臨床標本和研究標本規定要分開的.
CAP(College of American Pathologists)和CLIA (The Clinical Laboratory Improvement Amendments of
1988)對臨床病理標本保留多久有嚴格規定的, 各州更有進一步的規定. 不遵守的話實驗室可以lose CAP accredition的. 各州也有自己的規定的...
這就是為什麽有位網友的病理標本是被一位醫師"借"走的...
CAP contact info:
http://www.cap.org/web/submenu/contact?_adf.ctrl-state=edgweu64b_17&_afrLoop=550280139452751
http://home.ccr.cancer.gov/LOP/intranet/PolicyManual/GeneralPolicy/CAPCLIA.asp
LABORATORY OF PATHOLOGY ONLINE POLICY MANUAL
CAP & CLIA Retention Requirements
Each clinical section must have clearly defined and documented policies to ensure preservation of appropriate patient data, test requisition and authorizations, records, and materials which meet or exceed the CAP & CLIA retention guidelines. The following are minimum retention guidelines:
Test requisition and authorizations: at least 2 years
Test procedures: at least 2 years after a procedure is discontinued.
Quality control records, including instrument printouts: at least 2 years.
Records of test system performance specifications that the lab used to establish or verify performance specifications: for the period of time the lab uses the test system but no less than 2 years.
Proficiency test records (including records of test handling, processing, examination, results reporting, and signed attestation statements): no less than 2 years.
Laboratory quality systems assessment records: retain for 2 years.
Test reports: Retain or be able to retrieve a copy of the original report (including final, preliminary, supplemental, or corrected reports) after the date of reporting as follows: Surgical Pathology Reports: 10 years; Cytology Reports: 10 years; Non-Forensic Autopsy Reports: 10 years; Forensic Autopsy Reports: Indefinitely; Cytogenetics Reports or diagnostic images (digitized, prints or negatives): 20 years.
Cytology slides: 5 years; fine needle aspiration slides: 10 years from the exam date.
Histopathology slides: 10 years from the exam date.
Cytogenetics slides: permanently stained slides, 3 years; fluorochrome stained slides, at the discretion of the laboratory director.
Surgical Pathology/Histopathology specimens: Wet tissue, 2 weeks after final report; paraffin blocks, 10 years.
Non-Forensic Autopsy specimens: Wet tissue, 3 months after final report; paraffin blocks, 10 years.
Forensic Autopsy specimens: Wet stock tissue, 1 year; Paraffin blocks and dried blood stain or frozen tissues for DNA Analysis, indefinitely; Body fluids and tissues for toxicology, 1 year.
Cytogenetics specimens: Fixed cell pellet, 2 weeks after final report; wet specimen / tissue, until adequate metaphase cells are obtained.
Flow Cytometry dot plots and histograms: 10 years.
If the laboratory ceases operation, the lab must make provisions to ensure that all records and , as applicable, slides, blocks, and tissues are maintained and available for the minimum time frames specified in this section.
Last Updated 12/28/2009 10:41:01 AM
www.rand.org/content/dam/.../MR954.chap6.pdf
RAND Corporation
To be accredited, laboratories must keep pathological specimens for a mini-
mum amount of time. The Clinical Laboratory Improvement Amendments of
1988 (CLIA) set forth the conditions that laboratories must meet to be certified
to perform testing on human specimens. CLIA stipulates that laboratories must
retain cytology slides for a minimum of five years, histopathology slides for a
minimum or 10 years, and paraffin blocks for a minimum of two years (CLIA,
1996). In addition, some states have regulations that require retention of
pathology specimens for longer than the time specified in the CLIA regulations.
For example, New York, which has some of the most stringent regulations,
requires that laboratories retain abnormal cytology slides for 10 years, cytology
slides with no abnormalities for five years, and histopathology slides and paraf-
fin blocks for 20 years. Once the regulated length of time for storage is met,
institutions may continue to store pathology specimens based on the room they
have for storage, the philosophy of the institution, and several other variables.
CAP(College of American Pathologists)和CLIA (The Clinical Laboratory Improvement Amendments of
1988)對臨床病理標本保留多久有嚴格規定的, 各州更有進一步的規定. 不遵守的話實驗室可以lose CAP accredition的. 各州也有自己的規定的...
這就是為什麽有位網友的病理標本是被一位醫師"借"走的...
CAP contact info:
http://www.cap.org/web/submenu/contact?_adf.ctrl-state=edgweu64b_17&_afrLoop=550280139452751
http://home.ccr.cancer.gov/LOP/intranet/PolicyManual/GeneralPolicy/CAPCLIA.asp
LABORATORY OF PATHOLOGY ONLINE POLICY MANUAL
CAP & CLIA Retention Requirements
Each clinical section must have clearly defined and documented policies to ensure preservation of appropriate patient data, test requisition and authorizations, records, and materials which meet or exceed the CAP & CLIA retention guidelines. The following are minimum retention guidelines:
Test requisition and authorizations: at least 2 years
Test procedures: at least 2 years after a procedure is discontinued.
Quality control records, including instrument printouts: at least 2 years.
Records of test system performance specifications that the lab used to establish or verify performance specifications: for the period of time the lab uses the test system but no less than 2 years.
Proficiency test records (including records of test handling, processing, examination, results reporting, and signed attestation statements): no less than 2 years.
Laboratory quality systems assessment records: retain for 2 years.
Test reports: Retain or be able to retrieve a copy of the original report (including final, preliminary, supplemental, or corrected reports) after the date of reporting as follows: Surgical Pathology Reports: 10 years; Cytology Reports: 10 years; Non-Forensic Autopsy Reports: 10 years; Forensic Autopsy Reports: Indefinitely; Cytogenetics Reports or diagnostic images (digitized, prints or negatives): 20 years.
Cytology slides: 5 years; fine needle aspiration slides: 10 years from the exam date.
Histopathology slides: 10 years from the exam date.
Cytogenetics slides: permanently stained slides, 3 years; fluorochrome stained slides, at the discretion of the laboratory director.
Surgical Pathology/Histopathology specimens: Wet tissue, 2 weeks after final report; paraffin blocks, 10 years.
Non-Forensic Autopsy specimens: Wet tissue, 3 months after final report; paraffin blocks, 10 years.
Forensic Autopsy specimens: Wet stock tissue, 1 year; Paraffin blocks and dried blood stain or frozen tissues for DNA Analysis, indefinitely; Body fluids and tissues for toxicology, 1 year.
Cytogenetics specimens: Fixed cell pellet, 2 weeks after final report; wet specimen / tissue, until adequate metaphase cells are obtained.
Flow Cytometry dot plots and histograms: 10 years.
If the laboratory ceases operation, the lab must make provisions to ensure that all records and , as applicable, slides, blocks, and tissues are maintained and available for the minimum time frames specified in this section.
Last Updated 12/28/2009 10:41:01 AM
www.rand.org/content/dam/.../MR954.chap6.pdf
RAND Corporation
To be accredited, laboratories must keep pathological specimens for a mini-
mum amount of time. The Clinical Laboratory Improvement Amendments of
1988 (CLIA) set forth the conditions that laboratories must meet to be certified
to perform testing on human specimens. CLIA stipulates that laboratories must
retain cytology slides for a minimum of five years, histopathology slides for a
minimum or 10 years, and paraffin blocks for a minimum of two years (CLIA,
1996). In addition, some states have regulations that require retention of
pathology specimens for longer than the time specified in the CLIA regulations.
For example, New York, which has some of the most stringent regulations,
requires that laboratories retain abnormal cytology slides for 10 years, cytology
slides with no abnormalities for five years, and histopathology slides and paraf-
fin blocks for 20 years. Once the regulated length of time for storage is met,
institutions may continue to store pathology specimens based on the room they
have for storage, the philosophy of the institution, and several other variables.
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