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
Sign In

As medical laboratories struggle to reduce costs and squeeze their budgets, it is essential that the lab’s quality assurance/quality control program is run properly to protect and enhance the analytical integrity of lab test results

When does budget cutting in a clinical laboratory begin to undermine the accuracy and analytical integrity of the medical laboratory test results produced by the laboratory?

This question is apparently a subject of much discussion within some lab organizations where aggressive cost reduction programs are shrinking lab staff and reducing funds spent on controls and similar QA/QC resources.

Because patients can be harmed if a clinical laboratory turns out inaccurate test results, cutting costs too deeply is an activity that can have dangerous consequences. It is also a situation that attracts national attention. One example is how the laboratory at Maryland General Hospital in Baltimore reported inaccurate HIV and HCV results on thousands of patients for a period of almost two years, ending with a news report on the lab test errors published in March 2004  by the Baltimore Sun

Medical Laboratory Test Errors Lead to National News Headlines

That episode made the national news. It led to the dismissal of both the laboratory administrator and the pathologist serving as laboratory director. As well, the hospital’s CEO resigned and there were Congressional hearings into how and why this lab’s accrediting bodies had failed to detect these serious problems in lab test accuracy over the years in question.

Maybe that episode is what some readers had in mind when they contacted us in recent weeks following Dark Daily’s publication of two different ebriefings on the trend of cost cutting in the clinical laboratory industry. (See “related information” at the bottom of the page). In response to these stories, a number of readers expressed concerns that cost-cutting in their own laboratories had gone too far.

Reducing Clinical Laboratory Costs Might Affect Accuracy of Test Results

These readers feared that inexperienced or lesser-trained staff are being asked to perform the most complex tests and, as a consequence, that might lessen the quality of results. In some cases, it was pointed out that to save money, lab management had reduced the use of controls from levels that previously exceeded the minimum requirements of federal and state regulations, such as CLIA.

Similarly, some readers noted that—to save money—lab managers were streamlining certain longstanding QA/QC activities that might have gone over and above the minimum statutory requirements.

Question about Effective QA/QC in the Medical Laboratory

A common question asked by some of these readers was: “As our clinical laboratory changes quality assurance and quality control activities, how does it monitor the accuracy and quality of its test results to have confidence that it has not failed to detect errors or erroneous results?”


Even as clinical laboratories work to cut unnecessary costs from medical lab operations, they increase the risk of eroding the quality of lab testing activities. However, an effective QA/QC program is essential to sustaining the integrity of the clinical lab’s testing activities. Pictured above is Glen Fine, CEO of the Clinical Laboratory Standards Institute (CLSI). He will be speaking at the seventh annual Lab Quality Confab on the new quality management system that has just been announced by Medicare officials and how clinical lab managers and pathologists can use this to improve the precision of their lab’s QA/QC activities.

The answer to that question falls outside the technical expertise of the editorial staff here at Dark Daily. However, experts in this aspect of medical laboratory management and operations will be speaking on this topic at the upcoming Lab Quality Confab, which takes place on October 1-2, 2013, at the Astor Crowne Plaza Hotel in New Orleans.

How to Use QA/QC to Ensure Quality While Cutting Lab Budgets

For example, the agenda at Lab Quality Confab includes these three sessions that specifically address how you can combine lab cost-cutting programs with effective QA/QC methods to accurately measure lab test quality:

• Elevating the Analytical Integrity of Your Lab’s Test Results: Why Your QA/QC May Be Sub-optimal and How to Find and Fix those Problems; presented by James O. Westgard, Ph.D., FACB, of Westgard QC

Reality Check on the True Cost of Recurring Bad Quality in Your Lab: How to Find It. How to Fix It. How to Sustain the Cost Savings! presented by Lucia Berte, MA, MT(ASCP), of Laboratories Made Better!

Quality Control Based on Risk Management and Its Role in Quality Management Systems for Laboratory Accreditation;

presented by Glen Fine, MS, MBA, CEO, Clinical Laboratory Standards Institute

Even the Medicare program is paying attention to the need for more sophisticated and effective methods of QA/QC in the clinical laboratory. On August 16, the Centers for Medicare & Medicaid Services issued the first details on a “new quality control option based on risk management, IQCP.” The CMS document provides full details of this voluntary option.

IQCP is built around the concepts of quality management systems (QMS). This is an important development and sessions at Lab Quality Confab will provide some of the first public presentations about IQCP and how clinical laboratories can use it to have greater confidence that they have accurately gauged the quality of their testing activities and properly identified the root causes of failures and fixed them.

Juggling the Need to Cut Lab Costs while Protecting Quality

For any clinical lab manager or pathologist seeking to drive out unnecessary costs while sustaining and improving the quality of lab test results and the services they provide to physicians, these quality management sessions are essential learning opportunities. Those interested in attending Lab Quality Confab can visit for information on the full program and to register.

As most pathologists and clinical lab administrators know, even tougher financial times lie ahead, not just for the medical laboratory profession, but for all of healthcare. For that reason alone, labs will face even greater financial challenges going forward. The challenge will be for lab managers to more effectively control their costs without undermining the quality and integrity of lab test results produced by their clinical laboratories.

Related Information:

Hit by Lower Lab Test Prices, Nation’s Clinical Pathology Laboratories Embark on Cost-Cutting Programs

Speakers, Topics, Agenda for seventh annual Lab Quality Confab: Everything you need to know to Register

Part Two on Cost-Cutting Trend in Nation’s Clinical Laboratories and Pathology Groups: How Innovative Labs Are Responding to Falling Lab Test Prices

From the Centers for Medicare & Medicaid Services: Individualized Quality Control Plan (IQCP): A New Quality Control (QC) Option

City hospital’s HIV testing manipulated; Evidence of false results ignored by lab workers at Md. General, state says; More than 400 people affected; Hospital president says patients will be notified to return for free re-tests (Baltimore Sun, 2004)

Lab workers warned Maryland General 2 years ago; Hospital’s managers ignored them, letter says (Baltimore Sun, 2004)

Westgard QC on: Maryland General; Blowing the Whistle: In the aftermath of the 2004-2005 Maryland General Scandal, the hospital laboratory in question was back in compliance. Regulations were changed. Standards were toughened. But is everything well now in the laboratory?