generalist – Page 34

Test Utilization Made Easy

Just kidding–this sort of thing isn’t easy. Right?

Not so fast. A few days ago I attended a session on test utilization management at the AACC meeting in Chicago. While the issue is quite complex–it’s not just a matter of right test/right patient/right time (which is tough enough already)–the speakers gave the audience a few relatively easy ways to improve test utilization.

Find and fix ordering errors
Identify tests with limited clinical use and eliminate them from your menu
Suggest a better test for the same disease/condition
Identify and correct deviations from established guidelines
Investigate odd patterns. (For example, if General Hospital generates 5% of your business but accounts for 70% of test X.)
Monitor year-to-year practice variations

As I said, this issue is quite complex, but implementing even a few of these changes could improve your lab’s bottom line.

–Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.

Validate, Transfer or Establish: What Are You Doing with Your Reference Intervals?

Reference intervals are absolutely necessary for proper interpretation of laboratory tests, and yet obtaining appropriate reference intervals can be the bane of the laboratory. I mentioned establishing, validating or transferring reference intervals in an earlier blog post, but didn’t talk about exactly what these are and when to use which one.

Establishing a reference interval is exactly what it says. A reference interval must be established if a new assay has never been performed in the lab and there is no current reference interval to start with. Most often, laboratory developed tests (LDTs) that are developed from scratch will require the establishment of a reference interval. To do this, ideally 120 samples from healthy individuals for each sub-population (gender or age sub-group) is used, although there are methods available using smaller sample sizes. Samples used to establish reference intervals may be collected a priori, meaning they are collected from individuals for the express purpose of establishing a reference interval, with well-defined inclusion or exclusion criteria used, or a posteriori, meaning they are samples collected and analyzed first, with exclusion criteria applied after statistical analysis.

Validating a reference interval is the easiest way to obtain one, and is what is hoped for when a new method is introduced. Validation is usually used when a new instrument or method replaces an old one, and reference intervals are currently in place. A patient correlation study is done using at least 20 patients. The data is analyzed with regression, bias and correlation statistics. If the bias and regression are acceptable, the reference interval that is currently in place will also work with the new assay. The interval has been validated and can be used with the new method.

When a validation study is done for a new method and the results of the data analysis are NOT acceptable to validate the assay, then a transference study is necessary. A transference study is simply an extended correlation. More than 20 patients are used, enough to determine the amount of bias between the two methods. Then the old reference interval is adapted to fit the new method, using the amount of bias determined. For example if the new method measures 15 percent higher than the old method, the reference intervals will be increased 15 percent across the board. Transference is recommended to be performed once. If another new method is brought in for that analyte, rather than transfer the reference interval again, a new interval should be established.

All three of these methods for obtaining reference intervals are useful in the right situations. It is important to know when to use which method.

-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.

-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.

Point of Care Testing Competency Assessment

Healthcare facilities can use point of care testing (POCT) devices to improve healthcare delivery. The majority of these POCT devices are waived tests, such as glucometers and hemoglobinmeters. In recent years, however, more facilities have moved toward moderate complexity testing such as troponin cardiac biomarker, blood gasses, prothrombin time, and bilirubin. Most POCT devices are operated by non-laboratory clinical personnel, such as nurses and respiratory therapists. Under CLIA regulations, these individuals are classified as testing personnel (an individual who perform laboratory testing and report test results for patient care) and must comply with competency assessment regulations.

CLIA does not have any requirement for assessing personnel competency on waived testing; however, CLIA requires that waived testing results are accurate to assist in making accurate patient diagnosis. This requires that personnel follow all manufacturer’s instructions, which generally includes personnel training, skill assessment for QC and patient testing, device maintenance and infection control procedures as the device is moved from patient to patient. When waived tests are included in the main laboratory’s CLIA license, most accrediting agencies (CAP, Joint Commission, COLA, HFAP, etc.) will also require fully established and documented personnel competency testing on all personnel who performed waived tests. It’s not uncommon for a healthcare facility to receive findings of non-compliances on POCT personnel competency assessment due to incomplete QC (both internal and external) skill assessments for each personnel. Some healthcare facilities erroneously have the laboratory POCT coordinator or supervisor perform the external QC on their POCT. All testing personnel must know how to perform all QC and their corrective action for out of control situations and documentation requirement pursuant to the organization policy.

Reference: CLIA Brochure #10.

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.

Personnel Competency Assessment

On December 21, 2012, the Center for Clinical Standard and Quality/Survey & Certification group (part of the United States Centers for Medicare and Medicaid Services) published S&C-13-07-CLIA. This letter outlines competency assessment requirements for compliance with federal regulation 42 CFR, Part 493, Subpart M. The Clinical Laboratory Improvement Amendments (CLIA) law for personnel competency applies to testing personnel, clinical and technical consultants, and technical and general supervisors. Competency assessments can only be performed by personnel qualified as technical consultants, technical supervisors, or general supervisors. The competency assessment must cover a minimum of six required procedures in addition to their federally regulated responsibility:

Direct observations of testing procedure, including specimen preparation, and handling/ pre-analytical as appropriate,
Monitor of recording and reporting of results,
Review of intermediate test results or worksheets, QC results, preventive maintenance and proficiency testing results,
Direct observation of actual preventive maintenance or function checks procedures,
Assessment of test performance on external proficiency testing samples, internal blind unknowns or previously analyzed samples,
Assessment of problem solving skills (42 CFR 493.1413 (b)(8) and 493.1451(b)(8)).

It’s important to note that peer reviews among testing personnel are NOT acceptable for regulatory personnel competency assessment.

An update to this policy involves the laboratory director’s competency assessment requirement. When the director is the only individual testing and reporting test results (such as a pathologist in a small hospital), the organization must establish and document a minimum level of competency via external proficiency testing or peer reviews for the tests reported on patients. This competency must be performed a minimum of three events throughout the year.

The competency assessment procedure is further differentiated by the regulations for moderate and high complexity testing. For moderate complexity testing, the technical consultant can perform the competency assessment, whereas in high complexity this can be performed by the technical supervisor, which can be further delegated to a general supervisor as long as the general supervisor is qualified for high complexity testing. All delegations must be delineated appropriately by the laboratory director as a written policy. Testing personnel requirements might additionally vary from state to state because some states (CA, FL, HI, LA, MT, NV, ND, RI, TN, WV, and Puerto Rico [PR]) require licensures for their laboratory practitioners.

For new employees, competency assessments must be performed six months and one year after employment; this assessment happens annually thereafter. Whenever testing errors serious adverse events occur, management should conduct personnel retraining and requalification to establish personnel competency. Also, establish limits on how many times such events can occur before prompting a transfer for other work duties or termination.

How can you measure the effectiveness of your organization’s personnel competency assessment? Since personnel competency encompasses multi factors, developing a balance score card (BSC) for each department or specialty can be useful. Percentages can be assigned for external testing (such as CAP proficiency tests), attending internal education sessions, number of serious adverse events or errors, and accrediting agency findings on on-site personnel technical competency during licensing surveys. This BSC can aid management in producing score of effectiveness on each individual and department.

Reference: CLIA brochure #10.

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.

Laboratory Professional’s Role in Electronic Health Records

Electronic Health Records (EHRs) will play a large role in the future healthcare landscape; it’s imperative these systems display laboratory data accurately and efficiently. The Center for Surveillance, Epidemiology, and Laboratory Services at the Centers for Disease Control recently published a paper about the role Laboratory Professionals can play in the development of electronic health records.

The paper concludes, in part, that “Laboratory professionals and organizations can support the future vision and help improve the overall quality of healthcare for individual patients and the national population.”

If you’d like to read the announcement and the paper in full, it’s here.

Girls and Science

Almost 73 percent of laboratory professionals are women, so exposing young girls to science is important. The editors of Lab Medicine recently discovered this post on Scientific American that discusses gender bias in Lego’s minifigs. Series 11 features a woman scientist—complete with little Erlenmeyer flasks—which is definitely a step in the right direction.

Root Cause Analysis

Root Cause Analysis (RCA) is a problem-solving tool that is most frequently used to determine the basic underlying factor(s) responsible for an event (ie, its root cause). This analysis is then used to determine the best method of preventing that event from occurring again.

A multitude of different RCA methods are available, but most of them have some basic principles in common. An RCA involves a systematic, data-driven, well-documented investigation into an event. It is a reactive method used to identify the steps in a system or process that are prone to failure, to determine the one or ones that failed and caused the event under investigation, and to determine how to prevent the failure from recurring. The RCA will also determine how many other factors were affected by the event under investigation.

The first step in an RCA is to clearly and factually describe the event or problem. Often the initial description of the problem will involve a timeline description of the proper process, the way the system SHOULD work, and then define the point or points at which the event under investigation differed from the proper course of events. Thus most RCA include a timeline, qualitative and quantitative data depicting the proper process and the failure steps, and thorough documentation of each step. Data is collected wherever necessary in order to be making decisions from data rather than from assumptions of how the system works. Once the root cause or causes of a problem have been clearly determined, an RCA again uses data to identify corrective actions to remedy anything that is wrong due to problem, as well as corrective actions to prevent the same problem from occurring in the future

Let’s pretend that patient test results were reported with the incorrect reference interval. In order to determine why this happened, we start by making a timeline depicting each step in the normal process. In our example, this means reviewing all the procedures in place for setting, maintaining, and changing reference intervals. Then, step by step, it can be determined where the process failed in this specific case, as well as other steps that might be prone to failure. Corrective actions to amend any incorrect patient results and notify caregivers would begin immediately, with thorough documentation. Once the root cause of the process failure is clearly identified and the step or steps that failed have been determined, additional corrective actions would be taken to remedy the necessary steps in the process so that this error cannot recur. Occasionally an RCA will lead to instituting an entirely new process in order to prevent problem recurrence. It’s important to note that everything associated with the RCA is fully documented.

Identifying and implementing solutions is probably the most important part of an RCA, yet it cannot occur effectively if the actual bottom-line cause of the problem has not been correctly identified in the first part of the process. If the root cause has not been correctly identified, the solutions become only a temporary patch on the problem, and the problem it will occur again. RCA generally involve time and work to do properly, and yet can be incredibly useful in preventing a recurrence. In a hospital or laboratory environment where potential patient harm can occur when a mistake it made, the RCA is often an important part of operating a healthcare system.

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!

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

Improving Patient Safety: Effective Communication for Performance Improvement

In 2014, the Joint Commission updated its National Patient Safety Goals (NPSGs) in order to address areas of concerns for patient safety to reduce harms to patients. These goals include standards for clinical alarms, transfusion errors related to patient misidentification, reducing likelihood of patient harm due to anticoagulation therapy, reducing the risk of healthcare-associated infections, implementing evidence-based practices to reduce healthcare associated infections due to multidrug resistant organisms, and prevention of central-line associated blood stream infections. A multidisciplinary team comprised of all clinical areas including nursing, laboratory, pharmacy, radiology, biomedical engineering, and environmental services are necessary to become compliant in all of the NPSGs.

How do you effectively communicate the NPSGs (or any other change initiative) to all personnel? Sometimes organizations will implement initiatives and performance improvement training with score cards, only to find that the initiatives did not produce the expected results. Prior to launching any new initiative for performance improvement toward NPSGs compliances, management needs to take the extra steps to communicate clearly to employees the background of the current situation within the organization, explain why there is a need for performance improvement, and emphasize what the stake are if the organization isn’t compliant.

The transformation process in change management involves changing employees’ behavior to enhance personnel capabilities. According to Kurt Lewin’s model in the traditional change management, there are three phases of change: (1) unfreezing, (2) change, and (3) refreezing that specifically focuses on employees’ behavior or involvement. In general, employees would not necessarily change their behavior just because the organization performs poorly or there are new standards to follow. Employees will keep their attitudes or behaviors when they feel comfortable or safe with the current behavior and there’s no sense of urgency to change their behavior or the work environment allows them to choose not to change. Lewin’s model identifies that in the unfreezing phase there should be open communication and motivation to employees to understand the situation fully. Allowing employees to question the status quo or feel discomfort with the current practices creates “buy-in.” Employees feel invested in the process and that in turn facilitates employees’ participation in the next phase: “change,” when the new improvement strategy is adopted. The last phase, “refreeze,” is implementing and sustaining the change.

Employees’ attitudes are structured along three dimensions labeled as cognitive attitudes (beliefs), emotional attitudes (individual feelings), and intentional attitudes (evaluations based on past or intentional behavior). Communication to explain and motivate employees will help overcome uncertainties and enhance employees’ control and well-being, which in turn promotes empowerment. McEwan studied the indicators of personal empowerment include improved perceptions of self-worth, empathy and perceived ability to help others, the ability to analyze problems, a belief in one’s ability to exert control over life circumstances, and a sense of coherence about one’s place in the world. McEwan pointed out that within the empowerment framework change begins at an individual level; as an individual becomes more empowered, their increased personal capacity makes a positive impact on an organization or group, and ultimately, the wider community. In general, people are not resistant to change; however, they mostly object on being told to change. By investing the extra time and efforts on open communication to motivate employees and create buy-in, the organizational change initiatives will have a much higher probability of success and sustainability.

References:

http://www.jointcommission.org/assets/1/6/HAP_NPSG_Chapter_2014.pdf

Lewin, K. (1947), “Frontiers in group dynamics”, Human Relations, 1(2), 143-53.

Pideret, S.K. (2000), “Rethinking resistance and recognizing ambivalence: a multidimensional view of attitudes toward an organizational change”, Academy of Management Review, 25(5), 783-94.

McEwan, Alexandra B,B.A. (Anthropology)(Hons), L.L.B.(H., Tsey, K.,PhD.(Social Sciences), McCalman, J., & Travers, Helen J,GradDip Primary Health Care. (2010). Empowerment and change management in aboriginal organizations: A case study. Australian Health Review, 34(3), 360-7.

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.