Quality manual

Post-Examination Processes

5.7.1 Review of Results
Only authorized trained personnel review the results of examinations, evaluate them in conformance with the clinical information available regarding the patient and authorize the release of the results. The procedure to be applied to the review and release of results, including urgent results is defined in individual departmental procedures.
The procedures also describe that the authorised personnel ensures review of the results of examinations before release and evaluates them against internal quality control and, as appropriate, available clinical information and previous examination results.
When the procedure for reviewing results involves automatic selection and reporting, review criteria is established, approved and documented.

2. 
   Storage, Retention and Disposal of Clinical Samples
   

The Blood Bank has documented procedures for the identification, collection, retention, indexing, access, storage, maintenance and safe disposal of clinical samples.

The laboratory defines the length of time, clinical samples are to be retained. Retention times are defined by the nature of the sample, the examination and any applicable requirements.
All clinical material i.e. primary samples are retained and stored in accordance with the requirements, thus ensuring the validity of a repeat examination, if required. Samples are finally disposed of in accordance with the ED-GEN-0035 Guidelines for Management of Healthcare Waste 2010 and MP-GEN-0007 Staff Health and Safety Manual.
Safe disposal of samples no longer required for examination are carried out in accordance with the ED-GEN-0035 Guidelines for Management of Healthcare Waste 2010 and MP-GEN-0007 Staff Health and Safety Manual.

7. Reporting of Results

5.8.1 General
There is a procedure in place to describe reporting of results in the laboratory

MP-GEN-0014 Reporting of Results. The results of each examination are reported accurately, clearly, unambiguously and in accordance with any specific instructions in the examination procedures.
The laboratory defines the format and medium of the report (i.e. electronic or paper) and the manner in which it is to be communicated from the laboratory.
The format of reports is decided by the Chief Medical Scientist with input from Consultants, Scientific Staff and Laboratory IT Co-ordinator. Users may raise issues relating to the quality of the results report through QF-GEN-0001 Pathology Laboratory In-House Satisfaction Survey and QF-GEN-0002 Pathology Laboratory General Practitioner Satisfaction Survey which are distributed and reviewed, or the Complaints System, as described in QP-GEN-0001 User Satisfaction, QP-GEN-0008 Complaints Procedure.
The laboratory has procedures to ensure the correctness of transcription of laboratory results.
Reports include the information necessary for the interpretation of the examination results.

2. 
   Report Attributes
   

The Department of Pathology ensures that the following report attributes effectively communicate laboratory results and meet the users’ needs:

1. 
   Comments on sample quality that might compromise examination results
   

2. 
   Comments regarding sample suitability with respect to acceptance/rejection criteria
   

3. 
   Critical results, where applicable
   

4. 
   Interpretive comments on results, where applicable, which may include the verification of the interpretation of automatically selected and reported results in the final report.
   

2. 
   Report Content
   

The report includes, but is not limited to, the following:

a) Clear, unambiguous identification of the examination, where appropriate the examination procedure
b) Identification of the department which issued the report
c) Identification of all examinations that have been performed by a referral laboratory
d) Unique identification (Medical Record Number) and location of the patient (Hospital Ward) where possible, and destination of the report
e) Name or unique identifier of the requester (Clinician) and the requester’s contact details
f) Date of primary sample collection and time when available and relevant to patient care.
g) Primary sample type.
h) Measurement procedure, where appropriate
i) Examination results reported in SI units, units traceable to SI units or applicable units
j) Biological reference intervals, where applicable, clinical decision values or diagrams supporting clinical decision values, where applicable

11. 
    Interpretation of results, where appropriate
    

12. 
    Other comments such as cautionary or explanatory notes e.g. quality or adequacy of the primary sample which may have compromised the result, results/interpretations from referral laboratories, use of developmental procedure
    

13. 
    Identification of examinations undertaken as part of a research or development programme and for which no specific claims on measurement performance are available (this is rarely, if ever, applicable to this laboratory)
    

14. 
    Identification of the person reviewing the results and authorising the release of the report i.e. the individual identification of the Medical Scientist is printed on the report (if not contained in the report, readily available when needed). The initials of the Medical Scientist checking and releasing the report are recorded on the report (Blood Bank).
    

15. 
    Date of the report and time of release (if not contained in the report, readily available when needed)
    

16. 
    Page number of total number of pages (e.g. “Page 1 of 5”, Page 2 of 5”, etc)
    

The description of tests and results are presented in clear, unambiguous language, using syntax as recommended by:

• 
  International Council for Standardisation in Haematology (ICSH)
  
• 
  International Society for Blood Transfusion
  
• 
  SNOMED International (College of American Pathologists)
  
• 
  World Health Organisation (WHO)
  

7. Release of Results

5.9.1 General
The Department of Pathology has clearly documented procedures for the release of examination results, including details of who may release results and to whom. The procedures ensure release of results to requesting clinicians/clinical areas/hospital staff only. The Laboratory policy on result reporting is that a result of an examination/test is never issued directly to patients. This is implemented through MP-GEN-0014 Reporting of Results.
The procedures ensure that the following conditions are met:

1. 
   When the quality of the primary sample received is unsuitable for examination, or could have compromised the result, this is indicated in the report. The test report indicates if the quality of the primary sample received was unsuitable for examination or could have compromised the result e.g. haemolysis. It is endeavoured to check samples conformance to defined acceptability criteria as soon as possible upon receipt by the Department of Pathology. Where samples do not meet acceptability criteria, this information is entered on the LIS and is authorised immediately by a Medical Scientist to facilitate timely communication to wards. In urgent cases, this information is also telephoned to the requesting clinician.
   

2. 
   The Department of Pathology has procedures in place for immediate notification of a clinician (or other clinical personnel responsible for patient care) when examination results for critical properties fall within established “alert” or “critical” intervals. This practice also applies to results received on samples sent to referral laboratories for examination.
   

Records are maintained of actions taken that document date, time, responsible laboratory staff member, person notified and examination results conveyed and any difficulties encountered in notifications.

3. 
   Results are legible, without mistakes in transcription and reported to persons authorized to receive and use the information.
   

d) When results are transmitted as an interim report, the final report is always forwarded to the requester.

e) There are processes for ensuring that results distributed by telephone or electronic means reach only authorized recipients. Results provided orally are followed by a written report. There are records of all oral results provided.
Results of laboratory examinations that have been separated from all patient identification may be used for such purposes as epidemiology, demography or other statistical analyses.
Copies of all in-house generated results are retained electronically on the Laboratory Information System (LIS). This ensures prompt retrieval of the information.
5.9.2 Automated selection and reporting of results
The Department of Pathology does not use any system for automation and reporting of results.
5.9.3 Revised Reports
When an original report is revised there are written instructions regarding the revision so that:

1. 
   The amended report is clearly identified as an amended report
   

2. 
   The user is made aware of the revision
   

3. 
   The amended record shows the time and date of the change and the name of the person responsible for the change. This is viewable in the audit trail and paper copy of report.
   

4. 
   The original report entries remain in the audit trail when amendments are made
   

This is in accordance with MP-GEN-0014 Reporting of Results.

5.10 Laboratory Information Management

5.10.1 General

There is a procedure in place to describe the Laboratory Information System (LIS) used in the MP-GEN-0012 Management and Operation of Apex. Work undertaken in the department is logged on Apex and reports are stored indefinitely in the system.

The laboratory has a documented procedure to ensure that the confidentiality of patient information is maintained at all times. This is described in MP-GEN-0011 Management of Data and Information.

The central Apex main server is located at HSE DNE Headquarters, Kells, Co. Meath and is managed by the ICT Department, Kells. The LIS database is backed up nightly at 9.00pm and the whole system is backed up weekly on Wednesday mornings at 5.30am. The back-up tapes are stored in a secure fire proof location in the HSE DNE headquarters in Kells.

5.10.2 Authorities and Responsibilities

The laboratory ensures that the authorities and responsibilities for the management of the information systems are defined, including the maintenance and modification to the information system that may affect patient care. This is described in

MP-GEN-0012 Management and Operation of Apex, LP-HAEM-0018 Operation of APEX in the Haematology Laboratory and LP-BT-0003 Operation of Apex in Blood Transfusion, LP-MIC-0082 Microbiology Apex Procedures.

The laboratory defines the authorities and responsibilities of all personnel who use the system, in particular those who:

1. 
   Access patient data and information (all staff have read and signed off “Data Protection – It’s everyone’s responsibility: An Introductory Guide for Health Service Staff) Apex access levels and general security are defined in
   

MP-GEN-0012 Management and Operation of Apex.

2. 
   All users of the Laboratory Information System are trained to ensure competence for entering patient and examination data. Entering examination data is covered during departmental training.
   
3. 
   The procedure for the amendment of examination results is outlined in
   

MP-GEN-0014 Reporting of Results.

4. 
   The procedure for the authorization of results is described in MP-GEN-0014 Reporting of Results.
   

5.10.3 Information System Management

The systems used for the collection, processing, recording, reporting, storage or retrieval of examination data and information include:

• 
  Apex (Laboratory Information System)
  
• 
  Electronic Blood Track System
  
• 
  Q-Pulse
  

The laboratory information system is described for the Department of Pathology and Laboratory Medicine in MP-GEN-0012 Management and Operation of Apex, LP-HAEM-0018 Operation of APEX in the Haematology Laboratory and in LP-BT-0003 Operation of Apex in Blood Transfusion, LP-MIC-0082 Microbiology Apex Procedures. Apex is supplied by CSC and was upgraded to Version 5.8 in March 2013.

The main functions of the LIS are as follows:

• 
  To store patient, specimen and test details
  
• 
  To identify the status of tests
  
• 
  To enter results
  
• 
  To store test results in relation to patient details
  
• 
  To provide results enquiry options
  
• 
  To generate reports and labels of results and Blood Products respectively
  
• 
  To provide statistical information on laboratory throughput
  
• 
  Manage in part the traceability of Blood Products
  

If a procedure requires alterations to reports, the LIS transition log defines the time, date and name of person responsible for the change. An audit is maintained of reports, which have been revised. The audit trail provides details of who made the amendment(s), details of the amendment(s) and the date and time of all actions. These reports are easily retrievable and available to relevant clinical personnel. This is described in MP-GEN-0012 Management and Operation of Apex.

The Laboratory IT Co-ordinator and the Senior Medical Scientist manages the LIS software application. They ensure that:

• 
  Computer software, including that built into equipment, is adequate for use in the facility
  
• 
  Procedures are established and implemented for protecting the integrity of data at all times
  
• 
  Computers are maintained to ensure proper functioning with environmental and operating conditions necessary for maintaining the integrity of data.
  
• 
  Computer programmes and routines are adequately protected to prevent access, alteration or destruction by casual or unauthorised persons.
  

Access to the LIS is password controlled and user security is set up and maintained to ensure data integrity. External access to the LIS is read-only access to authorised blood results. Haemovigilance records are stored in a password protected computer in the Haemovigilance Office.
Electronic Blood Track System

The Electronic Blood Track System is used to monitor blood product from the time it is placed in the fridge or freezer to the time of removal for use. The system consists of two major components, the Blood Track Manager and the Blood Track Courier Kiosk. The database is located on a national server in a high availability virtualised server environment in the HSE National Data Centre in Clonshaugh. The system is subject to data protection and back-up as appropriate. The use of EBTS is described in LM-BT-0015 Crossmatching using Gel Technology and HP-GEN-0002 Collection of Blood Products from the Blood Transfusion Laboratory.

Q-Pulse

Q-Pulse is a tool which compromises a series of interacting modules designed to streamline key quality management system functions. Modules in Q-Pulse include Document Management for managing a document and change control of policies and procedures; CA/PA Module for capturing and managing non-conformances and complaints; and Audit Management for planning, scheduling and reporting on the audit and verification activities. An overview of the system is described in

MP-GEN-0018 Management and Operation of Q-Pulse.

These systems are:

1. 
   Validated by the supplier and verified for functioning by the laboratory before introduction, with any changes to the system authorized, documented and verified before implementation. For the Apex System see VMP-GEN-0001 Validation Master Plan and IOQ-BT-0008 IOQ APEX 5.8. For the Electronic Blood Track system see PQ-BT-001 Performance Qualification Protocol for Electronic Blood Track System.
   
2. 
   Documented and the documentation, including that for day to day functioning of the system, readily available to authorized users.
   

3. 
   Protected from unauthorized access. Access to all systems is password controlled and user security is set up and maintained to ensure data integrity.
   

4. 
   Safeguarded against tampering or loss. The requirement to provide a log on code for access, graded levels of access, audit trails and automatic logout safeguards from unauthorised adjustments or tampering that might invalidate examination results. Where adjustments are made, these are documented through MP-GEN-0019 Management of Change Control.
   

5. 
   Operated in an environment that complies with supplier specifications or, in the case of non-computerized systems, provides conditions which safeguard the accuracy of manual recording and transcription.
   

6. 
   Maintained in a manner that ensures the integrity of the data and information and includes the recording of system failures and the appropriate immediate and corrective actions.
   

7. 
   In compliance with national and international requirements regarding data protection. This is described in MP-GEN-0011 Management of Data and Information.
   

The laboratory verifies that the results of examinations, associated information and comments are accurately reproduced, electronically and in hard copy where relevant, by the information systems external to the laboratory intended to directly receive the information (e.g. computer systems, fax machines, e-mail, website, personal web devices). When a new examination or automated comments are implemented, the laboratory verifies that the changes are accurately reproduced by the information systems external to the laboratory intended to directly receive information from the laboratory.

The laboratory has a documented contingency plan to maintain services in the event of failure or downtime in information systems that affects the laboratory’s ability to provide service. This is described in LP-GEN-0015 Laboratory Contingency Plan.
The information systems are managed and maintained on-site and laboratory management is responsible for ensuring that the operator of the system complies with all applicable requirements of ISO 15189:2012. This is in accordance with MP-GEN-0011 Management of Data and Information.

2. APPENDICES

Appendix 1	Organisational Structures QF-GEN-0060 Pathology Laboratory Organisational Chart
Appendix 2	Schedules of Testing LF-BT-0111 Blood Transfusion Schedule of Testing (ISO 15189 Accredited) QF-BIO-0007 Biochemistry Schedule of Testing LF-HAEM-0111 Haematology Schedule of Testing
Appendix 3	QF-GEN-0063 Process Flow for the Quality Management System
Appendix 4	LF-BT-0110 Process Flow for Blood Products Through and To/From the Hospital
Appendix 5	LF-BT-0112 Process Flow for Receipt, Storage and Retention in Blood Bank
Appendix 6	LF-BT-0013 Process Flow for ABO Grouping & RhD Typing and Antibody Screen

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