Proposed Changes to Proficiency Testing

On February 1, 2019, CMS and CDC published proposed rules to update the CLIA Proficiency Testing Regulations. The PT Regulations had not been updated since first enacted in 1992. 

There are several areas wherein changes are proposed:

1: For non-microbiology specialties and subspecialties, they propose 29 analytes be added to the regulated analyte list. At the same time, they propose removal of five regulated analytes because they no longer are commonly used.  The total number of regulated analytes would rise to 105. 

In selecting the additional analytes CMS evaluated the availability of proficiency testing materials that would provide the needed analytes.  They required that at least three approved PT providers be available to support the program.  They also reviewed the volume of patient testing/analyte performed for each analyte nationwide.  They included analytes that had testing volumes of at least 500,000 plus an additional ten analytes that while below the 500,000 threshold were determined to be clinically important.

2: In addition, the proposal includes revising the scoring methodology for acceptable performance, a recognition of the improved accuracy and precision of testing available today compared with when first enacted in 1992.

3: In microbiology the proposal would institute updates to specify broad categories of tests for proficiency testing. The proposal states that this would enable flexibility for new technologies which have been developed since 1992 and also be appropriate for technologies that will be instituted in the future. 

4: The proposal also addresses waived proficiency testing performed in moderate and high complexity laboratories. The proposed change would enable CMS to apply the same sanctions for PT referral for waived testing as are in place for the moderate and high complexity testing.

These proposed changes are a recognition of the advances in laboratory technology and methodologies and the availability of analytes either not commonly used or in very limited usage when the original regulations were enacted. 

CMS acknowledged that there would probably be an increased cost to laboratories to comply with the new regulations; however, in view of the extensive use of these analytes and in the best interest of patient care, they and most in the laboratory community recognized the necessity of these changes.   In addition, the changes were not made quickly or in a vacuum.  The CDC and CMS working with the Clinical Laboratory Improvement Advisory Committee spent several years in the development of this proposal. 

CMS encourages public comments, questions or thoughts on the proposal and comments must be submitted by April 5.  The entire document can be viewed here.

To Outsource, or Not to Outsource?

The decision to outsource should be based on an organization’s mission and business strategy.

Like any other business, laboratories and the organizations they are affiliated with continually struggle with cycling budgets, staff, and capabilities. As such, a decision that lab directors and managers must periodically make is determining what portion of the lab’s tasks and support functions to keep in-house and what portion of the work to outsource.

The answer is not always simple. Not only do internal considerations account for the decision, but also the potential and existing clientele, though indirectly, are a factor. “People expect you to provide a full slate of services, and if there’s something missing from your catalog, they might think that you’re not the one-stop shop that they’re looking for, and so you have to be careful in determining what you think is vital for your core clientele versus what you can afford to outsource,” says Jerry Torrison, director of the Veterinary Diagnostic Lab at the University of Minnesota in St. Paul.

Read More…

5 Pros and Cons to Marketing on Social Media

Social media is a behemoth of the modern age. There are almost 3.4 billion active social media users worldwide, and those numbers are growing. With the increasing presence of Facebook and Twitter, many businesses have made those social media outlets a key part of their marketing strategy, with great success. Almost 90% of marketers say their social marketing efforts have increased exposure for their business, and 75% say they’ve increased traffic. That may work for McDonald’s, but is it worth it for businesses in the healthcare and medical technology field to invest time and money in social media? We’ve compiled a list of pros and cons to help you decide, along with a few helpful “Pro-Tips” to help you avoid the pitfalls.

Pro 1: Everyone Uses Social Media

If you’re looking to reach a wide audience, there are few places with a bigger audience than social media. Ever-expanding bandwidths and increased use and capability of mobile devices have caused social media to permeate almost every aspect of modern life. With Baby-Boomers retiring, millennials are taking over the workforce, and many of them have been using social media most of their lives. Many businesses have capitalized on this trend and use social media to get their services and products out there. 91% of retail brands use 2 or more social media channels.

When your audience is literally everyone, you have the chance to make some unexpectedly valuable connections. You will connect with potential customers of course, but you can also make meaningful connections with other business, future employees or partners, and business professionals that can help make your company even stronger.

Con 1: Everyone Uses Social Media

According to the latest social media statistics, 81% of the U.S. Population has a social media account. That amounts to about 264 million people. In a crowd that size, it becomes harder to reach your target audience. Some people really just want to watch cat videos and make-up tutorials. Marketing yourself to your desired audience will take time and dedication. Using memes and videos will get you a lot of likes, but may not drive traffic to your site and will probably not lead to increased sales. But paying close attention to your keywords and SEO can help drive the right people to your page. Nobody goes viral as soon as they create their page, but the audience is there if you can get their attention.

Reaching your targets is not the only problem when posting online.   One law of the internet is wherever there is a comments section, there are internet trolls. This can be particularly problematic if you post blogs, opinion pieces, scientific articles, or anything that gives the audience a chance to disagree with you, which trolls will love to do, aggressively.

Pro-Tip: Choose Your Social Media Outlets Wisely

There are a lot of social media outlets. Facebook, Twitter, Linkedin, Instagram, Google +, Youtube, Pinterest, Snapchat, WhatsApp, Tumblr, Flickr, and Reddit are just some of the most popular. But you don’t have to have a presence on all of them. You certainly can, but your target audience probably doesn’t. The average U.S. citizen has about 8 social media accounts, but they may only stay active on 2 or 3. Do some research to find out what your customers and colleagues use most often and pick between 2 and 5 outlets to post regularly to. Otherwise, you’re going to end up spending all your time making posts that nobody will ever see.

You should also remember to be flexible with your choice. As times change, some sites will become more or less popular. You may also find that you get more interaction with one of your pages than others. Respond to that. For example, when I began marketing on social media, I chose to focus on Facebook, Twitter, and Linkedin. I found that I got the most interaction on Facebook, and the highest quality interactions on Linkedin. I eventually found little value in the company Twitter page, so I abandoned it and started looking for a better option. I found one when I discovered the Mayo Clinic Social Media Network, which was highly targeted to my desired audience. Stay adaptable in the digital world, otherwise, you’ll end up making regular posts to MySpace.

Pro 2: Drive Traffic to Your Website

The reason to market on social media in the first place should be to bring people to your business. In many cases that means bringing them to your website so they can view and order products and services, or at least learn more about them. If that is your goal, display your website prominently and often on your social media pages. Simply having those links to your page will improve your website’s ranking on search engines and could lead to increased sales. The more people click those links, the more successful that strategy is. The best way to get people clicking is to use social media to promote content directly from your website, whether that means blogs, scientific articles or even just company updates and upcoming project announcements.

Con 2: It Can Be Time Consuming

If you don’t use social media regularly, it will take some time to set up these pages and learn how to use them effectively. Even if you use Facebook every day, you may find it difficult to transition to Instagram or even Twitter. This may result in your page looking a bit bare or even unprofessional in the beginning. But keep it up and you’ll eventually get the hang of it.

Once you have your pages set up, you will need to constantly provide updates and posts to keep user interaction high. Finding content to make regular updates can also be difficult and time-consuming. You should be posting to each of these pages AT LEAST once per week, but many companies choose to post several times per day. For larger companies, this is a full-time job in itself, sometimes even requiring multiple employees.

Pro-Tip: Use Helpful Time-Management Tools

The time-cost of keeping your pages and posts fresh is well known and there are a number of ways to mitigate the cost. My biggest recommendation is to use an online tool like Hootsuite. Hootsuite allows you to manage all your social media pages in one place and provides helpful tools for scheduling posts, tracking and improving return on investment (ROI), and allows you to search your social media for meaningful keywords and hashtags.

One lesson I learned from personal experience is: Always Be Posting. You may choose to schedule posts at regular intervals, but that doesn’t mean you can’t share more spontaneously as well. Did you just read an interesting article, or see a funny meme that pertains to your business? Post it now. It takes seconds to do on your phone or computer and the results are far more posts than you expect. You can also encourage your employees to send you enticing content that they find. This method leads to our next Pro.

Pro 3: It Builds an Authentic Relationship

Making regular meaningful posts will help showcase your brand and company personality. Because of its more personal approach, a business can interact with its audience like a normal person would, which is extremely important when moving people along the sales funnel. There are several tactics that improve this relationship. Reply to your customer’s questions with their names. It is not only a personal touch, but it will give the user a notification that his name or handle has been used. Use real (not stock) photos for your avatar and background. Users react more positively to an online presence that feels like a person than to one that feels like a faceless company. This all results in creating brand loyalty, company identity, and voice. People love it when Wendy’s or Campbell’s reply to customers or razz their competitors as many did to IHOP when they changed their name briefly to IHOB. These types of interactions are more likely to be shared and re-tweeted so it reaches a larger audience.

Con 3: Exposure to Attract Risks

While a personal touch is great for these pages, remember not to get too casual or controversial either. Know your target audience and always keep them in mind. 51% of people said that they would unfollow brands on social media if they posted irritating posts and 27% said they would mark/report the brand and page as spam and block them. You also may run into negative feedback in comments sections that give your company a poorer image.

Image issues aside, there are also standard risks to posting anything important online. Careless employee interactions could lead to privileged information leaks or even leave you open to hacking. Hackers can break into your accounts and access valuable information such as customer’s purchase information or at worst, use your account to gain access to your office computer or even your entire system.

Pro Tip: Establish Social Media Guidelines

To avoid some of the risks of human error, hacking, and generating the fury of internet backlash, it’s a good idea to set up some ground rules. This is especially helpful if you have more than one person contributing to your social networking sites. Formalize your policy objectives and share them with your entire company to ensure that employee interactions on these sites don’t pose a risk to the company.

Pro 4: It’s Cheap!

One of the best reasons to at least set up pages on social networks is that it is usually completely free! All the major sites have monetized and allow you to pay for promoting content or posting ads, but it’s not required. With a limited budget, you can promote your most meaningful content and leave the rest for your subscribers and followers to see. You can hire a professional digital marketing expert or team to manage your online presence, but if you own, or are part of a small company, it’s possible to manage your own social media in just a few hours per week.

Con 4: Competition

According to a survey in AdWeek, more than 88% of companies in the U.S. use social media for marketing. This means that all of your competition will also be out there with their own pages and content. If your competition has a bigger budget than yours, the social media site may even be showing competitor ads to your followers.

Sharing your company’s latest updates and activities is a great way to gain followers, but your competition can also see this information and may be able to glean valuable insight into your company’s strategies or even discover some of your accounts and customers. So resist the temptation to over-share or risk your brilliant ideas being stolen.

Pro-Tip: Have a Professional Manage Your Accounts

Although it may be costly to hire someone to set up and manage all your social media accounts, it may be worth it. This is especially true if you have limited knowledge and experience with social media. The risks of being present online are real and should not be taken lightly. At the very least, have a trustworthy, social media savvy employee set up and manage your account for you. The mistakes made by rookies have the potential to be far more costly than simply getting some help from a professional.

Pro 5: It Provides Marketplace Insights

Who is your audience? How do they interact with you? What are most people looking for when they find you? What are people saying about your business? These questions used to take entire marketing departments and teams of researchers to answer, but with the use of social media and a few online analytical tools you can get the answers to these questions with the press of a button. 66% of the marketers today use social media to gain insight into what the online community is saying about their business, their competitors and what topics are of the most interest to their audience. You can use all this information to either broaden your reach or focus down to your most desired prospective customers.

Con 5: ROI is hard to Measure

As scientists, we all want to see the data. How much does social media marketing really help the company? Unfortunately, it’s very difficult to determine how much interaction on social networks actually affects sales. The industry average for a full social media campaign done by a professional agency ranges from $4000-$7000 a month. But calculating your exact return on investment is almost impossible. Not all types of companies will benefit the same way from a social media presence, and in some cases, it may be better to keep these investments to a minimum.


While there are many pros and cons to marketing on social media, most companies would agree that the pros outweigh the cons. The simple task of setting up accounts on social media sites can have an immediate effect, and it opens up the chance to drive huge numbers of people to your business. Social media is one of the most widely used forms of media today, and that’s not going to change any time soon.

-Glen Ziolo

Posted 11/30/2018

5 Simple Ways to Keep Your Clients Satisfied

According to Entrepreneur.com it is 5x more costly to find a new client than to maintain your existing customers. Happy customers are also a great source of advertising. Personal referrals are excellent for growing the business and being more profitable. Consumers and clients are the heartbeat of all businesses, so performance improvement to their standards should be a priority. Our team has identified five ways that can help retain current clients and keep satisfaction levels high.

  1. Communication- You’ve all heard the saying “Communication is Key” or “It was a miscommunication” when something didn’t go according to plan. Communicating makes everything easier. Let your clients know they’re important by connecting regularly and replying promptly (Emails should be answered in less than 24 hours). Anticipate issues that may occur and address it before they do; this shows that you are on top of operations and transparency.
  2. Consistency and Accountability- One of the most important aspects of running a good business is your consistency. Your product, performance, and service should maintain a consistent delivery with the highest standards. Be accountable, with both negative and positive feedback. If a client expresses satisfaction with your company, let them know that this is your goal and you strive to keep it that way. On the other hand, if the opposite is expressed, take responsibility for your company’s part and thank them for their feedback. Run through the process and update it based on your findings that led to a negative review.  Always remember not to overpromise.
  3. Add a personal touch- Remembering a birthday or writing a handwritten thank you letter can strengthen an existing relationship. It doesn’t hurt to take a few minutes to make someone feel special.
  4. Value your client’s point of view- Create an active feedback operation that allows clients to communicate their questions, ideas or concerns. An annual survey is always a great way to hear from your customers. Their point of view is the most important when exploring opportunities to grow and improve.
  5. Be the expert- You were hired for your product, service, or knowledge. Know what you offer well and educate yourself on similar industry topics and current issues. Strive to be the best in your market and clients will feel confident to give you their business.

If client retention is not satisfactory, it may be wise to hire a 3rd party to access and determine the best solution for improvement. Furthermore, there are services that will provide additional training to your current client services staff.

-By Didiana Duque

Making the Most Out of Lab Meetings

There is no doubt that technology has influenced and even changed the way we communicate at the workplace. Whereas face-to-face and telephone conversations were likely the most common means for relaying information just a couple of decades ago, we now rely on email and instant text-based messaging for both ease and speed. And although these forms of interactions have taken root in our culture and are indeed useful, managers running businesses and laboratories still make time to meet with staff, both one-on-one and in the form of group meetings. That’s because managers understand that getting together allows their team to interact on a personal level, which can foster a sense of community within the organization, allow individuals to cite issues of what is and isn’t working, and give everyone a chance to brainstorm, among other things. Read more here…

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?


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.


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.


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

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…