The guide

The laboratory handbook provides an easy-to-use guide to all the general profiles and tests provided by Harley Street Pathology Services (HSPS). If you are unsure or are unable to find the test(s) and/or services, you require please contact us:
Telephone:02071002727
Email: lab@hspathology.com

Quality Assurance

Harley Street Pathology Services (HSPS) is a UKAS accredited medical laboratory reference number 25821. The current accredited scope can be found on the published schedule on the UKAS website www.ukas.com/download-schedule/25821/Medical/

Harley Street Pathology Services is committed to providing our users with pathology results of the highest quality. The quality of results is of fundamental importance and the laboratory operates to stringent technical and administrative standards as described in ISO15189: Medical Laboratories- requirements for quality and competence.

Internal quality assurance is achieved by strict adherence to standard operating procedures for all analytical processes. These processes are regularly reviewed following the document control procedure and monitored through an effective internal audit programme.

The qualified Biomedical Scientists employed by Harley Street Pathology Services are registered with the Health and Care Professions Council (HCPC) meeting their standards for training, professional skills, behaviour and health. All Consultant Pathologists are registered in the appropriate specialist register with the General Medical Council (GMC).

Harley Street Pathology Services participates in recognised External Quality Assessment Schemes. These schemes are subscribed to by NHS and private laboratories to compare performance and results between laboratories. All examination procedures are subject to rigorous internal quality control.

Service Level Agreement (SLA)

Doctors, clinics, laboratories 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, please contact sonal@hspathology to discuss requirements.

Data Protection and Confidentiality

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 the HSPS quality management system and the shared directors of Harley Street Pathology Services and Harley Street and Harley Street Fertility Clinic. 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.

HSPS is registered with the Information Commissioner's Office (ICO) and the Data Protection Officer may be contacted on suvir@hsfc.org.uk. Complaints, compliments and other feedback

If service is not as expected and a complaint is necessary, email Sonal Parikh (Laboratory Director) at sonal@hspathology.com giving details of the complaint. The information given will be treated as confidential and investigated fully thought our complaints procedure. A complaint may also be issued verbally or in person and this will be recorded in the same way. The process you can expect:

An acknowledgement of the complaint within 2 working days.
Feedback about resolution of the complaint within 2 weeks, usually by email or telephone call from the laboratory director.
Further information required to investigate the complaint may be needed in this time and will be requested by the laboratory as needed
If there is a delay in the investigation, the laboratory director will provide weekly updates.

Customers are also encouraged to telephone or email sonal@hspathology with compliments which will be logged and passed on to relevant staff and departments.

All feedback is useful for continuous improvement. Even if you don’t have a complaint, HSPS welcomes feedback which is logged on a feedback sheet and trended periodically to see if there are any patterns or themes that can be used to improve the service.

If a complaint is not satisfactorily resolved by the process above, please contact:

suvir@hsfc.org.uk

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 and the identity of the person collecting the primary sample(s).

Refer to the test catalogue for any specific sample requirements at the point of collection. If the sample needs to be separated or divided urgently, this will be stated in the test catalogue below and details of this with timings should be written on the request form clearly.

The request form must contain the identification of the requester including full address and email for the laboratory to return the results. No results will be faxed. 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
All samples are considered to be a potential risk for infection and handled with appropriate personal protective equipment and conforming to local health and safety policies.
Hazard Group 4 pathogens (such as Ebola or Viral Haemorrhagic Fever) must not be sent to the laboratory. Please telephone the laboratory for advice if these infections are suspected: 02071002727

Sample Collection and Transport Guide

HSPS do not offer a venesection service. As part of the agreement between HSPS and the customer, HSPS requires the requesting customer to have their own venesection and sample handling procedures that conform to the below requirements.

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 special consent is needed, for example for paediatric venesection or genetic testing in pregnancy. Consent is implied if the patient attends and willingly presents an arm for venesection.

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

Tubes must be gently mixed immediately after collection according to manufacturer instructions (see Appendix 2 – Mixing Guidelines).

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, see mixing guidelines appendix 2.
Collection order of draw:
Blood Cultures, Sterile Tubes
Citrate Tube (Light Blue)
SSTTM Gel Separator Tube (Red or Gold) or Serum Tube (Plastic or Glass - Red)
PSTTM Gel Separator Tube (Green) or Heparin Tube (Sodium or Lithium - Green)
EDTA Tube (Lavender)
Fluoride Tube (Grey)
A full list of tube guide can be found in the appendix 2
Please ensure all materials used in the collection are disposed of safely, including sharps, clinical waste and confidential waste.
The sample is labelled, packed appropriately, and is accompanied by the relevant paperwork. Check the test catalogue for any special transport requirements, unless otherwise stated the samples are ideally transported by courier same day or overnight with a temperature range of 4-25°C. Please telephone laboratory on 020 7100 2727 if there are any questions or concerns about transport.
All samples sent by courier or post must adhere to UN3373 https://www.gov.uk/government/publications/packaging-and-transport-requirements-for-patient-samples-un3373/packaging-and-transport-requirements-for-patient-samples-un3373
All samples sent by courier or post must comply with UN3373 – Biological Substance, Category B requirements. This includes triple packaging, leak-proof primary containers, absorbent material, secondary packaging, and rigid outer packaging. Failure to comply may result in sample rejection.
Consider weekends, bank holidays and extreme temperature events before sending samples, for example if sending through the post and ambient temperatures are more than 25°C in summer, please contact laboratory for advice. If sending just before Easter or Christmas weekends and delays may occur, please contact the laboratory and consider rearranging venesection appointments for after public holidays.

Temperature may be stabilised by using cool boxes or ice packs, call laboratory for advice.

If any specific requirements to ensure the integrity of samples has been compromised and there is a risk to patient results, the organisation responsible for transport will be notified and a non-conformity will be raised by HSPS internally, root cause will be established, and action(s) taken to reduce the risk and prevent recurrence.

Sample rejection criteria

Common Temperature Guidelines:

2-8°C (Refrigerated): Most routine blood, urine, faecal, and general microbiology samples, plus serum for short transport.
15-25°C (Room Temperature): Blood cultures, Cerebrospinal Fluid (CSF), and swabs for specific fastidious organisms (e.g., Neisseria gonorrhoea). Ambient (Uncontrolled): Some general diagnostic samples are stored at room temp if ambient is <22°C, but refrigeration is better if delayed.
Ambient (<22°C): Some diagnostic samples may be stored at room temperature for short periods; refrigeration is preferred if transport is delayed.

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. Details of any criteria for acceptance not met will be added as comments to the sample record in the laboratory information system and will appear on the report to aid interpretation.

Summary of Sample Rejection Criteria

Incorrect sample types received:
Basic incorrect blood tube.
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.

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 request further information to ensure the correct test can be performed using the correct sample.

Sample stability

Stability of each test can be requested by emailing the laboratory.

Patient reference ranges

Reference ranges for all tests are provided with test results based on the patient information provided with the test request. The laboratory takes no responsibility for further incorrect reference ranges where incorrect or incomplete patient details are provided. For further information, please contact the laboratory.

Referral laboratories

When tests are unavailable in-house or require confirmation, samples are sent to an accredited referral laboratory. The referral laboratory used is identified for the relevant result in the final pathology report by the following code(s):

Health Services Laboratories (HSL): 001

Current testes that are not analysed in-house are: Creatinine Kinase, Lactate Dehydrogenase & Uric Acid.

All referral laboratories are assessed for quality assurance and accreditation.

Pathology consumables

The laboratory shall provide appropriate consumables required for sample collection to all customers.

Reporting options

Reports are generally provided electronically via various methods. Please contact the laboratory to discuss your requirements. The laboratory will provide hard copy results, upon request, if required in specific circumstances.

For expected availability of results- turnaround times are stated in the test directory at the end of this guide.

Advisory services

Laboratory advice and interpretation are available as required to meet the needs of patients and users. For all requests for clinical or technical advice, please contact the laboratory director in the first instance sonal@hspathology, who may be able to answer the query directly or forward the request to one of our HCPC registered Biomedical Scientists or GMC registered clinical specialists as appropriate. Royal College of Pathologists Guidance is referenced wherever appropriate.

HSPS will communicate with laboratory users on the following:

Advising on the choice and use of examinations, including the required type of sample, clinical indications and limitations of the examination methods and the frequency of requesting the examination.
Providing professional judgements on the interpretation of the results of examinations
Promoting the effective use of laboratory examinations
Advising on scientific and logistical matters such as instances of failure of sample(s) to meet acceptability criteria (see sample rejection criteria in this document). Where samples fail to meet the acceptability criteria and are rejected, this will be fully documented on a report. If the samples are unrepeatable, please contact laboratory for advice.

Fees for services

Fees must be paid directly by the registered customer. Please refer to your Service Level Agreement for further details.

Protection of personally identifiable information

The GDPR requirements have been implemented within the context of an 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 are able to 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.