Introduction

In this issue ...
· CPA Accreditation and EQA Performance
· Pilot EQA Scheme Funding 2000
· Explaining CPA Terminology
· Reminders and Diary Dates

Standard F1 : The department must have a formal policy for internal quality control and must participate in approved External Quality Assessment Schemes

Participation in approved External Quality Assessment Schemes is mandatory for laboratory accreditation by CPA (UK) Ltd. However, scheme organisers have informed CPA that some participants erroneously believe that 100% success in EQA is essential for continued laboratory accreditation - this is not true. CPA requires satisfactory performance.

It is doubtful whether any laboratory in the country has a perfect track record of performance in EQA schemes: somewhere along the line a laboratory will have a quantitative or qualitative error in performance as defined by the scheme's steering committee and approved by its relevant National Quality Assurance Advisory Panel. Consequently, the important issue as far as this standard is concerned is not whether a laboratory made an error in an EQA sample distribution but how it responded to this failure. CPA inspectors will look for evidence that EQA performance is regularly discussed and documented and action plans established to investigate any failure and correct it. This is satisfactory performance.

Standard F1 : The department must have a formal policy for internal quality control and must participate in approved External Quality Assessment Schemes

At their November 1999 meeting the CPA (EQA) Committee members considered applications for the third round of pilot EQA Scheme funding, i.e. for the year 2000. Ten applications were considered; three requests for second year pilot funding and seven new applications. As in previous years the total of the bids received (in excess of £60,000) far exceeded the funds available and some very hard decisions had to be made which were subsequently endorsed by the CPA Board of Directors.

On the basis of very satisfactory progress reports from the EQA Scheme Organisers the Committee decided to support all three of the second year pilot funding applications, these were:

· UKNEQAS pilot scheme for Cholinesterase (Ms Goodall, Bristol and Dr Bullock, Birmingham)
· UKNEQAS pilot scheme for Haemophilia Genetic Analysis (Professor Preston and Mr Woods, Sheffield)
· UKNEQAS pilot scheme for Haemochromatosis Genetics (Dr Darke, Welsh Blood Service and Mrs Corbin, Bristol)

The Committee was able to support only three of the seven new applications, these were:
· Heathcontrol EQAS for Quantitative Toxicology in Blood (Dr Wilson, Cardiff)
· Interpretive comments in Clinical Biochemistry (Dr Challand, Reading)
· S & W Region's Haematologists' Morphology and Data Interpretation Scheme (Dr Prentice and Colleagues, Plymouth)

In supporting the latter two schemes CPA is opening a new chapter in the evolution of EQA Schemes in Clinical Biochemistry and Haematology. At present nearly all schemes in these disciplines test the ability of a laboratory to produce good quality numerical results. The two interpretive schemes to be supported test the ability of individual clinical practitioners to interpret data and/or morphological appearances. CPA believes that moving in this direction is entirely consistent with the overall thrust of present thinking in the areas of clinical governance, continuing professional development and professional revalidation. Schemes of this type will, we believe, become increasingly important in the future.

The level of support that CPA is providing for EQA development in the year 2000 is considerably greater than in previous years, totalling in excess of £38,000, but CPA is convinced that substantial investment in EQA development is a matter of high priority for the profession and for users of Pathology Services.

Following inspection applicants receive a copy of the inspectors' report accompanied by a letter of explanation from CPA regarding the outcome. This letter has recently been revised to include explanatory notes with regard to terminology used. It is copied in full here for information.

EXPLANATORY NOTES

The inspectors are asked to comment under each standard and give their view on compliance i.e. full, partial or non. The report is then assessed by the relevant CPA Specialist Advisory Committee. If the SAC have considered it necessary to modify the inspectors' interpretation the report has been overstamped to indicate the view of the SAC. Because of the nature of the inspection process, there may be non-compliances which were not identified at this visit.

Compliance with Standards
Full compliance:
a) with no comment - self explanatory
b) with comment - this may be made a point for checking on annual re-registration

Partial compliance:
a) minor - point to be checked at annual re-registration
b) major - a condition to be met before full accreditation granted

Non-compliance:
a) non-critical - a condition to be met before full accreditation granted
b) critical - a reason for referral

The categories are as follows:
Referred:

Critical non-compliance means that no CPA status has been granted.

Re-application will be required once the non-compliances have been rectified.

Conditions:
Deficiencies which require correction before accreditation can be granted.

Annual re-registration:

Points to be checked at your next annual re-registration. At the present time these do not affect the CPA status of the department but they may become more relevant in the future as standards evolve.

Definition of CPA Status

There is a great deal of confusion regarding the terminology used by CPA to define status of departments. The following will hopefully clarify the terms used.

Registered:

When an application is accepted the department is placed on the CPA database and registered pending an inspection visit. This term does not imply any form of approval by CPA at this stage.

Conditional approval:

Following inspection, if there are minor deficiencies to be rectified, departments are given a timescale in which to correct the deficiencies. Conditional approval is awarded in order to identify that the department is not simply registered but has been inspected. Conditional approval does not imply accreditation status and the department is not able to claim CPA accreditation. There is no such term as conditional accreditation.

If deficiencies are not corrected by the agreed timescale, the Advisory Committee may agree to remove conditional approval. The department is therefore no longer on the CPA register. If the department wishes to be in the system, re-application is required.

Referral:

Following inspection departments may have critical non-compliances which prevent any form of status being awarded. The department is therefore no longer on the CPA register. If the department wishes to be in the system, re-application is required.

Reporting the new policy on Extended Conditional Approval

When inspected laboratories receive conditional approval, a finite timescale is imposed for correction of those conditions, normally 6 or 12 months, depending on the nature of the condition.

Most laboratories are able to correct such conditions well within the deadline but two types of condition are associated with longer delays - staffing issues and building work. Some laboratories lose their status because they are unable to correct these conditions in time, even allowing for flexible interpretation by CPA.

The Board of CPA has agreed that the duration of conditional approval can be extended provided the following criteria are met:

· All other conditions must be corrected within the stated timescale.

· The department agrees an appropriate timescale for correcting staffing levels or completing building works with CPA and keeps CPA fully informed on planning and funding issues and their progress. Any agreed timescale will be on a case-by-case basis.

· Progress on correction of conditions will be monitored regularly by the Joint Advisory Committee which can terminate the extended conditional approval at any time.
February 2000

Interim Reporting

There has been a growing need to address the problem when departments holding CPA accreditation are issued with conditional approval following the second (or subsequent) cycle inspection visits. It has now been agreed that if the deficiencies noted are very minor and can be rectified within a short period of time the department will maintain accreditation status. The expiry date for rectifying deficiencies will be agreed with the department. This new policy will be put into operation immediately.

· February - April 2000
· March 2000
· May 2000
· April - June 2000
· July - August 2000
· September 2000
· October 2000
· January - October 2001
· September - December 2001
· April 2002
· October 2002

Consultation with CPA shareholding organisations
Presentation at Annual Conference
Information available at Pathology 2000
Widespread consultation
Editing by Standards Revision Group
Final version presented at CPA AGM
Inspector Updates
Education programme for applicants and inspectors
Volunteer pilot studies
Applications against the new standards
Inspections begin

Meeting with User Group

Feedback from users of pathology services and Trust Chief Executives is an essential part of the CPA inspection process. Sometimes the importance of these interviews is not acknowledged. This is a reminder to both applicants and inspectors of their obligation to arrange a meeting with an appropriate user group, membership of which should be mutually agreed beforehand. The names of those attending the meetings should be circulated to the inspectors prior to the visit. CPA Central Office will assist with this circulation.

CPA understand that there will be occasions when at short notice the Chief Executive is unavailable and it is then appropriate to interview a deputy. There will also be times when other commitments prevent user group members from attending. In these instances inspectors should obtain feedback either by telephone or arranging to meet later during the day of the inspection. This should be used as a fail-safe device which the team leader and/or inspectors could arrange at the time.

Pathology 2000

This is a reminder to delegates attending Pathology 2000 that CPA will be running a symposium on Tuesday 16 May at 10.00 am. The symposium is in the form of two one-hour debates and we would be delighted to have your support and votes. Details as follows:

Quality in Pathology
Debate 1: Accreditation Should be Mandatory
For: Professor Roddy MacSween, Glasgow and Mrs Julietta Patnick, Sheffield
Against: Dr Charles Shaw, Bristol and Dr Archie Prentice, Plymouth
Debate 2: External Assessment has Improved Quality
For: Professor Ian Lauder, Leicester and Dr Danielle Freedman, Luton
Against: Dr Brian Colvin, London and Mr Mike Hallworth, Shrewsbury

Diary Dates

15-17 May 2000

15-16 June 2000


26 September 2000

28 September 2000

3 October 2000

4 October 2000

10 October 2000

11 October 2000

To be advised

Pathology 2000 - Birmingham

Inspector Training for new inspectors - Birmingham

Inspector Update - Edinburgh

Inspector Update - London

Inspector Update - Bristol

Inspector Update - Birmingham

Inspector Update - London

Inspector Update - Sheffield

CPA(EQA) Inspector Update & Participants Meeting