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Guidelines on retention of pathology records and materials ... - MJPath

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Malaysian J Pathol June 2005<br />

3. Definiti<strong>on</strong>s<br />

The General Secti<strong>on</strong> <strong>of</strong> the guidelines (Part I) applies to all specialties <strong>of</strong> <strong>pathology</strong>. Thereafter, the<br />

guidelines reflect requirements according to the specialties <strong>of</strong> <strong>pathology</strong> specified.<br />

A document is any informati<strong>on</strong> or instructi<strong>on</strong> (e.g. forms, procedures, policy statements, charts,<br />

notices, biological reference intervals, work instructi<strong>on</strong>s).<br />

A record is a document c<strong>on</strong>taining data (e.g. analytical results, laboratory reports, pers<strong>on</strong>nel files,<br />

duty rosters, minutes <strong>of</strong> meetings).<br />

Laboratory or test results refer to data without interpretati<strong>on</strong>.<br />

A laboratory report refers to the interpretative report issued (usually by a pathologist) c<strong>on</strong>taining<br />

inferences from test results or analytical findings.<br />

1. GENERAL<br />

Applicable to all specialties <strong>of</strong> <strong>pathology</strong> unless otherwise specified in the specialty c<strong>on</strong>cerned<br />

Record/Material<br />

Retenti<strong>on</strong> durati<strong>on</strong><br />

1.1 Pers<strong>on</strong>nel <strong>records</strong> Durati<strong>on</strong> <strong>of</strong> employment + 3 years<br />

1.2 1.2.1 All QC <strong>and</strong> QA Records 3 years<br />

1.2.2 External QA end-<strong>of</strong>-cycle summary 5 years<br />

1.2.3 Remedial acti<strong>on</strong> log 5 years<br />

1.3 Equipment<br />

1.3.1 Maintenance, service, repair <strong>and</strong> Life <strong>of</strong> machine + 3 years<br />

calibrati<strong>on</strong> <strong>records</strong><br />

1.3.1 Daily, weekly, m<strong>on</strong>thly maintenance<br />

log<br />

6 m<strong>on</strong>ths<br />

1.3.2 Temperature <strong>records</strong> 6 m<strong>on</strong>ths<br />

1.4 Disc<strong>on</strong>tinued laboratory methods/ 3 years after disc<strong>on</strong>tinuati<strong>on</strong><br />

procedures (manuals)<br />

1.5 Management<br />

1.5.1 Accident <strong>and</strong> incident reports Indefinite<br />

1.5.2 Records <strong>of</strong> Department training 5 years<br />

activities<br />

1.5.3 Feedback suggesti<strong>on</strong>s 5 years<br />

1.5.4 Laboratory statistics 5 years<br />

1.5.5 Duty rosters 1 year<br />

1.6 1.6.1 Referring doctor’s request. 3 years, unless otherwise specified<br />

1.6.2 All laboratory <strong>records</strong> under the specialty c<strong>on</strong>cerned.<br />

1.7 All specimens, unless specified otherwise Retain specimens under appropriate<br />

under the specialty c<strong>on</strong>cerned.<br />

storage c<strong>on</strong>diti<strong>on</strong>s for 2 days after<br />

issue <strong>of</strong> report/result<br />

1.8 All <strong>records</strong> <strong>and</strong> reports known to have Indefinite<br />

medico-legal implicati<strong>on</strong>s up<strong>on</strong> receipt <strong>of</strong><br />

specimen<br />

52

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