1OVERVIEW OF THE ACCREDITATION PROCESS FOR POCT
This is a supplement to, and should be read in conjunction with, ‘The Conduct of CPA (UK) Ltd Assessments’.Accreditation of POCT is dependent upon, and can only be achieved, if the applicant laboratory is accredited to the CPA Standards for the Medical Laboratory. Status of POCT accreditation will not, however, affect the status of the applicant laboratory.
The first step in seeking POCT accreditation is foran applicant to undertake the normal self-assessment against therelevant CPA Standards (Medical Laboratoryand Additional Standards for Point-of-Care Testing (POCT) facilities) and then submit a completedapplication form, including POCT appendices 1 and 2to CPA, accompanied by acopy of the organisation’s Quality Manual including reference to POCT.
On receipt of the documentation theapplicant is enrolled for POCT accreditation and CPA assesses theapplication. If the application is notacceptable the department remains enrolledand CPA assists the medical laboratory withprogressing its application. If the applicationis acceptable arrangements are made forapre-assessment visit. This is carried out onsite by a Regional Assessor appointedby CPA.
Following the on site pre-assessment, a summary issubmitted to CPA by the assessor, a copy of which is sent to the applicant. The pre-assessment is designed to ensure that the applicant is at a suitable stage to proceed with a full assessment visit. Provided the pre-assessment visit is satisfactoryarrangements are made foran assessment visit. This is carried out onsite by a team of Regional and Peer assessors appointedby CPA.
Theoutcome of the visit may be accreditation,the identification of non-conformities that must be cleared beforeaccreditation is granted (interim or iterative), orthat accreditation be refused and theapplicant advised to reapply at a later date.The final decision about accreditationstatus rests with CPA.
2APPLICATION
The first step in seeking accreditation is foran applicant to undertake the normal self-assessment against therelevant CPA Standardsand then submit:
- a completedapplication form
- Acopy of the organisation’s Quality Manual which includes reference to POCT.
- A copy of POCT Appendix 1 and 2
The POCT Appendix 2 is in the form of an Excel spreadsheet. This requires the applicant to provide full workload details for the POCT to be assessed broken down into five types. These are:
- Hospital ward-based POCT
- Hospital Clinic-based POCT
- Hospital Pharmacy-based POCT
- External Clinic-based POCT
- GP surgery-based POCT.
Applicants can elect to be assessed for all of these POCT types or for individual types e.g. it is possible to apply for just Hospital ward-based POCT. Additional POCT types can be applied for separately but this will incur additional cost for the applicant.
Within each POCT type applicants can also decide upon which POCT analytes/platforms they wish to be assessed e.g. blood glucose testing, blood gas analyses. As the certificate will indicate that accreditation is granted for e.g. Hospital ward-based blood gas analyses it follows that applicants cannot specify individual wards for assessment for a particular analysis.
3ENROLMENT AND PROCESSING OF APPLICATIONS
Once the application is accepted the applicant medical laboratory will be issued with aPOCT enrolment date and details of the future schedule for assessments and timetable for submission of paperwork to CPA. Initial assessment is likely to be 3 to 12 months from the acceptance of the application. The applicant will be listed on the CPA POCT website as “Awaiting Assessment”. A Regional Assessor will be given responsibility for the department and will contact the applicant to discuss the application and to arrange a pre-assessment visit. CPA needs to assure itself that the department applying for POCT accreditation is itself accredited to the CPA Standards for the Medical Laboratory. POCT assessments will therefore, wherever possible, be carried out in the same schedule as the main laboratory assessment visit.
The applicant and the Chief Executive of the parent organisation will be informed by CPA if an assessment visit cannot be arranged within the scheduled timeframe.
3.1 Re-application for Accreditation
It is widely understood that laboratories are normally assessed every two years having a full assessment every four years and a surveillance on the two year date. Laboratories are required to renew their registration every year,confirming that they are continuing to operate according to the CPA Standards.
For laboratories applying for accreditation for their POCT activities, in addition to their laboratory activities, assessment will be separate to the laboratory visits. The frequency of POCT assessments will be dependent upon the size and scope of the POCT service offered.
It is the intention to conduct a full assessment either annually or every two years in order to cover the scope of the POCT services in a short period of time. CPA will need to demonstrate that all sites and services have been assessed over this period. There will be no need for re-application as the visits are ongoing. If services are added or removed then the applicant is required to keep CPA informed and submit a revised excel spreadsheet showing the changes.
4THE VISITS
4.1Pre-Assessment Visit
After the receipt and acceptance of a point of care testing application a pre-assessment meeting with the laboratory and POCT personnel is required to assess the readiness of the department and confirm general arrangements. The outcome of this meeting will determine if a POCT assessment can go ahead. It is important that at this meeting the Regional Assessor is able to meet with appropriate laboratory and POCT personnel who are responsible for managing POCT. A record of the meeting will be sent to the applicant.
If the outcome of the meeting is that a POCT assessment can go ahead, a date will be made approximately 3-4 months after the date of the laboratory visit. This will allow the laboratory findings to be cleared and a POCT peer assessors to be assigned. The maximum time between laboratory visit and POCT visit should be no more than 12 months.
4.2Main Visit
The procedure followed at any site visit can vary according to local situation i.e.
- the nature of the institution concerned
- how many types of POCT are to be assessed at any one time
- any geographical constraints
- Peer Assessors resource
For single site, single POCT type, the assessment team normally consists of a Regional Assessor and two Peer Assessors and is carried out over two days. For larger, complex or multi-disciplinary applications, and at the discretion of CPA, extra Peer Assessors may be used and assessment time extended. It would be the intention to cover the majority of the POCT scope over a four year period which is why annual visits will be required for larger organisations.
The usual format is for the assessment team to spend two days on a visit. A timetable will be issued prior to the visit. The team will assess for conformity with CPA standards and meet with users of the service and organisational governance groupto solicit their confidential views. Geographically scattered services will require more time for assessment. It is important that all premises from which one or more key activities are performed are visited. The Regional Assessor will be present on site throughout. Peer Assessor(s) will attend during the assessment with the amount of time needed decided when the application is reviewed. This is the responsibility of the Assessment Manager and Regional Assessor. The applicant will be informed once the timetable has been confirmed.
4.3 Responsibilities of applicant medical laboratories
In advance of the visit the applicant will be required to provide information within a timeframe.
This will include where relevant:
- Application Form, Quality Manual and Annual Management Review Summary relevant to POCT
- names, positions and contact details of the users to be interviewed(no later than three weeks prior to the visit)
- name and position of the governance group member(s) to be interviewed
- any changes following the submission of either the Application Form or Quality Manual
5MEETINGS WITH USERS AND POCT GOVERNANCE GROUP
For a main assessment visit the applicant is asked to arrange two separate meetings:
- Meeting with one or more members of the POCT Governance Groupusually conducted by the Regional Assessor alone N.B. this is not the multi-disciplinary POCT management group but is the group responsible to the organisation’s top management for defining the scope of POCT.
- User meeting with representatives of the clinical user group. This is to be held on a day when the Peer Assessors will be in attendance. It is preferable for this to be arranged over lunch time. Users are defined as those individuals who request POC tests so this meeting may include individuals who both request POCT and carry out the test. If it is not possible to convene a meeting of users e.g. if POCT is offered from multiple sites, then a questionnaire will be sent to a selection if users in order to assess user satisfaction with the POCT service.
6THE ASSESSMENT
The assessment will follow the usual CPA process with the following to be noted.
- In order to ensure the competency to perform the service across the scope of activity a representative number of staff need to be interviewed.
- The Regional Assessor will, in discussion with the Regional Assessment Manager, decide upon an appropriate sampling mechanism for assessing POCT devices in a number of areas.
- Peer Assessors will assess these areas using a standard format examination assessment.
Assessment of ‘sensitive’ areas
On occasions it may not be possible for assessors to enter some areas where POCT is performed as access may be restricted e.g. Baby Units, Theatre suites. In these cases assessors would expect to see evidence that the applicant has fully audited the POCT performed in these areas to assure themselves that the Standards are being met.
7THE REPORT
A single findings form will be provided covering all of the POCT types assessed, howevera separate report will be issued for each POCT type assessed. The Regional Assessor will also leave a recommendation of status with the applicant covering each POCT type.
For each POCT type the report will include:
- the status of each POCT type and any expiry date assigned
- findings raised
- a copy of Appendix 2 indicating the specific areas assessed
In addition there will be a single overview report containing statements about the competency of the organisation, the adequacy of the quality management system, and a balanced summary of the visit
Following issue of the report, the Regional Assessor then issues the Clearance Review Form to the applicant along with instructions for submission of clearance evidence.
No findings
If no non-conformities are raised accreditationis granted.
Raising a non-conformity
For POCT accreditation there is no status of Conditional Approval as there is with the main laboratory accreditation process.
A non-critical non-conformity reported in a non-accredited POCT service will result in an Iterative report being issued with the expectation that these would be cleared within 12 weeks of the visit. If the non-conformity is not corrected within the period identified then the status of the POCT will be reviewed.
For applicants already holding POCT accreditation, if the non-conformity is non-critical and can be cleared by CPA within twelve weeks of the visit date, applicants will be able to maintain their status and an interim report will be issued. If the non-conformity is not corrected within the period identified then the status of the POCT will be reviewed.
If the non-conformityis critical and cannot be rectified within a short time frame then POCT accreditation is withheld and the applicant will be required to re-apply for assessment when they have assured themselves that the issues have been dealt with.
8 Correction and clearance
Dealing with clearances will follow the usual CPA process with the following to be noted.
As the report for each POCT type is processed separately, clearances for each POCT type can also be submitted separately. Accreditation for each POCT type can therefore be granted separately.
9 Accreditation certificate
Awarding of certificates will follow the usual CPA process.
10 COSTS
A standard charge is levied for pre-assessment visits which will be invoiced immediately after the pre-assessment visit. Costs for main POCT assessment visits will be calculated based upon the scale and scope of the POCT service being assessed. Additions to scope will incur additional charges. Applicants will be notified of the proposed cost after the pre-assessment visit.
11 CHANGE OF LABORATORY STATUS
It is a requirement of POCT accreditation that the applicant laboratory maintains accreditation against the CPA Standards for the Medical Laboratory. In the event that the status of the applicant laboratory changes then the status of the POCT accreditation will be reviewed. This review will be carried out by the Regional Assessment Managers with reference to the CPA PAC.
Document Name: / AP-LAB-AssmHndbk POCT Supplement / Page: / 1 of 6Author: / Regional Assessment Managers / Date: / 09 July 2012
Owner: / Executive Manager / Version: / 2.00
“Valid For Day Of Print Only - 06/10/2018”