GOOD DOCUMENTATION PRACTICES GDP IN CLINICAL LABORATORY What

GOOD DOCUMENTATION PRACTICES (GDP) IN CLINICAL LABORATORY

What is GDP ? � � � Document is information (meaningful data) and its supporting medium, in form of paper, CD, Computer file, microfilm, x-Ray film etc Documents provides information or evidence or may serve as an official record. Record is a document stating results achieved or provide evidence of activities performed. Eli. S Lec. No. 8 2

What is GDP ? (Cont’) � � Eli. S Guidelines is a document that provides recommended practices and instructions Policy is a plan or adopted course or principle of action intended to influence and determine the decisions or actions of an organization Lec. No. 8 3

Purpose of Laboratory Documentation מטרת התיעוד n n Eli. S To provide the basic guide for good document practices with regard to creation, approval, review, maintenance, correction or errors, verification and archiving etc. Ensures documented evidence, traceability, provide records and audit trails for investigation Lec. No. 8 4

Purpose of Laboratory Documentation (Cont’) n n Ensures availability of data for validation, review and statistical analysis. Control of Process - Ensures all staff knows what to do and when to do it. n To improve performance n Regulatory requirements. Eli. S Lec. No. 8 5

Types of Documentation and Records in Laboratory סוגי תיעוד n Standard Operating Procedures (SOP) n Laboratory Analytical Plans n Laboratory Reference Standards n Laboratory Note Books Eli. S Lec. No. 8 6

Types of Documentation and Records in Laboratory (Cont’) n Temperature charts n Corrective Action Preventive Action (CAPA) n Lab staff training records n Levey-Jennings chart (as homework) Eli. S Lec. No. 8 7

What Includes Good Documentation מה כולל תיעוד טוב Readable: n everyone should be able to read what is written regardless of who, where or what has been written. n Essential: the document must provide clear information that is understood by all customers n Traceable: who recorded it, where and why Eli. S Lec. No. 8 8

What Includes Good Documentation (Cont’) n n n Eli. S In time: the information should be documented at the correct time frame along with flow of events Constantly: Long lasting and durable )יציב ולאורך ( זמן Accessible: Easily available for review. ( )נגיש Lec. No. 8 9

Documentation Process in the Laboratory מהלך התיעוד במעבדה n Document creation and approval n Document use and data collection n Document maintenance and verification n Record Review Eli. S Lec. No. 8 10

Documentation Process in the Laboratory (Cont’) n Record Modification and Correction n Record Archiving n Record Destruction Eli. S Lec. No. 8 11

Common Documentation Errors טעויות נפוצות בתיעוד n Missing signature and dates at the time of activity performed n The write-over n Non-uniform date and signature entry Eli. S Lec. No. 8 12

Common Documentation Errors (Cont’) n Writing a note that activity was performed on one day and signed for on other day n Blank spaces n Illegible writing ( )כתב לא קריא n Too many corrections Eli. S Lec. No. 8 13

Principles of GDP עקרונות התיעוד � A document bearing original signatures should never be destroyed � Never falsify information � Never you a White-out and cover-tapes � Never destroy information or record Eli. S Lec. No. 8 14

Principles of GDP (Cont’) � � Eli. S Never over-write a record Never use pencil – all information should be completed in permanent Black or Blue ink No spaces, lines or fields are to be left blank Never use symbols e. g. ditto marks ( )כנ"ל or arrows to indicate repetitive and consecutive Lec. No. 8 15

Benefits of GDP יתרונות התיעוד הטוב n Build confidence in the Laboratory Quality System n Reduce efforts to compliance with regulatory bodies n Allows for achievements of required results n Eli. S Correct, complete, current and consistent information effectively meets customers and stakeholders’ requirements. Lec. No. 8 16

Benefits of GDP (Cont’) n n Enables the Laboratory activities to be arranged into functional patterns for specific action Create structures so that staff can systematically coordinate to conduct business n Training of Laboratory staff n Solve complicated problems n Reduce or eliminate assumptions and second-guessing Eli. S Lec. No. 8 17

Benefits of GDP (Cont’) n Eliminate the need to re-ask the same questions n Specify clear instructions for staff Eli. S Lec. No. 8 18