LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
1.
Purpose of the Document
This document represents the minimum standards for retention of laboratory records and diagnostic material at LabPLUS. All laboratory records and
diagnostic material are kept secure, identifiable, and legible and stored in a readily retrievable form.
2.
Scope
1.
This policy applies to:
All patient and business-related information collected, created, received, stored, accessed or retained in the course of LabPLUS
business activity, which must be protected according to its level of sensitivity, criticality, or value, regardless of the media in which it is
stored in.
All locations where information is stored, accessed or retained, including offsite.
3.
Responsibilities / Information
1.
LabPLUS has a responsibility to comply with all legislation, standards, codes and guidelines relevant to the appropriate storage, management
and retention of laboratory records and diagnostic material, patient or business-related.
2.
It is the responsibility of
all staff to ensure information is accurate, stored securely, protected from loss or damage, unauthorised access,
alteration or corruption at all times.
3.
Electronic records may be kept in place of hard copies where applicable.
4.
Diagnostic records/reports belong in individual patient’s clinical records.
5.
All records containing patient information requiring disposal are to be placed in confidential rubbish.
6.
Disposal of CD’s and DVD’s to be cut in half prior to disposal.
7.
Minimum retention times are based on the following :
Disposal Authority Number: DA262 District Health Boards General Disposal Authority
(GDA) National Pathology Accreditation Advisory Council
(NPAAC)- Requirements for the Retention of Laboratory Records and Diagnostic
Material
Royal College of Pathologists
(RCP) Retention and Storage of Pathological Records
Specimens and National Cervical Screening Programme
(NCSP)Requirements for Retention
Classification Number: LPADMQASIN018 Page 1 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Hazardous Substances and New Organisms
(HSNO) Ministry for Primary Industries
(MPI)
4.
General Minimum Retention Time
4.1 Table 1 – General Items Minimum Retention Times
Ref
GENERAL
Minimum Retention Time
Storage
Disposal
Method
GDA 10.4
Assessments/ Audits of LabPlus
7 Years – final report
Quality Manager Medialab
Destroy
Systems, Compliance, Environs etc
3 Years – raw data *
IANZ
ADHB
Clinical Trials
Destroy
Research
Documentation
Variable depending on study
Prior to 2010: ACT database
Policy
(Refer to LPADMCTUIN007 Clinical Trials Retention 15 years from completion of
Current: stored on L drive
of Documents Letter)
the study
RCP
Communication Records– Clinical
Scanned into patient records
healthAlliance Server
Destroy
Appendix 1
e.g. communication of unexpected findings, urgent
30 years
reports, delayed reports, images or photographs, clinical
correspondence
Local
Communication Records
Individual disciplines
Destroy
LabPlus
Queries/ enquiries/ significant emails
3 years
Policy
Customer feedback forms
Customer survey forms
GDA 10.12
Complaints/ Quality Incident records and action taken
Destroy
10.13
Minor incidents
7 Years
Datix / RiskPro Individual disciplines
10.14
Complaints and major incidents
10 Years
ADHB Policy
Patient complaints
10 years
ADHB Consumer Liaisons / Quality
Manager
NPAAC 1.6
Digital Images / Graphical Output Used in Diagnosis
4 years
heathAlliance Server
Destroy
e.g. CD’s/DVD’s of radiology or x-rays
Classification Number: LPADMQASIN018 Page 2 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Ref
GENERAL
Minimum Retention Time
Storage
Disposal
Method
NPAAC 1.3
(Major) Equipment Records
Life of equipment plus 4 years
Individual disciplines, or offsite
Destroy
Refer QC /QA for minor equipment
GDA 13.4
Employee Attendance Records
Employment + 7 years
Department Manager /
Destroy
e.g. rosters, attendance registers, training/conference
Department Section Head
attendance, reports, time use recording
GDA 10.1,
Employee Health, Safety and Welfare
Destroy
13.11
13.12
Accident and First Aid Minor Records (Employees)
7 years after date of last
Prior to 2018:Kiosk
Incident, Accident, "Near Miss" and first aid records not
action
Post 2018:Datix
involving fatalities and/or prosecution , for example
accident, incident, near miss reports , first aid records .
Administration
7 years after date of last
Individual disciplines
Administration of OHS (Occupational, Health and
action
Occupational Health
Safety),employee welfare and support services such as
safety administration, accident compensation claims /
returns, vaccination and health checks, workplace support
services(employee counselling), employee assistance
programmes (EAP)
Individual Employee Files
10 years after last date of
Individual disciplines
Records outlining occupational health and safety issues in a employment
Occupational Health
separate employee file that contains information
summarised or reported elsewhere. For examples,
incident, accident, near miss reports, Employee health
information
GDA 13.9
Employee Training/ Competency Records/ HR records
Employment + 7 Years
Individual disciplines
Destroy
HR
Classification Number: LPADMQASIN018 Page 3 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Ref
GENERAL
Minimum Retention Time
Storage
Disposal
Method
GDA 11.1
Financial Approvals and Accounting Records
10 years after date of last
Operations Manager
Destroy
e.g. approval of capital and/or operational expenditure
action
Administration
Individual Disciplines
GDA 8.1, 8.2
Historical Records
Prior to 1920
Off site
Transfer
e.g. Post Mortem books, Mortuary books
Prior to 1946
On site in FP
to
FP-hold indefinitely
Archives
NZ
Offer to
Archives
NZ
GDA 14.6
I.S Systems – Installation, testing and ongoing
Retain for active life of system
LIS Office
Destroy
maintenance
Project Management Lead
e.g. test scripts, fixes, customisations, network operations
and monitoring, database management etc.
GDA 14.1
I.S. System
2 years after completion of
Individual disciplines
Destroy
eg records of DCF/TCP changes and testing
implementation
LIS office
MPI
MPI and HSNO Requirements
7 Years
Destroy
Biosecurity Clearance Certificates BACC
Operations Coordinator
HSNO
Containment/ Transitional facility approval
Operations Coordinator
Stds
Permits to import
Operations Coordinator
Containment controls, release approvals, records
Individual disciplines
after release, export and destruction of organism
Biosecurity Manual
Operations Coordinator
GDA 2.8
Manuals/ Methods/ Procedures/ Guidelines/Test Kit
While current + 4 years
Medialab
Destroy
NPAAC 1.4
Inserts
superseded
Pre IQMS in individual disciplines
GDA 9.15
Meeting Minutes
3 Years
Individual disciplines
Destroy
e.g. minutes, agendas, section/employee team meetings
including occupational health and safety committee
Classification Number: LPADMQASIN018 Page 4 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Ref
GENERAL
Minimum Retention Time
Storage
Disposal
Method
GDA 18.4
Procurement documents
7 years after date of last
Individual disciplines
Destroy
e.g. Freight consignments and delivery dockets, Stock
action
healthAlliance
records and inventories, tender documentations, sales
brochures and information, order/purchase
documentation, service contracts and requisition orders,
financial authority forms, equipment supply forms.
GDA 2.7, 6.3 QC/QA records
4 Years
Individual disciplines
Destroy
NPAAC 1.2
Includes internal QC
Local
EQA
LabPlus
Minor equipment etc
Temperature Charts: 5 years
Policy
Spatial Checks: 6 years
GDA 2.7
Reports (Diagnosis)/ Results (Final)
Adults: 10 Years from date
Delphic & LIS
Destroy
NPAAC 1.8
Copy of original report, or ability to reprint the
created
information content of an original report
Minors: 7 years from age of
maturity
Hard copy reports returned from referral labs
Scanned into Delphic or image
viewer.
Hard copy held 1 month post
scanning.
GDA 2.6
Request Forms
NPAAC 1.5
Scanned forms archived onto discs
4 years from date of request
heathAlliance Server
Destroy
Hard copies of scanned forms
1 month
30 years with instruction to review
Hard copies of non-scanned forms
4 years from date of request
before destruction
NB. request form storage
times may be subject to
special requirements
NPAAC 1.7
Specimens
7 days from receipt or until
Retain under appropriate storage
Destroy
NB. Unless specified otherwise under individual disciplines
2 days after report issued
conditions
(whichever is longer)
GDA 10.24
Standards and Regulations
While current plus 7 years
Individual Disciplines, Quality
Destroy
eg ISO15189, CLSI documents, IANZ Specific Criteria
superseded
Manager or Offsite once superseded
Classification Number: LPADMQASIN018 Page 5 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Ref
GENERAL
Minimum Retention Time
Storage
Disposal
Method
GDA 2.7
Worksheets, Workbooks, Records of analysis,
4 Years in retrievable form
Individual disciplines
Destroy
NPAAC 1.2,
Calculations, Observations, Instrument Printouts, Test
NB. Hard copies not required
1.5
Validity, Equipment Calibration Records, Lot
if identical info available
documentation, QA/QC and test result validity, etc
electronically
Exception Where data has
been changed on result sheets
from interfaced analysers,
individual record needs to be
retained (LabPlus Policy)
GDA 20.10,
Property and Asset Management
LabPlus Administration
Destroy
20.11
Security/ Buildings and Facilities (Minor)
2 years after date of last
Low level / minor routine management and administration
action
of security (both physical and electronic) of buildings and
facilities. Monitoring of visitors (e.g. visitors’ log,
contractors’ log)
Routine Management
7 years after date of last
Provision of building services (e.g. cleaning, heating,
action
refrigeration, power, gardening, lifts, pumping, lighting,
pest control, furnishings, air-conditioning), provision of
accommodation (e.g. layout planning, space allocation,
parking, plant/equipment), telecommunications (e.g.
systems installation and maintenance systems, telephone
extension allocation), occupational health and safety, rent
/rates and valuations, directional signage, accommodation
moves, building warrant of fitness, fire protection, building
certification, energy conservation, booking rooms and
venues, building registration, naming, numbering,
notification of plant, electrical, reticulation shutdowns,
building management systems, provision of storage for
Classification Number: LPADMQASIN018 Page 6 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Ref
GENERAL
Minimum Retention Time
Storage
Disposal
Method
equipment, records, routine maintenance of waste
management
5.
Department Specific Minimum Retention Time
Please refer to the
GENERAL section for retention of all specimens/ records unless otherwise specified below
5.1 Table 2 - Anatomical Pathology
Ref
ANATOMICAL PATHOLOGY
Minimum Retention Time
Storage
Histology
RCP 136
Slides
On site (1Year minimum )
Sections preserved in mounting
30 years
then off site
medium incl. stained sections from
frozen sections
Sections, fixed tissue not preserved
1 month
in mounting medium
Direct Immunofluorescence (DIF)
1 month post reporting
RCP 100
Tissue Blocks
30 years
On site (1Year minimum )
embedded in wax/ resin or other
then off site
permanent embedding medium
RCP 98
Specimens for intra-operative frozen
30 years
On site (1Year minimum )
NPAAC 2.5
section diagnosis:
then off site
Original section used for diagnosis
preserved on slides in permanent
Classification Number: LPADMQASIN018 Page 7 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Ref
ANATOMICAL PATHOLOGY
Minimum Retention Time
Storage
Histology
mounting medium.
Residual tissue from which the
frozen section s were prepared,
embed in paraffin blocks
All other blocks of paraffin –
embedded tissue from the same
specimen/s from which tissue has
been selected for frozen section
examination.
NPAAC 2.6
Frozen tissue blocks
1 month at -70°C or lower
In the Laboratory
including specimens for
immunofluorescence studies
NPAAC 1.7
Direct immunofluorescence (slides)
7 days from receipt or until 2 days after report issued (whichever is
In the Laboratory
LOCAL
longer)
LABPLUS
Direct immunofluorescence (frozen
tissue blocks):
POLICY
Skin/Renal
3 years maximum
Muscle
Indefinitely
NPAAC 2.7
Containers with no residual tissue
1 month after report issued
In the laboratory
Unblocked wet tissue from specimens
removed at surgery
RCP 120
Electron microscopy b
locks
30 years
On site (1Year minimum )
Electron microscopy g
rids for
10 years
then off site
Classification Number: LPADMQASIN018 Page 8 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Ref
ANATOMICAL PATHOLOGY
Minimum Retention Time
Storage
Histology
LOCAL
Electron microscopy Tol Blue
3 years
In the laboratory
POLICY
NPAAC 2.3
Digital images used for diagnostic
4 years
In the laboratory
analysis
Ref
CYTOLOGY
Minimum Retention Time
Storage
NPAAC 4.1
Copy of the original report, or ability to
10 years or
In the laboratory
reprint the information content of an
7 years from the age of majority for minors (whichever is the
original report.
greater)
NCSP
Report duplicates/records/block keys/
10 Years
3 Years minimum onsite
diagrams/ request forms and copies of
then off site
any representative images prepared
NCSP
Exfoliative cytology and FNA’s including 10 Years
3 Years minimum onsite
NPAAC 4.2
slides and cell blocks
then off site
NCSP
Gynaecological (cervical ) cytology
10 Years
3 Years minimum onsite
NPAAC 4.3
slides
then off site
NPAAC 4.4
Specimens of sputum, urine, other body 7 days from receipt or until 2 days after report issued (whatever is
In the laboratory
fluids
longer)
NPAAC 4.5
Specimens received in liquid based
1 month
In the laboratory
fixative
NPAAC 4.6
Digital images used for diagnostic
6 years
In the laboratory
analysis e.g. semi-automated pap
screening images.
Classification Number: LPADMQASIN018 Page 9 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
5.1 Table 3-Forensic Pathology
Ref
FORENSIC PATHOLOGY
Minimum Retention Time
Storage
NPAAC 2.8
Autopsy (Hospital and Non-Coronial):
Forensic Pathology – minimum of 3
Registers, Report duplicates, Records of tissue and organ
10 years
years on site, then off site
disposal or return to Family
NPAAC 2.4,
Blocks and Slides
10 years
Anatomical Pathology and offsite
2.8
Wet Tissue samples & unblocked tissue, Organs retained
3 months from date of issue of
Forensic Pathology
at post-mortem with consent
report unless limitation is imposed,
such as the need to reunite retained
specimens with the body before a
funeral has been stipulated by the
next-of-kin.
Coroners Act Forensic and medico legal
Indefinitely.
Forensic Pathology – minimum of 3
2006, 54(2)
Registers, Report duplicate, Records of tissue and organ
years on site, then off site
disposal or return to Family
Coroners Act Tissue
Indefinitely until written instruction
Forensic Pathology
2006, 54(2)
received from Coronial Service for
Disposal or Return to Family.
Slides, Blocks
Indefinitely unless written
Anatomical Pathology and off site
instruction received from Coronial
Service for Return to Family.
Classification Number: LPADMQASIN018 Page 10 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
5.2 Table 4 -Haematology
Ref
HAEMATOLOGY
Minimum Retention Time
Storage
NPAAC 7.1
Blood Films
Clinically Significant: 1 year
1 month on site then off site
Not Significant: 1 month
NPAAC 7.2
Plasma samples for special haemostasis
1 months at -20 degrees C or lower
In the laboratory
NPAAC 7.3
Blood samples other than NPACC 7.1-7.2
7 days from receipt or until 2 days
In the laboratory
including manual ESR tubes
after report issued (whatever is
longer)
For purpose of id and traceability,
noting repeat testing technically
unreliable after 2 days
RCP134
Bone marrow (and CSF) slides
30 years
At least 5 years on site then off site
RCP136
Cell Marker slide preparations
30 years
18 months on site then off site
NPAAC 11.3 Flow cytometry on non-haematological samples
4 years
Discuss haem
e.g. tissue, cerebrospinal fluid) - graphical outputs used in
diagnosis, such as gated dot plots and histograms of other
specimens
RCP47
Flow Cytometry Analyses and Archived Files
30 years
3 months onsite then offsite
RCP72
Lab Testing Records on Transplant Products
30 years
2 years on site then offsite
Classification Number: LPADMQASIN018 Page 11 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
5.3 Table 5 – Immunology/ Virology
Ref
IMMUNOLOGY VIROLOGY
Minimum Retention Times
Storage
Local
Rubella/ Syphilis etc
Cobas Serology Tests- : 7 days,
In the laboratory
LabPlus
(Refer to LPVIMADMIN011 Virology/Immunology Infectious
Includes Hep A,B,C /HIV /Rubella
Policy
Serology Sample Storage Variation)
/ Toxoplasma / Syphilis
(serology)/needle stick source
and recipient sera
ID Serology : 2 months
Local
Serum/plasma for infectious disease
2 months
In the laboratory
LabPlus
Antenatal Sera
2 months
2 months
Policy
Syphilis (Reactive)
Source and recipient sera from body fluid exposure (needle-
stick), where this has been notified to the laboratory
NPAAC 1.7
Viral specimens/ cultures
7 days from receipt or until 2 days
In the laboratory
after report issued (whatever is
longer)
NPAAC 9.2
Frozen tissue blocks, including specimens for
1 month at -70°C or lower
immunofluorescence studies
NPAAC 9.3
Immunofluorescence slides
7 days from receipt or until 2 days
In the laboratory
after report issued (whatever is
longer)
NPAAC 9.4
Digital images used for diagnostic analysis
4 years
In the laboratory
NPAAC 10.3 Molecular infectious disease
4 months
In the laboratory
DNA/ RNA extracts
Classification Number: LPADMQASIN018 Page 12 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
5.4 Table 6 - Microbiology
Ref
MICROBIOLOGY
Minimum Retention Times
Storage
NPAAC 10.1 Slides
Wet preps discard
In the laboratory
IMF slides 7 days
Gram stains 2 weeks
ZN stains 6 weeks
Other stains 2 weeks
NPAAC 10.2
Isolates:
In the laboratory
(i) Clinically significant§§§
5 days
(ii) Not clinically significant
Discard
NPAAC 10.3
Serum/plasma for infectious disease
All sera 4 months
In the laboratory
NPAAC 10.4
Urine Specimens for Microbiological examination
6 days
Under refrigeration
NPAAC 10.5
i)
Nucleic acid for diagnostic microbiological examination –
1 month from date of issue of report
extract or original specimen
(ii)
Nucleic acid for screening examination – extract or
1 month from date of issue of
original specimen
report****
Local Policy
Human heart valves for transplant:
RCPATH
Valves
Indefinitely until used
In the laboratory
Documentation
30 years
In the laboratory and off-site
§§§ Clinically significant isolate is considered to be all blood culture and sterile site isolates, plus any cultured isolate which is reported by the laboratory as
a potential pathogen (in contrast to contaminants and commensal flora).
Classification Number: LPADMQASIN018 Page 13 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
5.5 Table 7 - Genetics
Ref
GENETICS
Minimum Retention Times
Storage
NPAAC 6.1
Copy of original report, or ability to reprint the information
In the laboratory and off
content of an original report
site
(i)Constitutional genetic testing
100 years (effectively indefinite)
(ii)Somatic genetic testing
10 years***
Cytogenetics
Molecular Genetics
Molecular Haematology
Biochemical Genetics
New Born Screening
NPAAC 6.2
Cytogenetics:
In the laboratory and off
(i)Analysis records/karyotypes/digital images including FISH
4 years
site
images
(ii)Stained microscope slides in permanent mounting
4 years
medium
(iii)Fixed chromosome cell suspension or FISH slides
6 months
(iv)Original specimens and containers
1 month from date of issue of report
NPAAC 6.3
Cytogenetics/biochemical genetics/molecular genetics:
In the laboratory
Tissue cultures/cell culture lines
(i)Rare clinically significant variants
For indefinite cryopreservation
(ii)Common clinically significant variants or clinically non-
7 days from receipt or until 2 days after
significant
report issued (whichever is longer)
NPAAC 6.4
Biochemical genetics:
In the laboratory
Specimens of plasma, serum and urine
(i)Original container
7 days
(ii)Analytic aliquot
3 months after the date of issue of
report
Classification Number: LPADMQASIN018 Page 14 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
Ref
GENETICS
Minimum Retention Times
Storage
NPAAC 6.6
Molecular genetics:
3 months from date of issue of the report for
In the laboratory
(i)Nucleic acid extracts for somatic or constitutive testing
an individual, or from completion of a family
study where the proband’s sample is required
as a control, or from completion of testing;
whichever of the three periods is the longest
(ii) Nucleic acid extracts or frozen plasma for NIPT
12 months
NMSP Policy Neonatal screening (dried blood spot):
18 months on site then off
13.2
(i)Specimen (Guthrie) cards
Indefinite
site
(ii)Records
Indefinite
Local
Maternal Serum Screen Specimens
12 months
In the laboratory
LabPlus
Policy
NPAAC 6.7
Bioinformatics genetic data:
In the laboratory and off
(i)Read data (e.g. FASTQ) or aligned reads(e.g. BAM)
4 years from date of issue of report
site
(ii)Variant call files
10 years
(iii)Microarray analysis files
4 years
*** Where the report relates to a paediatric patient, the retention period should be the greater of 10 years or 7 years from the age of majority
5.6 Table 8- Point of Care
Ref
POINT OF CARE
Minimum Retention Time
Storage
Local Policy
POCT Samples
Analyse then discard
N/A
**** Unless otherwise stated in the
Requirements for Laboratories Reporting Tests for the National Cervical Screening Program (First Edition 2017)
Classification Number: LPADMQASIN018 Page 15 of 16 Authority to Issue: Quality Manager LabPlus
LabPlus - Auckland District Health Board
Labwide
RETENTION OF LABORATORY RECORDS / SPECIMENS
6.
References:
DHB General Disposal Authority 2007 (Archives Act)
NPAAC Requirements for the Retention of Records and Diagnostic Material, Seventh Edition, (2018)
AS/NZS4308:2008 Procedures for Collection, Detection and Quantitation of Drugs of Abuse in Urine
HSNO Acts (Hazardous Substances and New organisms 1996) (Low risk GM 1998)
Facilities for Microorganisms and Cell Cultures:2007a, MAFBNZ and ERMA Standard
National Cervical Screening Program Policies and Standards Section 5 (2015)
New Zealand Human Tissues Act 2008
Coroners Act 2006
The Royal College of Pathologists (IBMS) – The Retention and storage of Pathological Records and Specimens, 5th Edition, (2015)
New Born Metabolic Screening Programme Policy Framework (June 2011)
Classification Number: LPADMQASIN018 Page 16 of 16 Authority to Issue: Quality Manager LabPlus
