Vertical 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

SAMPLE DETAILS

• Lab number of sample

• Name of Test/Panel

• Date sample tested

  Date

• Method or Procedure number/s

5.4 PRE EXAMINATION PROCESSES

• 5.4.3 Does the request form for this sample contain the following?<br>

  tick boxes below

• Patient ID (including gender, DOB, location of patient, unique identifier (MRN or Medicare)?

• Name or ID of requestor?

• Type of primary sample?

• Test/s requested?

• Relevant clinical notes?

• Date of collection?

• Date and time of receipt? This may be recorded in z-tracking.

• Were all boxes above ticked?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.4.4 Is a procedure for the collection and handling of this test available?

  Yes

  No

  N/A

• State procedure number

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.4.5 Are transport temperature monitoring records available?<br>Esky monitoring should be one at least annually.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.4.6 was the sample traceable to the patient with at least 2 key identifiers?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.1 PERSONNEL

• 5.1.9 Do all staff involved with this testing process have training records that include the following?
  State name/s of staff records reviewed

Staff member

• Staff name

• Training for this test?

• Competency assessments (elearning or manual)?

• Qualifications?

• Previous employment?

• Job description?

• Induction?

• Continuing professional development (internal and external)?

• 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 laboratory to adequately perform this test?

  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 (coats, gloves, goggles, shower, fire extinguisher)?<br>Check date on fire extinguisher and safety shower records.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is Personal protective equipment worn?<br>Lab coat, gloves, goggles (if handling open vials)

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.2.3 Are reagents and consumables stored at the correct temperature and to avoid cross contamination?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are samples and reagents disposed of correctly? Yellow bags, sharps etc

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.2.6 Is the laboratory clean and uncluttered?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.3 LABORATORY EQUIPMENT, REAGENTS AND CONSUMABLES

• 5.3.1.1 Does the lab have the required equipment to perform this test?<br>Analyser, pipettes, timers etc<br>State what equipment is used.

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is the equipment in good repair?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.3.1.3 Are instructions for use of the equipment? <br>Can be manufacturers or lab instructions.

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.3.1.4 Has all of the equipment used for this test been calibrated in accordance with the calibration schedule?<br>Pipettes, thermometers: 6 months<br>Timers, centrifuges, bio safety cupboards: annually<br>Balances: 3 yearly cal, monthly and 6 monthly checks<br>Spectrophotometers: 3 monthly<br>

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is the date of the last calibration and due date of the next calibration recorded?<br>Can be on a sticker on the equipment or in a log.

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.3.1.5 Has preventive maintenance/servicing of equipment been performed in accordance with manufacturer's recommendation?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Where required, have all daily, weekly, monthly maintenance tasks been performed and recorded?<br>Check maintenance logs.

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.5 EXAMINATION PROCEDURES

• 5.5.1.1 Has the identity of the person/s performing this test been recorded?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• How?

• 5.5.1.4 For quantitative methods has the laboratory estimated MU for this test?

  Yes

  No

  N/A

• When?

  Date

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.5.2 Are reference intervals documented for this test?

  Yes

  No

  N/A

• Where?

• Are the reference intervals reported on the test report?

  Yes

  No

  N/A

• 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

• 5.5.3 Is the method and/or procedure for this test document controlled? I.e, only on the intranet or on controlled paper?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Does the method/procedure for this test contain the following

  tick boxes below

• Purpose of examination?

• Principle of examination?

• Verification/Validation?

• Sample type (including additive)?

• Patient preparation?

• Required equipment and reagents?

• Calibration and QC procedures?

• Interferences (lipaemia, hameolysis, drugs, cross reactions etc)?

• Clinical linterpretation?

• References?

• Were all boxes above ticked?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.6 ENSURING QUALITY OF EXAMINATION PROCEDURES

• 5.6.2.2 Was QC run at appropriate intervals for this test?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are QC concentrations for this test at or near clinical decision values?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.6.2.3 Are QC results rejected and patient results retested when QC rules are violated?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is QC reviewed at regular intervals? (eg monthly for biochem, by lot for FBE)

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.6.3.1 Is the lab enrolled in and external QAP for this test?

  Yes

  No

• Does the lab participate in inter laboratory comparisons instead?

  Yes

  No

• Why not?

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• With which other lab/s

• 5.6.3.3 Has the staff member who performed this test participated in QAP/interlab comparisons?

  Yes

  No

  N/A

• Why not?

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.6.3.4 Has the QAP been reviewed by lab staff?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Has the QAP been signed off by a pathologist or senior scientist with an FAIMS, FAACB or PhD?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.7 POST EXAMINATION PROCESSES

• 5.7.1 Are all results reviewed and validated?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• By whom?

• 5.7.2 Are patient samples stored in accordance with NPAAC guidelines (temperature, retention time)?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.8 REPORTING OF RESULTS

• 5.8.1 Are manual transcription checks performed and recorded? <br>Record can be on a work list or electronic (Ultra tracking)

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• How?

• 5.8.2 Does the report contain the following attributes?

  tick boxes below

• Comments on sample quality that may affect resuts?

• Critical results highlighted?

• Interpretive comments where appliccable?

• Were all above boxes ticked?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.8.3 Does the report contain the following content?

  tick boxes below

• Identification of the examination?

• Identification of the lab that issued the report? Check NATA number is correct.

• Name or ID of requestor and their contact details?

• Date of sample collection?

• Type of primary sample?

• Measurement procedure (where applicable)

• Results in SI units?

• Reference range or clinical decision value?

• Interpretation of results where appropriate?

• Identification of person authorising the release of the report?

• Date and time of issue of the report?

• Page number and total number of pages on each page?

• Were all above boxes ticked?

  Yes

  No

• State why if any information is missing.

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.9 RELEASE OF RESULTS

• 5.9.1 Where an interim report is issued, is the report followed by a final report?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• When results are telephoned is evidence of phoning recorded?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Where?

• 5.9.2 Does the lab have a procedure for automatic reporting of results?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are analyser flags transmitted to the interface and/or Ultra?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Can automatic reporting be suspended rapidly if required?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.9.3 When reports are amended is the amended report clearly identified as amended?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• How?

• Do staff notify the requestor by telephone if results are amended?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

PROCEDURE

• Was the procedure for this test correctly followed by staff

  Yes

  No

  N/A

• Is there a valid reason?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• What is the reason

• Was the procedure for this test easy to follow?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

OTHER

• Are there any other issues noted in the laboratory?

  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