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CRI Lab Quality Advisor

Procedure Manuals: Integral Part of the Laboratory Quality Matrix
September 17, 2014 10:25 AM by Irwin Rothenberg

I have never seen a well-run laboratory, providing quality patient service, that did not have complete up-to-date and well-organized procedure manuals. But the implication of “procedure manual” as a descriptive term is really incomplete. It is more than just the step-by-step directions for performing a test. If that was all we needed, then the manufacturer’s insert would be far more than sufficient. A complete procedure manual must also include all operational steps from the pre-analytical patient preparation and sample integrity to post-analytical reporting protocol for each test and each test system.  

Before putting together or updating your procedure manual(s), you should be aware of what CLIA requires and/or the requirements of your accrediting organization. These requirements include (but are not limited to):  

-              Instructions for specimen collection, rejection, labelling, processing and storage

-              Every step of the procedure (including calculations and interpretation of results)

-              Calibration and Calibration Verifications

-              Quality Control

-              Reportable Range and Reference Ranges

-              Panic Values

-              Steps to be taken if your test system is down, and you cannot perform testing as expected

-              Maintenance and Trouble Shooting procedures

-              Reference lab referral protocol

-              How the lab reports and stores results.

It is acceptable to utilize manufacturers’ inserts as the basis for describing test procedures, but additional required information must also be present.

But there is so much more. It is also helpful to consider the development and use of procedure manuals as a separate organizational piece of the laboratory operation. Why? Because, in addition to the requirements listed above, you must add in the personnel component: 

-              Training of all new personnel and training of all personnel to new/revised procedures

-              It is the source of information regarding the communication of test results, panic values, problems with specimen acquisition and operational problems to internal (clinic/office) staff as well as external customers, including physicians, nurses and patients.

There is also an organizational component:

-              All procedures should follow the same format and organization.

-              All procedures must be approved, signed and dated by the laboratory director. This process must be repeated anytime the lab director changes. 

-        Annual reviews by the laboratory director or by technical supervisors.

-              Discontinued procedures must be retained a minimum of two years; signed and dated when discontinued or replaced.

-              The procedure manual must be readily accessible to personnel, preferably in their work area.

Thus, when we discuss procedure manuals, we are really discussing a key component of laboratory quality matrix, involving not just the test procedures themselves, but personnel, organizational and regulatory requirements.

Beyond Competency
August 27, 2014 12:55 PM by Irwin Rothenberg
We all want our employees to succeed; that is, do well in their job, and do their job well. This requires more that the didactic aspect of training, and goes beyond competency assessment. This requires the skill and intuitive ability of the manager to understand and apply what motivates their employees to do as well as possible, as well as moving beyond defining boundaries when staff  do not meet standards.

Essentially, motivating your employees effectively means understanding the human component of work. While we are Professionals with a capital P, we are also human; both positive and negative reinforcement are essential to get the best out of our staff.

The plain fact is that everybody watches everybody else; how their fellow  staff are treated; wary of any hint of favoritism or unfairness. So, we need to go beyond implementing and using the important dictums of clear communication, transparency, and competency, to an awareness of not just what you are communicating, but how you communicate: the language that is used: the tone, the volume, your body language; your concern and your sincere involvement.

Once an employee has achieved competency, and is doing their job well, how often do they get recognized, praised, and rewarded? How often are they told that their efforts are not only saving lives, maintaining the quality and integrity of the laboratory and their organization, but serving as an example and inspiration for their fellow staff. How often do you instill pride in your staff?

If an employee is not performing to standards consistently, do you go beyond discipline? Beyond retraining? Do you try to find out if anything else is going on that is affecting their performance? This is not to say, you should go where you are not welcomed, but that you communicate your readiness to listen to your staff if they wish to talk to you about other issues?

How cognizant are you about the dynamics of your laboratory culture? Are you aware of the politics and power plays that go on, that may also affect performance? Do your supervisors share your philosophies of management? Do your employees feel comfortable having a private conversation with you about factors that may affect their work?

Good, solid, competent and experienced staff  are to be valued and supported; when things go awry, you may have to look beyond training and competency assessment to the human factors that govern behavior, and by extension, performance.

The result is truly effective management; and this aligns with driving quality laboratory medicine.

By the way, who do you talk to?

Operational Failures
August 12, 2014 3:07 PM by Irwin Rothenberg

We have all been in situations where we start our workday, and find the unexpected has happened, and that we cannot proceed as planned. Frustrating! From the viewpoint of a laboratory professional, this can include all those situations that prevent us from fulfilling our responsibilities to perform the testing ordered, and to report the test results in a timely manner.

These situations can include problems with:

  • Instruments and Kits
  • Quality Control / Reagents
  • Inventory control ("what do you mean that we are out of test packs?")
  • Personnel issues: sudden short staffing; performance errors; injuries on site.
  • Ancillary system malfunctions such as refrigeration and incubation failures
  • Computer / Laboratory Information Systems down
  • Utilities out; leaky plumbing in the work area......anything!

The bottom line is that when these occur, the laboratory cannot deliver what is expected.

 How do you handle this? After all, patient care is on the line; physicians are expecting test results in a timely manner; and there may be Stats among these orders. Without a plan, the credibility of the laboratory is at stake.

Whether the service interruption is a temporary delay measured in hours, or one that lasts for several days (or longer), the laboratory must have plans in place for dealing with service interruptions. These should include:

  • Protocol for contacting the ordering physicians as soon as you know there will be a significant delay;
  • Procedure for accurately informing the rest of the laboratory staff what has happened; so if they receive calls about the delayed work, they will have an informed response.
  • Procedure to inform other departments in the facility if their work will be affected by these delays.
  • Procedures for when and which specimens are to be retained or sent out for testing, depending on the length of the delay; and which laboratories to use for referred testing.
  • Procedures for reporting test results if it is the information system that is not operating.
  • Protocol for delays longer than one day.

Effectively planning for these situations, (as much as one can) will go a long way toward reducing stress for the staff, allowing them to focus on the tasks at hand; ensure proper communication to your clients, and preserve the credibility of the laboratory for its professionalism and quality.

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.


  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.
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.

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!

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

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.

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!

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!

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!

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.

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?

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.

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.