LDTs: Public Perception

It seems like everyone is getting into the act these days, related to the regulation of laboratory developed tests (LDTs). Even politicians and lawyers are talking about LDT regulation. A recent online post (http://thehill.com/policy/healthcare/211250-lawmakers-push-fda-oversight-of-lab-tests) reported that several lawmakers are now writing to the Office of Management and Budget (OMB), asking it to quickly approve the FDA’s guidance document for FDA regulation of LDTs, in order to protect the public from the depredations of the evil lab people developing tests that will harm the public. That last clause is my paraphrase of course, but is not that far off what the post actually says.

The harm in posts like this is that the general public, including lawmakers and politicians, have no understanding of the laboratory field in general, and definitely no understanding of the regulatory environment that all reputable labs operate under. The majority of hospital labs and big reference labs are accredited and operate under the regulations of an accrediting agency including such agencies as CMS, CLIA, various State regulatory bodies, CAP and The Joint Commission. The combined regulations of these agencies result in labs which not only produce test results using good laboratory practice, but when these labs develop tests (LDTs) they do so meeting many regulatory standards already. FDA oversight of these labs is overkill, in my opinion.

Where FDA oversight of LDTs would be useful is in the plethora of start-up companies offering the public a variety of tests to diagnose disease, monitor their health, or determine their genetic code. Many of these labs have no accreditation and have used LDTs as a loophole for bypassing FDA regulation of their tests. In fact it’s likely that many of them are in need of regulation from some agency.

John Q. Public in general is just beginning to understand what a lab test is. He has no idea that he should be looking for an accredited lab, and asking for some sign that minimum standards were used to develop tests. He simply Googles his symptoms and gets 4 million options for lab tests he can have run to diagnose his disorder. Laboratory professionals have an obligation to try harder to educate the public. We need to be involved and be visible. FDA regulation of laboratory tests is a “hot” issue currently that is being picked up by the public. We should take every opportunity to set the record straight.

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

Product Recalls and Patient Safety

Manufacturers issue product recall notifications when their product doesn’t perform as it should. A few examples include control materials not performing as expected, instrument software malfunctions, or in-vitro diagnostic devices (IVDs) such as glucometers and hemoglobinometers failing to perform. There are different classification of product recalls according to the Food and Drug Administration (FDA).

  • Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violate product will cause serious adverse health consequences or death.
  • Class II recall: a situation in which use of or exposure to a violate product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class III recall: a situation in which use of or exposure to a violate product is not likely to cause adverse health consequences.

In some cases, these situations also are considered recalls:

  • Market withdrawal: occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems would be a market withdrawal.
  • Medical device safety alert: issued in situations where a medical device may present an unreasonable risk of substantial harm.

These notifications require acknowledgement of receipt as well as an action plan to assess if the malfunctioning material or instrument affected patient care. Recalls need to be taken seriously due to the potential of patient harm resulting from inaccurate test results. It’s not uncommon for laboratories to receive non-compliance findings in this area, usually due to lack of documentation and proof of action to assure patient safety.

The Joint commission standard MSE.8.2 requires that an organization has a product/equipment recall system. Element of performance 11(EC.02.01.01) requires that hospitals have a way to respond to product recalls and notices. Accordingly, each laboratory needs to establish a product recall system that includes documentation of any actions taken in response to a Letter of Recall notice. This documentation should include distribution lists to departments in the hospital, acknowledgment of read/action from department (s), initial/ date, identification of the returned/ recalled products affected or confirmation that no products were affected per manufacturer’s instruction, and the patient safety assessment study conducted that’s reviewed and approved accordingly by the department manager and/or quality assessment manager. Management should insure that none of the recalled products were used to conduct patient tests. If the products were used and the resulting potential result inaccuracy might harm patients, communication to the providers and/ or patients, needs to be considered.

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

My 3Ts: Trials and Tribulations of Technology!

Like so many others, I figured it wouldn’t happen to me. Like countless others, I have been through the fires of Hades trying to straighten out a “hacked” email account. Like numerous others, I’ve come away from the experience knowing more and enjoying less of my techno-challenged universe! Changing your email address is about as complicated as changing your DNA. Consider, it’s not just closing down “yahoo” and opening up “gmail.” It’s re-capturing the twenty-year list of professional and personal contacts that were compromised and will never be found again. Or the list of archived documents that hold the history of your collective files, reference materials, all the “stuff” you keep. Never mind the cartoons and pictures…I gave up on those long ago.

After my gnashing of teeth and ultimate resolve to fix the issue, it occurred to me what a huge problem it would be to re-create a “hacked laboratory.” In the laboratory, it would be like wiping out every send-out log, every result, every known micro or blood bank patient history, every phlebotomy encounter, and every patient demographic that exists. Well, you get the picture! It’s a “do over” at the highest level. Back-up and clouds aside, it would be very difficult. What computers have done FOR us is to standardize and streamline data collection, improve error rates, and decrease turnaround times for diagnoses, test results and treatment. All VERY good things. I would also propose that….if a process is broken or not working, adding computerized technology only speeds it up and makes it go really really fast….it doesn’t fix the process! Technology is an enabler, and should be used to enhance where needed. As laboratory professionals, in addition to learning the skills of “medical technology”, we are also rely on LIS systems, HIS integrations, and the other “non-medical technologies” that make our systems more efficient. I encourage us all to remember that we must also focus first on improving our processes, so that when they go fast, they also go well. Having someone hack my email forced me to look at my processes…and indeed, some of them were going fast but needed improvements!

Technology is what we do. Technologist is in our title and licensure. It seems to me that science geeks, which most of us are, weren’t prepared to be computer geeks as well….and therein lies the hope for an even better next generation of “medical technologists.” Are we indeed still medical, still seeking continuous improvement and quality processes for our patients, or are we just highly computerized technology teams who can deliver results really fast? Something to ponder…

Cheers!

 

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Beverly Sumwalt, MA, DLM, CLS, MT(ASCP) is an ASCP Global Outreach Volunteer Consultant.

Improving Patient Safety: What is Your Laboratory’s Preanalytical Error Rate?

Errors can occur at any point in the preanalytical process: during patient preparation; the ordering process; sample collection; sample transportation, preparation, and storage. Some common errors include wrong test orders, missing specimens, improper mixing, and specimens contaminated with line fluid. Use of laboratory automation has reduced preanalytical errors within the laboratory, but what about those errors made outside of the laboratory’s four walls?

One way to decrease errors would be to implement computerized physician order entry. Due to the increased number and complexity of lab tests along with minimal training in medical schools, improper testing ordering is not uncommon. It would be wise for the core laboratory to provide adequate technical information on those commonly misunderstood tests by clinicians that could be accessed readily, such as an intranet website. Placing additional guards on high-priced molecular testing (such as requiring additional information at order entry) would be prudent. Making pathologists and laboratory professionals available to consult with clinicians about test ordering is also one way to reduce this sort of error.

As more facilities centralize their laboratory operations as a way to cut costs, preanalytical errors due to specimen transportation issues could be rise. Currently, there are no specific regulatory constraints on monitoring temperature and/ or humidity during sample transportation; however, studies show that depending upon the length of time and pressure and humidity involved, these external environment could influence the integrity, and therefore the result accuracy, of transported samples. Inaccurate test results could lead to delay in treatment or treatment errors that might harm patients, which also increase the organization’s liability and threaten the medical licensure and/ or the organization livelihood.

Quality Improvement or Performance Improvement program addressing these pre-analytical errors combined with appropriate training and tools to mitigate the errors by tracking the time points related to the sample transportation would improve patient care quality and safety. As part of a good quality management system, laboratories should track the preanalytical errors made each month and categorize them to make designing improvement efforts easier.

Suggested reading:

Felder, R. A. (2011). Preanalytical errors introduced by sample-transportation systems: A means to assess them. Clinical Chemistry, 57(10):1349-1350.

Plebani, M., & Piva, E. (2010). Medical errors: Pre-analytical issue in patient safety. Journal of Medical Biochemistry, 29(4):310.

Carraro, P., Zago, T., & Plebani, M. (2012). Exploring the initial steps of the testing process: Frequency and nature of pre-preanalytic errors. Clinical Chemistry, 58(3):638-42.

Plebani, M. (2012). Pre-analytical errors and patient safety. Journal of Medical Biochemistry, 31(4):265.

Tiwari AK, Pandey P, Dixit S, Raina V (2011). Speed of sample transportation by a pneumatic tube system can influence the degree of hemolysis. Clin Chem Lab Med. Nov 10;50(3):471-4.

Zaninotto, M (2012) Effect of Sample Transportation on Commonly Requested Laboratory Tests. Clinical Chemistry and Laboratory Medicine, 50(10):1755-1760

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

Prime Time: the Fine Line Between Innovation and Regulation

We live in an age of wonders. New technologies with new and usually improved capabilities are springing up far faster than we can keep up with them. And those new technologies occasionally revolutionize not only the field they spring up in, but other, sometimes unrelated fields. A good example of this is how tandem mass spectrometry revolutionized newborn screening (NBS). An instrument and test system once considered essentially a research tool has led the way to improving and standardizing NBS across the United States. Because this is true we must always be ready and willing to learn about the newest technology. However, sometimes it’s difficult to walk that fine line between leaping ahead too fast and not moving ahead at all.

In the laboratory field, and the medical field in general, a LOT of checks and balances are in place, many of them in the form of the regulations and controls we love to hate so much. If you are going to be possibly putting a person’s health, well-being or even life on the line, the level of checks and balances becomes totally understandable and even necessary. However, we must be careful not to refuse to see new technology because it doesn’t fit the mold of our current regulatory environment. Sometimes in order to move forward, we must reinvent the regulations as well as the technology. A good example of this was learning to deal with and regulate electronic quality control when instruments like the I-STAT were introduced to the field.

There can be an incredibly fine line between stifling innovation and having necessary and appropriate controls in place. It takes an astute eye, keen insight, and understanding of not only the new technology, but also the purpose and design of the regulations. It’s not enough to blindly follow the letter of the regulation. We must ask ourselves: What was the intent of the crafters? Why is this important? Is there a way to make sure the new technology meets the regulation? Can the regulation be reinvented to make sure the new tech does follow the intent of having that regulation in place? Next generation sequencing has been struggling to perform this balancing act since its inception. We do not wish to sacrifice neither our ability to create and innovate, nor our need for safety and “do no harm.” When an innovation enters the laboratory, we need to make sure both it and the regulations which monitor its performance are “ready for prime time.”

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

 

Simplify Equipment Validation with a Validation Master Plan

How compliant are you with all your clinical equipment validation (including the point of care equipment)? The equipment validation process is a crucial component in any clinical laboratory practice; any serious deficiency in equipment validation could threaten the business continuance of the institution. Clinical Laboratory Improvement Amendments (CLIA) regulations set standards on test systems, equipment, instruments, reagents, materials, and supplies for clinical laboratories. Laboratories must properly qualify, monitor, and verify or establish performance specifications for any test systems used for patient testing. The federal regulations and explanation for Verification of Performance Specification and Calibration and Calibration Verifications (as well as other CLIA regulations) can be found on the CMS website.

New equipment comes to the laboratory with settings already in place by the manufacturer. For example, urine drug screen analytes may be preset at certain cutoff levels. It is the laboratory’s responsibility to recheck all new equipment validation on all the so called “manufacturer settings.” A detailed guidance document on equipment validation was published by the Clinical and Laboratory Standards Institute (CLSI) in August 2011. QMS13A (formerly GP37A Equipment Validation) outlines the equipment validation process into several crucial validation components: Selection Qualification (SQ), Installation Qualification (IQ), Operational Qualification, and Performance Qualification (PQ).

Laboratories should start a strategic and simple approach to equipment validation with a validation master plan (VMP). This plan provides a structured approach to equipment validation that will allow many problems to be addressed before they become crises. It also assures equipment needs (functional, business and technical) are met. A VMP should:

  • Be approved by the laboratory’s medical director.
  • Appropriately assess and mitigate any potential hazards.
  • Establish policies and procedures.
  • Assign equipment data reviews.
  • Include personnel training for all shifts.
  • Comply with all patient safety requirements.
  • Outline the timeframe from equipment acquisition to “go live” date.
  • Include accuracy and precision studies.
  • Specify the reportable range and normal values for all analytes.

Typically, 20 samples for each level of normal and abnormal results should be tested for accuracy and precision studies. Clinical equipment should never be used for patient testing until all validation processes reviewed, assessed and approved by the appropriate medical lab director. When determining the reportable range, calibrators and samples should reflect the full range. For example, if the manufacturer suggests a reportable range for glucose of 10 mg/dl to 600 mg/dl, having the lowest sample test at 50 mg/dl would be unacceptable.

In summary, creating and designing a good VMP can save all the agonies and time spent in later future in equipment validation in any clinical laboratory or point of care department. Once one successful VMP have been accomplished and produced, future equipment validation would become much easier and manageable. The overall process would ultimately assure accuracy and reliability of the equipment system in the institution, thereby improving patient safety.

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

 satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

 

 

Updated Information about Indiana MERS-CoV Patient

The Community Hospital in Munster, Indiana held a press conference today (5/5/2014) regarding the MERS patient. This hospital is in northwest Indiana near Chicago, Illinois. Speakers included Mike Pence, Governor of the State of Indiana; William VanNess II, MD, Indiana State Health Commissioner; Daniel Feikin, MD, Medical Epidemiologist with Centers for Disease Control and Prevention; Don Fesko, CEO of Community Hospital; and Alan Kumar, Chief Medical Information Officer at Community Hospital. During the discussion, several facts about the case emerged:

  • The patient lives and works in Saudia Arabia and is in the United States for a planned family visit.
  • Patient doesn’t remember working directly with a MERS patient but does work at a facility that houses MERS patients.
  • The patient presented to Community Hospital on the evening of 4/28 with flu-like symptoms. He has been in private triage, examination, and patient rooms for the duration of his visit.
  • Infectious Disease doctors consulted on the case; quickly suspected MERS based on travel history and notified the CDC.
  • Healthcare workers that came in contact with the patient are currently on home isolation. They will most likely be kept on isolation for 14 days, which is currently the longest known incubation period for the MERS virus.
  • Currently, all evidence about MERS-CoV suggests that direct, sustained contact and exposure to droplets (from a cough or sneeze, for example) is necessary for transmission. NO evidence currently suggests that MERS can be transmitted through casual community contact.
  • The current mortality rate for MERS is 30%; most patients who succumb to the virus are elderly, have concomitant health conditions, or both.
  • The virus could mutate, and if it does there is a possibility that it could become more transmissible. However, there is NO EVIDENCE that has occurred.
  • The CDC is working to identify people who traveled on the same plane and bus as the patient. So far, three-quarters of travelers have been contacted and identified.
  • The patient is in good condition and is expected to go home soon.
  • Discharge instructions, including how long the patient will be in isolation, are still being determined.

If a suspected case comes to your facility and your laboratory needs to handle specimens, contact your local health department for instructions. Also, bookmark Lab Medicine’s resource page for up-to-date information.