CPA Medical Laboratories Assessor Update (Issue 2)

Transcription

1 CPA Medical Laboratories Assessor Update (Issue 2) Technical Tips and Policy Reminders Background As experience of ISO 15189:2012 assessments increases, it is now possible to identify trends in certain issues. This update has been produced to disseminate information regarding the roll-out and address some of these questions. In this update: 1. Assessment of Clinical Staff Competence including Requirements of the Laboratory Director - Historically, there has been apparent inconsistency in the way the laboratory director role has been assessed under the associated CPA Standards (B1) and consequently, clarification of position is required. Details on the assessment of clinical staff competency and its adequacy have been variable in the first UKAS Assessment Reports that have been completed. 2. Verification and Validation - Identified as one of the key gaps for the transition from CPA assessments to UKAS assessment under ISO 15189, depth of assessment and the degree of information provided by laboratories has been variable. 1.1 Requirements and policies 1.1a The laboratory shall be directed by a person or persons who has the competence and delegated responsibility for the services provided (ISO 15189, ). 1.1b Laboratory management shall document personnel qualifications for each position (ISO 15189, 5.1.2). 1.1c The personnel making judgements with reference to examinations shall have the applicable theoretical and practical background and experience (ISO 15189, 5.1.2). 1.1d The laboratory shall assess the competence of each person (ISO 15189, 4.7; 5.1.6). Notes associated with suggest that competency assessment should be designed as specific and fit for purpose. 1.2 Requirements of the Lab The term the laboratory allows sufficient flexibility for different organisations to address requirements in different ways. Between different organisations, different grades of staff CPA Medical Laboratories Assessor Update #2 April 2015 Page 1 of 5

2 may take responsibilities for different areas and equally the delegation of laboratory director duties will vary (although ultimate responsibility remains the same). The laboratory must ensure that the duties of the laboratory director and all clinical staff are documented and that records of competency are maintained. Requirements apply whether clinical staff are staff members of the host Trust or contracted in demonstrable evidence of coverage by the laboratory s management system is required. This will include, but not necessarily be limited to: Documenting their own acceptance criteria for competence of the laboratory director and clinical staff. Notes associated with are helpful as well as, for instance, the qualifications, training and experience required. Establishing which of the duties in can be delegated, and to whom. Maintenance of records to demonstrate that all of the requirements of have been suitably discharged. Dependent on the area, the visit plan, and who the task has been delegated to, this may naturally fall into an area covered by the Assessment Manager and the Peer Assessor. It is likely that conclusions on conformance with requirements are reached towards the end of the assessment by all of the team. Defining an on-going competency assessment programme with defined acceptance criteria for the laboratory director and clinical staff. It would be expected that such an on-going programme is suitably robust to cover all of the staff member s scope of activity, at sufficient frequency. It may be that the laboratory uses some or all of the tools identified in 1.3, below. Maintaining records of qualifications, experience and training for the laboratory director and clinical staff. Personnel records need to include assessments of competence of all personnel (ISO 15189, 5.1.9), as well as sufficient information that demonstrates their incorporation to, and coverage by, the management system. Coverage of all of these areas by the internal audit programme, including auditing of competency assessment programmes. Ultimately, the basis on which the laboratory feels an individual does have the competence to perform such tasks needs to be justified and how this meets requirements documented. 1.3 Assessment Tips Assessment of ISO 15189, is focused on the breadth of a laboratory director s activity and whether competency is demonstrable across this scope of this activity. FRCPath status in isolation does not confer competency. Equally, the absence of such status does not automatically mean lack of competence. Rather, that UKAS will assess the laboratory s justification as to how it feels it meets requirements and seek evidence to support this. Similarly, in assessment of clinical staff competence generally, the assessment team will look to the laboratory to justify how this competence is defined and how it is evidenced. For the assessment team, this may include assessment of, but not necessarily be limited to: CPA Medical Laboratories Assessor Update #2 April 2015 Page 2 of 5

3 Qualification records, experience, knowledge and training EQA records Suitability of acceptance criteria Appraisal records* Mechanisms to monitor on-going competency and associated records CPD relevant to the scope of practice Review of test reports * It is acknowledged that appraisal records are personal and it is not necessary for the assessment team to view personal information that is not relevant to the assessment. The assessment team need to assess the evidence that is used to demonstrate competence and if all such information is held within appraisal records (which it does not have to be), that is naturally where the assessment will lead. The strength of the assessment process is that assessors are used who have the demonstrable knowledge, skills and experience to interpret a laboratory s justification and evaluate whether an individual truly has the relevant competence to meet requirements. In support of qualification evidence, an assessor will evaluate the systems in place to define clinical competence and how this is monitored on an ongoing basis in order to introduce the appropriate level of rigour into the assessment. 1.4 Reporting The Assessment Report supports the decision on accreditation and consequently needs to provide objective evidence and conclusions on the extent of competence and conformity of the assessed organisation. Documenting whether a laboratory s approach to clinical staff competence or the laboratory director role meets, or does not meet requirements and why, gives added value to the laboratory and is crucial information for the Decision Maker. CPA Medical Laboratories Assessor Update #2 April 2015 Page 3 of 5

4 2. Verification and Validation 2.1 Requirements and Policies 2.1 a The requirement for validation and verification of examination procedures is expressed in ISO and This requires the laboratory to have evaluated procedures as being able to meet the needs of their users including clinical appropriateness. 2.1 b In some areas information is provided from the manufacturer as to the amount of validation completed; in other cases the laboratory undertakes the validation required. In all examinations the laboratory is responsible for undertaking verification (please refer to ISO for definitions). 2.1 c Although equipment verification is also important and is a requirement under ISO verification should not be considered to be solely concerned with the equipment used. Personnel and reagent batches for example should also be considered. 2.2 Assessment Tips Manual methods which have been in place for many years the laboratory will need to have reviewed current data (IQC, EQA etc.) together with any previous work (if available) to demonstrate that the methods are clinically appropriate for the users of the laboratory and that through the generation of this data, the requirements for validation (and verification) have been fulfilled. Automated systems or products validated by the manufacturer the laboratory will need to have documented their review of the validation completed by the manufacturer and whether it is complete and meets their requirements (ISO ). The information from the manufacture could be in a summarised format. A decision should then be taken by the laboratory as to whether this validation is sufficient or whether supplementary validation needs to be undertaken. Acceptance by the laboratory against defined criteria will need to be demonstrated. When reviewing the information provided by the Assessment Manager prior to an arranged visit in order to establish the effort required for the assessment consideration should be made of the following: What various techniques and measurement principles are apparent form the application form (if not apparent more information from the laboratory should be sought). Are there any particular procedures which are more challenging that if assessed, could provide commentary on the competence of the laboratory at validation/ verification. There will be insufficient time to effectively assess all of the validation/verification completed by an individual laboratory and therefore we need to identify those which could provide an overall comment on the competence of the laboratory in this aspect. CPA Medical Laboratories Assessor Update #2 April 2015 Page 4 of 5

5 What do you as an assessor really need to see prior to the visit e.g. a summary of the data, conclusions, and acceptance criteria? Raw data could always be reviewed during the visit if issues arise as a consequence of the pre-visit evaluation. It is not our role to evaluate the raw data to establish whether the method is fit for purpose. An assessor s role is to assess whether the laboratory has a suitable approach and appropriately evaluated the data to justify their conclusions. 2.3 Reporting The Assessment Report (UKAS equivalent of the CPA overview report) will need to comment on the assessment of validation and verification completed by the laboratory and whether it shows the methods are suitable for their intended use. This should not be an audit trail of what the laboratory has done but a commentary on the appropriateness of the validation/verification for the particular user group(s). CPA Medical Laboratories Assessor Update #2 April 2015 Page 5 of 5