Refer to MP515 – Information for Staff

A record of each staff member’s training and copies of HCPC Registration certificates are kept in the OM’s office.  

Held by individuals and by Operational Manager/Line Manager

To allow each member of staff to know their duties, responsibilities and rights, they are given a written job description.

Job descriptions include:

• Job title
• The location within the organisation
• Accountability
• Main purpose of the job
• Main duties and responsibilities
• Staff annual joint review

All staff have a contract of employment, which is in compliance with current legislation and provides clear terms and conditions of service

GG&C Health Board has a comprehensive staff orientation and induction programme. An induction pack is issued on or before a new employee's starting date and local induction training is carried out on the first day of work. Details for induction are located within the Training Policy TRP500 & induction paperwork. Records of staff orientation and induction are kept in individuals' personal files.

A training and education programme exists for all staff, which is in accordance with guidelines from the relevant professional and registration bodies. The training policy TRP500 outlines the requirements. The laboratory management appoints a Training Manager, who coordinates all aspects of training. The criteria used to assess competence in carrying out analyses and tests are detailed within the training policy TRP500. Trainees are supervised until signed off as competent to work unsupervised.

Consultant medical staff are required to successfully participate in the CPD programme of the Royal College of Pathologists.

There are competence records held for all processes in the department and individual records are kept for all staff members. Full details of the competency procedure and requirements are detailed within TRP500

All staff participate in an annual joint review (Turas) that includes consideration of:

• Outline for the job role
• The quality objectives and plans of the laboratory
• The current job content
• Documentation of training needs and agreed personal objectives with the appraiser
• Evidence that management has recognised the agreed development needs of individual staff members

All staff performing PDPs have had training and records of all staff PDPs are kept.

All staff are encouraged to participate in "Continuing Professional Development" (CPD), which is mandatory for continuing registration with HCPC. TRP500 & Personal CPD cover the requirements for staff. Opportunities for further education and training are available in relation to the requirements of the service and individual personal development. The Department provides resources for such education that includes:

• Access to library and information services
• Suitable accommodation for private study
• Opportunity to attend meetings, seminars and conferences
• Financial support

Records of training and education are kept for each member of staff.

The Human Resources Department of the Diagnostic Directorate of the Acute Division of NHS Greater Glasgow and Clyde holds the complete staff record. The Occupational Health Department holds vaccination records and the Payroll Department holds records of payments.

In addition, confidential staff records are kept including:

• Personal details
• Employment details
• Job description
• Terms and conditions of employment
• A record of staff induction and orientation
• A record of attendance at fire lectures
• A record of attendance at manual handling courses
• A record of education and training
• Relevant educational and professional qualifications
• Certificate of registration with the Health & Care Professions Council (HCPC)
• Absence record
• Accident record
• Record of annual joint review
• Occupational health record
• A record of disciplinary action

All of the above paperwork is held with either the OM or the Training Manager.

We aim to ensure there is a working environment in which staff can perform required functions in accordance with national legislation and guidelines. The premises are a state-of-the-art buildings which meets all current regulations for medical laboratory accommodation.

The premises have space for:

• Specimen reception
• The functioning and use of all equipment
• Separation of incompatible activities (e.g. Office and laboratory)
• Storage facilities

Access to the premises is by swipe card entry via locked doors.

These are well separated / demarcated. 

Paper-light systems operate with regards to reports and storage of paper records. Scanning options are available. Consumables and reagent storage is appropriate with large functional areas (cold and ambient). 

Common room refectory, with a cooking, eating and drinking facility provided. Toilets, including disabled, as well as shower facilities are substantial and adequate.

(N/A)

Building with temperature and air management systems in place. Quarterly workplace inspections are carried out and reported to facilities.

Laboratory management’s safety responsibilities are defined in the Health & Safety Management Manual and in the Division's H&S Policy.

A hard copy of this manual is kept in the each of the OM’s office.

The Department provides containment level 3 (CL3) accommodation for processing high risk samples and ACDP Hazard Group 3 organisms.

The Department maintains the security of its premises following Safety and Security procedures. The Head of Technical Services has overall responsibility for laboratory security. The Department restricts access to general laboratory work areas to laboratory personnel and authorised visitors. Access to the Containment level 3 laboratory is restricted as per departmental policy. Visitors to the Department are dealt with following Safety and Security procedures described in the Department’s Health & Safety manual.

Protocols for regular cleaning and disinfection are described in the Department’s Health & Safety Manual. 

We aim to ensure that sufficient & appropriate equipment is available so that service quality is at the highest level. A commitment to this effect is included in the quality manual. This includes rules for equipment procurement.

Laboratory management ensures the availability of the reagents, calibration material and quality control material required to provide a service which meets the needs and requirements of users. Procedures are established for the management of reagents, calibration material and quality control material, refer to QP520 QC of Media, Reagents and Material and to Procurement and Management of Equipment MP514. The documents include:

• Selection, purchasing and ordering
• Assessment of suppliers
• Receipt and verification of identity and condition
• Issue and inventory management
• Safe disposal

Control of Substances Hazardous to Health files (Risk Assessment and COSHH sheets) are maintained for all hazardous materials, and manufacturers’ safety data sheets (MSDS) are held where available. Materials in use are correctly identified with date of receipt, lot numbers and expiry. Equipment management procedures are described in MP514 & held within the RMS system.

All staff are trained to operate all items of equipment that they may be expected to use during the course of their duties and the trainee’s competence and ability to use the equipment recorded in their training records. This is achieved by the Technical Manager observing the trainee performing certain tasks using equipment they have received training on and being satisfied that all parts of the training procedure have been covered and that the trainee has understood them. The training programme is coordinated by the Training Manager.

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. Key information for service users includes:

• Contact details of key staff
• Location of the laboratory
• Opening hours
• Details of the out of hours emergency service
• Instructions for specimen transport and collection (where appropriate)
• Availability of clinical advice and interpretation
• The repertoire of tests offered, specimen types required and turnaround times
• Key factors which are known to affect the validity of results

Request form

The request forms are designed to include:

• Sufficient information to allow unique identification of the patient
• The source of the request
• The requesting individual
• 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

The date & time of receipt at the laboratory is recorded using either a date/time electronic stamp or in the LIMS system upon receipt at computer entry of Patient Identifiable Data. The department encourages proper completion of the request form.

Specimen Collection and Handling

• 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

Specimen 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

Specimen reception

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.

Referral to other laboratories

When using referral services GGC Microbiology ensure the following is carried out:

• Maintaining a record of all samples referred
• Recording of dispatch dates
• Monitoring the return of reports from referral laboratories
• Turn around time of results from referral laboratories

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.

Selection and validation of examination procedures

Prior to introduction, all examination procedures 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.

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 QPulse.

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 (PHE), 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.

17025 Metrological traceability

The Department ensures that reference standards of measurement, reference materials, measuring equipment and test equipment are calibrated and labelled accordingly. The Department maintains an inventory of equipment to be calibrated on an annual basis or other specified period.

The laboratory has a policy of using annually calibrated measuring devices (MP514): thermometers, weighing device, automatic pipettes. These are calibrated to International System of Units (SI). Equipment such as pipettes that are used in the Environmental Testing Laboratory are used exclusively for that purpose.

In terms of control microorganisms used in the laboratory; only reference cultures of known provenance such as NCTC/ATCC organisms and Lenticule discs acquired from source material (UKHSA) are used.

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

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.

Review of results

We aim to ensure that authorised personnel review the results of our examinations in order to ensure that patient safety is not compromised.

Storage, retention & disposal of clinical 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 produce reports which are clear and unambiguous and which contain sufficient information to enable our users to interpret the results for accurate treatment of their patients. 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

The amended report

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

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.

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, supported by other IT equipment for specialised tasks and it is accessed by CSW, 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