Quality manual

4.13 Control of Records

The identification, collection, indexing, access, storage, maintenance and safe disposal of documentation pertaining to the Quality Management System is implemented through the following procedures:

• 
  QP-GEN-0010 Writing of a Standard Operating Procedure
  
• 
  MP-GEN-0002 Management of Documentation, Preparation and Control
  
• 
  MP-GEN-0003 Management of Process and Quality Records
  

Retention and storage of pathological records and specimens are in accordance with the recommendations of the Royal College of Pathologists as they apply to the retention and storage of pathological records and specimens and also the INAB Regulations.

Records are created concurrently with performance of each activity that affects the quality of the examination.
All personnel involved in the delivery of services are required to read and sign off on MP-GEN-0002 Management of Documentation, Preparation and Control which stipulates that all records must be completed in a legible manner.
Records are stored on hard copy and by electronic means. The Department of Pathology take all possible steps to ensure that technical records are stored in an environment that prevents damage, deterioration or unauthorised access. Access to both the Laboratory Information System and Q-Pulse are password protected.
MP-GEN-0002 Management of Documentation, Preparation and Control stipulates the length of time that each type of documentation generated through the Quality Management System and documents pertaining to pre-examination, examination and post-examination processes are retained. Reported results are retrievable for as long as medically relevant or as required by regulation.

For some records, especially those stored electronically, the safest storage may be on secure media and an offsite location.

These records include but are not limited to the following:

1. 
   Supplier selection and performance and changes to the approved supplier list
   

2. 
   Staff qualifications, staff training and competency records maintained in individual staff folders
   

3. 
   Request forms (including the patient chart or medical record only if used as the request form)
   

4. 
   Records of receipt of samples in the laboratory stored in the laboratory information system
   

5. 
   Information on reagents and materials used for examinations [e.g. lot documentation, certificates of supplies, package inserts]
   

6. 
   Laboratory work-books/work-sheets
   

7. 
   Instrument printouts and retained data and information
   

8. 
   Examination results and reports stored in the laboratory information system
   

9. 
   Instrument maintenance records, including internal and external calibration records
   

10. 
    Calibration functions and conversion factors
    

11. 
    Quality control records
    

12. 
    Incident/accident records and action taken
    

13. 
    Accident records and action taken
    

14. 
    Risk Management records
    

15. 
    Nonconformities identified and immediate or corrective action taken logged on Q-Pulse
    

16. 
    Preventive action taken logged on Q-Pulse
    

17. 
    Complaints and action taken logged on Q-Pulse
    

18. 
    Records of internal and external audits
    

19. 
    Inter-laboratory comparisons of examination results
    
20. 
    Quality improvement records
    

21. 
    Minutes of meetings that record decisions made about the laboratory’s quality management activities
    

22. 
    Records of management reviews
    

All of these quality and technical records are available for laboratory management review. A list of authorising signatures and the name printed in capitals allows traceability of the requesting clinician. Storage of Quality and Technical Record hard copies are externally contracted to Iron Mountain. There is a Service Level Agreement in place with Iron Mountain and Our Lady’s Hospital, Navan.

Records	Minimum Retention Period
Request forms (Blood Transfusion) Request Forms (All other Departments)	30 yrs (as contains signatures) 1 Month
Examination results and reports	30 yrs
Instrument printouts	5 Years
Examination procedures	While method is current and 5 years
Laboratory work-books or sheets	30 yrs
Accession records	30 yrs
Calibration records and conversion factors	Life time of instrument and a minimum of 10 yrs
Quality control records	10 yrs
Complaints and action taken	5 yrs
Records of internal and external audits	5yrs
External quality assessment records /inter laboratory comparisons	5yrs
Quality improvement records	5 yrs
Instrument maintenance records, including internal and external calibration records	30yrs
Lot documentation, certificates of supplies, package inserts	30yrs
Incident/accident record and action taken	30yrs
Staff training and competency records	30yrs

Table 4 List of Blood Transfusion Records and their Associated Minimum Retention Times