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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Why Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions

Test ordering and results interpretation can confuse the public says Dartmouth Institute, which is why some clinical laboratories limit the types of lab tests that people can request

Giving consumers direct access to medical laboratory testing continues to be a subject of some controversy. One factor in this debate is Theranos, which brought much attention to direct access testing, followed by extensive news coverage in recent months of its problems with reporting accurate clinical laboratory test results.

Concerns about allowing consumers to have direct access to lab testing were the subject of a recent National Public Radio (NPR) Shots Health News story. Several medical experts were interviewed and described why they had concerns about direct access testing (DAT).

One such expert is H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine at The Dartmouth Institute (Dartmouth). According to Welch, DAT could contribute to over-diagnosis and give people an inaccurate impression of what good health actually means. (more…)

Internationally-respected Experts in Clinical Pathology and Laboratory Medicine Ask: Why Don’t We Know More about Theranos’ Technology?

This secretive start-up medical laboratory testing company has not disclosed how its diagnostic test technology works, nor has it given laboratorians an opportunity to examine the technology

Several internationally-respected clinical laboratory experts are asking serious questions about Theranos and its diagnostic testing technology, and they’ve gotten few answers to date. Though the number of experts is small, their credentials in the clinical laboratory profession are impressive. In addition, some have published their critiques of the start-up medical laboratory company in well-respected medical journals.

One question these clinical pathologists and laboratory directors ask is why Theranos has so far been unwilling to provide more information about the lab testing technology it uses to deliver medical laboratory test results to patients and their referring physicians. Even as the company has declined to speak to the medical laboratory profession, Theranos has mounted a major public relations campaign designed to make a big impression on investors, business partners, and most recently on health insurers.

The clinical laboratory company in Palo Alto, Calif., gets plenty of attention because it claims to have disruptive technology that will allow it to perform medical laboratory tests equivalent to the current standard of care. Theranos says it can do this using a capillary specimen and return results in four hours, while charging a price that is just 50% of Medicare Part B lab test fees. Given these assertions, it is natural that pathologists and laboratory scientists who perform tests for patients, are curious about the scientific basis of Theranos’ proprietary diagnostic technology and what evidence Theranos has developed to support its claims of comparable accuracy and reproducibility. (more…)

A New Issue for Laboratories: Consumers Who Want to Keep Their Own EMR

In recent years, the laboratory industry has debated how to best meet the demand from some consumers to order laboratory tests and receive results without the involvement of their physician. However, direct access testing (DAT) never gained much momentum. Now comes a trend likely to have a greater impact: the Personal Health Record (PHR).

In an age where the Internet is a secure way to capture information and paper medical records are slowly being converted to electronic ones, more individuals are taking over active management of their personal health information. Enter the Personal Health Record or PHR. This will be a key element in the complete patient medical record and is part of national healthcare IT policy. The Office of the National Coordinator of Health Information Technology (ONC) set as Goal 3 of it strategic framework “to personalize care through the adoption of PHRs.”

Lab managers and pathologists may be surprised to learn that there are already two types of PHRs currently in use: One type is the standalone PHR. This is a PHR created by individuals or by one institution to be used by patients and their families. They are useful for getting consolidated information, but standalone PHRs only work when patients are diligent in keeping records up-to-date. Integrated PHRs with EMR are currently tied directly to one institution and hospital system. This integration allows for helpful services such as appointment scheduling, physician messaging, and prescription refill capabilities.

Because an individual’s PHR is controlled and stored by an individual hospital or clinic at this point, the usefulness of the information is not fully recognized. EMRs are becoming the norm, but, as Dark Daily has reported in the past, adoption of EHRs by physicians and hospitals is slow and falls significantly behind national goals. The obvious goal for the future is to fully integrate PHRs and EMRs not only in one institution, but across institutions in a city, and, eventually, nationwide so that a person’s medical history is safely and accurately stored so that it can follow the person around his or her whole life through.

The emergence of PHRs affects clinical laboratories because lab data is a major component of a person’s permanent health record. Once test results, medications, doctor visits, etc are stored on a single electronic record, it will be easier for all parties involved to make more accurate medical diagnoses. The cost of implementation is great, but a well-developed system will save a significant amount of time and lead to reduced error in the long run. Dark Daily observes that forward-looking laboratories and pathology groups have an opportunity to develop a strategy that supports PHRs. Going forward, that strategy can help the laboratory create greater loyalty with those patients interested in maintaining PHRs.