Open Forum

Subject: Question for Members concerning staff and testing complexities in clinical settings

1.  Question for Members concerning staff and testing complexities in clinical settings

Posted 10 days ago
Edited by Susan Edralin 9 days ago
Dear ASCLS colleague,
I have a few questions concerning personnel testing and complexities and am hoping for feedback from various states.
Thank you in advance for taking the time to respond about your state.
It is my hope that this conversation may define an area of opportunity for further unity within our profession.
Susan E.

1.)  Does your state regulate the who may or may not perform moderate and high complexity testing?
                    example:  The state of California permits MLTs to perform moderate, while CLS may perform high complexity testing.

2.)  Does your state acknowledge administrative directors?  Is there a license or an advanced degree requirement?
                     example:  The state of California acknowledges clinical administrative directors but does not have a requirement for licensing separate from the CLS license.  The decision of any advanced degree requirement is left to the employer.  Most employers do require a masters or high for the office of administrative directorship.

3.)  Does your state require a masters degree of the laboratory manager?  Do you think it should?
                       example:  The state of California offers no requirement regarding manager's education level.  While most employers would at least require a CLS in the managers role, there are a few hospitals that do not even require a CLS as a manager.  Yes, I think a CLS should be required to manage a clinical laboratory.

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Susan Edralin. DBA, MBA, MT(ASCP)

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2.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 10 days ago
​In Minnesota, as with the majority of states in this in this country, there is no licensure (only 12 states plus Puerto Rico require a licensure).  We therefore follow CLIA, but most laboratories operate at a higher level.  In my organization all employees are required to be certified by ASCP )BOR) or AMT.  For an MLT or Histotech they are required to have an associate degree and be certified.  For MLS and cytotech they are required to have a Bachelors degree and be certified.  MLTs are allowed to perform moderately complex testing and a significant amount of high complexity testing.  We utilize them in all of our clinic laboratories and also utilize them heavily in a mix with MLS in our hospital laboratorie

For lab managers and administrative directors we would require a Bachelors degree, with MAsters preferred.  Certification in MLS, HTL or CT required.

There is no MN state requirement for a lab director or manager to be a certified lab profesiona.  I agree that they should be, but am aware of a number who are not.

Rick Panning

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Rick Panning
Senior Administrative Director
HealthPartners
Bloomington MN
6512805909
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3.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 8 days ago
Edited by Susan Edralin 6 days ago
Thank you.  I hope to see more responses.

-SE






4.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 8 days ago
1) Idaho has no regulations about who performs  moderate and high complexity testing.  Facilities may choose to set requirements, but it is not required.

2) There is no acknowledgment of administrative directors. Licensure is not required for administrative directors, and Idaho has no state licensure for any level of personnel, including testing personnel. Again, this is at the facility's discretion. CLIA regulations are the only requirements for all levels of testing and management in Idaho.

3) There is no state requirement for a masters degree for a laboratory manager. Many facilities state that the Masters degree is preferred for this position, but not required. Many small rural labs have relatively new B.S. MLS and even MLT's as Lab Managers.

ASCLS-Idaho has tried for the last few years to get the legislature to pass a licensure bill for clinical laboratories, but without success. What types of opportunities are you hoping to find?

Debbie Shell
ASCLS-Idaho Government Affairs Chair

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Debbie Shell, MLS(ASCP)SM,DLM
Laboratory Instructor
Idaho State University
Pocatello, ID
208-863-6710
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5.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 7 days ago
Edited by Susan Edralin 6 days ago
Thank you Idaho!  I am first highlighting our differences & welcome more input into my table!
I'm not sure yet where I will see opportunity until I get more data but am thinking Federal Regulation 493.1489 is a good place to start.

On first glance I see DCLS programs gearing up for a Clinical Administrator as a director, which is differentiated from the manager.
I'd suspect most MLS/CLS could agree with to help push forward this career advancement opportunity for our managers.

Many MLS/CLS may like to see career ladder differentiation for associate MLTs in the area of complexity testing.  Career ladders a great for the lab as we've heard about stagnation and lack of opportunity for years.  Having hope for next level opportunities is great for our field and I'm thinking of next generations.  With our many online opportunities, employers of rural areas may need to help our MLT and MLS/CLS staff advance to the next level.

Need more Data ;-)





6.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 7 days ago
South Carolina does not have a state license.  Most facilities will employ registry eligible  (MLT or MLS) graduates, but certification is preferred and usually required by end of probationary periods.  The trend is becoming certification required and progression to higher level of education after initial entry employment (MLT to MLS).

We do not have a state MLS college  program, but we do have several neighboring states and 2 hospital schools to educate selected candidates with BS in Biology, Chemistry, or MIcrobiology to achieve MLS.

MLTs are allowed to do both moderate complexity and in some instances high complexity.  We do have a mix of  MLS employees and MLT employees sharing same types of workload.  Some facilities with the MLS schools will train MLT students but not employee them.  Some will allow them to only work in the Hematology, Chemistry, Coagulation, Urinalysis, and Point of Care.

The facilities that allow them to work in all areas, usually require an MLS with a degree as the department supervisor except in small rural facilities. Most of our facilities statewide require a Masters level or Bachelors with lengthy  supervisory experience and managerial training   to become the lab director.

We have tried   several major attempts to tackle licensure, but have not been successful with  the legislature.


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[Janis] [Livingston] [MT (ASCP)]
MLT Clinical Ed Coordinator]
[Midlands Technical College]
[Columbia] [SC]
[803-822-3556]
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7.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 6 days ago
Thank you South Carolina!

I'd like to ask for clarification.  Do MLT's in South Carolina enter the MLT program with a bachelors degree?

I've seen this before.  California has only had MLT's for about 5 years now, there were some bachelor degree students accepted into the early MLT student spots, who would then have to reapply for a CLS/MT/MLS training spots.  The externship was 6 months vs. 1 year.  The MLT programs assured us that this was a temporary transitional issue since the state did not have MLTs prior.
-se


8.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 5 days ago
Yes, we have students with and without Bachelor's degrees.  Many times they have a BS in Biology or Chemistry with no distinctive specialty or experience and have difficulty finding jobs.  In some instances their GPA while average or above is not sufficient to qualify them for interview in the few Medical Laboratory Science Hospital programs.  Both programs only take 4 students a year with stringent qualifying requirements.

According to ASCP-BOR qualifications, they have to work 2 years and sit for the MLS exam then.  We do not have state licensure.

In my opinion, the ASCP- BOR 2 year work requirement should be lowered to possibly 6 months of experience for the MLT students completing with a BS and an AS, as they have met  MLS requirements by education and clinical training experience.


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[Janis] [Livingston] [MT (ASCP)]
MLT Clinical Ed Coordinator]
[Midlands Technical College]
[Columbia] [SC]
[803-822-3556]
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9.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 5 days ago
Wow, very insightful for South Carolina!  Opportunity exists for USC and MUSC to have an MLS program!!

NAACLS lists three programs for S.C. - Lexington MC, McLeod Regional, and Palmetto Health.   Are all of these programs doing didactic lectures in addition to lab externships at the bench?

The 2 year work rule before ASCP testing...is that an ASCP requirement or a state/hospital requirement?


10.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 6 days ago
#1 Does your state regulate who may or may not perform moderate and high complexity testing?  Kansas does not license laboratory personnel, nor have any regulations pertaining to the clinical laboratory or the personnel.  The federal CLIA regulations are the only requirements.

#2 
Does your state acknowledge administrative directors?  Is there a license or an advanced degree requirement?  Kansas does not license  laboratory personnel, nor have any regulations pertaining to the clinical laboratory.  The federal CLIA regulations are the only requirements. The CLIA regulations do not mention administrative directors.

#3  Does your state require a master's degree of the laboratory manager?  Do you think it should? Kansas does not license laboratory personnel, nor have any regulations pertaining to the clinical laboratory or the personnel.  Laboratories with a Certificate of  Accreditation may have additional requirements, but the majority of laboratory managers do not have a master's degree.  In fact, due to a shortage of BS degreed MT/MLS, a number of rural hospital laboratories are managed by medical laboratory technicians with an associate degree. 

​​

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Ruby K Brower
--
Manhattan KS
(785) 539-6867
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11.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 6 days ago
Thank you Kansas!

Based on your information, it would seem that Kansas employers have an obligation to help MLT students advance their education.  This is another opportunity that I think my study will highlight.  There are many online programs and where there is a dire need (as you have mentioned in rural areas) employers have an obligation to step up and help their employees.  I will add this opportunity to my discovery list. Thank you for sharing.
-SE


12.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 5 days ago
​In the absence of state requirements, if you are a CLIA laboratory, you must comply with the personnel requirements for waived and non-waived testing, they are specified in the Interpretive Guidelines, Appendix C subpart 493.1351.  It spells out the Personnel Qualifications and Responsibilities of all Laboratory Personnel.  Certification i.e. ASCP is a facility requirement, not CLIA.

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Owen Bain, MT(ASCP)
Huron Regional Medical Center
Huron SD
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13.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 5 days ago
Hi Owen,
The idea in this thread is for me to gather knowledge about your personal experience in your state (regulated, or the typically accepted practice).  We know that CLIA is broad.  We also know that CLIA doesn't typically inspect CAP or JCO inspected facilities because those sites are inspected at a higher standard even than CLIA.  So in South Dakota which does not have state licensing for personnel, what's the standard being followed that you see?
-SE


14.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 6 days ago
Edited by Susan Edralin 4 days ago
Need data from our 12 states that license.  I'm also keeping an opportunities list based on your comments.
Thank you again Team!

Here is what we have so far:

STATE State License requirement Do facilities allow MLTs may perform High complex testing Do Employers require ASCP or AMT certification Staffing Ratio requirements (#MT to #MLTs) Does Employer preferred Masters for lab manager Administrative Directors acknowledged separately from manager
California Yes No No - but state does Yes Mostly yes Yes
Minnesota No Yes some No Yes No
Idaho No Yes   No Yes No
South Carolina No Mostly No Yes No Yes No
Kansas No Yes No No No No
South Dakota            
New York Yes No   Yes Yes  







15.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 5 days ago
Here's what I have from New York.  I'm a little unsure of answer 1, but answers 2 and 3 I just looked up to confirm on our DOH website and in our legal codes.

1 - It's complicated.  I believe an MLT can run any test of medium or high complexity that an MLS can in NYS.  However, they can not independently release results - they must be supervised in the release of results.  So, I'd call that a no in so far as the MLT can't independently get all the way to the released result, but there's obviously room for argument.  My best source is our Title X code ("Clinical laboratory technologists shall be sufficient in number to adequately supervise the work of technicians and trainees.")

2 - Lab Directors must have an M.D., Ph.D., D.O., D.D.S., etc. and post-doctoral work/experience/education must be spoken to or evaluated.  In particular they want to see 2 years of experience with methods/skills and 2 years of experience with management.  My source here is NYS Wadsworth's Clinical Laboratory Evaluation Program site and application for being a Lab Director

3 - The answer is yes and no.  Three options for being a lab supervisor exist in NYS: 1) Have a M.D./Ph.D. or other related terminal grad degree, 2) Have a masters with four years of lab experience, at least two of which are clinical, 3) Be a CLS with at least 6 years of experience.  Source here is again the Title X Code.

Hope that helps.  It's not as simple as yes/no but at least its (hopefully) thorough.

Matt

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Matthew Schoell
--
Rochester NY
(585) 389-2587
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16.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 4 days ago
Thank you New York!
One clarification point - Do employers require certification?  or does the state require certification to issue state license?

Your response lists the Supervisor and the Medical Director.  What about the Manager and/or Administrative Director?  Are these positions you see in New York?


17.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted 4 days ago
I've never seen an employer *not* require certification.  I believe they expect you to have both credentials.  That's simplified by the fact that NYS uses the ASCP BOC exam to grant licensure as well, so if you're a new grad, you can get them both in one exam.

The manager = supervisor, I believe, so that's the same position.  Supervisor is the language the code uses.

I think there are no requirements on administrative directors.  I couldn't find anything in the codes, and in the hospital I worked at previously (I'm at a college now) there is a medical director with an MD and a senior admin director who I think does not have an M.D. or Ph.D.



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Matthew Schoell
--
Rochester NY
(585) 389-2587
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18.  RE: Question for Members concerning staff and testing complexities in clinical settings

Posted yesterday
Greetings,

Just a small addition to NYS MLT's and releasing results. They can run high complex testing according to their license however, in regards to the supervision part, as long as a lab supervisor or technologist is on staff at the time, a technician can release results. Matt is correct, they can't work independently in the lab let alone release results (unless waived testing) however, according to NYS regulation, a supervisor has to be available for all shifts. So technically, MLT's could release results as there should be at minimum a technologist or supervisor on duty for every shift.

Also, NYS regulation states that all labs must have 2 reviewers for releasing results, regardless to MLT or CLS status. In many NYS labs, this is done by having the initial person (MLT/CLS) enter or verify their results. Then, either a supervisor or lead CLS reviews all released results, verifies them, then finalizes their release in the system. Not sure if other states follow this protocol. But this is how MLT's in NYS can release results.

Sincerely,

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Diane Price Banks
Program director
Bronx Community College
Bronx NY
(718) 289-5536
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