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CRI Lab Quality Advisor

The Error-Prone Zone
July 28, 2014 11:55 AM by Irwin Rothenberg

By Irwin Rothenberg and Nancy Alers

In recent years, the concept of quality monitoring for laboratory testing has broadened beyond quality control focused on the analytic phase, to encompass the entire spectrum of the testing process from the physician's order through the final report.  The impetus for this has been the realization that "up to 70% of all errors made in laboratory testing occurs during the pre-analytic phase, most of which arise from problems in patient preparation, sample collection, transportation, and preparation for analysis and storage."1   

It is somewhat surprising to think that we are just now recognizing the importance of quality monitoring in the pre-analytic phase. However, unlike the analytic and post analytic phases, the processes of the pre-analytic phase often involve personnel that are not under the direct supervision of the laboratory, making it more challenging to control.  

In house, laboratories must check the orders received for accuracy and completeness.  One thing that is often overlooked is the importance of providing correct instructions to the patient for the self-collection of specimens. Patients may need to fast, observe specific guidelines such as the clean catch urine procedure, or collect samples over a 24 hour period prior to testing. Not following the correct instructions for sample collection has a direct impact on the quality of the samples received. 

Next, the specimen labeling system and patient identification procedures must be in place and followed.  It is imperative that labs utilize at least two unique identifiers for the correct identification of patients and their specimens.  

For phlebotomy related tasks, it is recommended that labs assess the competency of all drawing staff, whether they are part of the laboratory or not.  This includes nurses, respiratory therapists, medical assistants, anyone who draws blood or collects other specimens for laboratory testing. It is a good idea to track all rejected specimens, making sure to specify the reason for the rejection. For example, an increase in the number of samples rejected for insufficient quantity; for hemolysis; wrong vacutainer utilized, and so on, may point to a phlebotomy training issue that needs to be addressed.

Equally important is specimen handling and transport. A specimen collected properly is not going to be of use if it is not handled and transported correctly. Are specimens centrifuged and aliquoted within the specified time? How about refrigeration or freezer requirements if testing cannot be performed immediately?

Specimens received from outside collection sites pose a different risk for laboratories.  Upon receipt of specimens, utilize a checklist to ensure that all the above requirements have been met prior to accepting the specimen. A specimen rejection policy is a must. 

Your Quality Assessment plan should include evaluations of all phases of the testing process to ensure that errors detected have been addressed effectively.

Reference

  1. Quality Indicators To Detect Pre-Analytical Errors In Laboratory Testing. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC3428256. Last accessed July 28, 2014.
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Correcting Laboratory Report Errors
July 1, 2014 11:29 AM by Irwin Rothenberg

By Irwin Rothenberg and Nancy Alers

When a laboratory report must be corrected, and the amended results are sent to the ordering physician, questions may be raised regarding the quality of the laboratory work; the proper operation of the instrumentation involved; the competency of the testing staff, and whether the laboratory director or technical consultant/supervisor were fulfilling their oversight responsibilities.

While the report is the end result of the testing process, the reasons for the release of an erroneous report must be investigated, and the investigation may need to go all the way back to the pre-analytical phase, from test ordering to specimen collection and handling, through the analytical phase (instruments/reagents/staff competency), to the post-analytic phase that includes verification of the LIS (lab information system) for automated and manual results transfer.

Of course, erroneous reports may be due simply to a manual transcription error, initial verbal reports that were misunderstood; or a manual patient mix up. But as simple (though serious) as these are, the reasons these occurred at all still indicates a problem that may involve the core issues of oversight, training, communication and documentation.

There needs to be a formal laboratory policy and procedure for the correction of erroneous laboratory reports (after the correct results are obtained), and for sending amended reports as soon as possible.

These should include the following policies:

  1. Identify who to notify when the error is detected?
  2. Document all steps taken to correct the error;
  3. Provide the ordering physician with the corrected report;
  4. Retain the original report and the corrected report for future reference
  5. Perform a Root Cause Analysis if systemic issues are involved; if serious enough, perform an Incident Management study.
  6. Alternative contact plans if the laboratory is unable to reach the ordering physician or provider in a timely manner.
  7. Inclusion of this event as part of Quality Assessment; include follow up to ensure that the corrective actions taken were effective.

Following these policies and procedures will ensure a consistent quality laboratory response when erroneous reports are issued.

6 comments »     
Right-Sizing Your Lab
June 19, 2014 11:35 AM by Irwin Rothenberg
When we discuss the characteristics of a quality laboratory, we naturally look at those areas of the laboratory operation encompassed by CLIA/AO requirements, including Personnel training and Competency Assessment, Organization, Instrument Verification, Quality Assessment, Record Keeping and Documentation, Proficiency Testing, Facility safety, and so on. 

However, one area that is often overlooked when assessing factors that contribute to quality laboratory work is the appropriateness and "do-ability" of the test menu. In fact, this is really such a fundamental aspect of the lab operation, that problems in this area affect everything else.

Whether you are planning a new, start-up lab operation, or performing a cost/benefit analysis of current testing, or thinking of purchasing a new or replacement instrument, you must do a realistic assessment of not only what you want to offer your patients, but what you can realistically offer your patients.

When your instrumentation/test menu creates problems with staffing, time management; work overload, and expiration of unused reagents; when quality control, calibration and maintenance requirements exceed test time for infrequently utilized instruments ... you've got problems!

Your decision making  should first include a cost/benefit analysis:

  • Instrument cost (purchase or lease?)
  • Reagent cost (are you obligated to purchase reagents from a particular manufacturer?)
  • Reagent life (expiration dates: days, weeks, months before/after opening packages)
  • Storage requirements (buying a new refrigerator or freezer?)
  • Calibration, maintenance frequency.
  • Tests run singly or in batch mode?
  • Comparison to reference laboratory charges and turn-around time
  • Staffing requirements: number, training expenses; qualifications and experience beyond present staffing; continuing education.
  • Proficiency testing
  • Facility space, ventilation, electrical needs; hazardous disposal requirements
  • Time and involvement of the lab director, and the technical consultant
  • Document storage requirements/LIS capacity
  • Adjusting the front office staffing to handle additional pre and post analytical paperwork and communications.

Of course,  providing the highest level of service for your patients may justify costs associated with the above considerations, but you must right-size the instrumentation to meet the demand in terms of test volume capacity, variety  of tests offered, operating times and staffing. Having a laboratory with excess capacity and operating requirements can ultimately bankrupt a practice. Investigate what instruments can meet your present needs, and for the near future, and be cost effective.

In today's world, when compensation for laboratory testing is constantly under pressure, right-sizing your lab means better financial health; better resource utilization, and ultimately, better service for your patients.  This spells Quality!

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Apples to Apples
June 3, 2014 11:54 AM by Nancy Alers

Were you ever one of those techs that questioned the utility of parallel testing?  Ok, I admit it, me too! I used to think that lot-to-lot verification, also referred to as crossover studies or parallel testing, was a nuisance, but that is because I didn’t fully understand it. Therefore, I get it when customers call me with questions about this process. In fact, lot-to-lot verification is one of the hot topics of the CQA line.

Simply put, parallel testing helps ensure the integrity of the new lot before it is used. Parallel testing helps us assess: 1) the integrity of the lot (kit, controls and reagents) and 2) lot performance or, in other words, ensures that the recovered expected results are accurate. It is essential to assess the integrity of the new lot before being used and to ensure that there were no changes during shipment. This is particularly important if there is any chance supplies were subjected to drastic climate changes in transit.

While qualitative tests just need to have positive and negative reactivity verified, quantitative assays need to be verified over a range of values. Generally, five values are considered adequate when verifying a new lot number.* Be sure to check the package insert and your accrediting agency’s recommendations for specific requirements. Essentially, parallel testing, in addition to being a regulatory or compliance requirement, is an exercise in good laboratory practices. Here are a few tips when doing lot to lot comparisons:

1.       Check the lot inventory to ensure expiration date of reagents, storage conditions and that inventory levels are adequate to perform the crossover studies.

2.       Assign the lot to lot verification to a specific staff member or communicate to all testing staff assigned to the bench, so as not to miss any runs. It is recommended the verification is done over the span of a few days vs. all in one day.

3.       Check your accreditation agency standards and manufacturer’s instructions to determine the number of data points or values needed.

4.       Follow procedure manual/package insert instructions to perform the verification.

5.       For qualitative tests, the laboratory must ensure positive and negative reactivity.

6.       For quantitative test, if the new lot results are within the manufacturer’s specifications or the criteria established by the lab director, then the verification was successful.

7.       Make sure to analyze the data and note any calculations needed. Remember, documentation is key!

8.       The laboratory director or designated person must review and evaluate the verification and determine if it was acceptable or not.

9.       If the verification is not acceptable, be sure to perform a root cause analysis and implement a corrective action plan.

Have you ever had a situation where the current lot runs out before the new lot gets verified? How did you handle that?

*COLA Laboratory Accreditation Manual, April 2014

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Laboratory Control of POCT
May 15, 2014 5:26 PM by Irwin Rothenberg

An ongoing concern among our laboratories is how to ensure that bedside or remote laboratory testing is of the same quality as that performed in-house.

Technological advances have resulted in an explosion in the number of tests that can be performed outside the laboratory setting; locations include the operating room, the nursing station, bedside, and nursing homes to name a few. More than ever, the laboratory must be proactive in monitoring this if quality care is to be maintained. This means that all point-of-care testing (POCT) personnel must be properly trained (with the training documented) and have their competency periodically assessed, even if all of their testing is waived. All instruments involved should be used in accordance with manufacturer’s requirements with quality control, calibration and maintenance records monitored; and test results verified to accuracy and (if the patient has been previously tested) consistent with a patient’s history. Don’t forget to monitor reagent storage and handling as well. Utilization of split sampling and proficiency testing is also recommended for monitoring quality.

Many laboratories, mindful that POCT may be performed by non-laboratory staff, often have a staff tech responsible for monitoring this testing, acting as both a liaison to the laboratory as well as a technical resource for the POCT staff. This is an important responsibility, as feedback from the field to the laboratory is needed to identify potential communication problems, complaints and the needs of both patients and staff.

In this new era of the Affordable Care Act and PCMH, the same standards now apply to POCT as to in-house laboratories: the need for efficient test utilization, the importance of interfacing remote test results with all laboratory testing on that patient and ensuring that all healthcare providers have the same access to these results as they would for in-house testing. New generations of POCT instruments have interfacing capabilities.

There is even talk of using smart phone technology for performing certain tests (such as reading indicator strips) and interfacing these results with the patient database. I can almost see the vision of the original Startrek infirmary where Dr. McCoy diagnosed his patients with the use of a Medical Tricorder.

The bottom line is that there should be no difference in the quality of patient care provided by the laboratory, whether performed within the confines of the laboratory itself or anywhere else. Ultimate responsibility lies with the laboratory administration and staff.

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Not Another STAT, Please!
April 29, 2014 10:46 AM by Nancy Alers

Recently, CRI had a webinar, titled “Effective Laboratory Utilization: New Health Care Models,” and somehow the word utilization made me think of STATs. It made me remember the years when I was right out of lab school and was often stressed out every time a STAT was dropped off in the lab.  For this week, let’s talk about the lab’s responsibility in ensuring the correct utilization of STATs, as well as strategies to help your lab meet the turnaround time requested.

When I was a brand new lab tech, I remember receiving an increasing number of STATs requested 15-20 minutes prior to shutting down for the day. It was quite obvious what the emergency was -- this was not only poor test priority utilization, because some of those tests could very well have been ordered as routine and ran the next day, but it added to the level of stress already present. In retrospect, this situation could have been better handled by:
1) Assessing if the right priority was selected, setting limits if it wasn’t, and
2) Having a strategy to help the lab meet the request.

If the test priority is not a true STAT and can be ordered as routine, or ASAP, then it is the lab’s responsibility to ask questions and make sure the right priority for the test has been ordered. If the priority is not the correct one, the lab has the right to change the priority to manage the workload.

For true STAT requests, the recommendation is to have a process to incorporate them into the workload. Labs use different ways to track STAT specimens from pre-analytic to post-analytic phase. Some of the methods used are colored stickers, which make it easier to locate/track specimens; this can also be done by having a designated STAT person, or a stop watch or other time tracking device setup when the specimen is first received. If the lab is a sophisticated one, it may even have a screen with the different priorities highlighted and how much time is left, very much like a flight screen at an airport.

Delivering the right result is as important as delivering the right result at the right time! In accomplishing this, labs have opportunities to assess if the correct priority was indeed selected to help manage the workload. It is also essential for labs to have a strategy in place to incorporate and track STATs from the pre-analytic to post-analytic phase to ensure test results are reported out on time.

What are some of the ways STATs are handled in your laboratory? Please share!

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World Wide Records
April 17, 2014 1:28 PM by Irwin Rothenberg

One of the key activities of a laboratory is maintaining complete and comprehensive documentation of all activities carried out. Every step of the testing process -- from requisitioning tests; to specimen acquisition, labeling, handling, and storage; to specimen testing; to reporting test results -- must be documented. In addition, documentation is a key activity of laboratory management from approvals of policies and procedures to personnel issues from training and competency assessment; to hiring and disciplinary activities. We must also include facilities issues as well, from maintaining temperature records; to inventory control We must also not forget maintenance, calibration and performance specification records, among other aspects of the lab operation.

How we document has changed more radically than what we document. Remember all the excitement of beginning the new Millennium? We could not have imagined how rapidly these changes would actually occur! A whole new vocabulary has emerged: EHR, EMR, LIS, ACO, PCMH, PCLE -- not to mention IM, texting, etc.

Not only have we moved from paper to electronic record keeping, but we have moved data input, access and retrieval from desktops to laptops to smart phones. We are not just referring to technical and personnel record keeping -- this includes patient (test) records (still quaintly referred to as Charts) as well. But the most radical innovation of all is the tremendous increase in capacity for interconnectedness of all databases. It is now worldwide. Testing can be performed by laboratories half a world away with results instantly transmitted. Instruments can be repaired remotely; personnel training can be achieved via webinars; and lab directors qualified via on-line training.

Imagine potentially any records generated by your laboratory, from technical records (quality control, maintenance, calibrations; operational histories including corrective actions; all patient test results), to personnel records (yes, really!) to operational records (laboratory finances, coding used, organization), all have the potential to be shared worldwide both for good purposes as well as for harm.

These technological changes, when used to enhance the quality of patient care, are nothing short of revolutionary. The development of Accountable Care Organizations (ACO) and the concepts of the Patient Centered Medical Home (PCMH)as well as Patient Centered Laboratory Excellence (PCLE) could not have come about without the ability to have instant world-wide communication of patient data. But behind that, from a laboratory perspective, is the same growth in capacity. This enhances the quality of laboratory work done by sharing all manner of operational information from guaranteeing the qualifications of all testing personnel to proximate or remote oversight of instrument operation, supply inventory and quality assessments.

What an age we live in!

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Top 5 Deficiencies for Laboratories, Part II
April 1, 2014 1:24 PM by Nancy Alers

In part II of this blog, we will touch on Calibration and Quality Assurance. These two areas are among the most common areas of deficiencies and also tend to be frequently cited.

Calibration: I get it. Out of sight, out of mind, right? Calibration being missed is among the most common citations for laboratory deficiencies. Some instruments have safety features that prevent you from running patient samples if calibration needs to be performed. Others do not. If your instrument allows you to run samples even if calibration is out, beware! One of my recommendations is to create some sort of alert or calendar to ensure that calibration is done on time. Such an alert can be setup using the lab’s email system or simply posting a notice by the instrument. The idea is to create some sort of reminder to ensure that it is not missed. It is important to keep all calibration documentation together, including instrument tapes. Also, be sure to evaluate the data and document if the calibration was found to be acceptable or not.

Another issue with calibration is that it is often confused with calibration verification. These are two different processes. Calibration verification is required for non-waived tests (moderate and high complexity) to ensure that the instrument is accurately measuring values of known concentration throughout the reportable range. So, while calibration sets or adjusts the instrument readout, calibration verification checks to ensure the instrument is recovering the right values. There are instances where calibration and calibration verification will be due at different times in which a reminder for both must be setup in order to prevent issues.

Last but not least, we have… drumroll please….

Quality Assurance (QA): this is the one area I spend most of my time on as a Quality Advisor. One issue laboratories face is that QA can be a very broad topic and a task that is easy to forget when worried about the day to day activities. What I often tell labs is not to take QA for granted, QA is your friend! A good quality assurance plan is an internal quality improvement tool that can help detect issues labs may not be aware exist, for example calibration not being performed on time. Something I often clarify for labs is that a good quality assurance review looks at not only what’s wrong in the lab or known areas of deficiencies (complaints, rejected specimens, incorrect results reported out, etc.), but ALL AREAS. The goal is to select elements of the entire testing process (pre, analytic, post-analytic) to assess the quality of lab operations and help detect areas that may need improvement.

And that concludes my Top 5 deficiencies for Laboratories. How did you do? What are some other areas you would list here? Stay tuned for my next blog titled: Not another STAT, please!

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Competency Assessment: The Changing Landscape
March 18, 2014 11:35 AM by Irwin Rothenberg

I know that this is not the first time that I have discussed competency assessment on this blog site, but I continue to find (as a quality advisor) a lack of knowledge about  changes to the required processes;  who is qualified to perform these  and when, and the reasons why these assessments are so important.  More and more, I’ve seen that as technological change accelerates, not only for how we test, but how we communicate these results and store data, that the old ways of performing routine annual assessments are not sufficient to guarantee the continuous quality that we all strive for.

We know by now, that your CLIA qualified technical consultant / supervisor has overall responsibility for the training and competency of the staff, but that there are many situations, such as in Point of Care (POC) and Physician Office labs (POLs) where this responsibility is carried out through the training of on-site competent individuals who then train the testing staff.  But, I reiterate, that the technical consultant /supervisor should always be monitoring this training and competency assessment to ensure all steps are followed and assessments are accurate.

Since change, represented by new instrumentation, new LIS, new kits, and new tests is an on-going process, assessing competency must go beyond set evaluation schedules arranged before these changes occurred.  Continuous quality is derived from , and dependent upon,  continuous  training, continuous feedback, and continuous competency assessment.  Feedback from patients, physicians, and staff provide important indicators of whether quality standards are being met.

The most important recent change is the mandate from CLIA that competency assessment must include (where and whenever relevant to the particular process under study) the following six components:

Direct observation of routine patient test performance;  monitoring and recording of test results; review of intermediate test results and worksheets;  direct observation of instrument maintenance; blind sample testing (such as proficiency testing); and problem solving skills.

Competency assessment is not only performed in response to changes going on in the lab, but must also be periodically performed for routine work as well;  you cannot assume that once competent , always competent;   personnel may experience changes to competency for any number of reasons, such as changes in work assignments.  Never assume that competency is a constant for any individual.

Think of competency assessment as the backbone of lab quality; and the backbone runs the length of the lab operations both in terms of time and structure.

2 comments »     
Top 5 Deficiencies for Laboratories
March 4, 2014 12:28 PM by Nancy Alers

As a Quality Advisor, I spend a lot time speaking with labs that are either brand new, in the process of getting started, or laboratories that have been in operation for years. One interesting thing I find is that, regardless of whether the lab is new or has been accredited for years, there are some common areas where labs tend to have deficiencies and therefore receive citations. Here's some insight into what I've designated as the Top 5 Deficiencies for Laboratories and How to Prevent Them.

  • Personnel: This area tends to be one of the top cited; one reason is lack of awareness about personnel requirements for the complexity of the testing being performed. Another reason is personnel files not being complete, often the files are missing the correct type of proof of education (Diploma, Transcript), the training checklist for when the employee was first hired (or training that took place when new tests were added) or a job description. Competency Assessment also tends to get included in this category. The requirement for Competency is to have an assessment done six months post hire and then yearly after that. To prevent deficiencies in this area ensure that you are familiar with CLIA, State and your specific Accreditation Agency's personnel requirements for the complexity level of your lab (waived, moderate, and high). Also, make sure to have a robust Competency Assessment plan and a calendar or reminders in place to ensure assessments are done on time.
  • Proficiency Testing: When it comes to deficiencies in proficiency testing (PT), what I see most often is labs not treating proficiency testing samples the same as patient samples. Sometimes this can be a source of confusion for labs. The Physician Office laboratories (POLs), as well as labs that are short staffed or have staff working less than full time, have to ensure everybody who performs patient testing has an opportunity to participate in performing Proficiency Testing. Attestation forms not being signed and corrective action not being performed for failed PT events are also among the most common reasons why this area may be deficient. To prevent deficiencies in PT, ensure that attestation forms are signed by both testing personnel and the lab director. Also, ensure that Proficiency Testing samples are treated the same as patient samples. A schedule must be devised to ensure that part time staff gets to participate in PT. Remember, Proficiency Testing serves as a test of your laboratory's processes, the competency of your staff and is a good indicator of the level of quality in your lab.
  • Quality Control (QC): For QC the issue encountered most often is lack of appropriate corrective action. Running a control repeatedly until it comes in does not fix the problem! A root cause analysis must be done to determine the real reason behind the QC failure. If the lab has documented corrective action consistently, sometimes by reviewing the corrective action log one can determine what the real problem is. In other instances, a more in depth investigation may be needed. Another situation I see often is laboratories that choose to run QC and patients simultaneously. For some systems running QC before running patients is just not time efficient or even possible. But if the system allows it, my recommendation is to always run QC first and make sure that it is in PRIOR to running patients.  

Stay tuned for Part II of this blog where we will touch on Calibration and Quality Assurance. How does this compare with your experience of the most common areas where labs tend to have deficiencies? Which ones would you have selected?

18 comments »     
Incident Management
February 17, 2014 11:30 AM by Irwin Rothenberg
The concept of an incident has evolved over the years, as laboratory medicine, like healthcare in general, has been affected by changes in government regulation, legal definitions, and increased public awareness of patient rights. Competent incident management is another key component of providing quality patient care.

Many years ago, when I began my career as a laboratory professional, an "incident:" was a reportable error, such as an employee needle stick due to an uncapped syringe, or causing a hematoma in a patient.  Generally, a form was completed, the employee counseled, the report filed, and that was the end of it.  Certainly, more significant occurrences  (especially in healthcare facilities) always warranted additional attention by administrations.

However, my sense has been that one of the key forces behind a more complex view of incidents, along with an increased emphasis on  incident management  was the anxiety and fears brought on by the HIV/AIDS epidemic, as well as new information about the viruses that cause Hepatitis.

It became ever more imperative that when an incident occurred, whether defined as an accident, a non-conformance to standards, an act of nature, or a deliberate action by an individual, that procedures for investigation,  evaluation, determination of cause, corrective action and effective follow up, had to be carefully defined, confirmed and monitored.  Incidentally (excuse the pun), follow up not only meant that resolution, but also included tracking the health needs of those impacted by the incident.

Today, we have specific requirements for maintaining policies and procedures for the management of incidents.  These not only include all of the above, but must define the Who, What, When and Why for investigative procedures: Who is in charge? What are their responsibilities? What is the time-line? Questions to be answered include Why did this occur and how can it be prevented in the future? (Root Cause Analysis)

It is also important to make the determination as to whether an incident reflects a systemic problem or if it was a random occurrence.

Thus, as regulation of healthcare has evolved, including concerns for workplace and patient safety (OSHA), patient confidentiality (HIPAA), quality of testing (CLIA), the need for competent  incident management  continues to grow. In a larger sense, Incident Management is a guardian for quality patient care and accountability.

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A Targeted Approach
February 4, 2014 2:08 PM by Nancy Alers

A while back, a laboratory in preparation for their first inspection asked me an interesting question. This lab was reviewing their personnel files to ensure they were in compliance and wanted me to take a look at their job descriptions to make sure they were adequate. While I proceeded to help this lab with the information they needed, I began to think about the importance of having an adequate job description and what this can do for a laboratory. I started to think about my early years as a bench tech, in which I wore different hats  and was often a jack of all trades, and master of nada.

So why is a job description important? An adequate job description outlines the main duties or responsibilities associated with the position. From management's point of view, having a detailed job description allows for a more targeted approach when hiring because it makes clear what kind of skills/knowledge a person must possess in order to fit the bill.  But an adequate job description is not only important for Human Resources or for hiring purposes, it is also important when it comes time to assessing employee performance as well. A detailed job description communicates to staff the manager's expectations for the position. And if the hiring process was successful in identifying the candidate that best fits the skills and knowledge necessary for the job, having a clear understanding of expectations should yield an effective performance!

From the employee's point of view, there is nothing more frustrating than working hard, or going above and beyond and being evaluated as sub-par or just average. If an employee is thinking about moving up the ladder, looking at the job description is a good starting point to understand how to exceed management's expectations. Having clear communication regarding the duties and expectations associated with the position will make it easier for both management and staff to measure effectiveness and/or identify opportunities for improvement. So next time you get a chance, check out your job description and see if your understanding of your role and responsibilities matches that of management.

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Waived Testing: The Last Mountain
January 20, 2014 11:08 AM by Irwin Rothenberg

Have you noticed how much more attention waived testing is getting these days?

We know that CLIA has defined waived tests as laboratory procedures which employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; and which pose no reasonable risk of harm to the patient if the test is performed incorrectly. Tests cleared for home use by the FDA are also classified as waived;

We also know that facilities performing only waived tests have no routine oversight and no personnel requirements and are only required to obtain a Certificate of Waiver (CW), and follow manufacturers' test instructions. The latter account for over 70% of all clinical laboratories in the U.S.

As efforts intensify to reduce medical errors, improve health-care quality, and increase patient safety, there is a renewed focus on how to better monitor waived testing. After all, since 1988, the number of CLIA approved waived tests has increased from 8 to 120. Technology has facilitated this growth by enabling the development of ever increasing numbers of test systems that have been approved for the performance of these tests; now numbering over 1400.

As the number of approved analytes for waived testing has increased, the potential for serious impacts on healthcare has also increased. Think of the consequences of incorrect Prothrombin times, Glucose values, electrolytes, and HIV screens for patient care.

The concern is usually not about the kits or instruments themselves, but the human factor: is the testing staff adequately trained and competent to perform the testing as required by the manufacturer? Is quality control monitored, and corrective action taken if needed, before patient results are reported? Are reagents and specimens properly stored? Who is supervising the staff?

Studies have shown a higher level of quality issues in waived only laboratories that were randomly surveyed. These included lack of available written procedures, personnel training and competency assessments, and environmental issues. Qualified oversight of the testing process and personnel competency DOES make a difference.

We are finally beginning to move in the direction of codifying these standards into universal lab practice for all patient testing. For example, COLA, one of the leading laboratory Accreditation Organizations, has added ten new criteria specifically for waived testing. These include requirements for competency testing for staff performing testing at all levels of complexity.

Really, when you think about it, why should a lesser complexity of the testing compromise standards once it is realized that patient care is affected by these results.

Now, the last remaining issue is: how do we adapt these concerns for good laboratory practice into the public arena of non-lab performed waived tests (home use) people are performing in greater numbers, especially as the concept of taking greater control of one’s healthcare becomes technically easier. Obviously this issue goes beyond the traditional laboratory paradigm, and may well be the highest mountain to climb.

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The Best Gift
January 8, 2014 11:41 AM by Nancy Alers

As a laboratory quality advisor, I offer advice and guidance to laboratories that are preparing for their upcoming laboratory inspection. The goal is to not only reduce the number of citations that labs receive, but most importantly offer advice on how to improve their processes and ultimately provide better patient care.  It is not uncommon for laboratorians to feel that, when it comes to ensuring a lab's readiness for inspection, the list of things to check seems never ending. Each laboratory is unique and may have different requirements depending on the complexity level and the test menu that it offers.

If you are a laboratory manager who oversees different laboratories in multiple locations, with different requirements, this makes even more sense to you.  From quality control, to calibration & personnel files, quality assurance, temperature logs, corrective action, maintenance, training, competency assessment, etc. the list goes on and on. Fortunately, many accrediting organizations provide a pre-inspection checklist also called a self-assessment questionnaire that can be of assistance to ensure that all your Is are dotted and all your Ts are crossed.

What is the problem, you would ask? That most labs don't use it! The pre-inspection checklist (Self-assessment) is one of the most underutilized tools laboratories have available! A pre-inspection checklist is a comprehensive instrument to ensure that your laboratory has met the level of compliance expected by the Accrediting Organization.

An interesting phenomenon is that laboratories that do use the self-assessment tend to answer the questionnaire as if trying to obtain a perfect score, when in fact the goal is to uncover deficiencies preemptively and correct them before the inspection takes place. Utilized correctly, a pre-inspection checklist can help a laboratory lower the number of citations and improve the overall level of quality. As a quality advisor, I recommend not waiting until the last couple of months before inspection to perform a self-assessment. This tool is more effective when the laboratory has plenty of time to make the necessary changes.

Next time your laboratory is up for inspection, I encourage you to utilize your accrediting organization's pre-inspection checklist (self-assessment). Performing a self-assessment is the best way to prevent citations and to ensure the laboratory is aligned with the level of quality that is expected.

4 comments »     
Proficiency Testing Proficiency
December 5, 2013 3:33 PM by Irwin Rothenberg
Proficiency Testing is an important part of any laboratory quality assessment program.  It is an external assessment of your staff's performance  by facilitating  the comparison of your laboratory's test results with other laboratories using the same instruments or kits, and methodology.  While we have discussed proficiency testing before, in the context of competency assessment, today we will focus on the process and requirements of proficiency testing itself.

Once  you receive your specimens from your PT provider,  you  must follow the same procedures for the storage and handling of these specimens that you would for any patient specimen received by your laboratory. This is a must if you are to get the maximum value from these programs. In effect, think of PT specimens simply as additional patient specimens and treat these accordingly. This rule applies through all phases of testing: pre-analytical, analytical and post-analytical. True, you are not "drawing" or "collecting" these specimens directly from the patient, but receiving them is only one step removed.

All staff who normally perform this testing, even if only occasionally, should participate at some point during the year.  

These specimens should be treated in exactly the same manner as all other specimens; that is, if your routine is to test the specimen once on your instrument or with your kit reagents, then the same holds true for PT specimens. If on the other hand, you would rerun abnormal results to verify the efficacy of the result, then by all means do so for your PT specimen as well. Do not have several staff run these specimens and pool the results before reporting them. If you treat these specimens in a "special" manner, then what are you achieving?

It is a good idea to save "left over" samples when possible, so if you need to recheck your results after your results are graded, you will be able to do so easily.

Remember: NEVER, NEVER, share your results with another laboratory, even a "sister" laboratory, until your results are sent off, and the official window of time for accepting specimen results by the provider, has closed.

Record keeping and documentation are of high importance, as there are specific requirements by CLIA and/or your accreditation organization: Your files should include:

  • Original instrument tapes,  as well as worksheets, if using kits.
  • Signed Attestation forms by your LD or qualified designee, as well as testing staff involved; 
  • Copies of your result forms submitted for grading or sent in electronically; 
  • Graded results received with documentation of review by Lab Director or qualified designee;
  • Documentation of corrective actions taken if there is an unsatisfactory or unsuccessful results

When you follow both the spirit and the letter of the regulations for handling Proficiency Testing, treating it as a valuable  quality indicator, then you will truly be proficient in how you are using PT.

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