News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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CLIA Inspections of Clinical Pathology Laboratories Appear to Be Tougher on Loosely-Managed Labs

Pathologists and medical laboratory managers should be alert to compliance changes

CLIA inspections of medical laboratories may be getting more rigorous in certain areas of laboratory operations, according to anecdotal information emerging from the field. Clinical laboratory management consulting firms report that they are experiencing an increased number requests for help from hospitals following a recent CLIA inspection of their laboratories.

Laboratory management consultants tell Dark Daily that, for the most part, well-run medical laboratories are having few problems when CLIA inspectors show up on site. Because these laboratories are diligent about compliance with legal requirements, the CLIA inspection seldom turns up a serious deficiency nor identifies a major compliance failure within the laboratory.


Auckland Hospital Laboratories Play Defined Role in Supporting Patient Care

Highly-automated hospital labs are organized to serve inpatient testing and don’t compete for “outreach” lab business from office-based physicians in the community

DATELINE: AUCKLAND, NEW ZEALAND—In this nation’s single payer health system, clinical laboratory testing services are allotted to hospital laboratories and commercial laboratories in very specific ways. Consequently, hospital laboratories in New Zealand tend to provide testing primarily for inpatients and for outpatients seen by specialists who practice within the hospital’s facilities.

This is an interesting distinction which sets New Zealand hospital laboratories apart from hospital labs in such countries as the United Kingdom, the United States, Canada, and Australia. In each of these countries, it is common for hospital laboratories to provide some laboratory testing to the outpatient and outreach sector, particularly to primary care clinics and office-based specialist physicians.


Regional Laboratory Networks Sprouting in the United Kingdom

BIRMINGHAM, ENGLAND – Here in the United Kingdom, regional laboratory networks are finally catching on. The number of “pathology networks,” as they are called here, has increased in recent years. As was true of Canada in the late 1980s and the United States and Australia during the 1990s, clinical lab leaders in the United Kingdom are finding regional laboratory networks to be effective business models to achieve tight integration of lab services, realize significant cost savings, and eliminate excess lab testing capacity in regional markets.

These achievements were confirmed by presentations delivered yesterday in Birmingham, England, at the sixth annual Frontiers in Laboratory Medicine (FiLM) conference yesterday. Produced jointly by the Association of Clinical Biochemistry and The Dark Report. Your editor, Robert Michel, is here and participating in all the sessions. Four regional laboratory networks presented their accomplishments yesterday.

In the northwest of England, the Greater Manchester Pathology Network, formed in 2005, is composed of laboratories from 16 hospitals and serves a population of 2.5 million people. In his presentation, co-presenters Neil Jenkinson, Ph.D., Network Director, and Keith Hyde, Ph.D., Deputy Director of Laboratory Medicine, reported how participating pathology laboratories (as clinical laboratories are called in this country) are progressively developing integrated lab testing services. One key objective is to develop a common laboratory informatics capability that allows the 16 hospital laboratories to more effectively serve primary care clinics in the region.

Local to the Birmingham area, Coventry and Warwickshire Pathology Services was created in May 2007, by two acute care trusts that had always been wary of each other, According to Neil Anderson, Ph.D., Director, this pathology network has 412 employees and provides lab testing services to a population of 950,000. Steps toward integration and consolidation of lab testing services centered around three areas of lab testing:

  • Blood sciences (Chemistry, Hematology, Transfusion medicine and Immunology)
  • Microbiology (Microbiology, Virology, and Laboratory Infection Control)
  • Cellular Pathology (Histopathology, Cytology and Mortuary services).

Anderson explained that, within two years, the pathology network had delivered £1.9 million (U.S.$2.8 million) in savings to its two parent trusts. As well, steps had been taken to install a common laboratory information system (LIS), and flexibility in staffing was contributing to improved levels of service to clinicians.

Two overseas regional laboratory networks were at FiLM to share their successes learned. In Australia, Sullivan Nicolaides Pathology Laboratories, a division of Sonic Healthcare, LTD, operates a regional laboratory network in Northeastern Australia that serves a population of 3 million people. With a central laboratory in Brisbane, it has 21 other laboratories located across a service area of millions of square miles in the states of Northern Territory, Queensland, and New South Wales. Executive Manager Tony Badrick, Ph.D., observed that, with an operating history of several decades, this regional laboratory network’s current objective is to quality management systems to advance the performance of operations. Sullivan Nicolaides is certified under ISO 9001 and ISO 15189. It is working on its ISO 14000 certification.

The fourth regional laboratory network presented at FiLM Tuesday was Calgary Laboratory Services in Calgary, Alberta, Canada. This case study was presented by Fred Swaine, M.D., Chief Operating Officer. This regional laboratory network was created back in the mid-1990s, when the government of Alberta mandated an immediate reduction of 35% in funding for laboratory services. Swaine described how this regional laboratory network is in the midst of its third cycle of lab consolidation and integration since 1996. It serves 1.2 million people and is currently comprised of one central laboratory, with rapid response labs in four hospitals.

Swaine noted that one notable accomplishment of the early network organization was to install a single laboratory information system (LIS). That has made it easier for Calgary Laboratory Services to collect, store, and provide access to laboratory data across its entire service region.

Dark Daily notes that these four examples of regional laboratory networks demonstrate how this trend has established strong roots. For almost two decades, operational regional lab networks in Australia, Canada, and the United States have proved to be effective providers in their respective service areas. It is expected that the number of pathology networks will continue to expand.

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