Disposal schedule - Section K

Disposal schedule - Section K - pathology, pathology documents, records, specimens and preparations - transfusion laboratories

Work Area - Organisation

Ref Record Type Minimum Retention Period Relevant Legislation / Derivation Final Action

Pathology Records  

Human Tissue Act 2004
Human Tissue Act’s Code of Practice 

EU Directive 2002/98/EC
The Blood Safety and Quality Regulations 2005 (SI 2005 No. 50)

 

 
K1 Accreditation documents; records of inspections 10 years or until superseded  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 
see AD-007

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

Guidelines for validation

appendices

Haematology guidelines

 

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

 

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