Data Entry Audit

• SCOPE: to determine compliance with NPAAC guidelines, AS15189 and NATA FAD
  OBJECTIVE: to ensure laboratories are compliant with the relevant regulations, guidelines and code of practices covered in this audit by examining a sample of written, physical and verbal evidence.

• INSTRUCTION
  1. Select a sample that has been reported within the last 7 days and follow it through the laboratory process.
  2. For all non conformances state finding in the drop box and classify as MAJOR, MINOR or OBSERVATION.
  3. Evidence can be attached as MEDIA where applicable.
  4. Enter findings in riskman and forward report to state quality manager
  5. Photographic evidence may be inserted into media field, do not photograph patient information

• Audit Title

• Location
  Address

• Department

• Conducted on

  Date

• Auditor

• Add signature

  Sign

• Name of Lab Manager/Supervisor

PREVIOUS AUDIT/S

• Have all actions from the previous audit been closed out?<br>If not state outstanding items and riskman numbers.

  Yes

  No

4.1 ORGANISATION AND MANAGEMENT

• 4.1.1.3 Is confidentiality of information maintained? <br>

  Yes

  No

  N/A

• How do operators ensure results are not given out to unauthorised people.

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.1.2.2 Does management communicate the needs of users (advisory and interpretive services), regulatory and accreditation requirements to staff?<br>Ask a staff member if they know about pathologist advisory services and NATA.

  Yes

  No

  N/A

• How?

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.1.2.5 Are relief arrangements for the department supervisor documented? <br>Should be in the department manual or staff structure document.

  Yes

  No

  N/A

• Where?

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.1.2.6 Does the laboratory have an effective communication system?<br>

  Yes

  No

  N/A

• What system is in use? eg communication book, email group, minuted meetings

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

4.2 QUALITY MANAGEMENT SYSTEM

• 4.2.2.2 Does the lab manual have a staff structure document that includes reporting lines for all staff?

  Yes

  No

  N/A

• What is the document number?

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

4.11 PREVENTIVE ACTION

• 4.11 Is the lab proactive in identifying opportunities for improvement?<br>

  Yes

  No

  N/A

• How?

• Please classify finding as Major, Minor or Observataion

  Yes

  No

  N/A

• Riskman number

4.14 EVALUATION AND AUDITS

• 4.14.4 Does the lab include staff suggestions for improvement in meetings?

  Yes

  No

  N/A

• Date of meeting minutes reviewed

  Date

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.14.6 Does the lab have any work processes that may adversely affect patient results?<br>List.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.14.7 Does the department have a set of quality indicators? eg Number of errors, number of forms entered?

  Yes

  No

  N/A

• What are they?

• How are they reviewed and communicated to staff?

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

4.3 DOCUMENT CONTROL

• 4.3a Do all memos have a date of issue and an author?

  Yes

  No

  N/A

• State titles or subjects and issue dates of memos reviewed

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• Are all hard copy manuals (or excerpts) on controlled paper (orange line)?

  Yes

  No

  N/A

• State document number/s of procedures.

• Is the procedure meant to be available to the lab in hard copy?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.3b & 5.5.3 Do all policies, instructions, flow charts, procedures, etc have a title, unique number, date of issue, number of pages and title of authoriser?<br>Check a sample of documents

  Yes

  No

  N/A

• List documents reviewed

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.3d Are any obsolete copies of documents available to staff?<br>Check the lab for hard copies and compare to intranet. Ensure no docs listed as Obsolete on the intranet.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.3e Are there are any hand written amendments?

  Yes

  No

  N/A

• Are they signed and dated?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

• 4.3h Are all documents reviewed as per schedule? <br>Check not issued more than 2 months ago.

  Yes

  No

  N/A

• List documents reviewed.

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

4.4 SERVICE AGREEMENTS

• 4.4.1e Are users (doctors etc) notified if there is a significant change that will impact on results? (eg downtime)

  Yes

  No

  N/A

• How?

• Please classify finding as Major, Minor or Observation.

  Major

  Minor

  Observation

• Riskman number

4.12 CONTINUAL IMPROVEMENT

• 4.12 Are systems in place to monitor continual improvement?

  Yes

  No

  N/A

• What systems are in place? eg Data entry operator stats

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

4.13 CONTROL OF RECORDS

• 4.13 Can either the original request form or an image be easily retrieved?

  Yes

  No

  N/A

• State request numbers checked?

• Please classify finding as Major, Minor or Observation

  Yes

  No

  N/A

• Riskman number

5.4 PRE EXAMINATION PROCESSES

• 5.4.6 Is there a procedure for urgent samples?

  Yes

  No

  N/A

• State procedure number

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.4.7 Is there a procedure for add on tests?

  Yes

  No

  N/A

• State procedure number

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.1 PERSONNEL

• 5.1 Do all staff have training records that include the following<br>State name/s of staff records reviewed.

  tick boxes below

• Training record reviewed

Staff member

• Staff name

• Initial training?

• Competency assessments (elearning or manual)?

• Qualifications?

• Previous employment?

• Job description?

• Induction?

• Performance reviews? May be stored in a separate file.

• Were all boxes ticked for all staff records reviewed?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS

• 5.2.1 Is there sufficient space in the department to adequately perform all tests?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.2.2 Is the environment suitable for the task being performed?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are the facilities adequate (noise, lighting, water, ventilation)?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is safety equipment provided (fire extinguisher, fire blanket)?<br>

  Yes

  No

  N/A

• Have all fire extinguishers been checked within the last 6 months?

  Yes

  No

  N/A

• State date last checked?

  Date

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.2.4 Is there adequate access to washrooms, drinking water and storage for PPE and clothing?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.2.6 Is the department clean and uncluttered?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.8 REPORTING OF RESULTS

• 5.8.1 If the department manually transcribes any results are transcription checks performed and recorded?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• How?

5.10 LABORATORY INFORMATION MANAGEMENT

• 5.10.1 Is confidentiality of patient results maintained?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.10.3 Does the laboratory have a procedure for computer downtime?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• State procedure number?

OTHER

• Are there any other issues noted in the deparment?

  Yes - Other issues noted

  No - Compliant

• Click "Add Finding" for any additional non-conformances.

Finding

• State finding or add evidence

• Add evidence.

  Media

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number