Information

  • 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
  • Department

  • Conducted on

  • Auditor

  • Add signature

  • Name of Lab Manager/Supervisor

Details

PREVIOUS AUDIT/S

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

SAMPLE DETAILS

  • Lab number of sample

  • Name of Test/Panel

  • Date sample tested

  • Method or Procedure number/s

5.4

5.4 PRE EXAMINATION PROCESSES

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

  • 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?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • State procedure number

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

5.1

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?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

5.2

5.2 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS

  • 5.2.1 Is there sufficient space in the laboratory to adequately perform this test?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • 5.2.6 Is the laboratory clean and uncluttered?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

5.3

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.

  • Please classify findings as Major, Minor or Observation

  • Riskman number

  • Is the equipment in good repair?

  • Please classify findings as Major, Minor or Observation

  • Riskman number

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

  • Please classify findings as Major, Minor or 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>

  • Please classify findings as Major, Minor or 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.

  • Please classify findings as Major, Minor or Observation

  • Riskman number

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

  • Please classify findings as Major, Minor or Observation

  • Riskman number

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

  • Please classify findings as Major, Minor or Observation

  • Riskman number

5.5

5.5 EXAMINATION PROCEDURES

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • How?

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

  • When?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • 5.5.2 Are reference intervals documented for this test?

  • Where?

  • Are the reference intervals reported on the test report?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • Please classify finding as Major, Minor or 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?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • 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?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

5.6 - 5.7

5.6 ENSURING QUALITY OF EXAMINATION PROCEDURES

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Does the lab participate in inter laboratory comparisons instead?

  • Why not?

  • Please classify finding as Major, Minor or 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?

  • Why not?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • 5.6.3.4 Has the QAP been reviewed by lab staff?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

5.7 POST EXAMINATION PROCESSES

  • 5.7.1 Are all results reviewed and validated?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • By whom?

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

5.8

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)

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • How?

  • 5.8.2 Does the report contain the following attributes?

  • Comments on sample quality that may affect resuts?

  • Critical results highlighted?

  • Interpretive comments where appliccable?

  • Were all above boxes ticked?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • 5.8.3 Does the report contain the following content?

  • 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?

  • State why if any information is missing.

  • Please classify finding as Major, Minor or Observation

  • Riskman number

5.9 - Other

5.9 RELEASE OF RESULTS

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • When results are telephoned is evidence of phoning recorded?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • Where?

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • Can automatic reporting be suspended rapidly if required?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • How?

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

  • Please classify finding as Major, Minor or Observation

  • Riskman number

PROCEDURE

  • Was the procedure for this test correctly followed by staff

  • Is there a valid reason?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

  • What is the reason

  • Was the procedure for this test easy to follow?

  • Please classify finding as Major, Minor or Observation

  • Riskman number

OTHER

  • Are there any other issues noted in the laboratory?

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

  • Finding
  • State finding or add evidence

  • Add evidence.

  • Please classify finding as Major, Minor or Observation

  • Riskman number

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