VERTICAL AUDIT CHECKLIST FORM

VERTICAL AUDIT CHECKLIST FORM Lab Accession Number (s) 04/9999 Report number AUD-04-001 Examination date 11/02/04 Department Title NGRL (Manchester) Section DNA Lab Name of assessor Simon Patton Date and signature of assessor 11/02/04 Signed Name of assessor A Nother Date and signature of assessor 11/02/04 Signed Name of assessor Date and signature of assessor Instructions 1. Select laboratory accession number(s) either from the computer record or from work sheets/day book etc. 2. Audit from receipt of request to issuing of report. Information for users Is there information readily available to users relating to specimen requirements for these tests? Check:- User handbook E 1.1 E 1.2 Request card checked / summary information for service users ( ) () () Summary information available for referrers not under document control Non NC-04-001 E 1.3 E 1.4 Does not apply No direct patient contact with laboratory. Version no. 1.0 Page 1 of 8

Specimen transportation Are there procedures for specimen transport? ( ) () () E 4 Test request cards Card could benefit from additional information such as transport and packaging needs. Check also that it meets posting regulations. Non Is there evidence of procedures meeting all Health and Safety requirements? C 5 SOP checked Check:- Model rules for couriers, porters and general public C 3 E 1.2 Check with referring departments Packaging, labelling and dispatch procedures C 5 Check with referring departments Procedures in the event of spillage C 5.3 SOP checked Incident reporting procedures C 5.3 SOP checked Request form Is the request form available for the specimen? E 1 E 2 Test request card for 04/9999 Is there sufficient information to allow unique identification of: Sufficient information available on request card the patient the specimen Version no. 1.0 Page 2 of 8

Are details relating to the patient and specimen available: ( ) () () Non date and time of collection type of specimen investigations requested date and time of receipt clinical information Has transcription of the tests requested been done accurately? Check:- computer entry with original request form. D 2 LIMS entry for 04/9999 Data transcription looks OK. Checked by Duty Scientist. Sample collection Has the sample been collected in the appropriate container and in the correct manner? E3 E 1.3 LIMS entry for 04/999 and patient referral card Correct tube was used EDTA vacutainer discarded after blood transfer. Are facilities for patients satisfactory? Retained material Are there documented procedures available for storage of clinical material? Are records /logs held of all items retained relating to this laboratory number? Have the relevant specimens been retained in accordance with this procedure? C 3 Does not apply laboratory does not see patients. A 10 Q-Pulse No laboratory policy on storage of clinical material LIMS All material is archived indefinitely consent was given at time of consultation. Need policy on retention and disposal of tumor blocks. Policy needed see above NC-04-002 Version no. 1.0 Page 3 of 8

Is retained material uniquely identified? ( ) () () Laboratory freezers All samples are allocated unique laboratory number on entry into LIMS system. Non Is material readily accessible? Laboratory freezers Stored in freezers location available on LIMS Are facilities for storage suitable for the purpose and in accordance with current legislation and guidelines? C 4 Laboratory freezers Rooms are locked, freezers maintained and temperature logged with automatic warning system. Disposal procedures Are procedures established for safe disposal of these samples? Are procedures in accordance with current legislation and guidelines? C 5 Q-Pulse / LP 000 088 Check current guidelines Specimen Reception Are there procedures for sample receipt and booking in? Are there procedures for handling urgent work? E 5 Q-Pulse E 5.1 Q-Pulse Are there criteria for rejection of specimens? E 5.2 Q-Pulse Are there procedures for ensuring staff safety? E 5.1 Q-Pulse If the sample or sub sample was referred to another laboratory, are records in place of tests sent away? E 6 A 8 LIMS Version no. 1.0 Page 4 of 8

Examination procedures Have procedures been validated for intended use prior to introduction? List data examined Are there documented standard operating procedures readily available and are they detailed enough to allow a consistency of application? List those checked Is there evidence of document control procedures in place? State last revision date. Is there evidence of review of procedures? State date of last review. ( ) () () F 1.2 Q-Pulse All tests are validated prior to use BUT no document procedure available F 2 Q-Pulse LP 000 061: operating protocol for a Cystic Fibrosis test. A 8 Q-Pulse LP 000 099: Policy on document control. Last updated on 23 rd April 2003 Q-Pulse Q-Pulse has auto tracking of review dates. Archive last reviewed on 23 rd Jan 2004. Non NC-04-003 Were procedures followed in accordance with documented method? F 3 SOP, MTO and clinical scientist A Nother 1, A Nother 2. Possible examination audit? Not possible to tell whether SOP followed correctly. List analysts checked. Are records available for each stage of the procedure such that there is a complete audit trail of staff, equipment reagents and quality control procedures involved? D 1 D 3 LIMS, PCR sheets, Worksheets, Reports Full audit trail of sample possible. Batch numbers not recorded on worksheet XXXX. NC-04-004 List all records examined Where equipment was observed being used, is there evidence of : Retrospective audit this does not apply to this audit. Routine maintenance and daily checks been performed as appropriate? Version no. 1.0 Page 5 of 8

Is there review of quality control results and EQA F 3/H5 Q-Pulse, Quality Manager s EQA files ( ) () () Regular review of QC results and EQA reports Non List equipment checked Staff training For those staff observed performing the tests, is there evidence of appropriate staff training and education? B 2.2 B 6 B9 Staff interviews Retrospective audit staff not observed doing the test. Both staff members have training records which appear to be up to date. Is there evidence of adequate supervision, where appropriate? Staff interviews Do staff have job descriptions and contracts of employment? List records examined. B 5 Staff interviews, staff records Have staff had recent annual joint review? B 7 Staff interviews Staff member A Nother 1 is 2 months overdue for annual staff appraisal NC-04-005 Do the laboratory hold evidence of state registration where relevant? B 2.2 Staff interviews Is there evidence of annual leave and sickness review? B 6.2 Monthly audit of staff attendance by secretary Is there evidence of attendance at fire lectures and other health and safety training? B 6.2 H&S log held by Laboratory Head. Do staff on questioning attend staff meetings? B 8 Staff interviews Minutes of meetings confirm regular attendance Version no. 1.0 Page 6 of 8

Is there evidence of continuous professional development? Reporting results Is a copy of test report able to be generated? ( ) () () B 9 Staff training records Both staff members have attended a recent conference. Staff member A Nother 2 is also participating in a distance learning course G 1 LIMS Electronic copies held on LIMS Non Are there any transcription errors between worksheets and the test report? G2.4 LIMS, worksheets None found Does the report contain sufficient information? G 2 Laboratory report for 04/9999 Found to be compliant with all required information and contains all relevant points set out in SOP on reporting Laboratory name Unique identifiers Dates of sample receipt, testing & reporting Sample description etc. Reference intervals and interpretative comments as appropriate G 5 Pagination e.g. Page 1 of 1 included where appropriate Is there evidence of the result being telephoned? G 3 LIMS Does the laboratory have procedures for telephoning results?? Check report Q-Pulse Version no. 1.0 Page 7 of 8

Have results been authorised by approved staff? Is the turnaround time acceptable? Does the laboratory monitor turnaround time routinely? A 1.3 G 5 ( ) () () LIMS, report Results verified on electronic genotyping form. Laboratory report countersigned by state registered clinical scientist after checking. H 4 LIMS, report Results reported in 14 days within turnaround time. The laboratory regularly monitors turnaround time and reports back quarterly to laboratory meeting. Non Version no. 1.0 Page 8 of 8