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How to Avoid the Most Common Lab Citations

Most labs will have citations during their inspection, however, knowledge of the most frequent areas of noncompliance can help reduce the number and severity of them. The top noncompliance areas include Calibration, Quality Control, Personnel, Quality Assurance, and Proficiency Testing. Let’s take a look at some examples:

 

  • Calibration: Observe the performance of instrument maintenance (if applicable) to make sure that maintenance and regular calibration is being performed correctly, and on time. Direct observation can be documented in the competency assessment by noting the date of the observation of the specific maintenance procedures that were observed. Any need for retraining should be documented in the records as well.
  • Quality Control: QC programs should be established and maintained to identify failures in quality as they occur. Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system. Assure that appropriate technical staff reviews QC regularly to confirm that policies and procedures are being followed by all staff.
  • Quality Assurance: Assure that QA reviews are effective at identifying and preventing errors, and that corrective actions are followed up for effectiveness. Establish written policies and procedures for evaluating performance specifications. It’s a good idea to specify the remedial actions to take when they are not met. Most importantly, make sure your lab policy states that patient results are NOT to be reported when the test system is not functioning properly (i.e., QC is out of range, etc.). Ensure that all staff know and follow this policy.
  • Personnel: Competency is required to be documented for all testing personnel, except the Laboratory Director, and must include the 6 elements required by CLIA. If personnel do not perform testing (i.e. CC, TC, GS), then a competency based on their job description must be documented. Competencies should be completed by the reviewer and given a final sign off by the Technical Consultant or Lab Director. There should be an SOP in place for all competency requirements. Remember that training does not count as competency!
  • Proficiency Testing: PT results should be reviewed once made available by the PT provider. Review can be designated to the Technical Consultant or General Supervisor, but the Laboratory Director should review the results as well. When reviewing PT results, don’t just focus on the analytes that were incorrect. Be sure that every analyte in your test menu is present based on what the PT is showing as present. Document any corrective action, if necessary, as well as who performed the review and when.  Review should take place within 1 month of result receipt.
  • Bonus! Laboratory Directors should be involved! Many times we hear the saying, “Where do I sign?” If you have an LD like this, try to involve them as much as you can, even with a simple explanation for what they are signing. LD’s can delegate any signature within the laboratory EXCEPT the signing of policies and procedures. If an LD delegates a signature, only the delegated person has to sign, not both.

 

If you do struggle with compliance, it may be wise to hire a consultant to do a mock audit before your inspection to see where your lab’s strengths and weaknesses are. Preparation is always better than remediation when it comes to inspections. There are endless citation possibilities, but focusing on the areas of Calibration, QC, Personnel, QA, and PT is sure to keep noncompliance in your laboratory to a minimum.

-Written by Jennifer Kelley and Glen Ziolo

June 15th 2018

What Can and Can’t Your Assistant or Phlebotomist Do In A Laboratory?

As consultants, we often get asked the question, “What can my lab assistant or phlebotomist do in my laboratory?” As laboratories continue to experience a shortage of qualified individuals, and feel the pinch from PAMA reimbursements cuts that went into effect Jan 1st, 2017, many laboratories are having to find increasingly clever ways to reduce spending while maintaining the same or higher quality of patient care.

This is where a laboratory assistant or phlebotomist comes in handy. While you still need a licensed individual to perform certain essential aspects of patient testing, many other duties can be handed over to your entry level team members.

Note: If you want your assistant or phlebotomist to take on some of the more traditional medical technician or technologist roles, make sure that you are defining in their job description what they can do, and specify what they cannot do, very clearly. Make sure that you include them in your personnel competency assessments – you will want to update your competency to ensure that they are correctly performing the “Can”, and not accidentally performing the “Cannot”.

DISCLAIMER: As with everything in your laboratory, your lab director must ultimately decide what tasks they will allow unlicensed individuals to perform, and sign off on that position’s job description. This article is an opinion piece and is not necessarily acceptable in all U.S. states or provinces. Consult with your lab director and your technical consultant or supervisor before implementing any of the suggestions contained in this article.

Common Lab Activity Can Your Assistant or Phlebotomist Do It Instead?

PRE-ANALYTICAL

Record temperatures for fridges and freezers Yes – They must let a supervisor know if a result is out of range.
Record eyewash, fire extinguisher, and shower safety checks Yes – They must let a supervisor know if a result is out of range.
Perform inventory checks and ordering Yes
Enter requisitions into an LIS or EHR system Yes
Label tubes; centrifuge and pour off samples Yes
Perform daily, weekly, and monthly maintenance of instruments and equipment Yes, with documented training
Load reagents onto instruments Yes
Maintain a record of opened reagents, label reagents, dispose of expired reagents Yes
Run calibrators and quality controls on instruments Yes, with documented training
Accept the results of calibrators and quality controls NO, these have a direct effect on the accuracy of patient results. Exception: Waived tests may be performed by anyone who meets CLIA requirements.
Perform troubleshooting on an instrument Yes, with documented training
Create corrective action logs Yes, as long as they are reviewed and finalized by a CLIA approved individual who can create a corrective action plan, implement it, and follow-up on it.

ANALYTICAL

Load patient samples on an instrument that is not running, or is currently running. Yes, as long as it does not interrupt the operation of the instrument.
Start an instrument that was not previously running to test patient samples. NO. This is initiating testing of a patient sample.
Perform an activity that alters the original matrix, such as mixing in another substance. NO. This is part of the testing process. Exception: Waived tests may be performed by any individual who meets CLIA requirements.
Perform any activity (other than waived) that directly generates a patient result. NO. This is patient testing.

POST-ANALYTICAL

Enter results into an LIS or EHR system Yes
Release results from an LIS or EHR system for the doctor or caregiver to make medical decisions. NO. This is considered as making a decision regarding the accuracy of patient results. Even if a licensed individual has already approved them, most LIS and EHR systems record who released the result, making it appear as though an unlicensed individual had the final decision regarding the validity of results. Exception 1: The LIS system has a supervisor or MRO review function that prevents the final release of samples. Exception 2: Waived tests may be reported by anyone who meets CLIA requirements.
Report critical (life-threatening) results NO. This should be done by a licensed individual, and received by a licensed healthcare provider, with a read-back which includes 2 patient identifiers and the result. Documentation must be kept on both sides. Notification should be done promptly.

Written by Danielle Ziolo
June 3, 2018

Lawmakers Banning Synthetic Urine Sales

Several media outlets have reported recently about a rising challenge to drug abuse management – a growing demand by individuals to purchase synthetic urine. Synthetic urine is commercially used in laboratories, research, and manufacturing of reagents. It has also been sought out by drug users seeking to defeat urine toxicology testing and can be seen in online stores, truck stops, and dispensaries. Since synthetic urine is intentionally created to have very similar properties to human urine, testing for adulterants is unhelpful in identifying its use.

As reported by the Washington Post, Fox News, and various other periodicals, some U.S. states are banning the sale and use of synthetic urine. It sounds ludicrous for those of us who use synthetic urine scientifically, but when I did my research, I found the supporting legislation. Indiana and New Hampshire have already passed laws banning synthetic urine, and Mississippi and Missouri have bills in their legislature to create the same laws. 18 states in total are moving to ban the substance. The federal government is also making moves to standardize testing that use hair and saliva instead of urine.

Will you and your team be affected if this trend of banning synthetic urine continues? Would it prevent you from using urine when testing for drugs of abuse? Do you expect that this involvement from lawmakers will increase the overall interest in oral or hair testing? Are you concerned about the false positives associated with hair samples, or the short timeframe associated with oral testing? Have you had an experience with these new laws?

I’d love to hear your stories and opinions in the comments section below.

By Danielle Ziolo

May 11 2018

Graphic by Quest Diagnostics

Star Wars Day Reminds Us, The Future is Here!

Happy Star Wars Day Everybody! Today is a great day to consider how new technologies can make your job, lab or hospital more efficient. Whether that means a better LIS system or purchasing an automated workflow unit, there are ways that technology can make our lives easier. Read More…

Lab Services: What’s Best for Your Business?

It’s all about protecting the business value of the measurement.   In previous decades, it was relatively common to simply purchasing annual contracts where the original equipment manufacturer (OEM) provided full maintenance services for its products. However, as instruments became more reliable and cost reduction mandates swept through labs, the situation became more complicated as managers began to seek less costly alternatives.  Read More…

CMS Wants Your Opinion on Regulations

“The CMS is taking a hard look at whether regulations governing clinical laboratories need to be updated. Industry groups hailed the move, which they say is long overdue…”

“The CMS posted a request for information on Friday asking the industry for input on how the policies should be updated. Specifically, the agency is interested in whether personnel requirements, testing standards and industry fee structures need to be updated.”

Read More…

 

ZC @ MSACL

Our first conference of the year is MSACL (Mass Spectrometry: Applications to the Clinical Laboratory) in Palm Springs, California. We are looking forward to meeting new people and learning from other experts in the field.

Come and visit us at booth 34 for your chance to win great prizes!

Check out the website for MSACL at: https://www.msacl.org/index.php

A Year to Shine and Share

Happy New Year Everyone!

Join us in a new endeavor as we begin an active blog, filled with ZC Family fun, important healthcare news stories, medical discovers and innovations, and new offers from Zephyr the Chameleon.

Also, sign up for our monthly newsletter to keep up-to-date on changes to industry regulations, tips and pointers for your healthcare business, and featured stories and articles relevant to your success.

We at Ziolo Consulting are excited for the new opportunities awaiting us and the ZC family. We can’t wait to share in the adventure with you!

Ziolo Consulting at AACC

Ziolo Consulting attended the American Association of Clinical Chemistry Conference this year in Philadelphia PA. CEO Danielle McDonald, and Vice President Glen Ziolo enjoyed several classes and lectures offered.  Some of those classes include: “Technologies that Could Change the Future of Clinical Chemistry” and “The Next Frontier in Precision Medicine – Targeted Peptide Diagnostic Mass Spectrometry Assays”. They also toured the booths at the Expo and connected with several of the companies that made advances in technology that could change the future of LC-MS labs. “We both had a great time and met so many great people working in our field.  We look forward to bringing these technologies and connections to better service our clients now and in the future.”

-Written by Glen Ziolo