Work Area - Organisation
Ref | Record Type | Minimum Retention Period | Relevant Legislation / Derivation | Final Action |
---|---|---|---|---|
K |
Pathology Records |
Human Tissue Act 2004 EU Directive 2002/98/EC
|
||
K1 | Accreditation documents; records of inspections | 10 years or until superseded | |
Destroy |
K2 | Annual reports (where required by EU directive) | 15 years | The Blood Safety and Quality Regulations 2005 (SI 2005 No. 50) | Determined on review |
K3 | Archived blood donor samples | three years |
Destroy |
|
K4 |
Autopsy reports, specimens, archive material and other where the deceased has been the subject of a Coroner’s autopsy |
These are Coroner’s records – copies may only be lodged on the health record with the Coroner’s permission | Destroy | |
K5 | Batch records results (relating to products) |
10 years | Consumer Protection (Northern Ireland) Order 1987 | Destroy |
K6 | Blood bank register, blood component audit trail and fates | 30 years to allow full traceability of all blood products used | EU Directive N 2002/98/EC The Blood Safety and Quality Regulations 2005 (SI 2005 No. 50) |
Destroy |
K7 | Blood donation session slips | 15 years | The Blood Safety and Quality Regulations 2005 (SI 2005 No. 50) | Destroy |
K8 | Blood Donor Health Check | 15 years | The Blood Safety and Quality Regulations 2005 (SI 2005 No. 50) | Destroy |
K9 | Blood for grouping, antibody screening and saving and/or cross-matching | one week at 4ºC | Destroy | |
K10 | Blocks for electron microscopy | 30 years | Destroy | |
K11 | Blood gas results | Retain for the period of time appropriate to the patient/specialty, for example, children’s records should be retained as per the retention period for the records of children and young people; mentally disordered persons (within the meaning of the Mental Health (Northern Ireland) Order 1986) 20 years after the last entry in the record or eight years after the patient’s death if patient died while in the care of the organisation | Destroy | |
K12 | Body fluids/aspirates/swabs | 48 hours after the final report issued by laboratory | Destroy | |
K13 |
Bound copies of reports/records, if made | 30 years | Destroy | |
K14 | Cleaning Records | two years | Destroy | |
K15 | Daily Work Logs, Day books and electronic equivalents and other records of specimens received by a laboratory | two calendar years from receipt of specimen | Destroy | |
K16 | Donor lymphocyte preparations in cell or tissue transplantation | For the lifetime of all recipients | Destroy | |
K17 | Electrophoretic strips and immunofixation plates | five years unless digital images taken, in which case two years and stored as a photographic record | Destroy | |
K18 | Equipment/instruments maintenance logs, records of service inspections
Procurement, use, modification and supply records relevant to production of products (diagnostics) or equipment |
See GMGR Section D1 | Destroy | |
K19 | External quality assessment records | five years but see Paras 134-136 The Royal College of Pathologists - The retention and storage of Pathological records & specimens (4th Edition, 2009) for external quality assessment schemes | Destroy | |
K20 | Foetal serum | 30 years | Destroy | |
K21 | Forensic material – criminal cases | Permanently, not part of the health record | Permanently Preserve | |
K22 | Frozen tissue for immediate histological assessment (frozen section) | Stained microscope slides – 10 years
Residual tissue – kept as fixed specimen once frozen section complete |
Destroy | |
K23 | Frozen tissue or cells for histochemical or molecular genetic analysis | 10 years | Destroy | |
K24 | Grids for electron microscopy | |||
Grids for human tissue diagnosis |
10 years |
Destroy | ||
Grids for virus identification |
48 hours after final report has been issued provided that all derived images are retained for 30 years | Destroy | ||
K25 | Human DNA and RNA | Four weeks after final report for diagnostic specimens. 30 years for family studies for genetic disorders (consent required) | Destroy | |
K26 | Internal quality control records (relating to products) | 10 years | Consumer Protection (Northern Ireland) Order 1987 | Destroy |
K27 | Laboratory file cards or other working records of test results for named patients | One year from Specimen Receipt if all results transcripted into a separately issued and stored formal report. Otherwise 30 years | Destroy | |
K28 | Microbiological cultures | 24–28 hours after final report of a positive culture issued. Seven days for certain specified cultures – see RCPath document | Destroy | |
K29 | Museum specimens (teaching collections) | Permanently. Consent of the relative is required if it is tissue obtained through post mortem | Destroy | |
K30 | Near-patient (point-of-care) test data | Result in patient record, log retained for lifetime of instrument | Destroy | |
K31 | Newborn blood spot screening cards | Five years – parents should be alerted to the possibility of contact from researchers after this period and a record kept of their consent to contact response | Destroy | |
K32 | Paraffin, Wax or Resin embedded blocks | 30 years and then appraise for archival value | Determined on review | |
K33 | Pathological archive/museum catalogues | 30 years, subject to consent For as long as the specimens are held or until updated, subject consent |
Destroy | |
K34 | Photographic records | 30 years where images present the primary source of information for the diagnostic process | Destroy | |
K35 | Protocols of Standard operating procedures (current and old) | 30 years | Determined on review | |
K36 | Records of serious events | 15 years | EU Directive 2002/98/EC The Blood Safety and Quality Regulations 2005 (SI 2005 No 50) |
Determined on review |
K37 | Records of telephoned reports
|
Two calendar years | Destroy | |
K38 |
Records relating to donor or recipient sera |
11 years post transplant | Destroy | |
K39 | Records relating to the collection, testing, storage and issue of cord blood which contribute to traceability | 30 years after unit is issued or discarded | Destroy | |
K40 | Records relating to or resulting from, the testing of blood which are not required for traceability purposes | 15 years | Destroy | |
K41 | Records relating to investigation or storage of specimens relevant to organ transplantation, semen or ova | 30 years if not held with health record |
Destroy | |
K42 | Refrigeration and freezer charts | Destroy | ||
K43 | Reports, copies Post mortem reports see K4 and see AD-007 |
Six months
Held in the patient’s health record for eight years after the patient’s death |
Destroy | |
K44 | Request forms for grouping, antibody screening and crossmatching | Destroy | ||
K45 | Request forms that are not an unique record | One month after final checked report received by requestor | Destroy | |
K46 | Request forms that contain clinical information not readily available in the health record | 30 years | Destroy | |
K47 | Results of grouping, antibody screening and other blood transfusion-related tests | 30 years to allow full traceability of all blood products used | EU Directive 2002/98/EC
The Blood Safety and Quality Regulations 2005 (SI 2005 No. 50) |
Destroy |
K48 | Separated serum/plasma, stored for transfusion purposes | Up to six months | Destroy | |
K49 | Serum following needlestick injury or hazardous exposure | Two years | Destroy | |
K50 | Serum from first pregnancy booking visit | Two years | Destroy | |
K51 | Stained slides | Depends on the purpose of the slide – see RCPath document for further details | Destroy | |
K52 | Storage of material following analyses of nucleic acids | 30 years
See Royal College of Pathologists document for further guidance |
Destroy | |
K53 | Surgical (histological) reports | 30 years | Destroy | |
K54 | Validation projects | 15 years or the life time of the process, equipment, facilities or systems, whichever is the longest |
|
Destroy |
K55 | Wet tissue (representative aliquot or whole tissue or organ) | Four weeks after final report for surgical specimens
Cases where a supplementary report is anticipated, specimens should be retained until the additional report is finalised. |
Destroy | |
K56 | Whole blood samples, for full blood count | 24 hours | Destroy | |
K57 | Worksheets | 30 years to allow full traceability of all blood products used | EU Directive 2002/98/EC
The Blood Safety and Quality Regulations 2005 (SI 2005 No. 50) |
Destroy |