Quality manual

Document Control

The laboratory controls documents required by the quality management system and ensures that unintended use of any obsolete documents is prevented.

Documents considered for control are those that may vary based on changes in versions or time. Examples include policy statements, instructions for use, flow charts, procedures, specifications, forms, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements and documents of external origin such as regulations, standards and text books from which examination procedures are taken.
MP-GEN-0002 Management of Documentation, Preparation and Control describes the method by which the Department of Pathology controls all documents, including procedures, forms and information, from both internal and external sources.
The Document Control System is an electronic system i.e. Q-Pulse. Where there is a requirement for a change to a document due to a change in practice, procedure, material, and equipment etc., the change is requested, assessed, approved and authorised as per MP-GEN-0019 Management of Change Control.
All documents are retained for a defined period. The retention period shall meet minimum requirements of the Royal College of Pathologists.
Master copies of documents are maintained as hardcopies or on Q-Pulse.
The procedure MP-GEN-0002 Management of Documentation, Preparation and Control ensures that:

1. 
   All documents issued as part of the Quality Management System are reviewed and approved by authorized personnel prior to issue.
   

• 
  Quality – This review is performed by the Quality Co-ordinator.
  

• 
  Technical – This review is performed by a person with suitable knowledge of the discipline in question. For laboratory documents, this is the Chief Medical Scientist. For Haemovigilance/Traceability, this is the Haemovigilance Officer. For Phlebotomy documents, this is the Senior Phlebotomist.
  

• 
  Management – This review is performed by the Chief Medical Scientist
  

• 
  Clinical – This review is performed by the relevant Consultant.
  

2. 
   A unique Document Number, allocated by the Quality Co-ordinator from the Documentation Register. This is made up of four distinct units e.g. QP-GEN-0001.
   

The units are as follows:

• 
  The first unit describes the procedural activity and document type
  
• 
  The second unit defines the department to which the document applies.
  
• 
  The third unit defines the actual number of the document. This number is composed of four digits, starting with 0001.
  

A Documentation Register is maintained on Q-Pulse identifying current valid versions of each document, their distribution and the following information:

• 
  Document Title
  
• 
  Document unique identifier on each page
  
• 
  Source identification – The source is identifiable from the unique
  

Document Number, examples as follows:

Management Procedure MP

Management Form MF

Quality Manual QMn

Quality Procedure QP

Quality Form QF

Laboratory Procedure LP

Laboratory Form LF

Laboratory Instruction LI

Haemovigilance Procedure HP

Laboratory Manual LMn

External Document ED

Effective Date

Page number to total number of pages [e.g. page 1 of 5]

Personnel responsible for approval of document

Revision Number
c) Current authorised revisions are identified by means of the document register. The distribution of all documents, either electronic or paper copies, is recorded on Q-Pulse in the Distribution List.

4. 
   Only currently authorized versions of appropriate documents are available for active use at relevant locations.
   

5. 
   MP-GEN-0019 Management of Change Control documents how changes to documents maintained in Q-Pulse are to be made and controlled.
   

6. 
   Changes to documents are identified.
   

7. 
   Documents remain legible from revision to revision and the review history is stored in Q-Pulse.
   

8. 
   All documents are reviewed at least every two years for adequacy and revised when necessary. All revisions are authorised prior to implementation.
   

9. 
   Obsolete controlled documents are placed in the obsolete file on Q-Pulse. Hard copies are destroyed and information is recorded on Q-Pulse.
   

10. 
    One copy of an obsolete controlled document is retained on Q-Pulse.
    

4. 
   Service Agreements
   

4.4.1 Establishment of Service Agreements
The services of the Department of Pathology are described in the LP-GEN-0007 User Manual.
Contractual arrangements between the Department of Pathology and the hospital wards, internal and external locations are defined by the request forms as follows:

• 
  LF-GEN-0011 Blood Transfusion Request Form which is used to requisition the tests related to the Blood Bank
  

• 
  LF-GEN-0019 Pathology General Request Form which is used to requisition the routine tests related to Haematology and Biochemistry,
  
• 
  LF-BIO-0024 Troponin-I Request Form which is used to requisition Troponin-I,
  
• 
  LF-BIO-003 Gentamicin/Vancomycin Request Form which is used to order Genatmicin or Vancomycin Levels
  
• 
  LF-GEN-0023 Microbiology Request Form which is used to requisition Microbiology tests
  

In accordance with MP-GEN-0016 Management and Review of Contracts.

Each request accepted by the laboratory for examinations is considered an agreement. Acceptance of the contract in the Department of Pathology is based on the incoming acceptance process as per LP-BT-0001 Specimen Handling in Blood Transfusion and LP-GEN-0014 Specimen Handling in Biochemistry, Immunochemistry and Haematology, LP-MIC-0063 Specimen Reception in the Microbiology Laboratory.
Agreements to provide medical laboratory services take into account the request, the examination and the report. The agreement specifies the information needed on the request to ensure appropriate examination and result interpretation.
Only requests on the official request forms are accepted by the Department of Pathology. The acceptance of a contract is based on the incoming inspection process. Checks are performed upon receipt of specimens and there are mandatory requirements which the specimens must meet in order to be successfully processed. If incoming inspection process fails i.e. if sufficient requirements are not met, the customer is informed by phone and a repeat specimen may be requested. All rejected contracts are documented on the non-conformance register.
Review of contracts with customer is performed periodically by the Department of Pathology Management Team using LF-GEN-0002 Quality Assurance Confirmation Form. This ensures that:

1. 
   Requirements, including the methods to be used, are adequately defined, documented and understood by the Department of Pathology and the Client / User of the Service.
   

2. 
   The Department of Pathology has suitable physical resources and capacity to meet the requirements.
   

3. 
   There is adequate numbers of skilled personnel, who have the required qualifications, expertise and relevant training, necessary to perform the required examinations in accordance with MP-GEN-0017 Pathology Training Policy. The Department of Pathology provides access to the clinical advisory services of Consultants to all users of the services. This also includes a review of participation in External Inter-Laboratory Quality Assurance Schemes in order to determine uncertainties of measurement, limits of detection and confidence limits.
   

4. 
   Appropriate procedures selected are able to meet the contract requirements and clinical needs (section 5.5) of the customer.
   

5. 
   Customers and users are informed of deviations from the agreement that impact upon the examination results.
   

As per procedure, MP-GEN-0016 Management and Review of Contracts if a contract needs to be amended after work has commenced, the contract review process is repeated and any amendments are communicated to the customer. This amendment is communicated on the reports issued with the results. Where additional testing/blood products are required on an original sample, an additional form is required. In an emergency situation the amendments are communicated to the customer by telephone and then followed up with the required form at later time.

Any deviation from the agreed service to be provided will be reported and investigated as a non-conformance or reported as a “Planned Deviation” through QP-GEN-0005 Control of Non-Conformances. Affected users will be informed by way of a memo. The document number of the memo will be referenced on the non-conformance pertaining to the deviation.
Where a change to the contract between the Department of Pathology and the Referral Laboratory affects the service provided, users will be informed of the change, prior to implementation, as described in MP-GEN-0019 Management of Change Control, usually by way of a memo, which is registered on Q-Pulse in the documentation module under ‘Memos’.

6. 
   Reference is made to any work by the Department of Pathology to a referral laboratory.
   

Records of reviews including any significant changes and pertinent discussions are maintained and include:

• 
  Minutes of Meetings
  
• 
  Customer Satisfaction Survey data and reports
  
• 
  Customer Complaints
  
• 
  Change Control Request Forms
  
• 
  Laboratory Test Request Forms
  

Any changes are documented through MP-GEN-0019 Management of Change Control.

The laboratory does not enter into financial arrangements with referring practitioners or funding agencies where those arrangements act as an inducement for the referral of examinations or patients or interfere with the practitioner’s independent assessment of what is best for the patient.

2. 
   Review of Service Agreements
   

Reviews of agreements to provide medical laboratory services include all aspects of the agreement. Records of these reviews include any changes to the agreement and any pertinent discussions.

User satisfaction surveys which are carried out annually are used as a forum to review the contract. Review and changes may be made following discussion at the Quality Meetings and/or the Pathology Governance Meetings.
When an agreement needs to be amended after laboratory services have commenced, the same agreement review process will be repeated and any amendments will be communicated to all affected parties.

4.