Department Audit

• Document No.

• 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. Answer all questions and state evidence sighted
  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

• Name of Lab Manager/Supervisor

PREVIOUS AUDIT/S

• Have all actions from the previous audit been closed out? If no then state outstanding items and riskman numbers. <br>

  Yes

  No

4.1 ORGANISATION AND MANAGEMENT

• 4.1.1.1 Are all tests in this department listed on the scope of accreditation?

  Yes

  No

  N/A

• Do reports for tests not on the scope state that they are not accredited by NATA?<br>List any tests that are not on the scope.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

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

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 4.1.2.5 Are relief arrangements for the department supervisor documented? <br>State where: ie document number.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 4.1.2.6 Does the laboratory have an effective communication system? <br>State what system is in place.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• 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? State document number

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

4.11 PREVENTIVE ACTION

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

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

4.14 EVALUATION AND AUDITS

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

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 4.14.6 Does the lab have any work processes that may adversely affect patient results?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 4.14.7 Does the lab have established TATs for each test that reflect clinical needs?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are the TATs periodically reviewed and evaluated?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

4.3 DOCUMENT CONTROL

• 4.3a Do all memos have a date of issue and an author?<br>State the date of memos reviewed

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are all hard copy manuals (or excerpts) on controlled paper (orange line)?<br>What manuals are available in hard copy?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• 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 and state name/number of documents

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

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

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 4.3e Are there are any hand written amendments?

  Yes (no score)

  No (no score)

• Are they signed and dated?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 4.3h Have all documents been reviewed as per schedule? <br>Check not issued more than 2 years ago. State documents reviewed

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• 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)<br>State how.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation.

  Major

  Minor

  Observation

• Riskman number

4.6 EXTERNAL SERVICES AND SUPPLES

• 4.6 Are all supplies and equipment purchased through authorised channels? <br>State what channels are used (eg tech one)

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation.

  Major

  Minor

  Observation

• Riskman number

4.7 ADVISORY SERVICES

• 4.7 Are there staff available who can give clinical advice and interpretation of results? <br>State who.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation.

  Major

  Minor

  Observation

• Riskman number

4.12 CONTINUAL IMPROVEMENT

• 4.12 Were last months KPIs accurately reported?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

4.13 CONTROL OF RECORDS

• 4.13 Record keeping can be in electronic or hard copy format. Does the laboratory keep the following records?

• Reagent information (lot number, invoices, package inserts)?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Instrument printouts and stored data (where raw data does not transmit to Ultra)?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Worksheets?<br>

  tick boxes below

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Examination results and reports?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Instrument maintenance records?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Calibration records?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.4 PRE EXAMINATION PROCESSES

• 5.4.6 Are all samples and aliquots traceable to the patient with at least 2 key identifiers? State lab numbers of samples reviewed

  Yes

  No

  N/A

• Has lab obtained verification of the patient's identity from the collector?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is this noted on the test report?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is there a procedure for urgent samples? <br>State procedure number.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.4.7 Is there a procedure for add on tests? <br>State procedure number

  Yes

  No

  N/A

• 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

• 5.1 Review a selection of training records, for each record reviewed click "Add staff member" and tick boxes where records are available.

Staff member

• Staff name

• Initial training?

• 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.

• If any records are missing, state why

• Were all boxes ticked?

  Yes

  No

• Is there a valid reason?

  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 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 (coats, gloves, goggles, shower, fire extinguisher)?<br>State what is provided

  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

• Is safety equipment checked where applicable? <br>(Safety shower, fire extinguisher) Fire extinguisher should be checked every 6 months

  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?<br>State reagents/consumables checked.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are samples and reagents disposed of correctly? <br>State where e.g yellow bags, sharps etc

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 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 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 Are equipment installation verification records available where required?<br>State records reviewed

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Does all equipment have a unique identifier (may be a serial number)?<br>State equipment checked

  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 available? <br>Can be manufacturers or lab instructions. State instructions sighted.

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.3.1.4 Review 3 pieces of equipment and check it has been calibrated in accordance with the calibration schedule.
  Click "Add Equipment"

Equipment

• Select equipment type

  Select Pipette Timer Centrifuge Balance Thermometer Specrophotometer CO2 Incubator Bio safety cupboard Autoclave

  • Pipette
  • Timer
  • Centrifuge
  • Balance
  • Thermometer
  • Specrophotometer
  • CO2 Incubator
  • Bio safety cupboard
  • Autoclave

• Equipment identifier

• Calibrated 3 monthly for new pipettes, or 6 monthly for pipettes with a stable calibration history of 5 consecutive passes.

  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

• Does the lab have a record of certification of the reference device used for calibrations?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Equipment identifier

• Calibrated/checked 6 monthly?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is the date of the last calibration/check and due date of the next calibration/check 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

• Does the lab have a record of certification of the reference device used for calibrations?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Equipment identifier

• Calibrated or checked annually?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is the date of the last calibration/check and due date of the next calibration/check 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

• Does the lab have a record of certification of the reference device used for calibrations?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Equipment identifier

• 1 point check monthly, repeatability check 6 monthly, ,service annually, calibration 3 yearly?

  Yes

  No

  N/A

• Which is non compliant

  Select Monthy 1 point check 6 monthly repeatability Annual service 3 yearly calibration

  • Monthy 1 point check
  • 6 monthly repeatability
  • Annual service
  • 3 yearly calibration

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is the date of the last calibration/check and due date of the next calibration/check 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

• Does the lab have a record of certification of the reference device used for calibrations?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Equipment identifier

• Calibrated 3 monthly?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is the date of the last calibration/check and due date of the next calibration/check 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

• Does the lab have a record of certification of the reference device used for calibrations?

  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>State maintenance logs reviewed

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is defective equipment that has been taken out of service clearly labelled? State how.

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.3.1.7 Select 3 items and review the equipment records (and/or equipment register). Are the following records available?
  Click "Add Equipment"
  

Equipment

• Equipment description

• Serial number and/or equipment ID?

• Manufacturers name?

• Model

• Date of receipt of equipment?

• Date equipment was put into service?

• Location of equipment?

• Condition of equipment when received?

• Schedule for preventive maintenance?

• Service records?

• Were all boxes for all equipment reviewed ticked where applicable? <br>

  Yes

  No

  N/A

• Is there a valid reason?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.3.2.3 Are all new reagent and consumables lot numbers verified for performance prior to use (QC)?<br>State records reviewed

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.3.2.4 Are new shipments of reagents and consumables marked or segregated from those that have been accepted prior to use?<br>State how.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• How?

• 5.3.2.7 Are the following records kept for reagents?
  Must be retrievable for 3 years.

• Identity of reagent?

• Manufacturers name and lot number?

• Contact information of supplier or manufacturer?

• Date of receipt?

• Date of expiry?

• Date of entering into service?

• Condition when received (damaged or acceptable), can be done in tech 1

• Were all boxes above ticked where applicable?

  Yes

  No

  N/A

• Please classify findings as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are any reagents prepared? State name of reagents

  Yes (no score)

  No (no score)

• Is the date of preparation and name of person preparing the reagent recorded and accessible for 3 years?

  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 Is the identity of the person/s performing tests recorded?<br>State how/where.

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.5.1.2 Are methods that have been validated by the manufacturer verified prior to putting into use?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.5.1.3 Does the lab have any in-house methods?

  Yes (no score)

  No (no score)

• List in-house methods

• Has the lab validated the methods prior to putting into use?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 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

5.6 ENSURING QUALITY OF EXAMINATION PROCEDURES

• 5.6.2.2 Is QC run at appropriate intervals?<br>State how often.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are QC concentrations (where applicable) at or near clinical decision values? <br>State QC reviewed

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are the correct QC lot numbers recorded in Ultra. State QC reviewed

  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?<br>State QC reviewed.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is a record of repeated patient results kept 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).<br>State how often and by whom.

  Yes

  No

  N/A

• 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?<br>State QAP reviewed.

  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?<br>State QAP reviewed.

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.6.3.1 Is the lab enrolled in external QAP for all tests?

  Yes

  No

• Which tests are not enrolled?

• 5.6.3.2 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

• Is this a serology department that performs HIV and/or HCV testing?

  Yes (no score)

  No (no score)

• NPAAC S9.4 Is the lab enrolled in the NRL QAP program for HIV and HCV?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.6.3.3 Is QAP treated the same as a patient as much as possible (including data entry)?

  Yes

  No

  N/A

• Is there a valid reason?

  Yes

  No

  N/A

• What is the reason?

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Is QAP rotated amongst all lab staff?

  Yes

  No

• Why not?

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.6.3.4 Have QAP results been discussed with lab staff?<br>Check meeting minutes, state date on minutes.

  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? <br>State QAP reviewed.

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are QAP outliers and late or non-submissions recorded in RiskMan?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Does the lab use analysers to conduct testing?

  Yes (no score)

  No (no score)

• 5.6.4 Are patient comparisons performed between analysers?

  Yes

  No

  N/A

• 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

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.7.2 Are samples stored in accordance with NPAAC guidelines (temperature, retention time, avoiding cross contamination)? Choose department from list

  Select Biochemistry Cytogenetics Cytology Haematology Histology Immunology/Serology IVF Microbiology Molecular

  • Biochemistry
  • Cytogenetics
  • Cytology
  • Haematology
  • Histology
  • Immunology/Serology
  • IVF
  • Microbiology
  • Molecular

• Are routine samples stored for at least 7 days unless stated otherwise?

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Karyotypes: 3 years?

• Microscope slides: 3 years?

• Fixed chromosome suspensions: 6 months?

• Original specimens: 1 month from issue of report?

• Clinically significant tissue cultures: Cryopreservation?

• Clinically insignificant cultures: 7 days?

• DNA extracts: 3 months from issue of report?

• Unprocessed cultures: 2 days after a final result is issued?

• Are all relevant boxes above checked?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• FNA, slides and blocks: 10 years?

• Cervical slides: 10 years?

• Liquid based cytology: 1 month?

• Are all relevant boxes above checked?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Clinically significant films: 1 year?

• Clinically insignificant films: 1 month?

• Special haemostasis plasma: 3 months at -20C

• Bone Marrow slides: 10 years?

• Are all relevant boxes above checked?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Blocks: 10 years? Blocks from a person <18 years must be kept for 10 years after they turn 18

• Slides: 10 years? Slides from a person <18 years must be kept for 10 years after they turn 18

• Frozen section tissue: 10 years?

• Tissue for immunofluorescence: 1 month at -70C?

• Containers with no residual tissue: 1 month

• Unblocked tissue: 1 month from report date?

• Unblocked autopsy tissue: 3 months?

• Autopsy registers: 10 years?

• Forensics: 20 years?

• Are all relevant boxes above checked?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Immunofluorescence slides: 7 days?

• Infectious sera: 4 months?

• Antenatal sera: 12 months?

• Syphillis (reactive): 12 months?

• Are all relevant boxes above checked?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Semen: 3 days?

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Z-N stains: 6 weeks?

• Gram and other stains: 2 weeks?

• Clinically significant isolates: 5 days?

• Urine: 3 days?

• Are all relevant boxes above checked?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Specimens: 1 month from issue of report?

• Fixed chromosome cell suspensions: 6 months?

• DNA Extracts: 3 months from issue of report?

• Are all relevant boxes above checked?

  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 Are manual transcription checks performed and recorded? <br>State how. (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

• 5.8.2 Do reports contain the following attributes?

• Comments on sample quality that may affect resuts?

• Critical results highlighted?

• Comments regarding acceptance/rejection criteria not being met?

• 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

• 5.8.3 Does the report contain the following content?

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

• Name of person authorising reports (pathologist or senior scientist)?

• 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

• Is this department Cytogentics?

  Yes (no score)

  No (no score)

• NPAAC S7.1 Does the report contain the following information?

  tick boxes below

• Type of tissue studied?

• Number of cells counted and metaphases analysed?

• Banding techniques applied?

• Whether specific studies were undertaken (eg FISH)?

• The chromosome constitution?

• An indication that the result is abnormal, no abnormality detected or inconclusive?

• 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 Is evidence of telephoning results recorded in Ultra?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 5.9.2 Does the lab have a procedure for automatic reporting of results? <br>State procedure number<br>

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are analyser flags transmitted to Ultra?<br>

  Yes

  No

  N/A

• Does the laboratory keep a copy of raw data (either electronic or hard copy)?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Can automated reporting be suspended rapidly if required?<br>State how.

  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? (AMEN comment used)

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• Are requestors notified by telephone of all amended reports?

  Yes

  No

  N/A

• Why not?

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

5.10 LABORATORY INFORMATION MANAGEMENT

• 5.10.1 Is confidentiality of patient results maintained? <br>State how

  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?<br>State procedure number.

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

NPAAC - In House IVDs

• Are any in-house IVDs in use?

  Yes (no score)

  No (no score)

• Have they been validated?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman numbere

• Have they been notified to TGA?

  Yes

  No

NPAAC - Information Commmunication

• S1.8 Are passwords used on all electronic records?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Obbservation

  Major

  Minor

  Observation

• Riskman number

• S1.9 Does the lab retain all information even if it is later found to be inaccurate

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Obbservation

  Major

  Minor

  Observation

• Riskman number

• S4.3 & S8.1 Do all staff have individual logins?

  Yes

  No

  N/A

• Are any staff using a generic login?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Obbservation

  Major

  Minor

  Observation

• Riskman number

• Please classify finding as Major, Minor or Obbservation

  Major

  Minor

  Observation

• Riskman number

NPAAC - Department Specific

• Select Department from the list

  Select Biochemistry Cytogenetics Cytology Environmental Haematology Histopathology Immunology IVF Microbiology Molecular Serology Transfusion

  • Biochemistry
  • Cytogenetics
  • Cytology
  • Environmental
  • Haematology
  • Histopathology
  • Immunology
  • IVF
  • Microbiology
  • Molecular
  • Serology
  • Transfusion

• Does the laboratory perform cervical cytology screening?

  Yes (no score)

  No (no score)

Requirements for gynaecological (cervical cytology)

• 9.4 Are results reported to cervical cytology registers?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 9.5 Are 90% of samples reported within 5 working days?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

Requirements for the use of liquid based collection systems and semi-automated screening devices in the practice of gynaecological (cervical) cytology

• 1.3.1 Does the workload in the lab exceed 70 slides per person per day for manual primary screening of liquid based saamples?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• 1.3.2 Does the workload in the lab exceed 150 slides per person per day for semi-automated imaging techniques for liquid based cytology?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

Performance measures for Australian laboratories reporting cervical cytology

• Are all performance measures met?

  Yes

  No

• Has an investigation and appropriate actions been undertaken?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• No additional NPAAC specific questions, move to next section

Requirements for the performance of anatomical cut-up

• S1.1 Do all staff performing cut-up have training records for the level of complexity of tissue?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Obsesrvation

  Major

  Minor

  Observation

• Riskman number

• S2.2 Are cut-up competencies performed at least annually for all cut-up staff who are not pathologists?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Obsesrvation

  Major

  Minor

  Observation

• Riskman number

• S3.1 Does the lab have a cut-up manual?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Obsesrvation

  Major

  Minor

  Observation

• Riskman number

• Does the laboratory perform HIV and/or HCV testing?

  Yes (no score)

  No (no score)

• No additional NPAAC specific questions, move to next section

HIV and HCV

• S6.2 Are all methods in use on the Australian Register of Therapeutic Goods?

  Yes

  No

• Please classify finding as Major, Minor or Obsesrvation

  Major

  Minor

  Observation

• Riskman number

• S6.3 Are all reactive screening results confirmed?

  Yes

  No

• Please classify finding as Major, Minor or Obsesrvation

  Major

  Minor

  Observation

• Riskman number

• S6.4 Are all methods documented? Note: kit package inserts are not sufficient

  Yes

  No

• Please classify finding as Major, Minor or Obsesrvation

  Major

  Minor

  Observation

• Riskman number

• S7.10 Are written records of reactive or equivocal screening results available for HCV and HIV before supplemental test results are available?<br>(Reports should not be available)

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Obsesrvation

  Major

  Minor

  Observation

• Riskman number

Requirements for cytogenetic testing

• S3.2 Are prenatal specimens divided and cultured in 2 separate incubators?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S3.4 Do all CVS studies include analysis of long term cultures?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.1 For prenatal karyotype studies are at least 5 banded cells analysed?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.4 Is a copy of the most recent ISCN available in the lab?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.5 Are all chromosomal analysis results checked by a second cytogeneticist?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.6 Are at least 2 karyotype images prepared and archived?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S5.4 Is a separate area available for FISH analysis?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S5.5 Are signals for FISH analysis scored by 2 independent analysts?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S8.2 Are images duplicated and spatially separated for storage?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

Requirements for medical testing of human nucleic acids

• S6.18 Is the quality, intensity of labelling, quality of hybridisation, scanning and analysis of microarray samples monitored?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

Requirements for medical testing of human nucleic acids

• S1.3 Is consent for level 2 testing obtained and documented?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S2.3 Are reports annotated where tests are performed on samples already used for other purposes?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.1 Are genetically modified organisms used?

  Yes

  No

• Does the laboratory take appropriate precautions and monitor?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.3 Are procedures in place to prevent and detect contamination including no-template controls?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.5 Are the following activities in separate areas? Tick boxes below

• Preparation of reagents?

• Nucleic acid extraction, preparation and handling before ampliication?

• Amplification and product detection?

• Manipulation of sample prior to a second round of amplification?

• Was each box above ticked?

  Yes

  No

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.8 Are lab coats and gloves changed before staff move between areas where there is a risk of contamination?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S4.10 Does the laboratory maintain records of contamination events?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S5.2 Are nucleic acids stored and labelled in a way that minimises degradation, contamination, misidentification and loss of identification?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.3 Is the sensitivity of the screening assay for detecting pathogens cited in reports?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.4 Are genotypes of variants detected by a screening assay confirmed by a second method?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.6 Is the region of interest that is to be sequenced clearly identified?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.7 Are quality score limits for acceptable sequence data established?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.9 Are positive and negative controls used for each genotype being assayed?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.10 Are multiplexed assays validated for cross reactivity?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.12 Is the sequence of PCR primer sites regularly assessed for polymorphism?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.14 Is the quality of nucleic acids used as the substrate for a quantitative assay assessed and reported?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.18 Is the quality, intensity of hybridisation, scanning and analysis of microarray samples monitored?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.23 Are procedures for determining the adequacy of a sample in terms of amount of template and quality validated?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S6.26 Is maternal cell contamination assessed in all prenatal tests?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S7.7 Are any samples tested from any external laboratories?

  Yes

  No

• Is the sample ID of the referring laboratory reported?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S7.8 Are gene/s or genetic loci being assayed identified on the report?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S7.9 Is the reference sequence used by the lab specified on the report?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• S7.16 Is predictive testing reported?

  Yes

  No

  N/A

• Is there a statement regarding the use of a positive control for a family specific variant?

  Yes

  No

  N/A

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number

• No additional NPAAC specific questions, move to next section

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 photo evidence if required

  Media

• Please classify finding as Major, Minor or Observation

  Major

  Minor

  Observation

• Riskman number