Disposal schedule - Section K | Department of Health

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
K	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K1	Accreditation documents; records of inspections	10 years or until superseded		Destroy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

Disposal schedule - Section K

Work Area - Organisation

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