Quality manual

5.4 Pre-examination Procedures

1. 
   General
   

The laboratory has documented procedures and information for pre-examination activities to ensure the validity of the results of examinations.

2. 
   Information for Patients and Users
   

The Department of Pathology has information available for patients and users of the laboratory services in LP-GEN-0007 User Manual. The information includes as appropriate:

1. 
   The location of the laboratory
   

2. 
   Types of clinical services offered by the laboratory including examinations referred to other laboratories
   

3. 
   Opening hours of the laboratory
   

4. 
   The examinations offered by the laboratory including, information concerning samples required, primary sample volumes, special precautions, turnaround time, biological reference intervals and clinical decision values
   

5. 
   Instructions for completion of the request form
   

6. 
   Instruction for preparation of the patient
   

7. 
   Instructions for patient-collected samples
   

8. 
   Instructions for transportation of samples, including any special handling needs
   

9. 
   Any requirements for patient consent (e.g. consent to disclose clinical information and family history to relevant healthcare professionals, where referral is needed
   

10. 
    The laboratory’s criteria for accepting and rejecting samples
    

11. 
    A list of factors known to significantly affect the performance of the examination or the interpretation of the results
    

12. 
    Availability of clinical advice on ordering of examinations and on interpretation of examination results
    

13. 
    The laboratory’s policy on protection of personal information
    

14. 
    The laboratory’s complaint procedure
    

5.4.3 Request Form Information

• 
  The request forms in use in the Department of Pathology (LF-GEN-0011 Blood Transfusion Request Form, LF-GEN-0019 Pathology General Request Form, LF-BIO-0024 Troponin-I Request Form, LF-BIO-0003 Gentamicin/Vancomycin Request Form, LF-GEN-0023 Microbiology Request Form) are designed to capture sufficient information to identify the patient, the authorised requester as well as pertinent clinical data.
  

The request forms allow spaces for the inclusion of, but not limited to, the following:

1. 
   Unique Identification of the Patient;
   

• 
  Forename and Surname
  
• 
  Date of Birth
  
• 
  Medical Record Number
  
• 
  Location/Address
  
• 
  Gender
  

b) Name of the Requesting Clinician and Contact Details

c) Type of primary sample and the anatomic site of origin, where appropriate
d) Examination(s) requested

6. 
   Clinical relevant information about the patient for examination purposes and interpretation purposes. This includes clinical details, antibiotic therapy, and transfusion history.
   

7. 
   Date and time of primary sample collection
   

8. 
   Date and time of sample receipt
   

9. 
   Name of sample taker
   

10. 
    Date and time of receipt of samples by the Department of Pathology & Laboratory Medicine.
    

The format of the request form (paper) and the manner in which requests are to be communicated to the Department of Pathology are determined in discussion with the users of the service and through reviews of the QF-GEN-0001 Pathology Laboratory In-House Satisfaction Survey, QF GEN-0002 Pathology Laboratory General Practitioner Satisfaction Survey.

In exceptional circumstances, the laboratory accepts verbal requests for examinations provided the verbal request is followed up by request form.
The laboratory is willing to co-operate with users or their representatives in clarifying user’s request.

5.4.4 Primary Sample Collection and Handling
5.4.4.1 General
Specific instructions for the proper collection and handling of primary samples are documented in LP-GEN-0007 User Manual are available to all users of the service.
All hard copies of LP-GEN-0007 User Manual are controlled through MP-GEN-0002 Management of Documentation, Preparation and Control. The LP-GEN-0007 User Manual on J drive is updated on revision of the document.
All procedures carried out on a patient need the informed consent of the patient. For most routine laboratory procedures, consent can be inferred when the patient presents himself or herself at a laboratory with a request form and willingly submits to the usual collecting procedure, for example, venepuncture. Patients in a hospital bed are given the opportunity to refuse.
5.4.4.2 Instructions for Pre-collection Activities
The laboratory’s instructions for pre-collection activities include the following:

1. 
   Completion of the request form or electronic request
   

2. 
   Preparation of the patient (e.g. instructions to caregivers, phlebotomists, sample collectors and patients)
   

3. 
   Type and amount of the primary sample to be collected with descriptions of the primary sample containers and any necessary additives.
   

The current sample volumes required were determined with knowledge of sample volume requirements for manual testing and for assurance that a sample will be sufficient for further testing and investigations, e.g. antibody investigations and/or crossmatching, as required. It is not expected that required volumes will change. However, this will be reviewed periodically to ensure that neither insufficient nor excessive amounts of sample are collected.

4. 
   Special timing of collection, where needed
   

5. 
   Clinical information relevant to or affecting sample collection, examination performance or result interpretation (e.g. history of administration of drugs)
   

5.4.4.3 Instructions for Collection Activities
The laboratory’s instructions for collection activities includes the following

1. 
   Determination of the identity of the patient from whom a primary sample is collected
   

2. 
   Verification that the patient meet pre-examination requirements [e.g. fasting status, medication status ( time of the last dose, cessation,), sample collection at predetermined time or time intervals, etc ]
   

3. 
   Instructions for collection of primary blood and non-blood samples with descriptions of the primary sample containers and any necessary additives
   

4. 
   In situations where the primary sample is collected as part of clinical practice, information and instructions regarding primary sample containers, any necessary additives and any necessary processing and sample transport conditions is determined and communicated to the appropriate clinical staff
   

5. 
   Instructions for labelling of primary samples in a manner that provides an unequivocal link with the patients from whom they are collected.
   

6. 
   Recording of the identity of the person collecting the primary sample and the collection date, and when needed, recording of the collection time
   

7. 
   Instructions for proper storage conditions before collected samples are delivered to the laboratory
   

8. 
   Safe disposal of materials used in the collection
   

5.4.5 Sample Transportation
The laboratory’s instructions for post-collection activities include packaging of samples for transportation.
The laboratory has a documented procedure (LP-GEN-0002 Specimen Transportation) transportation of samples to ensure they are transported:

1. 
   Within a time frame appropriate to the nature of the requested examinations and the laboratory discipline concerned.
   

2. 
   Within a temperature interval specified for sample collection and handling and with the designated preservatives to ensure the integrity of samples.
   

3. 
   In a manner that ensures the integrity of the sample and the safety for the carrier, the general public and the receiving laboratory, in compliance with established requirements.
   

The Department of Pathology also adheres to regulations controlling the transport of samples outside the hospital including packing requirements.

Refer to ED-GEN-0108 The European Agreement Concerning the International Carriage of Dangerous Goods by Road (UNADR).
5.4.6 Sample Reception
The laboratory’s procedure for sample reception (LP-GEN-0003 Specimen Reception) ensures the following conditions are met:

1. 
   Samples are unequivocally traceable, by request and labelling to an identified patient or site.
   

2. 
   Laboratory developed and documented criteria for acceptance or rejection of samples are applied.
   

It is the policy of the Department of Pathology to have a request form for every test requested. However, where a sample is already in the department and a verbal request is received, the testing may commence prior to receipt of the request form, as described in LP-GEN-0007 User Manual. The lack of a request form does not impede the processing of an urgent sample. Verbal requests for the Blood Bank are recorded on the LF-BT-0012 Telephone Request Form. For Haematology and Biochemistry, telephone requests are logged on LF-GEN-0007 Telephone Log and they may also be recorded on Q-Pulse in accordance with LF-GEN-0044 Accessing the Telephone Log on Apex.

All samples received by the Department of Pathology must meet the acceptability criteria. This ensures that primary samples are traceable to an identified individual. Samples that do not meet acceptability criteria will result in a delay in processing or rejection of the sample. These are communicated to the requesting clinician or area to which the patient has presented. Rejected samples are recorded as per LP-BT-0001 Specimen Handling in Blood Transfusion, LP-GEN-0003 Specimen Reception, LP-GEN-0014 Specimen Handling in the Blood Sciences Laboratory and Lp-MIC-0063 Specimen Reception in the Microbiology Laboratory. Rejected samples for Haematology and Biochemistry are logged on QF-GEN-0047 Specimen Rejection/Amendment Form.

3. 
   Criteria are developed and documented for acceptance or rejection of primary samples. If the primary sample cannot be easily repeated the person responsible for the collection can present at the laboratory to label the specimen correctly and take responsibility for same. If compromised primary samples are accepted, the final report will indicate the nature of the problem and, if applicable, that caution is required when interpreting the result. This is implemented through the LP-GEN-0007 User Manual.
   

If an amendment is made, the final report indicates the nature of the problem and, where applicable, that caution is required when interpreting the result.

4. 
   All primary samples received are recorded/logged onto the LIS as per procedure. The date and time of receipt of samples, as well as the identity of the receiving member of staff, are recorded.
   

5. 
   Authorized personnel evaluate received samples to ensure they meet the acceptance criteria relevant for the requested examination(s).
   

In the Blood Bank, crossmatch requests that deviate from the HF-GEN-0003 Maximum Surgical Blood Ordering Schedule OLH are clarified by contacting the requesting clinician, as described in LP-BT-0001 Specimen Handling in Blood Transfusion. To verify the appropriateness of specific requests for platelets, factor concentrates and requests for SD plasma outside the Massive Blood Loss Protocol, these are checked with the Consultant Haematologist, as detailed in QP-GEN-0007 Advisory Services.

In the Haematology and Biochemistry Departments requests that deviate from LP-GEN-0014 Specimen Handling in the Blood Sciences Laboratory are rejected and the details are logged on QF-GEN-0047 Specimen Rejection/Amendment Form.

6. 
   Where relevant, there are instructions for the receipt, labelling, processing and reporting of samples specifically marked as urgent. The instructions include details of any special labelling of the request form and sample, the mechanism of transfer of the sample to the examination area of the laboratory, any rapid processing mode to be used and any special reporting criteria to be followed.
   

As part of HF-GEN-0019 Acute Massive Blood Loss all users of the Blood Bank are advised to telephone in advance of sending urgent samples to ensure that they are received and prioritised. It is also recommended that urgent samples are hand-delivered to a Medical Scientist in the Blood Bank by the sample taker, to ensure that acceptability criteria can be checked in the presence of the sample taker to minimise delay in processing the sample.

Urgent requests received in Haematology and Biochemistry are managed in accordance with LP-GEN-0003 Specimen Reception.

Aliquots of samples frozen for future testing are labelled with permanent marker to include the primary sample ID number and the patient’s name, date of birth and medical record number, and date of freezing, thus ensuring that sample portions are traceable to the original primary sample.

5.4.7 Pre-examination Handling, Preparation and Storage
The Department of Pathology has procedures and appropriate facilities for securing patient samples and avoiding deterioration, loss or damage during pre-examination activities and during handling, preparation and storage.
Samples are stored for a specified time, under conditions ensuring stability of sample properties, to enable repetition of the examination after reporting of the result or for additional examinations that may be requested (as long as time requirements are met). LP-BT-0001 Specimen Handling in Blood Transfusion and LP-GEN-0003 Specimen Reception, LP-GEN-0014 Specimen Handling in the Blood Sciences Laboratory and LP-MIC-0063 Specimen Reception in Microbiology.