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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As Accreditation Inspections of Clinical Laboratories Become Tougher, Innovative Labs Use Internal Audits and Continuous Quality Improvements to Help Prevent Deficiencies

Savvy medical laboratory managers conduct internal audits of processes involved in deficiency citations so they can uncover how deficiencies occur and help eliminate recurrences

One trend that places clinical laboratories at risk involves increased regulation of lab processes, along with more thorough accreditation inspections. Compared to past years, both developments mean more ways for lab assessors to find greater numbers of deficiencies.

However, leading laboratory accreditation and quality improvement experts say that many deficiencies could be avoided if lab leaders conducted their own internal audits and continuous quality improvement projects ahead of visits by accrediting authorities.

In an exclusive interview with Dark Daily, Randall Querry, Director of Government Relations at the American Association for Laboratory Accreditation (A2LA) said, “Clinical laboratories can do a better job of preparing for the external assessment by doing an internal audit. That is, watching personnel perform tests and noting if they aren’t following the same sequences that standard operating procedures address before the external assessors arrive.”

A2LA is one of the primary accrediting bodies with authority from the Centers for Medicare and Medicaid Services (CMS) to accredit medical laboratories relative to Clinical Laboratory Improvement Amendments (CLIA). Others include:

“This doesn’t have to be an ‘us against them’ exercise. We are all in this together for continual improvement and to ensure we’re doing a better job at the end of each day—that we have had a win,” said Querry said. 

How Should Clinical Laboratories Conduct Internal Audits?

So, what is the best method for clinical laboratory leaders to conduct their own audits of operations and avoid citations of deficiencies?

Lucia Berte, President of Laboratories Made Better, suggested medical laboratories should “Pick a sequence and follow it through.” In the Dark Daily interview, she suggested labs should focus on:

  • The sequence of receiving samples in the laboratory to make certain they are properly accessioned, processed, and distributed;
  • Steps to setting up and running an analyzer; and
  • The process of ensuring tests’ critical values are reported to ordering clinicians and how reports are made.

An internal audit may suggest areas where the clinical lab is not on target to meet regulatory and accreditation criteria. Or, the lab may discover what Querry calls “gray areas”—places where criteria are currently being met, but a trend suggests there could be problems down the road.

“And in those cases, it’s always good to identify areas of improvement for preventative action. They may not be a top priority—such as a deficiency—but the areas are on the radar screen as something to address to prevent it becoming a worsening problem,” Querry said.

Quality Improvement Processes to Address Deficiencies

Berte notes that citations in one area of the lab may suggest the need for continuous improvement projects across all laboratory departments or sections. For example, an accrediting body may cite chemistry for a deficiency while hematology and other departments do okay. However, that determination can be deceiving. 

“There is always an underlying process. And the better question for the clinical laboratory is ‘can we make an improvement project out of this that can solve this problem not only for the area where it was cited, but perhaps prevent this problem from occurring in other lab [departments] prior to the next external accreditation assessments?’” Berte said.

Lack of Uniformity among a Clinical Laboratory’s Departments

Berte says a common deficiency is “lack of a uniform competency assessment program” for staff throughout the lab. Assessors expect laboratory departments to have the same competency assessment in regard to processes, records, and the way documents are created, she explained.

Lucia Berte (above), President of Laboratories Made Better, advises improving quality of documents as a project across the entire lab. “We still have a lot of silo-mentality in labs—where chemistry is different from hematology which is different from transfusion. Labs should have a uniform approach to the way their documents are written, and this is not necessarily the case,” she told Dark Daily. (Photo copyright: Whitehat Communications.)

Competency-related Citations

Berte also said competency-related citations may happen when documents read by auditors are not in sync with what the officials see in the clinical lab during inspections. “People not doing things in the order in which things have to happen. That’s the disconnect.”

Querry, speaking from the perspective of an assessor, adds, “We see a discrepancy and ask—do they have the appropriate work procedures with them at the workstation? Is it accessible? Where is this discrepancy? We identify it and then it’s up to the lab to address it—in training, and between the written procedure and the process.”

Consistency, he says, is important especially in organizations where staff rotate among lab areas and different shifts.

Quality System Essentials for Clinical Laboratories

The website for the Clinical and Laboratory Standards Institute (CLIA) states that implementing a quality management system in the lab involves use of “quality system essentials (QSEs).” QSEs are key to lab workflow, communication, and training. They include documents and records management, assessments, and continual improvement.

Querry emphasizes that trying to predict what the hot citations may be in 2020 is not as important as focusing on the technical competence of the lab and its resources.

“We are not out to play gotcha. We are going in there, looking at all the systems, and doing a sampling of testing in various departments of the lab. It’s up to the lab to show us it is technically competent to perform those tests. And they have the equipment and records that the equipment has been checked and calibrated and maintained. We have an examination process,” he said.

Experts agree, clinical laboratories that prepare for external assessments with internal audits and continuous improvement programs may reduce deficiencies during inspections.

—Donna Marie Pocius

Related Information:

Top Laboratory Deficiencies Across Accreditation Agencies

Implementing a Quality Management System in the Laboratory

Lab Quality Confab hosted by The Dark Report

25th Annual Executive War College on lab and pathology management April 28 – 29, 2020

Clinical Pathology Laboratories in the United States Face Tougher Accreditation and CLIA Environment

Federal and state laboratory regulators tighten down during inspections of nation’s medical laboratories

Across the United States, medical laboratory accreditation and CLIA compliance is quietly getting tougher. This is a trend which affects every clinical laboratory and anatomic pathology medical group that must comply with CLIA and meet the accreditation requirements of the Medicare program.

One sign that laboratory accreditation and compliance is getting tougher is the increased number of hospital laboratories willing to publicly acknowledge that a recent assessment, survey, or inspection resulted in serious deficiencies.

Federal and state clinical laboratory regulators are backing up tough talk about tighter enforcement of the requirements of the Clinical Laboratory Improvement Act (CLIA) requirements. Over the past 18 months, Dark Daily is aware that two nationally-prominent medical laboratory companies—following CLIA inspections of certain lab facilities—were required to cease certain types of clinical testing until serious deficiencies were corrected. These consequences demonstrate that it is not just hospital laboratories feeling the brunt of more rigorous CLIA inspections.

New Insights on the Globalization of Healthcare and Laboratory Testing

In the United States and many countries around the world, primary goals for healthcare reform commonly center on better patient safety, improved health outcomes, and higher quality services. As clinicians in these countries actively work to achieve these goals, the clinical laboratories that serve them must respond to these efforts with appropriate lab tests and services.

Last week, Dark Daily Editor Robert Michel traveled to New Jersey to participate in a lab management meeting specifically organized to look at healthcare globalization and identify how this globalization trend is influencing clinical laboratory services. It was the annual meeting of the Customer Advisory Board (CAB) for the Pre-Analytical Services division of Becton, Dickinson and Company (BD) (NYSE:BDX) of Franklin Lakes, New Jersey. To foster productive discussion about globalization in healthcare and laboratory testing, BD arranged for presentations via teleconference from laboratory experts in India, South Africa, Belgium, and Mexico. Here are noteworthy points from each presentation:

INDIA: Healthcare services in this country are provided through government programs and the private sector. Annual spending on health is about US$37 billion. Government health services are delivered at the state level and India has 22 states. Experts identify the need for 896,000 more hospital beds in this nation and the private sector is responding to meet this goal. Because of the lack of healthcare resources in rural areas, telemedicine services are being pushed because it extends the reach of physicians and greatly increases their productivity. In the laboratory sector, there may be as many as 40,000 independent labs. Consolidation and acquisitions have created at least five major laboratory companies. There is a shortage of laboratory technologists. Phlebotomy is performed by medical technologists, each of who must have a four-year degree. Laboratory accreditation often involves an ISO standard and ISO 15189 is gaining favor.

SOUTH AFRICA: This government provides a minimum health insurance program to individuals who fall below a certain level of income. Above that income, private health insurance is the major source of healthcare. One challenge for the country is that it has at least 13 different races which are genetically unique. As genetic medicine advances, personalized services appropriate to these patients must be developed. HIV is a major factor in South Africa. Up to 90% of government health spending goes to HIV positive patients who undergo treatment for other health conditions. There is a shortage of pathologists in the public hospital sector of South Africa. Phlebotomy is done by trained nurses who attended college. Because it can take two or three days to move a specimen from some areas of the country, there is strong interest in point of care testing. (POCT). ISO 17025 is often used by private sector hospitals and laboratories for accreditation.

BELGIUM: As a developed nation with aging demographics, healthcare in this country faces many of the same challenges as the United States. Hospitals have their own laboratories and independent lab companies serve physician offices. There has been some consolidation of the independent lab sector. There is a shortage of both pathologists and technical laboratory staff in Belgium. Laboratories must be accredited with a quality management system (QMS) and ISO 17025 has been used. However, up to 20% of the nation’s laboratories are using ISO 15189 for their accreditation. Lean and Six Sigma is gaining wide acceptance and integrates well with accreditation under ISO standards.
Phlebotomy must be done only by physicians, nurses, and medical technologists.

MEXICO: Healthcare in this country reflects the extremes of wealth and poverty among the population. The government’s social security system provides minimum health benefits to everyone with a job. However, self pay and private health insurance play significant roles in the Mexican healthcare system. A national health priority is extending health services to remote areas of the country. There are still deaths from diseases such as cholera simply because individuals in these areas have no access to healthcare. Phlebotomy is done by nurses and medical technologists. Physicians do not draw blood in their offices, but refer patients to the collection sites operated by independent laboratories. Laboratory accreditation is mandatory in Mexico and ISO 9000 has been used. ISO 15189 is an option to meet accreditation requirements and growing numbers of laboratories are using ISO 15189.

Not surprisingly, everyone participating at the BD meeting on healthcare globalization was fascinated by the similarities and differences in healthcare and laboratory services in each of these four international presentations. Observation number one: Across these four countries, it was obvious that standards of care are tightening. Accreditation of laboratories is one example. In this regard, the quiet inroads being made by ISO 15189 in all four countries caught the attention of the American lab managers participating at this meeting. They recognized that other countries are moving rather rapidly to bring their laboratory services up to the level seen in developed countries.

Observation number two is that the adage “all healthcare is local” remains true. That was illustrated by the different national objectives. In India, use of telemedicine to support rural needs is different than in Mexico, where there are major efforts to create healthcare infrastructure in regions totally lacking any health services whatsoever. Similarly, In South Africa, meeting the health needs of so many HIV positive patients is the primary objective, whereas Belgium’s healthcare system is preparing to serve the many aging, but reasonably well-off individuals soon to reach their retirement years.

Further, it was pointed out that the demand for reliable and cheap point of care (POC) diagnostic tests by countries such as India, South Africa, and Mexico as a way to support rural care, would make these attractive and sizable markets for the IVD industry. Thus, more innovation in POC testing innovation is likely to occur first in those countries, rather than in the United States or Europe.

Your Dark Daily Editor,

Robert Michel