Non-conformances / Document Control

1. Non-conformances / Document Control Dr A A Khine Chemical Pathology NHLS TYGERBERG Lab Management Workshop June 4-6 2019

2. Non-conformance in medical laboratory • A failure to conform to accepted standards or SOP • Non-conformance analysis involves the recognition of deviations, recording immediate corrective action, finding root causes and implementing preventive action. • Critical component of quality policy and included in quality manual • This is part of (ISO) 15189:2012, thus laboratory accreditation

3. Major: NCs that pose immediate or imminent danger in patient care Minor: no direct effect on patient care or no immediate or imminent danger but in long term may pose indirect danger to patients or business Give examples

4. Operators • Managers Where and Why do NCs occur? Breakdowns Out of stock Expiries Contaminations Loss • SOPs Lack of training Lack of discipline Lack of monitoring Lack of clarity Lack of consequences

5. How NCs are picked up • Checking – who is checking? • After checking and finding something wrong, do you report it? Does everyone report it? • Reporting- who is reporting? • Incidence reporting • Complaint reporting • Audit reporting • NC in a process -> who was involved? • Reporting a NC or reporting a person? Can we separate them?

6. Closure of NC • Who must close it? • How to close it? • Complete the NHLS NC form • All 3 sections (identification and description of NC, CA, RTA, PA) • Monitoring of PA ???

7. Sample non-conformance Form

8. Corrective Action Process CA - Action taken immediately or as soon as possible to correct the NCs as they occur RTA - Investigate what happened– root cause analysis PA - Eliminate root cause so it won’t recur Monitor Closing NC- within 25 days

9. CAPA process is a cycle • Define what will be considered as NC and what is major and what is minor (problems/errors/deviations) • Major or minor (consult with pathologists re: impact on patient) • Define CA for each NC (do this when that happens- as far as one can predict) as it may require fast response • Establish a system (or tools) to identify NCs (must be in a SOP) • Register all NCs either manually in log books or electronically using standard form • Complete the CA taken and discuss with relevant parties involved if CA was appropriate and adequate or not • Investigate root cause(s)- many times multiple causes- analyze information thoroughly and without BIAS • Provide feedback to staff involved in NC • Discuss PA with staff for implementation • Observe for recurring problem. If recur, CA and look for root causes why • Review all NCs logged annually or bi-annually • Redefine NCs • Adjust CAPA • Staff feedback

10. Root causes analysis • Analysis of cause and effect

11. Ishikawa diagrams

13. Trend analysis: Internal audits Periodic examination of non-conformances to find and document repeated non-conformances Improvement goals: departmental and personal KPI # of NCs (# major and minor) and # repeats Annual accreditation visits- expect all NCs from internal audits have been closed and CAPA implemented

14. Audit of NCs and impact

15. Exercise • There was persistent negative bias in your BNP and Troponin I EQAs. Please help the bench supervisor and lab manager to close this NC. • You are a regional pathologist in the NHLS. The rejection rate for serum K due to various reasons was 20% at the referral provincial lab and 15% for the local labs in average. Write up a plan in how you would investigate this problem and close the NC.

16. Document control

17. Document control • One of essential elements of quality system • One of the standards required and checked during accreditation

18. What is document control? • Document control is all to do with transferring information between relevant parties. • This could be a law firm sending a report to a client, a construction firm receiving technical drawings from a designer, or a bakery giving an employee a recipe to follow. • We need to ensure that the information that reaches the end user is correct, therefore the document must be controlled to ensure that this is the case. • Sometimes the information contained in a document needs to be altered • Placing controls on a document means that we ensure that the document always contains the correct information

19. Documents vs records Documents Records Collected information captured on worksheets, forms, labels and charts Need to be easily retrieved and accessed Raw data – instrument No changes can be made to any records. They are the history of actual events. • Written policies, process descriptions, procedures • Communicate information • Need to be updated • Templates/blank forms • Communicate information. Living documents which can be changed and updated.

20. Documents are the communicators of the quality management system Verbal instructions often are: • not heard • misunderstood • quickly forgotten • difficult to follow

21. What makes a good document? • Written clearly and concisely • User-friendly style • Explicit and accurate • Maintained to stay up to date • Accessible to all staff

22. Documents are a reflection of the laboratory’s organisation and its quality management. A good rule to follow is:“Do what you wrote and write what you are doing.”

23. Policy - Statements of intentions • National policies • (all labs within NHLS shall participate in PT scheme, all staff of NHLS shall work from 8 am to 5pm and 40 or 56 hours per week depending on their category, registrars shall complete their training within 4-6 years) • Lab specific policies (this laboratory runs in 3 shifts, all staff of this laboratory shall participate in CPD activity once a week) • defined by those in the organization and endorsed by management • Aligned to organizational vision (what is envisaged) and mission (set goals to get there) • Each policy fulfils the goal or part of the goal in the mission

24. Process and Procedure Process: Steps involved in carrying out policies • A process is a series of related tasks or methods that together turn inputs into outputs. (example: disciplinary action, registrar training, lab accreditation etc.) • A procedure is a prescribed way of undertaking a process or part of a process. A procedure describes: (SOP) • Who is responsible for each part of the process • When each part of the process occurs • The specifications applicable to each part of the process

26. Quality Manual • Overall guiding document and compilation of quality processes in pre-A, A, Post-A processes (TQM) • Requirement of ISO 15189 • Clearly communicates information – internally & externally • Serves as a framework or roadmap for meeting quality management system • Demonstrates management’s commitment to quality • Kept up to date- always being improved • Read, understood and followed by EVERYONE

27. Generic template of SOP • Author • Reviewer • Approver • Scope • Background and introduction • Purpose or Objective • Clinical Relevance • Responsibility (who must do and who must monitor) • Step by step procedure (if testing, starts with assay principle)- this can be copied from package insert • References • Distribution list

28. Controlling Documents • Update so that what is in the document reflects the current practise • Ensure that most up to date version in use (Archive old versions) • Ensure availability (all staff must have access to Qpulse)

29. Common problems • Outdated document in circulation • Distribution problems • Failure to account for documents of external origin

30. 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 sample transfer log (completed) You have found all these papers lying on a desk. Which of these are documents and which are records? Tick the “D” and circle the “R”.

31. Exercise • You changed the dilution protocol of serum and urine IFE. • Show how you will implement this change in the document control.

32. 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 sample transfer log (completed) You have found all these papers lying on a desk. Which of these are documents and which are records?

33. Summary • Documents: • include written policies, processes, and procedures • need to be updated and maintained • Records: • include information captured in processes • are permanent, do not require updating • A good document control program: • most current version used • availability and ease of access