Quality manual

Examination by Referral Laboratories

1. 
   Selecting and Evaluating Referral Laboratories
   

MP-GEN-0016 Management and Review of Contracts describes the system in use for evaluating, selecting and using referral laboratories.

The procedure ensures that the following conditions are met:

1. 
   The laboratory, with the advice of users of laboratory services where appropriate, is responsible for selecting the referral laboratory, monitoring the quality of the performance and ensuring that the referral laboratories are competent to perform the requested examinations.
   

2. 
   The Department of Pathology operates an appropriate system for evaluating and selecting referral laboratories. Arrangements with referral laboratories are reviewed and evaluated periodically to ensure compliance with the relevant parts of ISO 15189.
   

3. 
   Records of such periodic reviews are maintained.
   

4. 
   A register of all referral laboratories is maintained.
   

5. 
   Requests and results of all samples are kept for a pre-defined period.
   

2. 
   Provision of Examination Results
   

The following circumstances may require the referral of accredited tests:

• 
  Following equipment breakdown and where urgent specimens must be processed and resulted immediately and where a backup methodology is not available or practicable
  

• 
  In the case of the Blood Bank, where external serological investigations are required to confirm or identify a pattern of results e.g. complex antibody investigation including provision of compatibility services by the Irish Blood
  

Transfusion Service.

• 
  In the case of Haematology, Biochemistry and Microbiology, where the tests requested are not processed in the Haematology, Biochemistry or Microbiology Departments.
  

Unless otherwise specified in the agreement, the laboratory (and not the referral laboratory) is responsible for ensuring that examination results of the referral laboratory are provided to the person making the request. As described in MP-GEN-0014 Reporting of Results, it is the policy of the Department of Pathology to ensure that results, (specifically all essential elements of results) are returned to the requesting clinician.

When the laboratory prepares a report, it includes all essential elements of the results reported by the referral laboratory or Consultant, without alterations that could affect clinical interpretation. The report indicates which examinations were performed by a referral laboratory or Consultant. The Department Of Pathology retains a record of all referral tests specific to individual patients on Apex. In addition, in the Blood Bank, LF-BT-0053 IBTS Referral Record Form is used and this contains the details of all samples referred. In Haematology, LF-HAEM-0040 Haemoglobin S Screening, Internal Quality Control and Test Results and LF-HAEM-0038 Record of Malaria Screen, Internal Quality Control and Patient Test Results are used and they include the results of the referred tests for Sickle Cell and Malaria Screening.
The name and address of the referral laboratory responsible for the examination result is clearly indicated on the result report. Results from the referral laboratory are reviewed for accuracy by a Senior Medical Scientist and entered into the LIS system including all essential elements of the results reported by the referral laboratory, without alterations that could affect clinical interpretation. The relevant Consultant may elect to provide additional interpretative remarks to those of the referral laboratory, in the context of the patient and the local medical environment.

In such a case, the Consultant is clearly identified as author of the comments. The Consultant’s comments is entered on the LIS and double checked by another member of staff in accordance with MP-GEN-0014 Reporting of Results.

The laboratory adopts the most appropriate means of reporting referral laboratory results, taking into account turnaround times, measurement accuracy, transcription processes and interpretative skill requirements. In cases where the correct interpretation and application of examination results needs collaboration between clinicians and specialists from both the referring and the referral laboratories, this process is not hindered by commercial or financial considerations.

3. 
   Service Level Agreements
   

A Service Level Agreement is set-up for the use of the referral laboratories. An annual Quality Assessment Confirmation LF-GEN-0002 Quality Assessment Confirmation Form is sent annually to the referral laboratories for completion.

5. External Services and Supplies

The procedures for the selection and purchasing of external services, equipment, reagents, consumable supplies and off-site archiving that affect the quality of services provided by the Department of Pathology are defined through the following procedures:

• 
  MP-GEN-0009 Procurement and Management of Equipment
  
• 
  LP-GEN-0009 Equipment Validation
  
• 
  MP-GEN-0016 Management and Review of Contracts
  
• 
  VMP-GEN-0001 Validation Master Plan for the Blood Transfusion Laboratory
  

• 
  LP-BT-0002 Monitoring of Materials in Blood Transfusion
  
• 
  LP-BIO-0007 Batch Acceptance of Reagents, Calibrators, Q.C. and Consumables
  
• 
  LP-HAEM-0012 Batch Acceptance of Reagents in Haematology
  
• 
  LP-MIC-0065 Batch Acceptance in Microbiology
  

The Quality Co-ordinator maintains a list of equipment in use for Blood Bank, Haematology, Biochemistry and Microbiology. This list identifies at a minimum the following:

• 
  Name / Title of item of Equipment
  
• 
  Asset Number
  
• 
  Model Number
  
• 
  Manufacturer
  
• 
  Supplier
  
• 
  Criticality of the item of Equipment
  
• 
  Validation carried out (Yes / No)
  
• 
  Service Contract required (Yes/ No)
  
• 
  Calibration Required (Yes / No).
  
• 
  Maintenance required (Yes / No)
  
• 
  Service Contract set up and renewed (Yes / No)
  
• 
  Date of Last Service
  
• 
  Date next Service is due.
  

A log of reagents and consumables in use are also retained in each department.

The laboratory selects and approves suppliers annually based on their ability to supply external services, equipment, reagents and consumable supplies in accordance with the laboratory’s requirements; however, it may be necessary to collaborate with other organizational departments or functions to fulfil this requirement. All suppliers who supply external services, equipment, reagents and consumables that affect the quality of service are required to complete MF-GEN-0035 Supplier Questionnaire. All information obtained through supplier postal audits is reviewed on MF-GEN-0049 Evaluation of Supplier Form and retained.
Where information provided on MF-GEN-0049 Evaluation of Supplier Form does not meet requirements, the Department of Pathology may request additional information or visit the supplier’s premises to oversee the production facility and carry out an inspection audit to determine the suitability of the supplier.
Where documentation is provided that confirms the suppliers conformance with its quality management system, where a contract or service level agreement is in place and where there is a record that the equipment/consumable adequately complies with standard specifications and requirements, such suppliers are listed in the Suppliers module in Q-Pulse.
The laboratory monitors the performance of suppliers to ensure that purchased services or items consistently meet the stated criteria.
Purchased equipment that affects the quality of service are not used until they have been verified as complying with requirements defined in VMP-GEN-0001 Validation Master Plan for the Pathology Laboratory. The schedule and status of Preventative Maintenance for all items of equipment is logged in the Assets module in Q-Pulse.
Reagents and consumables that affect the quality of the service are only used when expected results are achieved, as defined in the procedure LP-BT-0002 Monitoring of Materials in Blood Transfusion, LP-BIO-0007 Batch Acceptance of Reagents, Calibrators, Q.C. and Consumables, LP-HAEM-0012 Batch Acceptance of Reagents in Haematology and LP-MIC-0065 Batch Acceptance in Microbiology.
Non-conforming external services and supplies are reported and investigated through QP-GEN-0005 Control of Non-Conformances and discussed as required at Quality Meetings as described in MP-GEN-0021 Quality Meetings.
Postal Audits have been carried out on key suppliers in order to obtain documentation of conformance with their quality management system.

There is an inventory control system for supplies. Appropriate quality records of external services, supplies and purchased products are established and maintained for a period of time, as defined in the Quality Management System. This system includes the recording of lot numbers of all relevant reagents, control materials and calibrators, the date of receipt and the date the material is placed in service. All of these quality records are available for management review. This is implemented through the procedure LP-BT-0002 Monitoring of Materials in Blood Transfusion, LP-BIO-0007 Batch Acceptance of Reagents, Calibrators, Q.C. and Consumables, LP-HAEM-0012 Batch Acceptance of Reagents in Haematology and LP-MIC-0065 Batch Acceptance in Microbiology.