Lab Policy And Procedure Manual PDF

POLICY AND PROCEDURE MANUALS TRANSES BY: ASEOCHE - MLS 2D TOPICS Internal Manuals Administrative Policy...

POLICY AND PROCEDURE MANUALS TRANSES BY: ASEOCHE - MLS 2D TOPICS Internal Manuals Administrative Policy Technical Safety – A statement or memo that outlines Quality management the institution’s position on an administrative or operational issue. POLICY MANUAL FORMAT Procedure Policies, by their nature are not as – An instructional document that specific or detailed as procedures so provides explanations and step- they are usually organized by topic and by-step directions on how to composed according to standard perform a task, test, or process. writing styles. Policy Manual A policy can range from a one- – A manual that contains policies sentence statement to a more that apply to the general and extensive discussion of a topic. overall operations of the institution. PROCEDURE MANUAL FORMAT Procedure Manual – A manual containing procedures Procedures, in contrast to policies are that apply to specific work tasks detailed and comprehensive and duties. documents. The primary objective of policy and Package inserts and manufacturers’ procedure manuals is to ensure instruction sheets are not acceptable effective communication between as a procedure if they do not actually the members of the organization. The describe the work being done; they manuals must attempt to remove any may be accepted if they are followed in ambiguities and allow uniform and practice and documented accordingly. consistent application of the Items included: laboratory’s policies and procedures. 1. Name of test, procedure, task, or duty TYPES OF POLICY AND PROCEDURE 2. Effective date and any subsequent MANUALS changes 3. Summary of the main elements of the External Manuals procedure, or a list of items that may Specimen collection frequently be checked or looked up Laboratory service like wavelength, specimen/reagent volumes, calculations, and so on.  POLICY AND PROCEDURE MANUALS TRANSES BY: ASEOCHE - MLS 2D 4. Brief discussion of the principle of the test, with key points that may be of use to the analyst, 5. Specimen requirements, patient preparations, and rejection criteria. 6. Instrumentation, equipment, and glassware requirements and care. 7. Reagents and their preparation. 8. Calibration and control material requirements and preparation. 9. Calibration procedures, including linearity and test limitations 10. Quality control procedures, including run acceptance and rejection protocol. 11. Primary problem detection, such as interfering substance/special testing situations (temp, light, spx handling, etc.) 12. Actual testing procedure, with detailed, step-by-step instructions. 13. Calculation and interpretation of results. 14. Results reporting parameters and instructions. 15. Normal or reference ranges, along with critical or panic values. 16. Procedure notes concerning important aspects of the tests. 17. Troubleshooting suggestions. 18. List of references and sources for additional information. 19. Authorization and schedule for review. This section includes signatures and dates and persons to contact.