Who can do the work?

A review of professional guidelines and legal requirements

Vickie Baselski, PhD, DABMM, FAAMProfessor, Department of Pathology, University of Tennessee Center for Health Sciences

Influences on microbiology employee job functions

Licensure: A designation of legal status which permits licensees to practice their profession in a given state (also given to healthcare facilities)Certification: A designation of professional status used in many healthcare professions based primarily on education, experience, and examinationAccreditation: The act of certifying that an educational institution maintains suitable standards Job description: States the minimum required education, certification, licensure, and experience for a given positionNLRB: 29 CFR 103, Collective-Bargaining Units in the Health Care Industry (Final Rule), April 21, 1989 designates laboratory workers as CBU eligible

Accreditation and CertificationAgencies for CLS

Programs (accredited to train individuals)NAACLS National Accrediting Agency for Clinical Laboratory SciencesCAAHEP Committee on Accreditation of Allied Health

Education ProgramsABHES Accrediting Bureau of Health Education Schools

Individuals (take examinations for certification)ASCP American Society for Clinical PathologyNCA National Credentialing Agency for Laboratory PersonnelAMT American Medical TechnologistsAAB American Association of BioanalystsSpecialty societies

Specialty Society Certification

ASCP American Society for Clinical PathologyMT/MLT Categorical Technologist, minimal experienceSpecialists Technologist, greater experienceAABB American Association of Blood BanksSBB Specialist in Blood Bank TechnologyAACC American AssociationABT American Board of ToxicologyNRCC National Registry of Clinical ChemistsASM American Society for MicrobiologyNRM National Registry of Microbiologists (RM, SM)

Categories of US laboratory employees

Non-certified “laboratory assistants”Medical laboratory techniciansMedical laboratory technologists

(clinical laboratory scientists)GeneralistSpecialist (categorical)

What is the difference in education?

“Non-certified” or MLA: Usually high school graduate with “on-the-job-training”MLT: 2 year Associate’s degree +/including 1 year clinical trainingMT: 4 year Bachelor’s degree +/including 1-2 years clinical trainingSpecialist: 4 year Bachelor’s degree in related science + 1 year clinical training

What’s the difference in responsibilities?Certification distinctions

Medical technologist (clinical laboratory scientist):Performs hands-on testingSpecimen quality and test validity assessmentPerformance and evaluation of QCOperation, maintenance, calibration, troubleshooting of instrumentsCommunication of abnormal resultsReview of quality assuranceEvaluation of new testing methodsClinical education

“Medical technologists are responsible for the interpretation and reporting of tests”

What’s the difference in responsibilities?Certification distinctions

Medical laboratory technicianPerforms many automated and manual testsAssesses specimens for correct handling and qualityPerform and evaluate quality controlPerform periodic maintenance and assist in calibration of instrumentsCommunicate information to healthcare providers

“MLT’s work with MT’s under the direction of the department manager to perform and report many types of testing”

What’s the difference in responsibilities?Certification distinctions

Medical laboratory assistantProcesses specimensCollects specimensPerforms tests in accordance with state and federal law (including microscopic)“Assists with processing, reading and reporting of specimens to determine the presence of bacteria, fungi, parasites, or other micro-organisms”

NOTE: Represented by non-degree AMT and AAB POL certification programs

ASCLS Complexity Model (1995)

Level I: Clinical Laboratory Assistant performing simple tests requiring little to no independent judgment and interpretationLevel II: Clinical laboratory Technician performing more technically demanding tests with some degree of independent judgment and interpretationLevel III: Clinical Laboratory Scientist performing technically complex tests requiring a considerable amount of independent judgment and interpretation

Federal licensure requirements

Defined in CLIA ’88, updated ‘03Personnel based on complexityComplexity categories:Waived (COW)Provider performed microscopyModerate complexityHigh complexity

CLIA Complexity

Waived tests:Simple laboratory examinations Likelihood of erroneous results negligiblePose no risk of harm if incorrectCleared by the FDA for home use

Provider performed microscopy:Only physicians and other primary care providersSimple microscopy Dipstick urinalysis with microscopy

Moderate and High Categorization Criteria

Knowledge: Minimal vs. specializedTraining and experience: Minimal vs. specializedReagents and materials preparation: Stable vs. labileCharacteristics of operational steps:Automatic vs. monitoredCalibration, quality control, and proficiency testing: Stable vs. labileTroubleshooting: Self correcting vs. decision-makingInterpretation and judgment: Limited vs. extensive

What’s in these categories? Examples

COWMembrane EIA’s AbH. pylori ureaseFem Card

Moderate complexityThroat culturesGC culturesUrine colony countsOther sites reported asNG/G/G referred for ID

PPMWet prepsWBC nasal/fecalFern tests

Highly complexBroth culturesAny identificationAny susceptibility

Kits now categorized by the FDA

CLIA requirements for testing personnelare based on test categorization

Provider performed microscopy (PPM):Physicians and other primary care practitionersWaived (COW): No personnel requirementsModerate complexity: High school diploma and documentation appropriate for all aspects of the testing performedHigh complexity: MLT (Associate degree level or higher)

Comparison of CLIA to professional descriptions

Some infectious disease testing is waived with no requirementsSome infectious disease testing is moderate complexity with HS degree plus OJTMost infectious disease testing is high complexity with MLT or MT (no distinction at testing level)

Regulatory requirements for microbiology appear to be less stringent than professional certification descriptions

State licensure requirements

24 states and 1 territory with facility licensure

12 with personnel licensure:California NevadaFlorida North Dakota Georgia Rhode IslandHawaii TennesseeLouisiana West VirginiaMontana Puerto Rico

Categories:MT, BS Specialist, MLT, (MLA), (Phlebotomy)

Components of state personnel licensure

Annual feeMinimal education and professional competencyRecognition of national certification (11)Description of responsibilities (9)CE requirement (8)Fingerprinting (LA)

State distinctions in education:Tennessee

Medical laboratory technologistBaccalaureate degree and approved trainingNational certification

Medical laboratory technicianAssociate degree and approved trainingNational certification

Special analyst technologistBaccalaureate degree and approved trainingNational certification

State distinctions in functions:Tennessee

Technologist: A person who performs tests which require the exercise of independent judgment and responsibility with minimal supervision by the director or supervisor in only those specialties in which they are qualifiedTechnician: Any person who functions under the supervision of a director, supervisor, or technologist and performs only those procedures which require limited skill, responsibility, and minimal exercise of judgment

What can unlicensed personnel do?CLIA clarification (April 24, 1994)Office of Survey and Certification, HSQB“For all microbiology subspecialties, the total

process of isolation and identification is considered a complete system that is categorized as high complexity. In (microbiology), specimen processing, primary inoculation of culture media, and staining are portions of testing and are not categorized separately for complexity”

This led to a strict state interpretation thatspecimen processing in microbiology requiredCLIA high complexity personnel

Tennessee Preparatory Portions of Laboratory Tests (effective 6/24/03)

Unlicensed personnel may perform:Centrifuging, pouring off, and preparing specimens for testingPreparing peripheral smears at bedside or in the laboratoryStaining peripheral smear by automated methodsLoading primary bar-coded specimens onto analyzersAutomated process of sorting, decapping, aliquoting, and archiving of specimensPrimary inoculation of microbiology specimens

California personnel licensure

Licensure of medical technologists by state exam (national certification not recognized)Educational requirements comparable to national certification2002 recognized MLT for moderate testing or testing under supervision in 2002 (currently on hold)

State distinctions in functions:California

Unlicensed personnel may:Collect specimensAssist in PMPrepare reagents and culture mediaAssist in QCPerform phlebotomy if trainedPerform specimen handling/preparation if trainedAdd reagent to “spot, tablet, or stick tests”

Unlicensed personnel may NOT:Record results but may transcribePerform any quantitative measurement or calculation

calculationPerform any testingCalibrate instruments

California:

In microbiology, unlicensed personnel may:Make primary inoculations onto

appropriate test mediaStain slide preparationsSubculture from liquid media

LA Administrative Code Chapter 35Clinical Laboratory Personnel

“Independent judgment” : MT vs. MLTThe performance or conduct of clinical

laboratory tests and assumption of responsibility for determination of the validity and interpretation of clinical laboratory test results without intervention by or the supervision of another health care provider.

Nevada Administrative Code, Chapter 652: Medical Laboratories

A medical technologist may:(a) Perform tests which require the exercise

of independent judgment, under minimum supervision, and

(b) Supervise the work of medical laboratory technicians

Nevada Administrative Code, Chapter 652: Medical Laboratories

A medical technician may perform a testclassified pursuant to 42 CFR Part 493,Subpart A as:(a) A waived test(b) A moderate complexity test(c) A high complexity test and :

(1) The results are read directly from an instrument; and

(2) The test requires no interpretation and no intervention by the operator of the test during its analytic phase

GA Rules: Chapter 290-9-8 Licensure of Clinical Laboratories

“Call –back technician” may call back results when no technologist is available if:

(a) Have two years experience(b) Training certified in writing(c) Documentation that an on-call technologist

or supervisor is available to come to the lab within 30 minutes of call

(d) If results are outside normal limits, a supervisor must be consulted before resulting

(e) All results must be verified by a technologist no later than the following day

Comparison to the Canadian System

Canadian Society for Medical LaboratoryScience (CSMLS):

MLT’s or RT’s (technologists): 2-4 year degree considered equivalent to MT (ASCP)LT or LTA (technicians): High school or community college in non-approved program considered roughly equivalent to MLT (ASCP)DO NOT do “interpretive” work

NLRB Rulings

In most rulings, medical technologists have been designated as “professional employees”

In some rulings, MT’s have been ruled as professional while MLT’s have ruled as “technical”

NLRB distinctions in functions:NLRB 238 (1995), Section 2(12)(a)

The work of a professional:Predominantly intellectual and varied in character as opposed to routine mental, manual, mechanical, or physicalInvolving the consistent exercise of or discretion in judgment in its performanceOf such a character that the output produced or the result accomplished cannot be standardized in relation to a given period of timeRequiring knowledge of an advanced type in a field of science or learning customarily acquired by a prolonged course of specialized intellectual instruction and study in an institution of higher learning or a hospital, as distinguished from a general academic education or from an apprenticeship or from training in the performance of routine mental, manual, or physical processes

Job descriptionsMust be specific to and unique for each job categoryMust establish the minimum education and experience requirementsMust be compatible with all applicable state and federal statutes and regulationsMay require specific professional certificationMust consider NLRB implications (i.e. equal pay for equal jobs?)

Summary:Who can do the work in microbiology?

There are differences between professional certification organizations, CLIA, and state licensureMinimum for some microbiology testing is high school degree plus trainingProfessional society guidelines are vague and do not make specific recommendationsWhat should each level do? (e.g. MLA, MLT, MT/Specialty MT)

Professional Society Guidelines:Recommendations

There are significant financial benefits to using a skill set mix that accomplishes laboratory goals in a cost-effective mannerWorkforce shortages may be alleviated by using a mixed skill set mixThere are some data that higher skill sets perform better at certain tasks (e.g. in POL’s)Professional societies should establish minimum personnel criteria for all aspects of testing (preanalytical, analytical, postanalytical)

Future opportunities and obstaclesObstacles:

Workforce shortagesFinancial pressures“Dumbing down” of laboratory scienceExcessive productivity expectations

Opportunities:Use an evidence-based approach to determine who can do what and how muchDevelop realistic collaborative professional guidelines for personnel expectations

Outlook: http://jobprofiles.monster.com

Advents in technology are eliminating need for some laboratory workers

BUTAn aging population is creating more work

THEREFOREJob growth will be stable

ANDWe will need qualified laboratory workers!

Microbiologists are not insignificant little people in healthcare!