The PathDirect Laboratory will offer the following Service Conditions. The purpose of which is to ensure the delivery of consistent standards of service that fulfil the requisites of ISO151189.
Agreements to provide medical laboratory services shall take into account:
- the request
- the examination
- the report
- Referral Laboratories
- Patient Clients
- Ethical Conduct
- Codes of Conduct
- Data Protection
- Confidentiality
The Request
The following information is required on the request to ensure appropriate examination and result interpretation.
The customer will be provided with a Request Form.
The following information shall be provided to the laboratory
- Patient first name and surname, their date of birth, the location/contact of the patient, and a unique identifier.
- Name or unique identifier of the clinician, healthcare provider, or other legally authorised to request examinations or use medical information, together with the report and contact details.
- The customer will be guided on the Request Form what sample type(s) to use and/or any special collection conditions. The customer can also refer to the Laboratory Guide or contact the phone number on the Request Form for any further test queries.
- Where relevant the customer must provide the anatomic site of origin.
- On the request form is a list of routine tests, indicate by ticking the box which tests are required. If a test is required that is not listed, please add it to the section “Other Tests”.
- In the section Clinical Information, add any clinically relevant information about the patient and the request, for examination performance and result interpretation purposes.
- Special instructions for samples – the provider will be made aware that certain information is required before the tests are performed. These may include ancestry, family history, travel and exposure history, communicable diseases and other clinically relevant information. The patient should be made aware of the information collected and the purpose for which it is collected. The laboratory will contact the requesting client if information is required prior to testing. The laboratory can be contacted for advice on any special instructions.
- Please indicate the date and, where relevant, time of the primary sample collection.
- Verbal requests are to be made only to experienced staff within the laboratory and includes providing confirmation by request form or electronic equivalent within a given time.
- Before a report is issued, the customer will provide information to the laboratory to guarantee the safe and confidential handling of patient reports sent back to the requesting clinician (user).
- Secure site of receipt
- Authorised personnel to receive reports
- Contact details to send critical/urgent results
- The laboratory will accept no responsibility for any error or defect in the services arising from inaccuracies or omissions of information provided by the client. The client shall indemnify and hold harmless the laboratory and members of the laboratory in respect of all liabilities, cost, claims, loss, damage, demands, actions and expenses arising directly or indirectly from the client.
The Laboratory Information
The location of the laboratory:
PathDirect Laboratory
The Coombe Suite,
171 Clarence Ave,
New Malden
KT3 3TX
On site services
- Clinical Chemistry
- Endocrinology
- Haematology
- Immunology
- Virology
- Tumour Markers
- Vitamins, Nutritional & Lifestyle
Referral tests services
- Clinical Chemistry
- Endocrinology
- Haematology
- Microbiology
- Histology
- Cytology
- Cytogenetics
- Immunology
- Virology
- Sexual Health
- Tumour Markers
- Vitamins, Nutritional & Lifestyle
- Drugs of Abuse & Occupational Health
Below is a list of the opening hours of the laboratory and other departments:
DEPARTMENT | DAYS FROM | DAYS TO | OPENING TIMES | CLOSING TIMES |
Patient Reception | Monday | Friday | 08:00hrs | 19:00hrs |
Saturday | 08:00hrs | 13:00hrs | ||
Sunday | Closed | Closed | ||
Phlebotomy Services | Monday | Friday | 08:00hrs | 19:00hrs |
Saturday | 08:00hrs | 13:00hrs | ||
Sunday | Closed | Closed | ||
Laboratory Services | Monday | Friday | 08:00hrs | 19:00hrs |
Saturday | 08:00hrs | 13:00hrs | ||
Sunday | Closed | Closed |
The laboratory will provide information of the criteria for accepting and rejecting samples. The phlebotomists are requested to contact laboratory with the list of tests requested in order to ascertain the laboratory’s criteria for accepting and/or rejecting the samples.
The laboratory will make available clinical advice on ordering of tests and on interpretation of results.
The laboratory will have available the Instructions for Use of each method used in the laboratory. The customer can use this information to ascertain whether the test is fit for its intended use. The following information, where appropriate is made available on request:
- The intended use and fit for purpose statement
- Principles of the procedure
- Performance characteristic
- Specimen collection and preparation
- Type of sample (e.g. plasma, serum, urine etc.)
- Type of container and additives
- Patient preparation
- Required equipment and reagents
- Environmental and safety controls
- Transport conditions
- Protection from light
- Rejection of specimens for testing criteria
- Specimen storage times post examination
- Measuring (Reportable or Dynamic) Range and method of reporting results that are not within the measuring range
- Calibration procedures
- Traceability of Calibration
- Reportable units and unit conversions where appropriate
- Laboratory clinical interpretation
- Potential sources of variation
- Limits of the procedure
- Interferences (e.g. lipaemia, haemolysis, bilirubinaemia, drugs, Biotin) and cross reactions
- Expected reference interval and clinical decision values
- Alert/critical values, where appropriate
- Principles of procedure for calculating results including, where relevant, the measurement uncertainty of the measured quantity values
- References
LABORATORY PROCESSES
The Laboratory will provide on request the following laboratory processes.
Verification and uncertainty of measurement:
- The laboratory uses methods with specified instructions for use of in vitro medical devices. All IVD medical devices used in the laboratory have the Conformité Européenne marking (CE) affixed to them. The procedures are used without modification and have been independently verified by the laboratory before use.
- The laboratory has determined the measurement uncertainty for each measurement procedure where appropriate.
Biological reference intervals or clinical decision values.
- The laboratory has defined and documented the biological reference intervals and clinical decision values for the procedures performed on site and for those sent to referral laboratories. These reference intervals are communicated with the results.
- When a reference interval or Clinical decision value are no longer relevant for the population served, appropriate changes will be made. A comment will be added to the report to communicate the changes.
- When the laboratory changes an examination procedure the laboratory will review the associated reference intervals and clinical decision values and communicate the changes.
LABORATORY SERVICES
The laboratory shall ensure:
- The laboratory’s services will be provided using reasonable skill and care using facilities and resources that meet the requirements with the UKAS Medical Laboratory accreditation standard (ISO15189).
- The staff have suitable skills, experience and resources to carry out the services provided.
- Examination procedure selected shall be appropriate and able to meet the customers’ needs. Periodic customer satisfaction questionnaires are distributed for feedback on how best to improve the service.
- Customers and users are informed of deviations from the agreement that impact on the examination results. Any amendments to the agreement shall not be effective unless in writing and signed by an authorised signatory on behalf of each of the parties.
THE REPORT
The laboratory shall provide reports of examination results to clients authorised to request such examination procedures. The laboratory shall provide the following information in the report:
- The quality of the primary sample received shall be examined on receipt and the following reported:
- Date and time taken
- Date and time received
- Type of samples received
- Condition of the samples that may compromise the result
The integrity of the results is maintained by:
- Reporting legible results
- Traceable S.I. or appropriate units of measurement
- Reference ranges and interpretations reviewed by authorised personnel
- Critical Alerts
REFERRAL LABORATORIES
- Work not performed in-house is sent to a UKAS ISO15189 accredited laboratories.
- Systems have been set up with these laboratories and the choice of referral laboratory is dictated by the needs of the customer
- The laboratory will provide, on request, a list and the method used of all out-sourced tests and the name of the laboratory where they are processed.
PATIENT CLIENTS
- Where patients are customers, (e.g. when patients can directly request examinations) or where the clinician requests reports be sent directly to the patient:
- The Clinical Director will decide what changes are required with regards to explanatory information contained in the report.
ETHICAL CONDUCT
The provider (laboratory management) is committed to the following Ethical Conduct:
- There is no involvement in any activities that would diminish confidence in the laboratory’s competence, impartiality, judgement, or operational integrity.
- Management and personnel are free from any undue internal and external commercial, financial, or other pressures and influence that may adversely affect the quality of their work
- Where potential conflicts in competing interests may exist, they shall be openly and appropriately declared
- There are appropriate procedures to ensure that staff treat human samples, tissues, or remains according to relevant legal requirements
- Confidentiality of information is maintained at all times.
CODES OF CONDUCT
The qualified Biomedical Scientists and or Clinical Scientists are governed by the following code of ethics:
- Be dedicated to the use of clinical laboratory science to benefit mankind
- Actively seek to establish co-operative and specific working relationships with other health professionals
- Provide expertise to advice and counsel other health professionals
- Maintain strict confidentiality of patient information and test results
- Safeguard the dignity and privacy of patients
- Be responsible for the logical process from acquisition of the specimen to the production of data and final report of the test results
- Be accountable for the quality and integrity of clinical laboratory services
- Exercise professional judgement, skill and care while meeting established standards
- Uphold and maintain the dignity and respect of the profession and strive to maintain a reputation of honesty, integrity and reliability
DATA PROTECTION
The laboratory shall maintain, in accordance with Data Protection Laws binding on PathDirect Ltd:
- written records of all categories of processing activities carried out on behalf of the customer
- a professional authorised Data Protection Agent is contracted to maintain compliance with the Data Protection Laws
CONFIDENTIALITY
The Laboratory agrees it will hold and maintain the confidence of all information of a confidential nature, received from the user. All information will be limited to:
- Those personnel employed or who have signed a contract with PathDirect Ltd, who management have trained and authorised to handle confidential information i.e. those staff delegated to perform tests, book in samples, phlebotomists, finance credit controllers etc.
- Accreditation bodies who have signed a confidentiality agreement prior to mandatory inspections
- Service provider engineers who (having signed an agreement of confidentiality) may, in the event of their duties, have access to information stored on medical equipment and/or Laboratory Information Systems
- Data Protection Agency personnel authorised to oversee the obligations of Data Protection Laws.