Contents
INTRODUCTION
Formation of the Joint Committee
A Joint Committee of the College of Pathologists, Academy of Medicine Malaysia (CPath) and the Ministry of Health of Malaysia (MOH) was established in early 2004 to develop guidelines on the minimum requirements for retention of pathology records and materials for Pathology Laboratories in Malaysia. In order to cover a broad perspective and maintain a practical approach, the Committee comprised pathologists from the various pathology specialties, from University Hospitals, Ministry of Health public hospitals and Private laboratories, as well as a nominee from the Medico-Legal Society of Malaysia. Each Committee member further consulted other pathologists and technical personnel in their specialty and brought their views to the discussion table.
Purpose of the Guidelines
Part I of these guidelines are intended to reflect best laboratory practice for the benefit of patients. This was completed in March 2005. In developing these guidelines, prime considerations were given to time that should be allowed for review of test results and reports by the requesting doctor, the possibility of further testing on existing samples without having to inconvenience the patient for another sample, medico-legal implications, the deterioration of samples and the constraints of storage space in the laboratory. It is emphasized that the recommendations of these guidelines represent the minimum requirements. It is recognized that many laboratories in Malaysia have retained their records and materials for longer periods and will continue to do so.
Part II of the guidelines will address retention of records and materials (in particular) for other purposes, such as training and education, quality control usage, professional development and research. These will be developed in the near future.
Definitions
The General Section of the guidelines (Part I) applies to all specialties of pathology. Thereafter, the guidelines reflect the equirements according to the specialties of pathology specified. A document is any information or instruction (e.g. forms, procedures, policy statements, charts, notices, biological reference intervals, work instructions). A record is a document containing data (e.g. analytical results, laboratory reports, personnel files, duty rosters, minutes of meetings). Laboratory or test results refer to data without interpretation. A laboratory report refers to the interpretative report issued (usually by a pathologist) containing inferences from test results or analytical findings.
GENERAL
Record/Material | Retention duration | |
1.1 | Personnel records | Duration of employment + 3 years |
1.2 | 1.2.1 All QC and QA Records 1.2.2 External QA end-of-cycle summary 1.2.3 Remedial action log | 3 years 5 years 5 years |
1.3 | Equipment 1.3.1 Maintenance, service, repair and calibration records 1.3.1 Daily, weekly, monthly maintenance log 1.3.2 Temperature records |
Life of machine + 3 years
6 months 6 months |
1.4 | Discontinued laboratory methods/ procedures (manuals) | 3 years after discontinuation |
1.5 | Management 1.5.1 Accident and incident reports 1.5.2 Records of Department training activities 1.5.3 Feedback suggestions 1.5.4 Laboratory statistics 1.5.5 Duty rosters | |
Indefinite 5 years | ||
5 years 5 years 1 year | ||
1.6 | 1.6.1 Referring doctor’s request. 1.6.2 All laboratory records | 3 years, unless otherwise specified under the specialty concerned. |
1.7 | All specimens, unless specified otherwise under the specialty concerned. | Retain specimens under appropriate storage conditions for 2 days after issue of report/result |
1.8 | All records and reports known to have medico-legal implications upon receipt of specimen | Indefinite |
ANATOMICAL PATHOLOGY
Record/Material | Retention duration | |
2.1 | Request form accompanying specimen | As long as the corresponding report is kept. |
2.2 | Report duplicates/ records/ block keys/ diagrams and copies of any representative images prepared | 20 years |
2.3 | 2.3.1 Immunofluorescence slides 2.3.2 All other slides including special stains and frozen sections | 2 days after issue of report 7 years |
2.4 | Blocks, including paraffin blocks from frozen section tissue | 20 years |
2.5 | Frozen tissue blocks for immunofluorescence studies | 3 months |
2.6 | 2.6.1 Unblocked tissue removed at surgery 2.6.2 Unblocked tissue retained at autopsy | 1 month after issue of report 3 months after issue of autopsy report |
2.7 | Autopsy 2.7.1 Registers and report duplicates 2.7.2 Tissue blocks 2.7.3 Slides 2.7.4 Records of tissue and organ disposal |
Indefinite 20 years 7 years Indefinite |
CYTOLOGY
| Record/Material | Retention duration | |
| 3.1 | Request form accompanying specimen | As long as corresponding report is kept |
| 3.2 | Report duplicates/ records/ block keys/ diagrams and copies of any representative images prepared | 20 Years |
| 3.3 | Exfoliative and Fine Needle Aspiration Cytology (FNAC) 3.3.1 Slides 3.3.2 Cell blocks |
7 years 20 years |
| 3.4 | Sputum, urine, cerebrospinal fluid and other body fluids | 2 days after issue of report |
| 3.5 | Specimens received in liquid based fixative | 1 month after issue of report |
HAEMATOLOGY
Record/Material | Retention duration | |
4.1 | Request form accompanying specimen 4.1.1 Routine test 4.1.2 Test with interpretative report |
1 month after issue of result 3 years after issue of report |
4.2 | Reported blood film (i.e. slide) | 3 years after issue of report |
4.3 | 4.3.1 Blood samples 4.3.2 Urine samples (e.g. for haemosiderin) | 2 days after test is done 24 hrs after test is done |
4.4 | Bone marrow slides | 7 years after issue of report |
4.5 | Reports 4.5.1 Bone marrow 4.5.2 Haemoglobin analysis 4.5.3 Special coagulation tests (e.g. Factor assays, platelets ) 4.5.4 Special tests (e.g. Osmotic fragility test, Ham’s test, Sickling test, Sucrose lysis test) 4.5.5 G6PD assay 4.5.6 Immunophenotyping 4.5.7 Full blood picture | |
20 years 20 years 20 years | ||
20 years | ||
7 years 20 years 7 years | ||
4.6 | Results 4.6.1 Full blood count 4.6.2 Routine coagulation tests (e.g. Disseminated intravascular coagulation, Prothrombin time.) 4.6.3 G6PD Screening |
3 years 3 years
7 years |
Reference :
Malaysian J Pathol 2005 : 27(1) : 51-56