7.0 Process requirements

Identifying and mitigating potential risks to patient care throughout pre-examination, examination and post-examination is crucial for ensuring the quality and safety of laboratory testing.  Risk from pre-examination process, such as sample mislabelling, sample contamination and improper storage will be identified on receipt and notified to user. Specimen reception SOP and specimen rejection criteria in place for these samples types. Risk identified from examination process, test procedure, equipment error, calibration error and training are mitigated through regular auditing, equipment maintenance and servicing and process reviews. Amend protocol also in place for post-examination risks.

We aim to ensure that our users are fully aware of our service in order that they can make the best use of it. The information includes how to contact us, how to correctly send specimens for analysis, and how to obtain clinical advice. This is available in the user manuals MP506 & MP507.

Laboratory information for patients and users

Laboratory users and patients have access to appropriate laboratory information via GGC Microbiology website which contains departmental user manuals. 

Key information for service users includes:

• Location of the laboratory and opening hours
• Instructions for specimen transport and collection (where appropriate)
• The repertoire of tests offered, specimen types required and turnaround times
• Contact details of key staff
• Availability of clinical advice and interpretation
• Key factors which are known to impact the performance of the test or interpretation of results
• Laboratory complaints procedure

Requests for providing laboratory examinations

Each accepted laboratory request will be considered an agreement.

Laboratory requests will be a format deemed appropriate for the laboratory and user and are designed to include:

• Sufficient information to allow unique identification of the patient
• The source of the request, requesting individual and contact
• The date and time of specimen collection
• Specimen type and where appropriate the anatomical site of origin
• The investigation required
• Relevant clinical information
• Location to which report should be sent (including copy report)
• The unique laboratory accession number

Oral requests

Oral requests received by the laboratory would be documented and feasibility of testing discussed with consultant microbiologist. Upon acceptance, the request would be recorded on designated request form and test performed. All requests received must be accurately documented, traceable, and promptly actioned.

Primary sample collection and handling

Sample collection and handling instructions can be located within departmental user manuals, which are accessible on the GGC Microbiology website. Laboratory user manuals are reviewed regularly to ensure: appropriateness of tests, protocols for appropriate specimen collection, handling, testing, and reporting, and acceptance criteria. 

Sample received with deviations are reported to users in accordance with laboratory specimen rejections protocol LI555.  Each sample type will be risk assessed and actioned accordingly (i.e. CSF, Blood Culture etc). 

Information for pre-collection activities

We aim to ensure that our users are fully aware of our service in order that they can make the best use of it. The information includes how to contact us, how to correctly send specimens for analysis, and how to obtain clinical advice. This is available in the user manuals MP506 & MP507 and on Microbiology Right Decisions website.

Patient consent

AS per NHS policy, consent can be given in the following ways:

• Verbally – e.g. person stating they are happy to have procedure/test taken
• Writing – e.g. signing consent form
• Non-verbal – this can be given if patient understands the treatment or examination about to take place e.g. holding out arm for blood test, or giving sample when requested

Instructions for collection activities 

To ensure safe, accurate and clinically appropriateness of sample collection and pre-examination storage, the following steps are conducted:

• Checking the completion of the request form and confirming the identity of the patient
• Checking that the specimen container is correctly labelled
• Ensuring that the specimen is correctly collected
• Minimising the risk of interchange of samples and sub samples
• Ensuring that environmental and storage conditions are fulfilled
• Ensuring the safe disposal of all materials used in specimen collection
• Ensuring that high risk specimens are identified and processed correctly
• Ensuring that all spillages and breakages are dealt with correctly
• Minimising the risk to ensure the safety of the specimen collector carrier, the general public and the receiving laboratory

Sample transportation

The GG&C Specimen Transport Policy fulfils this standard and includes:

• Measures to ensure the safety of the courier the general public and the receiving laboratory
• Measures to ensure the confidentiality of patients' samples whilst in transit
• Measures to minimise delay in delivery
• Disinfection protocol following spillage
• Model rules on the type of outer container used to transport specimens
• This policy is also subject to audit

Sample receipt

Sample receipt procedure

The Specimen Reception procedures include instructions on:

• Accurate matching of request form and specimen
• Recording date of receipt
• Assigning a unique laboratory accession number
• Handling urgent samples
• Spillage protocol
• Staff safety

The procedure has instructions for the rejection of specimens that includes:

• The criteria for rejection of specimens
• The recording of rejected samples
• Notification of the user concerning rejected specimens.

Pre-examination handling, preparation, and storage

MP512 Control of Clinical Material in place and provides details for the handling and storage of sample received

Feasibility of additional testing will be assessed upon request and discussed with medical microbiologist and laboratory management, where applicable, prior to processing

General

We aim to use procedures that are selected to meet the needs and requirements of the users, in order to make them confident that our test repertoire is designed for the maximum benefit of their patients.

Verification/Validation of examination methods

Prior to introduction, all examination methods are validated for their intended use and the methods used and results obtained are recorded. When examination procedures are changed so that results or their interpretation may be significantly different, the changes are explained to users prior to the introduction of the new procedure. For tests under ISO 17025, the client is informed of the method chosen. The laboratory confirms that it can properly operate the standard methods before introducing the tests. If the standard method changes the confirmation is repeated.

Evaluation of measurement uncertainty (MU)

See QP512 Determining & Managing Uncertainty of Measurement

Documentation of examination procedures

The standard operating procedures (SOPs) for the conduct of all examinations are prepared according to the Document Preparation and Control procedure QP511

Procedures for the conduct of all examinations include the following:

• The purpose and scope of the examination
• Responsibility
• Definitions
• Documentation (e.g. cross reference to)
• Safety considerations
• Procedure (including limitations and QC)
• References
• Appendices (where necessary)

Procedural SOPs are available as hard copy in the relevant laboratory in addition to the master copy held electronically in Q-Pulse.

Refer to QP517 for details on evaluation, validation & verification procedures. Refer to QP512 for determination of uncertainty of measurement.   

The Department employs operating procedures, which are up-to-date and based on current legislation, ISO, EN, British Standards and Standard Microbiology Instructions (UKHSA), publications in standard textbooks, scientific literature and UKAS publications.  Reference is made to the source of all information. The laboratory employs the use of appropriate methods and procedures for all tests within its scope and where appropriate an estimation of the measurement of uncertainty. All microbiology investigations are performed using advice/guidelines stated in UK Standards for Microbiology Investigations (SMIs): a comprehensive referenced collection of recommended algorithms and procedures for clinical microbiology. This is supplemented with best practice as recommended by the Scottish Microbiology and Virology Network. All antimicrobial susceptibility testing is performed using guidelines and criteria as set by The European Committee on Antimicrobial Susceptibility Testing – EUCAST. Susceptibility testing is also supplemented with Clinical Laboratory Standards Institute (CLSI) criteria where appropriate.

Ensuring the validity of examination results

We aim to use a wide range of procedures in order to detect errors and prevent release of erroneous results. There is a comprehensive range of procedures for internal quality control (IQC) of all examinations, which verify that the intended quality is achieved. These include:

• Records of date, source and storage of IQC material
• A process for validation of IQC material prior to use
• The use of recognised control organisms (ATCC & NCTC strains)
• Appropriate statistical methods
• Acceptance criteria for results with IQC material (e.g. Assay control parameters)
• Evaluation of IQC results with corrective/preventive actions taken and recorded

External quality assessment (EQA)

The laboratories participate fully in the available External Quality Assessment schemes appropriate to the examinations and interpretations provided.

A record of results against agreed performance criteria of the EQA scheme is maintained. The Department has a procedure for dealing with EQA samples, QP522 EQA Participation. The performance results are reviewed and communicated to staff and decisions taken recorded, monitored and acted upon.

Comparability of examination results

Laboratory IQA schedule in place for comparability and consistency analysis. Results are reviewed and communicated to staff and decisions taken recorded, monitored and acted upon.

7.4.1 Reporting of results

We aim to ensure that authorised personnel report results accurately, clearly, unambiguously and in accordance with examination procedure.  Reports should include all the required information detailed within the relevant standard. The Department requires that procedures involving the transcription of information relating to sample identification or test results are carried out with the utmost care to ensure that the integrity of test data is protected and that it is systematically checked through audit. Reported results are checked before being sent for authorisation. The procedure MP510 & MP511 includes checks for data transfer errors on all samples and a check of any calculations carried out. When checks have been made, staff countersign the results to indicate that they have done so.

The telephoned report

The GG&C Telephone Policy MP509 details this procedure and includes:

• The circumstances in which reports may be given
• The individuals who may issue results
• The individuals who may receive results
• A method of mutual identification of the patient between reporter and receiver
• Confirmation of correct transmission
• The mechanism for recording the event
• Maintaining confidentiality
• The process for sending a follow up report

Result review and release

We aim to have procedures in place to ensure that the results of our tests are accurate and are reviewed by authorised staff before release, in order to prevent any patient being endangered. Refer to GG&C IT Policy MP510 & Use of LIMS Procedure MP511. Only designated staff can give verbal reports. The identity of the person to whom the report is given must be established. Confidentiality must be maintained at all times and test results must not be disclosed to unauthorised parties. On request, reports may be given by telephone prior to authorisation provided the client is made aware that the report is provisional and subject to confirmation.

Critical result reports

All result that fall with critical decision limits are escalated to authorised personnel. User will be notified as soon as relevant and details documented. Further detail can be found within LI733 GG&C Telephone policy.

Special considerations for results

If requested by user, modification or simplification of examination report would have careful consideration and be conducted in liaison with medical microbiologist to ensure safe reporting of results. Any laboratory interim reports will also be followed by an updated final report. Anonymised laboratory examination results may be used for purposes of epidemiology/laboratory projects, with patient privacy and confidentiality protected in compliance with legal and regulatory requirements.

Automated selection, review, release and reporting of results

Laboratory results are reported electronically using the laboratory information management system.  All results are reviewed and released in accordance with laboratory operating procedures. 

Requirements for reports

Each laboratory report must include the following information:

• Unique patient identification, date and time of sample collection and date of issue on each page
• Identification of laboratory issuing report
• Name of requestor
• Type of sample and any necessary descriptions of sample
• Test requested
• Test results
• Name of authoriser/reviewer
• Report status

Additional information that could be obtained include:

• Time of reporting
• Identification of examinations obtained from reference laboratory

Amendment to reported results

The procedure for issuing an amended report (detailed within MP511) includes:

• The criteria for issuing amended reports
• Authorisation level of staff able to amend reports
• The identification of amended reports to the user
• A process of recording the issue of an amended report
• The reason for issuing an amended report
• Instigation of corrective and/or preventive action, if required
• A process for archiving amended results

7.4.2 Post-examination handling of samples

We aim to comply with all regulations concerning this aspect of our service, in order to ensure that samples which must be stored are correctly handled and samples which are marked for disposal are dealt with in accordance with the relevant legislation. Storage, retention & disposal of clinical samples is described in procedure MP512

We aim to ensure that nonconformities are effectively managed in order to build the confidence of our users and to continually improve our service. The process is described in QP510 – Accessing & Use of Q-Pulse. Non-conformity reports are submitted to the quality manager as they arise, and cumulative data forms part of the annual management review. With each non-conformance the clinical significance/impact, corrective/preventative measures and root cause analysis is performed. The process is described in QP525 – Root Cause Analysis. RCA is trended and monitored through the quality manager meeting. With each nonconformity investigation, risk and opportunities are also assessed/identified and included in the corresponding record within Q-Pulse

Proactive approaches to preventive action include audit, identifying risk and opportunity from non-conforming work, feedback, staff suggestions, feedback from external organisations and complaints.

We aim to ensure that our data storage ensures accurate records are maintained in a form that is only accessible to authorised staff & users, in order to protect patient confidentiality. The laboratory information system is TelePath (Dedalus), supported by other IT equipment for specialised tasks and it is accessed by HCSW, Biomedical Scientist, Clinical Scientist, Medical and Administrative staff. They are supported by the IT Department of NHSGG&C.

I.T. security is governed by the Data Protection Act, NHSGG&C I.T. Policy, and local SOP. Data and information are available to provide a service that meets the needs and requirements of users. Laboratory IT Management ensures the following:

• Security
• Access is password protected
• Confidentiality and data protection
• Systems are backed-up
• Storage, archive, retrieval & safe disposal

7.6.4 Downtime plans

GG&C IT team have devised collated downtime plans for GGC diagnostic group. Downtime plan includes contingencies dependent on timeframe of downtime.

Refer to MP516 Complaints Procedure. We aim to continually improve the quality of our service by building confidence in our users that complaints will be thoroughly investigated and corrective action taken. All complaints will be logged within the CAPA module in Q-Pulse. The complaint must be reviewed and approved by persons not involved in the subject of the complaint.  Our Complaints Process encompasses the following:

1. To take all complaints seriously
2. To deal with the client in a courteous manner
3. To try to resolve the issue immediately at a local level
4. To inform the client about the progress of the complaint
5. To make corrective action as soon as possible
6. To investigate root cause analysis to prevent recurrence
7. To ensure that the outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory activities in question.

We aim to ensure risks associated with emergency situations are identified and an appropriate strategy planning put in place to ensure continued operation following disruption. QP513 Risk Management (Business Continuity) contains information on adverse incidents and the appropriate mitigations that are in place.