Quality Assurance

The quality of results is of fundamental importance and the laboratory operates to stringent technical and administrative standards as set out in ISO15189 standard and verified by our United Kingdom Accreditation Service (UKAS) accreditation for all tests performed. Please note our UKAS inspection has been performed and our accreditation is currently pending.

Service Level Agreement (SLA)

Doctors, clinics, and other users wishing to use Harley Street Pathology Services must have a service level agreement in place before sending sample(s) to the laboratory.

Data Protection

The General Data Protection Regulation (GDPR) came into force in May 2018 and has had a significant impact upon the way that personal data is managed; placing legal requirements upon data processors and controllers to manage that information securely, maintain records of the processing that is carried out, and report when breaches of the regulation do occur.

This has impacted the way many businesses operate and is not restricted to the healthcare sector. The GDPR requirements have been implemented within the context of a mature ISO 27001 Information Security Management System – the globally accepted standard by which information is secured.

This ensures that senior management have regular visibility of the threats to the confidentiality, availability, and integrity of the information that we process, and can steer the efforts of their teams to provide an efficient service that places the confidentiality of our customers and their patients at the heart of everything we do.

Complaints Policy

Where a customer needs to raise a complaint, they should email Sandeep Patel (Pathology Manager) at sandeep@hspathology.com giving details of the complaint. The information forwarded will be treated as confidential and investigated fully thought our complaints procedure.

Patient Request Form and Sample Labelling

Each service user will receive a unique client ID and be provided with bespoke test request forms. An example test request form can be found in appendix 1.0, of this user guide. Tests may also be requested electronically. Please contact the laboratory for further information.

To comply with good clinical practice, it is important specimens and form are correctly and fully labelled, to include three unique patient identifiers: First name, Surname, Date of birth, Hospital or Clinic number, Medical Record Number (MRN) are examples of patient identifiers. The sample and or form must also include date and time of collection. The form must also contain the identification of the requester including full address and email to receive the results.

Requirements to be fulfilled when ordering tests:

• Time and Date of collection of sample(s)
• Type of sample and Anatomical site, where appropriate (e.g. swabs, throat etc)
• Relevant clinical information (e.g. renal or diabetic)
• Relevant details of medication
• High Risk Samples should be clearly identified on the form and individually packed separately from other samples
• Hazard Group 4 pathogens (such as Ebola or Viral Haemorrhagic Fever) must not be sent to the laboratory.

Sample Collection Guide

Patient preparation

Make sure the patient is relaxed and can tell you their name and date of birth. Inform the patient of what is going to happen. At this moment check with the patient if they have fasted if applicable, if they have any patient collected samples or if consent is needed. Patients should avoid strenuous exercise before venepuncture; certain tests require patients to fast prior to blood being taken or certain drugs to be avoided.

Collecting blood samples

• Pathology samples must be collected from one patient at a time and labelled immediately by the collector.
• When collecting samples, the patient must first be positively identified by asking them to confirm their name and date of birth and cross-referencing against the information on the request form or pre-printed label.
• Do not collect a sample if there is any doubt as to the identity of the patient.
• Do not ask the patient leading questions as this may jeopardise positive identification.
• If the patient is incapable of responding for whatever reason, then the information should be obtained from a reliable person who is present and knows the patient.
• All samples, but particularly those from patients suspected of having certain blood borne and other infectious diseases, constitute a potential hazard to clinical staff during collection, porters/couriers whilst in transit and laboratory staff on receipt and during analysis. Consequently, all samples must be handled in accordance with defined general health and safety principles.
• Some blood samples may require mixing by gentle inversion after collection to prevent clotting.

Sample rejection criteria

Sometimes tests cannot be performed in the laboratory if the samples fall short of the quality, volume, or other eligibility criteria. In these cases, the laboratory may need to reject the samples, and not carry out processing. Sometimes the laboratory can rectify a situation – and although turnaround times may be affected, it avoids having to arrange for samples to be taken again.

Summary of Sample Rejection Criteria

• Incorrect sample types received:
  • Basic incorrect blood tube / other sample.
  • Samples without the appropriate preservative (e.g. acidified urine samples).
  • Samples that are received ambient when a frozen sample is required.
  • Samples that are received unprotected from light, when they are required to be covered at the point of venepuncture.
  • Samples in incorrect containers (e.g. cervical cytology must be a ThinPrep vial; urine cytology must be in a uricyte container).
  • Insufficient sample received.
  • No sample received.
  • Labelling or form issues (mislabelled / unlabelled / no forms / no clinical information).
  • Clotted / haemolysed / lipaemic / icteric samples.
  • Sample is broken or has leaked in transit.
  • Stability time has been exceeded. Stability time is test dependant, and also refers to tests that can only be carried out on certain days of the week.
  • Sample contamination (e.g. being in the same bag as a leaking sample).
  • Samples are high risk or infectious.
  • Samples that are received in expired tubes.

Spillages and leaks in transit

Sample bags containing leaking containers will be discarded and the sender notified in order that a repeat sample can be taken. Every effort will be made to rescue non-repeatable samples but the ability to do this will be limited by health and safety considerations.

Validity of results

In every test result there is some degree of uncertainty. Regardless of method, repeated measurements on the same sample may produce slightly different results if the system is sufficiently sensitive. The pathology department has made every effort to minimise the degree of uncertainty. But, where uncertainty does exist, this has been quantified and deemed acceptable to that method. Estimates of uncertainty are available to users upon request.

Requests for add on tests

Most samples received in the laboratory are kept for one week. If sample type and volume allow, further testing can be requested by email to lab@hspathology.com. When requesting an add on test, please specify the details of the test(s) to be added, patient details and laboratory number or collection date. The laboratory may