Quality manual

4.7 Advisory Services

In order to meet the needs of patients and all clinical personnel responsible for patient care, the Department of Pathology provides advisory services as required to all users, as described in QP-GEN-0007 Advisory Services.

The laboratory has arrangements for communicating with users on the following:

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  Advising on choice of examinations and use of the services, including type of sample, clinical indications and limitations of examination procedures and the requesting the examination LP-GEN-0007 User Manual.
  
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  The Consultants are available to provide advice on all issues relating to the individual specialities including appropriate interpretation of tests to meet the needs of patients and all clinical personnel responsible for patient care. The Consultants are contactable 24 hours through the switchboard at Our Ladys Hospital Navan (OLHN). The rota is located at the switchboard of OLHN.
  
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  Appropriate (qualified / experienced) scientific staff provides advice to clinicians / users on choice of examinations and use of services, including repeat frequency and type of sample required for testing. Where appropriate, interpretation of the results of examinations will be provided by either the Consultant or the Medical Scientist, as appropriate.
  
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  Promoting the effective utilization of laboratory services.
  

Meetings between Department of Pathology and Hospital staff e.g. Regional Hospital Blood Transfusion Committee, are held regularly regarding the use of the services and for the purpose of consultation on scientific and Haemovigilance & Traceability matters. The Consultant Haematologist responsible for Blood Bank gives advice on managing Serious Adverse Events and Reactions. Haematology staff attend the Hospital Project Group for the introduction of RAID, the software system used to manage the patients attending the Warfarin Clinic. Advice in particular is given on IT issues and the level of the Phlebotomy Services required and planned for the clinic. The Microbiology Consultant gives advice on Infection Prevention & Control.
The National Haemovigilance Office provides advice (through the Haemovigilance Officer) on all Haemovigilance & Traceability related issues, in addition to issuing recommendations and providing training and education for both Medical Scientists and the Haemovigilance Officer. The Medical Consultant and Medical Scientific personnel at the Irish Blood Bank Service (I.B.T.S.) provide clinical advice as required.

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  Consulting on scientific and logistic matters such as failure of samples to meet acceptance criteria
  

4.8 Resolution of Complaints

The Department of Pathology documents and investigates all perceived or real grievances from Clinicians, patients or other related parties pertaining to any aspect of the services, through QP-GEN-0008 Complaints Procedure. The procedure describes the management of complaints or other feedback received from clinicians, patients, laboratory staff or other parties.

All complaints are raised as non-conformances on Q-Pulse as described in QP-GEN-0005 Control of Non-Conformances.
All complaints are investigated as per QP-GEN-0008 Complaints Procedure by the Quality Co-ordinator in conjunction with the Chief Medical Scientist. Based on the findings, suitable corrective and preventative actions are identified as appropriate, to prevent a recurrence of the issue. All investigative actions, findings, root cause analysis, description and categorisation of the complaint as well as immediate corrective actions and corrective actions taken are documented.

The medical significance of the complaint is always considered and resolution of complaint addresses any issue in this area.

In addition, QP-GEN-0008 Complaints Procedure is used to evaluate and monitor the perceived quality and appropriateness of the service provided by the Department of Pathology and its contribution to patient care.
As defined in QP-GEN-0008 Complaints Procedure, the Quality Co-ordinator is responsible for the tracking and trending of complaints, associated non-conformances and user feedback, thus enabling a review of effectiveness of Corrective (and Preventative Actions if applicable).
All complaints and user feedback are discussed at Quality Meetings as described in MP-GEN-0021 Quality Meetings.

9. Identification and Control of Non-Conformances

4.9.1 The Department of Pathology implements a non-conformance system as per QP-GEN-0005 Control of Non-Conformances when it detects:

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  A non-conformance in any aspect of the quality management system including pre-examination, examination or post examination processes that does not conform to its own procedures.
  
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  The requirements of the Quality Management System that are not met.
  

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  The requirements of the requesting clinician that are not met.
  

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  Haemovigilance & Traceability requirements that are not met.
  

All staff can raise a non-conformance. Investigation, resolution and implementation of appropriate corrective and preventative actions are performed in conjunction with the relevant department.

Non-Conformances can occur in many different areas and can be identified in many different ways such as quality control indicators, instrument calibrations, checking of consumable materials, staff comments, reporting and certificate checking, audits, complaints etc.
The Quality Co-ordinator is responsible for implementing and managing the Non-Conformance System which is managed through Q-Pulse.
QP-GEN-0005 Control of Non-Conformances is designed to ensure that:

1. 
   The Quality Co-ordinator is responsible for implementing and managing the Non-Conformance System. The Quality Co-ordinator investigates and resolves the non-conformance in conjunction with the Chief Medical Scientist, Haemovigilance Officer and Consultant as appropriate.
   

2. 
   The immediate actions to be taken in the event of a non-conformance are defined in QP-GEN-0005 Control of Non-Conformances. Actions to be taken include reporting, investigative actions, investigation of impact, Corrective and Preventative Actions, Identification of the Root Cause and Classification of the non-conformance.
   

3. 
   The immediate actions to be taken are defined.
   

d) When a non-conformance has been identified which may impact upon other specimens being processed, examinations are halted and reports withheld as necessary. The responsibility for the halting of laboratory examinations lies with the Chief Medical Scientist. All affected clinicians / users of the service are informed of the halting and subsequent resumption of examinations by Chief Medical Scientist/Consultant as deemed appropriate. Corrective action is taken as soon as possible upon detection of the non-conformance. The timeframe for execution of corrective action is cognisant of the urgency of the incident. The target close out for non-conformances is up to 90 days depending on the nature of the non-conformance.

e) The medical significance of the all non-conformance is considered and signed off by the appropriate Consultant.
f) The results of non-conforming examinations already released are recalled or appropriately identified, as deemed necessary by the Chief Medical Scientist. Where reports with erroneous results have been released the procedure used for their retrieval, replacement and communication to the relevant clinician is detailed in MP-GEN-0014 Reporting of Results.

7. 
   The responsibility for authorisation of the resumption of examinations lies with the Consultant in conjunction with the Chief Medical Scientist.
   

8. 
   Non-conformances are reported via Q-Pulse. The Quality Co-ordinator is responsible for the tracking and trending of non-conformances at regular intervals enabling a review of effectiveness of Corrective and Preventative Actions. Non-conformances and emerging trends are discussed at Monthly Quality Meetings and Management Review Meetings.
   

Following investigation / review of a non-conforming pre-examination, examination and post-examination process where it is found that it could recur or that there is doubt about the compliance the department with its own policies or procedures as stated in the Quality Manual, then trouble shoot/cause and analysis methods are used to identify, document and eliminate the root cause of this problem. This corrective action is promptly implemented. All supporting documentation is attached to the non-conformance.

As defined in QP-GEN-0005 Control of Non-Conformances, if there is a non-conformance which has an impact on results, the release of such results or review of previously released results will be investigated by the Chief Medical Scientist and the Consultant, as appropriate.