The Laboratory Handbook

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: 020 7100 2727
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/

HSPS is committed to providing 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 HSPS 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).

HSPS 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 HSPS must have a service level agreement in place before sending sample(s) to the laboratory. Please contact sonal@hspathology.com to discuss requirements.

Data Protection and Confidentiality

The General Data Protection Regulation (GDPR) came into force in May 2018, significantly impacting the management of personal data. It places legal requirements upon data processors and controllers to manage that information securely, maintain records of processing, and report breaches when they occur.

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 Fertility Clinic. This ensures that senior management has regular visibility of threats to confidentiality, availability, and integrity of information.

HSPS is registered with the Information Commissioner's Office (ICO). The Data Protection Officer may be contacted at suvir@hsfc.org.uk.

Complaints, Compliments, and Feedback

If service is not as expected and a complaint is necessary, email Sonal Parikh (Laboratory Director) at sonal@hspathology.com with complaint details. The information will be treated confidentially and investigated fully.

Complaint Process:

• Acknowledgment within 2 working days.
• Feedback on resolution within 2 weeks, usually via email or telephone.
• Further information may be requested for investigation.
• Weekly updates if there is a delay in investigation.

Compliments and feedback can also be emailed to sonal@hspathology.com.

If a complaint is not satisfactorily resolved, 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. Tests may also be requested electronically. Contact the laboratory for more information.

To comply with good clinical practice, specimens and forms must be fully labelled, including three unique patient identifiers:

• First name, Surname, Date of birth
• Hospital or Clinic number, Medical Record Number (MRN)
• Date and time of collection and collector's identity

Refer to the test catalogue for specific sample requirements.

Sample Collection and Transport Guide

HSPS does not offer a venesection service. The requesting customer must have their own venesection and sample handling procedures that conform to the following requirements:

Patient Preparation and Consent

• The patient must be relaxed and able to confirm their name and date of birth.
• Inform the patient of the procedure.
• Confirm fasting status and special consent requirements.
• Consent is implied if the patient willingly presents an arm for venesection.

Collecting Blood Samples

• Pathology samples must be collected one patient at a time.
• The patient must confirm name and date of birth.
• Do not collect a sample if patient identity is in doubt.

Blood Draw Order:

1. Blood Cultures, Sterile Tubes
2. Citrate Tube (Light Blue)
3. SSTTM Gel Separator Tube (Red or Gold) or Serum Tube (Red - Plastic or Glass)
4. PSTTM Gel Separator Tube (Green) or Heparin Tube (Green - Sodium or Lithium)
5. EDTA Tube (Lavender)
6. Fluoride Tube (Grey)

For a full list, refer to appendix 1.

Sample Rejection Criteria

The laboratory may reject samples that do not meet quality, volume, or eligibility criteria. Reasons include:

• Incorrect sample types
• Insufficient or no sample received
• Labelling or form issues
• Clotted, haemolysed, lipaemic, or icteric samples
• Broken or leaked samples in transit
• Stability time exceeded
• Contaminated samples
• High-risk or infectious samples

Leaking sample bags will be discarded, and the sender will be notified.

Validity of Results

Each test result carries some degree of uncertainty. The pathology department minimizes uncertainty and provides estimates of uncertainty upon request.

Most samples are kept for one week. Additional tests can be requested via lab@hspathology.com.

Referral Laboratories

When tests are unavailable in-house, samples are sent to an accredited referral laboratory. The referral laboratory is identified in the final pathology report.

Pathology Consumables

The laboratory provides appropriate consumables required for sample collection.

Reporting Options

Reports are provided electronically. Hard copies are available upon request. Turnaround times are listed in the test directory.

Advisory Services

HSPS provides laboratory advice and interpretation:

• Guidance on test selection and clinical indications.
• Interpretation of test results.
• Promoting effective laboratory examination usage.

For clinical or technical advice, contact the laboratory director at sonal@hspathology.com.

Fees for Services

Fees must be paid directly by the registered customer. Refer to the Service Level Agreement for details.

Protection of Personally Identifiable Information

The General Data Protection Regulation (GDPR) came in to 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 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.