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Introduction In this issue ...

• CPA Support Website
• Diary Dates
• Christmas and New Year Holidays



• CPA Guidance on the Accreditation of Managed Pathology Networks
• Universal Precautions
• CPA Annual Conference

 


 

CPA SUPPORT WEBSITE

CPA’s current website has information about the company structure, contact details, accredited laboratories and EQA Schemes, newsletters, and documents and publications.

We have now created a support website and this can be accessed either via the current website, or by typing in www.cpa-uk.co.uk/support

This website has been introduced to provide a quick and easy way to pass on up-to-date information to all interested parties. It is useful for applicants currently preparing for a visit and for assessors planning a visit in the near future. 

The CPA Professional Advisory Committee meets on a monthly basis and there are often decisions taken at those meetings that will impact on future assessments. Some of the decisions become CPA policy, once endorsed by the Board of Directors. Please take the time to view this site and, if you are preparing for an assessment, please look for up-to-date information before your visit.

If there are other topics you would like to see explained on this site, please e-mail CPA Central Office, to office@cpa-uk.co.uk


 

 


 

   DIARY DATES

CPA Assessor Training Courses 

Two-day courses for assessor training will be held in Birmingham on the following dates:

 

 

13/14 January 2004
15/16 January 2004
17/18 February 2004
19/20 February 2004
11/12 March 2004
1/2 April 2004
11/12 May 2004
13/14 May 2004

 


CPA Annual Conference 2004


Thursday 25 March 2004 
– Royal Institute of British Architects, London


CHRISTMAS AND 
NEW YEAR HOLIDAYS

CPA Central Office will be closed as follows:

- Christmas Day 
- Boxing Day
- New Year’s Day
- Friday 2 January 2004



On behalf of CPA, we wish you all a very Merry Christmas and a Happy New Year.

 

 


 

CPA Guidance 
on the Accreditation of Managed Pathology Networks

1. The Department of Health has published Draft Guidance on Modernising Pathology Services.

2. The guidance advocates the establishment of managed pathology networks, while recognising issues of accountability and the need for an incremental approach to network development.

3. CPA will be asked increasingly to accredit a variety of managed networks as these evolve to meet local needs and circumstances.

4. CPA needs to formulate clear guidance on what is and is not a managed pathology network capable of accreditation.

The crucial test of a managed pathology network is that its Quality Management System can be assessed through a single horizontal audit at any one of its component units.


What is an accreditable Managed Pathology Network? CPA`s View

5. Every unit in the network will comply with all CPA standards but those key standards, mainly `A` standards, defining a true managed network are as follows:

> The network, or the parent organisation of which it is a part, shall be an entity that can be held legally responsible (A1.1)

> It shall have a single Quality Management System (A1.2)

> It shall be defined in a single organisational chart (A1.4)

> It shall have a single Quality Policy (A3)

> There shall be a single Quality Manual (A6) which may contain separate sections for its component units

> There may be more than one Quality Manager (A7) but they shall operate to the same policies and procedures

> There shall be a single Annual Management Review (A11)

> There shall be regular meetings between management and the staff involved in all branches of the network (B8)

> Users shall be assured of equity of access to pathology data ( D2) and interpretive advice (G2,G5)

> There shall be a single User Manual (E1) which may contain separate sections for its constituent units

> There shall be a common format for requesting investigations (E2) and reporting results (G2)

> There shall be a common format for written procedures (SOP`s) across the network (A8,A9,A10,B3,C6,D1,D2,D3,E3,E4,E5,E6,F2,F3,G1,G3,G4,H1)


6. A managed network will therefore:

> Operate under a single CPA reference number

> Submit one application form with one Quality Manual

> Be subject to a single assessment for which there will be a single report

> Have a single CPA status for all its constituent units


7. If a network feels it does not meet these standards during its formative period of incremental development, it is advised to apply as separate departments retaining their own registration numbers and separate CPA status.

8. In CPA`s view, a managed pathology network must be distinguished from,
for example:

> A Trust merger at management level where pathology departments retain separate identities

> Networks of co-operating professionals without identified management arrangements.

 

 


 

Universal Precautions

When doing on-site assessments in blood science laboratories (mainly Biochemistry, Haematology and Immunology) CPA assessors are finding laboratories that claim to be using “Universal Precautions” for handling specimens. They mean by this that all specimens, both high and low risk (with regard to the presence of blood borne viruses) are handled with the same “high” standard of precautions (to prevent inadvertent infection of laboratory staff). This is particularly relevant to laboratories that still perform numerous manual techniques with a high level of specimen handling. Such an approach has many benefits, and at least two are often quoted: 

1. It makes specimen handling simpler because you no longer need two specimen routes within the laboratory. For example, in departments such as Immunology with numerous manual techniques, it is traditional to store high-risk specimens separately and to test them as separate batches. In the highly automated disciplines of Biochemistry and Haematology high-risk specimens used to be left until the end of the day and then run through the analyser as a separate batch, after which the analyser was decontaminated. It is obvious that in both these scenarios the high-risk specimens must be clearly identified in the first place.

As both total and high-risk specimen numbers have increased, and demand grows for quicker and quicker turn round times, it has become increasingly difficult to maintain such approaches.

2. It better protects staff against unknown high-risk specimens – “it’s the train you don’t see that kills you, not the one you do see” syndrome. By the time many patients are diagnosed as HIV positive or Hepatitis B positive, the laboratory has often already processed numerous specimens from that patient. It therefore appeals to staff more and more to have the safety net of “universal precautions” - all specimens are treated as if they were high-risk.

However, the concern is that some laboratories have not properly thought through the issues.

The recently published latest edition of “Safe working and the prevention of infection in clinical laboratories and similar facilities” rightly cautions against universal precautions unless they are properly defined. It says, “The use of the term ‘universal precautions’ is not helpful with regard to the measures needed for handling biological agents, as it is not clearly defined. Adopting universal precautions may result in a standard of practice which is not high enough. The precautions needed must be based on an assessment of the risks involved…” (p17).

Several basic questions need to be answered before universal precautions are introduced: 

1. Have full risk assessments been performed and recorded?
2. Has the laboratory carefully defined what their universal precautions are?
3. When can the universal precautions be used?
4. Are there situations when the universal precautions may be inappropriate?


The risk assessment needs to look at such issues as: 

1. Specimen storage, testing and disposal, and decontamination of equipment.
2. Are there particular implications for unqualified staff e.g. reception staff and MLAs?
3. Are there particular areas of risk? e.g. tube breakage in the centrifuge; does the method produce aerosols; are sharps involved? These issues should already have been highlighted anyway in the laboratory’s basic risk assessments, but need re-evaluating in the light of a universal precautions policy.
4. Will the policy be applied just within one department, the whole of pathology, or the whole Trust? If applied just within pathology, the policy can be invisible to those outside. If applied to the whole Trust there will be significant 
communication and training issues involving clinicians, phlebotomists and porters. If applied to the whole Trust, will high-risk samples cease to be labelled with yellow high-risk stickers?
5. What training issues will there be, especially for unqualified staff?
6. Are there situations where the universal precautions are not appropriate and how will high-risk specimens therefore be handled in those situations?

The implementation of universal precautions can have many benefits, and in many situations can be done by introducing fairly simple manoeuvres – e.g. gloves and goggles to be worn at all times when handling specimens or dilutions thereof, all centrifugation to be done in sealed centrifuge buckets, and avoid the use of sharps. Laboratories are advised to think carefully though, before stating to a CPA assessor that they are using universal precautions for handling their specimens, unless they have done the necessary groundwork. Inspectors should and will ask for the written risk assessment and compare this with the highest standards of care necessary in their experience.

This article is not intended to be an exhaustive discussion on the subject and laboratories are recommended to read some of the following articles.

References
1. “Safe working and the prevention of infection in clinical laboratories and similar facilities” 2nd edition 2003, published by the Health Services Advisory Committee.
2. National Committee for Clinical Laboratory Standards: Clinical Laboratory Safety: Approved Guideline NCCLS Document GP17-A. Wayne, PA, NCCLS 1996
In America the Occupational Safety and Health Administration, and the National Institute for Occupational Safety and Health (a functional unit of the CDC) have published similar guidelines.


Mr Ray Russell, Senior Chief Biomedical Scientist
Lancashire Immunology Service, Royal Preston Hospital

 

 


 

CONFERENCE 2004

Date: Thursday 25 March 2004
Venue: RIBA, 66 Portland Place, London W1B 1AD
Registration: 10.00am - 10.30am

Full details of the programme will be posted on the CPA website at www.cpa-uk.co.uk.

Session 1 – Increasing burdens in Laboratory Medicine
Chairman: Professor Sir Duncan Nichol (Chairman of the CPA Board of Directors)
• Mandatory enrolment for accreditation
• EU Directive for In Vitro Diagnostics
• Lessons in Pathology - National Patients Safety Agency
• Reducing burdens in the NHS

Session 2 – Open Forum Discussion 
Chairman: Dr Mansel Haeney (Chief Executive CPA)
The afternoon session will be an open discussion on current topics; some examples include:
• New CPA Standards – what has been learned so far ?
• All disciplines are equal – are some more equal than others ?
• Professional input for serology
• Accrediting pathology networks

There will be a panel of advisors representing:
• The CPA Standards Training and Education Group
• The CPA Professional Advisory Committee

Registration Fee: Ł130 (to include coffee, lunch and tea)
The Conference is usually oversubscribed and booking is essential.
Royal College of Pathologists and IBMS CPD applied for.

 


 

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