Does Your Laboratory Personnel Meet the CLIA Regulation and Accreditation Requirements?

On December 21, 2012, the Centers for Medicare and Medicaid Services (CMS) published Survey & Certification letter: (S&C-13-07-CLIA) with Brochure #10 on Personnel Competency. It cites the six minimal regulatory requirements for assessment of competency for testing personnel:

  1. Direct Observation of testing procedure
  2. Monitoring the recording and reporting of test results
  3. Review of test results
  4. Performance of instrument Preventive Maintenance
  5. Test performances, i.e. blind unknowns, etc.
  6. Assessment of problem solving skills.

Since early 2013, some CMS surveyors have joined accrediting agencies such as The Joint Commission (TJC) and College of American Pathologists (CAP) in their bi-annual lab accrediting surveys to check testing personnel’s qualification. This qualification includes proof of a minimum education requirement (usually a college diploma). Healthcare organizations need to assure the qualifications for testing personnel are fully met pursuant to the federal, state, and accrediting agency requirements. This includes personnel that perform point-of-care testing (POCT). Because this testing might be performed by non-laboratory staff, these personnel might not have the required education requirements for moderate complexity testing pursuant to the CLIA requirements.

In such cases where the testing personnel licensure is required (for example, by the state) copies of staff diplomas would not be necessary. Licensure is different than certification, which is sponsored by a private sector, nongovernmental institution, such as American Society of Clinical Pathology (ASCP). By requiring personnel licensure, the state government has taken additional measures to protect harm to the public in the state. Currently, there are 12 states with laboratory personnel licensure requirements (California, Florida, New York, North Dakota, Rhodes Island, Tennessee, Louisiana, Nevada, West Virginia, Montana and Georgia). The components of the laws for personnel licensure vary from one state to another; it usually involves a fee, a continuing education provision, and a minimum education requirement, and a professional competency requirement.

Due to the economic situation in the United States and the laboratory workforce shortage, some state government agencies have not actively enforced all compliance aspects among healthcare organizations. For example, some laboratories allow medical lab technicians (MLTs) to perform high-complexity testing due to the medical lab technologists’ (MTs) shortages across the country. However, according to CLIA regulations, MLTs should only work in moderate complexity testing areas that require limited independent judgments. The high complexity testing environments that include blood banking, microbiology identification procedures, microscopy, etc. require a high level of independent judgment and should only be performed by MTs.

Technical supervisory positions in the clinical laboratory require a minimum of five years technical experience. It would not be in compliance with the regulations when the clinical laboratory general supervisors are chosen from MLTs or related field, such as cytology or histology or radiology. Healthcare organizations need to assess their lab personnel qualification and competency to assure that they are meeting the standard requirements pursuant to CLIA regulations, state regulations, and accreditation requirements.

If you’d like more information about these regulations, please read the Code of Federal Regulations part 493.

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

Prime Time: the Fine Line Between Innovation and Regulation

We live in an age of wonders. New technologies with new and usually improved capabilities are springing up far faster than we can keep up with them. And those new technologies occasionally revolutionize not only the field they spring up in, but other, sometimes unrelated fields. A good example of this is how tandem mass spectrometry revolutionized newborn screening (NBS). An instrument and test system once considered essentially a research tool has led the way to improving and standardizing NBS across the United States. Because this is true we must always be ready and willing to learn about the newest technology. However, sometimes it’s difficult to walk that fine line between leaping ahead too fast and not moving ahead at all.

In the laboratory field, and the medical field in general, a LOT of checks and balances are in place, many of them in the form of the regulations and controls we love to hate so much. If you are going to be possibly putting a person’s health, well-being or even life on the line, the level of checks and balances becomes totally understandable and even necessary. However, we must be careful not to refuse to see new technology because it doesn’t fit the mold of our current regulatory environment. Sometimes in order to move forward, we must reinvent the regulations as well as the technology. A good example of this was learning to deal with and regulate electronic quality control when instruments like the I-STAT were introduced to the field.

There can be an incredibly fine line between stifling innovation and having necessary and appropriate controls in place. It takes an astute eye, keen insight, and understanding of not only the new technology, but also the purpose and design of the regulations. It’s not enough to blindly follow the letter of the regulation. We must ask ourselves: What was the intent of the crafters? Why is this important? Is there a way to make sure the new technology meets the regulation? Can the regulation be reinvented to make sure the new tech does follow the intent of having that regulation in place? Next generation sequencing has been struggling to perform this balancing act since its inception. We do not wish to sacrifice neither our ability to create and innovate, nor our need for safety and “do no harm.” When an innovation enters the laboratory, we need to make sure both it and the regulations which monitor its performance are “ready for prime time.”

 

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-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.

 

All Good Things …

Without going into too much detail, I am no longer working side-by-side with my mentor. I have been under her for 6 out of the 7 years of my career so to say she helped me along the way would be a n understatement of large proportions. I have written on the importance of mentorship before and now in this time of transition for me I would like to reiterate just how much it means to both parties.

When I first starting working with my mentor I was a young buck almost straight out of school and tried to be the most solid technically that I could be. My mentor noticed this right away and said to me, “I’m going to start giving you projects because if I don’t you will get bored rather quickly.” This was the start of a relationship that has brought me all the way to now applying and interviewing for her level of employment. Starting out as a new technologist/technician, it is important to seek out a mentor so you have someone that can lead the way and ensure your success. I was lucky enough to have someone seek me out early because she saw a lot of herself in me. I tell new graduates that when you are applying for your first position to ask during the interview who on the staff is willing to be a mentor. This shows that you are looking to move forward in your career and will grab the attention of the people interviewing you. Make sure you also link up with someone who will be around for a significant period of time, especially in your first position. More than likely with your first position you will be there for a year or longer so don’t seek a mentor who will be leaving or moving into a new role within the next 6 months.

On the other side of things with this change of events I will more than likely be the one mentoring as well as being mentored. I have begun to look for technologists that are willing to learn some of the behind-the-scenes work that I do as a supervisor. Starting off as a mentor brings with itself new challenges one of which is finding enough time to be an effective mentor. If you feel you are too busy to get your own work done then being a mentor may need to wait. Always remember when we work with students or new technologists they are like a sponge and will take in the good and the bad. It is important to be a mentor, and I take the responsibility with a sense of respect for the profession. We play a very important role in the continuum of care and it is up to us to train the next generation.

My first week without my mentor and it has been a challenge. Not having a resource that could answer 99.9% of my questions off the top of her head has been the biggest challenge. I knew this day would come sooner or later but now that it is here I wish I had just a little more time. The amount of knowledge I have gained is immeasurable and I have no way of reciprocating what she has done for me. I can only tell her “thank you” and that every day I will use the knowledge she has given me to ensure the quality of my work and hopefully mentor someone as well as she has mentored me. Sadly, all good things must come to an end.

 

Herasuta

Matthew Herasuta, MBA, MLS(ASCP)CM is a medical laboratory scientist who works as a generalist and serves as the Blood Bank and General Supervisor for the regional Euclid Hospital in Cleveland, OH.

Second Case of MERS-CoV in the United States

A second case of MERS-CoV has been confirmed in the United States. The patient lives and works as a healthcare provider in Saudi Arabia. The patient arrived in the US from Saudi Arabia on May 1st and presented to an Orlando, Florida emergency room with a fever and respiratory symptoms on May 8th. The patient experienced symptoms during his flights from Saudi Arabia to London, England; London to Boston, Massachusetts; Boston to Atlanta, Georgia; and finally, from Atlanta to Orlando, Florida. The CDC and local health officials are contacting travelers who may have come into contact with the infected patient. As with the case in Indiana, the patient’s family is voluntarily quarantining themselves at home. The patient is still hospitalized and in good condition.

MERS does not pose a risk to the general public. Evidence suggests that close contact with infected individuals—such as care givers—is needed for transmission. Because antiviral therapy or vaccines aren’t currently available, infection control procedures and rapid detection are our only weapons against MERS.

For more information about this virus, its appearance in the US, and specimen requirements from suspected cases, visit Lab Medicine’s MERS information page.

Edited to add: two healthcare workers who came in contact with the Florida patient have flu-like symptoms.

 

The End of the Rotation

Since my program is on a monthly rotation schedule, last Thursday was the last day of my 2-month surgpath rotation at our busiest site, which is private practice at a community hospital that serves a more middle class and affluent patient population than our main academic hospital. So, it seems appropriate to finish my “Adventures in Grossing, Part I” post from 2 weeks ago now. As I think I mentioned in that previous post, my first day at this site (right after I just had gotten back from almost 10 hours of traveling due to layovers coming back from USCAP and getting a migraine during my flight to boot), was a disaster to say the very least.

I had made the mistake of jokingly saying to my rotation director that I was the most CP oriented of those in my year (I’m the last 2nd year to rotate at this site this year)…and he had mistakenly heard my statement as “I dislike surgpath and because of that probably wouldn’t work hard at this rotation.” We were reminiscing about it today as we had our face-to-face end of the rotation evaluation about how much has changed since that first day.

Communication is very important and sometimes that also entails knowing what not to say in a situation, especially if it can be misinterpreted. Luckily for me, after I had another talk with my rotation director, he was willing to ‘start fresh’ and see whether his initial impression of me held true. We did not work together again until the end of the month as I was assigned to other attendings during the interim. But by the time, we were assigned together again, he was “happy” with what he had heard about me from the other attendings.

As a first year, I had heard rumors about how hard this site and some of the attendings were…the stuff of legend so to speak. First years do not rotate at this site as we need to build up our grossing and time management skills to be able to adequately manage the higher volume of grossing at this site. We have a three-day schedule that includes two days allotted to finish grossing and a third intra-operative consultation day which includes frozen sections, sentinel node touch preps, and intra-op gross examination of specimens.

I still need to work on my grossing speed and time management skills but after two months of instruction and experience at this site, I do recognize that I have improved. It’s almost the end of my second year and I generally do fine with diagnoses at sign-out because they are either things I’ve seen before or things that I have some time to read about prior to sign-out. But when it comes to unknown conferences or my RISE surgical pathology scores for the past two years, I know that I am horribly deficient and need some work.

In two months, I will be transferring to a much smaller program in my home state for personal family reasons. My medical school friend will be one of the chiefs next year and one of their incoming first years is also from my medical school. Plus, they rotate mainly at one site and do 1-2 rotations/year at another site that is near where my parents live and where I went to medical school. So it will be different than my current program which has 27 residents that rotate at four sites. The culture also seems very different and I worry that I may be behind the curve in terms of my surgical pathology (SP) knowledge. I’m not worried about CP as my strengths and background are in CP.

So, I’ve been wondering…what are some good resources to learn SP and some good approaches to learn while busy on rotations? I still haven’t found a good solution to these questions yet.

 

Chung

Betty Chung, DO, MPH, MA is a second year resident physician at the University of Illinois Hospital and Health Sciences System in Chicago, IL.

Simplify Equipment Validation with a Validation Master Plan

How compliant are you with all your clinical equipment validation (including the point of care equipment)? The equipment validation process is a crucial component in any clinical laboratory practice; any serious deficiency in equipment validation could threaten the business continuance of the institution. Clinical Laboratory Improvement Amendments (CLIA) regulations set standards on test systems, equipment, instruments, reagents, materials, and supplies for clinical laboratories. Laboratories must properly qualify, monitor, and verify or establish performance specifications for any test systems used for patient testing. The federal regulations and explanation for Verification of Performance Specification and Calibration and Calibration Verifications (as well as other CLIA regulations) can be found on the CMS website.

New equipment comes to the laboratory with settings already in place by the manufacturer. For example, urine drug screen analytes may be preset at certain cutoff levels. It is the laboratory’s responsibility to recheck all new equipment validation on all the so called “manufacturer settings.” A detailed guidance document on equipment validation was published by the Clinical and Laboratory Standards Institute (CLSI) in August 2011. QMS13A (formerly GP37A Equipment Validation) outlines the equipment validation process into several crucial validation components: Selection Qualification (SQ), Installation Qualification (IQ), Operational Qualification, and Performance Qualification (PQ).

Laboratories should start a strategic and simple approach to equipment validation with a validation master plan (VMP). This plan provides a structured approach to equipment validation that will allow many problems to be addressed before they become crises. It also assures equipment needs (functional, business and technical) are met. A VMP should:

  • Be approved by the laboratory’s medical director.
  • Appropriately assess and mitigate any potential hazards.
  • Establish policies and procedures.
  • Assign equipment data reviews.
  • Include personnel training for all shifts.
  • Comply with all patient safety requirements.
  • Outline the timeframe from equipment acquisition to “go live” date.
  • Include accuracy and precision studies.
  • Specify the reportable range and normal values for all analytes.

Typically, 20 samples for each level of normal and abnormal results should be tested for accuracy and precision studies. Clinical equipment should never be used for patient testing until all validation processes reviewed, assessed and approved by the appropriate medical lab director. When determining the reportable range, calibrators and samples should reflect the full range. For example, if the manufacturer suggests a reportable range for glucose of 10 mg/dl to 600 mg/dl, having the lowest sample test at 50 mg/dl would be unacceptable.

In summary, creating and designing a good VMP can save all the agonies and time spent in later future in equipment validation in any clinical laboratory or point of care department. Once one successful VMP have been accomplished and produced, future equipment validation would become much easier and manageable. The overall process would ultimately assure accuracy and reliability of the equipment system in the institution, thereby improving patient safety.

 

Information on policies or practices are solely from my personal experience ONLY and have NO relation to my affiliation with any regulatory or government agency.

 satyadi

-Caroline Satyadi, MT(ASCP), SM, DLM, SLS, MBA, MS, CQA (ASQ) has been a laboratory management professional for over 25 years. She has worked with several different medical industries for CLIA/CMS, FDA/ICH/ISO, TJC/CAP/COLA/HFAP accreditation survey readiness.

 

 

Updated Information about Indiana MERS-CoV Patient

The Community Hospital in Munster, Indiana held a press conference today (5/5/2014) regarding the MERS patient. This hospital is in northwest Indiana near Chicago, Illinois. Speakers included Mike Pence, Governor of the State of Indiana; William VanNess II, MD, Indiana State Health Commissioner; Daniel Feikin, MD, Medical Epidemiologist with Centers for Disease Control and Prevention; Don Fesko, CEO of Community Hospital; and Alan Kumar, Chief Medical Information Officer at Community Hospital. During the discussion, several facts about the case emerged:

  • The patient lives and works in Saudia Arabia and is in the United States for a planned family visit.
  • Patient doesn’t remember working directly with a MERS patient but does work at a facility that houses MERS patients.
  • The patient presented to Community Hospital on the evening of 4/28 with flu-like symptoms. He has been in private triage, examination, and patient rooms for the duration of his visit.
  • Infectious Disease doctors consulted on the case; quickly suspected MERS based on travel history and notified the CDC.
  • Healthcare workers that came in contact with the patient are currently on home isolation. They will most likely be kept on isolation for 14 days, which is currently the longest known incubation period for the MERS virus.
  • Currently, all evidence about MERS-CoV suggests that direct, sustained contact and exposure to droplets (from a cough or sneeze, for example) is necessary for transmission. NO evidence currently suggests that MERS can be transmitted through casual community contact.
  • The current mortality rate for MERS is 30%; most patients who succumb to the virus are elderly, have concomitant health conditions, or both.
  • The virus could mutate, and if it does there is a possibility that it could become more transmissible. However, there is NO EVIDENCE that has occurred.
  • The CDC is working to identify people who traveled on the same plane and bus as the patient. So far, three-quarters of travelers have been contacted and identified.
  • The patient is in good condition and is expected to go home soon.
  • Discharge instructions, including how long the patient will be in isolation, are still being determined.

If a suspected case comes to your facility and your laboratory needs to handle specimens, contact your local health department for instructions. Also, bookmark Lab Medicine’s resource page for up-to-date information.