Module 15 Documents and Records.pptxDavid

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1. DOCUMENTS AND RECORDS

2. Learning Objectives At the conclusion of this session, you will be able to: Explain the difference between documents and records; Describe the hierarchy of documents and the role of each level; Outline the contents of a quality manual; Outline the content that should be included in a standard operating procedure; Explain the important steps, or elements, of a laboratory document management system; 2 Documents & Records-Module 15

3. Learning Objectives Describe methods and tools to properly store documents and records. Develop the relevant document for the QMS Develop the document control system Develop the records for the QMS Develop and maintain the storage and retrieval system Ensure proper characteristics of records Documents & Records-Module 15 3

4. Scenario testing algorithm safety manual client test results standard operation procedures (SOPs) for an approved HIV rapid test manufacturer test kit inserts summary of findings from on-site evaluation visit report of corrective actions temperature log (blank form) quality control record (blank form) daily maintenance log (completed) stock cards and stock book (completed) EQA specimen transfer log (completed) 4 You have found all these papers lying on a desk. Which of these are documents and which are records? Documents & Records-Module 15

5. Answers ’ testing algorithm safety manual client test results standard operation procedures (SOPs) for an approved HIV rapid test manufacturer test kit inserts summary of findings from on-site evaluation visit report of corrective actions temperature log (blank form) quality control record (blank form) daily maintenance log (completed) stock cards and stock book (completed) EQA sample transfer log (completed) Documents & Records-Module 15 5

6. Agenda Documents & Records-Module 15 6

7. Introduction Provide written information about policies, processes and procedures. Paper-based or computer-based. Should be permanent, secure, traceable and approved, up-to-date and easily accessible. Should be regularly updated or maintained when a policy, process or procedure changes. Documents & Records-Module 15 7

8. Purpose of Documents …… Communicate information to all users of lab. Point of reference for establishing facts regarding an incident. An aid in the recognition of trends and resolution of problems. To establish credibility of the laboratory. Documents & Records-Module 15 8

9. Why do laboratories need to manage documents and records? To find information whenever it is needed! Documents & Records-Module 15 9

10. Documents and Records—How do they differ? Documents communicate information via policies, processes, and procedures need updating Records capture information on worksheets, forms, labels, and charts permanent, do not change Documents & Records-Module 15 10 RECORDS

11. Information is the major product of the laboratory Documents & Records-Module 15 11

12. Policies Processes Procedures / Work Instructions “What to do” “ How it happens” “ How to do it” - ( SOPs ) Documents & Records-Module 15 12

13. Documents & Records-Module 15 13 Level 1  Quality Manual : Governing document that defines the QMS. Defines the Quality policy statement i.e. statement of intent and the objectives . The manual makes reference to supporting management and technical documents. Level 2  Quality Procedures: Describe the processes to be followed when carrying out activities involved in the system implementation Level 3  Technical Requirements /Operating Procedures/Supporting documents: Provide step by step instructions for carrying out testing activities at various levels of pre-examination, examination and post-examination Level 4  Records : Provide evidence of implementation. Can be in the form of completed worksheets, books, filled-in forms, computer printouts. Records can be either electronic or hard copies.

14. Definitions: Policy Statement of overall intentions and direction defined by those in the organization and endorsed by management. Give broad and general direction to the QMS. Policies: tell “what to do” , in a broad and general way; include a statement of the organizational mission, goals and purpose; serve as the framework for the quality system, and should always be specified in the quality manual. Documents & Records-Module 15 14

15. Processes Steps involved in carrying out quality policies. ‘‘Set of interrelated or interacting activities that transform inputs into outputs.’’ ISO 9000. ‘‘How it happens”. Processes can generally be represented in a flow chart, with a series of steps to indicate how events should occur over a period of time. Documents & Records-Module 15 15

16. Procedures Specific activities of a process (ISO 9000 ). Procedures are very familiar to laboratorians. Procedure is easily described as the performance of a test. A procedure tells “how to do it”, and shows the step-by-step instructions that laboratory staff should meticulously follow for each activity. Documents & Records-Module 15 16

17. Job Aids Or work instructions, are shortened versions of SOPs that can be posted at the bench for easy reference on performing a procedure. Meant to supplement, not replace the SOPs. Documents & Records-Module 15 17

18. Examples of Laboratory Documents Documents & Records-Module 15 18

19. Characteristics of Good Documents Written clearly and concisely Written in a user-friendly style Explicit and accurate Always up to date. Accessible to all staff. Documents & Records-Module 15 19

20. Quality Manual Describes the quality management system of an organization (ISO 15189). Its purpose is to: clearly communicate information serve as a framework for meeting quality system requirements convey managerial commitment to the quality system. Documents & Records-Module 15 20

21. The Quality Manual is a document describing the quality management system of an organization (ISO 15189) Documents & Records-Module 15 21

22. Key Points Documents & Records-Module 15 22

23. Standard Operating Procedures Written step-by-step instructions to follow when performing a procedure. Ensures: Consistency —everyone should perform the tests exactly the same way so that the same result can be expected from all staff. Accuracy —produce more accurate results than relying on memory alone because they will not forget steps in the process. Quality —consistent (reliable) and accurate results are primary goals of the laboratory, and could be considered as the definition of quality in the laboratory. Documents & Records-Module 15 23

24. A Good SOP Detailed, clear and concise. Easily understood by new personnel or students in training. Reviewed and approved by the laboratory management—signature and a date. Updated on a regular basis. Complete standardized header—typically the standardized header would appear on the first page of each SOP. Documents & Records-Module 15 24

25. Complete Standardized Header Use at the top of the first page only Documents & Records-Module 15 25

26. Reduced Standardized Header other pages of every procedure use at the top of all other pages Documents & Records-Module 15 26

27. Information on SOPs Title—name of test. Purpose—include information about the test (why it is important, how it is used, screening, to diagnose, or to follow treatment. Instructions—detailed information for the entire testing process. Name of the person preparing the SOP. Signatures of approving officials and dates of approval. Documents & Records-Module 15 27

28. Job Aid Shortened version of an SOP. Used directly at the testing site. Placed in a visible location, and serves as a reminder of the steps that need to be completed. Job aid and the SOP must include the same instructions. Job aids supplement—not replace—the SOP. Documents & Records-Module 15 28

29. Job Aids Documents & Records-Module 15 29

30. Documents & Records-Module 15 Job Aids 30

31. Scenario The following information was provided about your facility lab: Serum Glucose – Cobas c111 Analyzer SOPs were first written on June 4 th 06. SOPs were revised on Jan 15 th 07 and later on April 15 th 09. The effective dates of distribution were June 4 th 2006, Jan 20 th 07 and April 20 th 09 respectively. Input this information into the relevant document. Documents & Records-Module 15 31

32. Master File Index Document Name # Version Date Effective Date Distribution Location (s) Serum Glucose – Cobas c111 Analyzer Procedure 1 June 4, 2006 June 4, 2006 #1 Master File 2 Jan 15, 2007   #2 Chemistry Department 3 April 15, 2009   #1 Cobas c111 Analyzer Workstation Acid Fast Bacilli (AFB) Direct Smear Procedure 1 Aug 3, 2006 Aug 3, 2006 #1 Master File #2 Microbiology Department Reporting Critical Result Procedure 1 Feb 3, 2006 Feb 3, 2006 #1 Master File #2 Chemistry Department #3 Hematology Department #4 Urinalysis and Serology Depart. #5 Microbiology Department Documents & Records-Module 15

33. Document Control Procedures for formatting and maintaining documents and should: ensure that the most current version of any document is in use ensure availability and ease of use provide for the appropriate archiving of documents a uniform format that includes a numbering system a process for formal approval of each new document, a distribution plan or list, and a procedure for updating and revising laboratory documents a master log or inventory of all documents. Documents & Records-Module 15 33

34. Considerations System for standardizing the format and/or numbering. Approval, distribution and revision process. Master log. Accessibility—provide a process for ensuring that relevant versions of documents are available. System for archiving—old versions of documents archived. Documents & Records-Module 15 34

35. Requirements for Implementation Collect, review and update all existing documents and records. Determine additional needs. Develop Quality Manual if not present. Develop or obtain examples of documents, including forms and worksheets, if needed. To help with formatting, examples from other labs can be used. Involve stakeholders—involve all staff who will be using them. Documents & Records-Module 15 35

36. Common Challenges Outdated documents in circulation. Distribution problems—multiple copies of documents are dispersed throughout different areas of the laboratory Failure to account for documents of external origin – need updating as well. Documents & Records-Module 15 36

37. Purpose of Records Records are laboratory information, either written by hand or computer-printed. Permanent, and are not revised or modified. Should be complete, legible and carefully maintained. Purposes: Continuous monitoring — access to all the data collected . Tracking of samples —throughout testing process; essential for troubleshooting. Evaluating problems that arise. Management tool . Documents & Records-Module 15 37

38. Examples Sample logbook Registers Laboratory workbooks or worksheets Instrument printouts Quality control data External quality assessment or proficiency testing records Patient test reports Personnel records Results of internal and external audits Continuous improvement projects Incident reports User surveys and customer feedback Critical communications Documents & Records-Module 15 38

39. Important Information to record: Management and handling of rejected samples. Sample referral to another laboratory Adverse occurrences or problems. Inventory and storage records. Equipment records. Test reports. Documents & Records-Module 15 39

40. Test Reports …… Identification of test Identification of laboratory Unique identification and location of patient Name and address of requestor Date and time of collection, and time of receipt in laboratory Date and time of release of report Primary sample type Results reported in SI units or units traceable to SI units Biological reference intervals Interpretation of results Comments Identification and signature of the person authorizing release of the report; If relevant, notation of original and corrected results. Documents & Records-Module 15 40

41. Storing Documents and Records Considerations for paper-based records Permanence —last as long as needed - binding pages or using a bound book (log register); numbered for ease of access, permanent ink. Accessibility —easily retrieved whenever needed. Security —kept in a secure place, safe from spills, fires, floods or other environmental hazards. Traceability —trace a sample throughout all processes in the laboratory. Documents & Records-Module 15 41

42. Storing ….. Requirements for electronic records Permanence —backup systems; regular maintenance of computer system. Security —ensure computer access codes protect the data. Traceability —electronic record systems should be designed in a way that allows for tracing the specimen throughout the entire process in the laboratory. Documents & Records-Module 15 42

43. Storing ….. Factors determining Retention times for records Length of time the laboratory will need to have access to its records. Government requirements or standards that dictate record retention times. Whether the laboratory is engaged in ongoing research requiring many years of data. Time interval between the laboratory’s assessments or audits. Documents & Records-Module 15 43

44. Activity: What Would You Do? Purpose To integrate the module’s lessons and apply them to the case scenario. What will you need? Handout : Case Study Scenarios What will you do? Divide into groups of 4-5 Select a spokesperson for your group Formulate specific action steps to address the scenario from the Handout . The group’s spokesperson presents the proposed steps during the 2 minute class report. 5 minutes Documents & Records-Module 15 44

45. What Would You Do? You recently updated a policy to prevent the reoccurrence of a serious issue. Later in the month, the same situation occurred again resulting in a serious injury to a patient. When you questioned the staff member, you discovered he/she only had access to the old version of the policy that did not reflect the updated changes. You realize there are several copies of this policy, but you cannot recall where they are all located. What actions can you take in managing your documents and records? Documents & Records-Module 15 45

46. What Would You Do? You have heard rumors that patients in your community are hesitant to come to your facility because of confidentiality issues. What actions do you take to ensure the confidentiality of the laboratory results? When asked, how will you assure your patients that the laboratory maintains confidentiality? Documents & Records-Module 15 46

47. Tasks 10.1 Maintain a library of documents (policies, guidelines, SOPs, references, etc.); review and update annually 10.2 Maintain integrity, organization, and confidentiality of records (client test results, specimen transfer logs, maintenance logs, inventory logs, etc.) Documents & Records-Module 15 47

48. Tasks ……… 10.3 Assure proper record retention, rotation to storage, and disposal according to protocol 1.1 Organize work area to allow for smooth, efficient service operations. 6.1 Ensure that the Quality Manual with quality assurance policies and procedures is accessible to and reviewed by all staff. Documents & Records-Module 15 48

49. Summary Documents include written policies, processes and procedures Need to be updated and maintained. Records include information captured in the process of performing and reporting a lab test. Records are permanent and does not require updating. Good document control programme ensures that the most current version of a document is used, and ensures availability and ease of access when a document is needed. Information is our product. Documents are essential for assuring accuracy and consistency in the laboratory. Documents & Records-Module 15 49

50. What have we learned?