archives of          of certain cancer types, this recom-
the Johns Hopkins Medical Institutions, Bal-        mended timeframe falls short of the
timore, Md). B, Sample of writing from the                                                      ommend that tissue blocks on cancer
autopsy report 1498 (Department of Patholo-
                                                    survival some patients enjoy.               patients be maintained longer than
gy, Johns Hopkins Medical Institutions, Balti-         Having a relatively short retention      currently mandated.
more, Md).                                          time for laboratory records and ma-            We suggest that there be a major
                                                    terial is impacting patient enrollment      revision of the CAP-mandated re-
                                                    on clinical trials. We have noted that      quirements for retention of laborato-
topsy report. We continue to postu-                 some patients who relapse several
late that Dr Osler dictated part of the                                                         ry records and materials both to in-
                                                    years after initial diagnosis are being     crease the retention time and to in-
report while participating in the dis-              denied enrollment in clinical trials
section.                                                                                        stitute mechanisms by which patients
                                                    because their initial pathology was         are involved in the decision to dis-
       BRENDAN P. LUCEY, MD                         unobtainable from the hospital              card their material. We propose
       Department of Neurology                      where the initial surgery was per-          changing the mandated requirement
       Brigham and Women’s                          formed. In fact, in 1 clinical trial that   to retain tissue from 10 years to at
         Hospital                                   is currently open at our institution,       least 20 years, applicable at a mini-
       Harvard Medical School                       several patients were not eligible for      mum to all diagnostic material on pa-
       Boston, MA 02199                             enrollment solely because their initial     tients with cancer. Thereafter, if the
       GROVER M. HUTCHINS, MD                       diagnostic material had been dis-           cost of increased retention times is a
       Department of Pathology                      carded. The trial is a phase I vaccine      major concern at a particular facility,
       Johns Hopkins Hospital                       study that requires the patient to be       there should be an effort to find the
       Baltimore, MD 21287                          positive for HLA-A2 and the tumor           patient and ask whether he or she
                                                    to express prostate-specific mem-            would like to assume ownership of
                                                    brane antigen, preferentially ex-           the material so that the patient can
  1. Lucey BP, Hutchins GM. Did Sir William         pressed antigen on melanomas, and
Osler perform an autopsy at The Johns Hopkins                                                   provide the specimens if they are
Hospital? Arch Path Lab Med. 2008;132:261–            2-microglobulin. There are no re-         subsequently needed. This is partic-
264.                                                strictions with regard to the type of       ularly important as predictive bio-
  2. Cushing H. The Life of Sir William Osler.      cancer. To date, 40 patients have con-
Oxford, England: Oxford at Clarendon Press;                                                     markers are developed for personal-
1926.                                               sented to be screened for the trial, of     ized medicine.
  3. The William Osler Collection, The Alan         which 28 patients had a diagnosis of           The call for change in the require-
Mason Chesney Medical Archives of the Johns         prostate cancer. Five of the prostate
Hopkins Medical Institutions, Baltimore, Md.                                                    ments for retention of records and
  4. Koppenhaver KM. Report from Forensic           cancer patients were denied enr
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