Yvette S. McCarter, PhD, D(ABMM) Director, Clinical Microbiology

Yvette S. McCarter, PhD, D(ABMM)
Director, Clinical Microbiology
UF Health Jacksonville
Professor of Pathology
University of Florida College of Medicine‐Jacksonville
yvette.mccarter@jax.ufl.edu
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The Association of Public Health Laboratories and the American Society for Clinical Laboratory Science adhere to established standards regarding industry support of continuing education for healthcare professionals. The following disclosures of personal financial relationships with commercial interests within the last 12 months as relative to this presentation have been made by the speaker(s):
Nothing to disclose
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Thank you to Dr. Susan Sharp, Regional Director of Microbiology, Kaiser Permanente – NW for providing competency assessment examples
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• Describe the CAP/CLIA requirements for competency assessment for clinical microbiology laboratories • List the components of a successful competency assessment program
• Design a successful competency assessment program for your clinical microbiology laboratory
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• Prior to 1960s – few laboratory regulations
• 1967 – Congress passed Clinical Laboratory Improvement Act (CLIA ‘67)
– Creation of Healthcare Finance Administration (now Centers for Medicare and Medicaid Services)
– Required only hospitals and large clinical laboratories to adhere to QC, PT, test performance and personnel standards
CLIA
• Physician office laboratories and small 1967
healthcare facilities left unregulated
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• 1967‐1988 – Few clinical laboratories required by the government to meet minimum quality standards
– 1987 – Articles in Wall Street Journal reporting on women who died from uterine and ovarian cancer whose Pap smears were misread (“PAP mills”) called into question overall quality of laboratory results
• Congressional hearings revealed serious deficiencies in quality from physician office laboratories and in Pap smear testing results
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CLIA ‘88
• 1988 – Congress passed Clinical Laboratory Improvement Amendments (CLIA ‘88)
– Expanded CLIA ‘67 standards to any facility performing a clinical test
– Unified and replaced past standards with a single set of requirements that applied to all laboratory testing
– Purpose – ensure that all laboratory testing is performed accurately and according to good scientific practice
• Provide assurance to the public of availability of safe, accurate laboratory testing
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Mandated by CLIA ‘88
• 42CFR493.1445 Laboratory Director Responsibilities
– Prior to testing patient specimens, personnel have appropriate education, training and demonstrate ability to perform testing reliably
– Establish policies and procedures to establish and ensure continued competency – Specify in writing the responsibilities/duties of supervisory and testing personnel
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• 42CFR493.1451 Technical Supervisor Responsibilities
– Identify training needs and assuring personnel receive training/education appropriate for type and complexity of testing
– Evaluate competency of testing personnel and assure that staff maintain competency
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• Frequency
– Must be completed for each person performing testing • Semiannually for first year after training
• Annually
• Minimum regulatory requirements – 6 required elements to assess competency for each test
• Competency Assessment ≠ Performance Assessment
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Competency = Ability of personnel to apply their skill, knowledge and experience to perform their duties correctly
1. Direct observation of routine patient test performance
2. Monitoring recording and reporting of test results
3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records
4. Direct observation of performance of instrument maintenance and function checks
5. Assessment of test performance through testing previously analyzed specimens
6. Assessment of problem solving skills
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• Written documented system to establish competency of each employee
• Initial training documentation
GEN.55450 Initial Training Phase I
There is documentation that all staff have satisfactorily completed initial training on all instruments/methods applicable to their designated job.
– New methods and new instruments
– Before patient results are reported
– Competency assessment at 6 months and 1 year
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Technologist will:
Reviewed
Trainee
Observed
Trainee
Performed
Trainee
Acceptable
Trainer
Date/Initials
Date/Initials
Date/Initials
Date/Initials
General Information
Read “Qualitative and Quantitative RPR Card Test”
procedure
Read “Microbiology Infection Control-Significant Organism
Call Values” procedure in the Administrative Procedure
Manual
List which RPR results are called as a significant result
Quality Control
Define acceptable quality control criteria
Discuss use of QC Problem Log and steps taken if quality
control is out of range
Perform and record daily quality control
1.
Temperature
1.
RPR card test control card
1.
Rotator Speed
Perform and record lot specific quality control
1. Needle QC
1. Antigen QC
List sources of technical error associated with performing
qualitative and quantitative RPR testing
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Technologist will:
Reviewed
Trainee
Observed
Trainee
Performed
Trainee
Acceptable
Trainer
Date/Initials
Date/Initials
Date/Initials
Date/Initials
Call positive results to patient care area, as
appropriate
Perform Patient Testing Independently
Test, interpret and report 10 patient specimens (at
least 2 positive) under the supervision of, but without
the assistance of the trainer
List accession numbers tested and results
1.
2.
3.
4.
5.
_________
_________
_________
_________
_________
6.
7.
8.
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10.
__________
__________
__________
__________
__________
Record Keeping
Print out checklist for 6 month Serology-Flocculation
Assay competency and place in notebook
Set up 6 month Serology-Flocculation Assay-RPR
competency assessment reminder in Outlook for
technologist and Dr. McCarter (set reminder for the last
day of the month that competency is due)
Technologist has successfully trained and is competent to perform RPR testing and interpret and report patient results.
Trainee: ________________
Trainer: ________________
Date: ______________
Director: ________________
Date: ______________
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• Annual competency documentation of all testing personnel for each test system
GEN.55500 Competency Assessment Phase II
The competency of each person to perform his/her assigned duties is assessed.
– TEST SYSTEM ‐ process that includes pre‐analytic, analytic, and post‐analytic steps used to produce a test result or set of results
– Manual, automated, multi‐channel or single use and can include reagents, components, equipment or instruments required to produce results
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• Non‐waived test systems
– All six elements must be assessed annually for each person and test system
– Exception – if they are not applicable to the test system
• Waived test systems
– Laboratory can select which elements to assess
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• A plan for corrective action to retrain and reassess competency
GEN.57000 Competency Corrective Action Phase II
If an employee fails to demonstrate satisfactory performance on the competency assessment, the laboratory has a plan of corrective action to retrain and reassess the employee's competency
– If gaps in the individual's knowledge are found – re‐educate employee and allow to retake the portions of the assessment that fell below the laboratory's guidelines
– Action plan if employee is unable to satisfactorily pass the assessment (after re‐education and training)
• Supervisory review of work, reassignment of duties, or other actions deemed appropriate by the laboratory director
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Direct Observation of Routine Patient Test Performance
– Actual observation of work as it is performed
– Not limited to test performance
• Patient identification and preparation
• Specimen collection and handling
• Specimen processing
• Testing
• Reporting critical values
– Can be time consuming – maximize your return
• Choose processes with high degree of decision making
• Utilize specific criteria based on procedures
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Direct Observation Checklist
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Monitoring Recording and Reporting of Test Results
– Proper and correct recording and reporting of patient testing
– Methods
• Observing writing or entry of results in report forms or in computer system
• Review of worksheets with computer entries
– Can be performed with final result verification (before release of results) or after report is finalized
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Record Review
– What’s included
• Intermediate test results or worksheets
• Quality control records
• Proficiency testing results
• Preventive maintenance records
– Methods
• Observing writing or entry of results in report forms or in computer system
• Review of worksheets with computer entries
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Record Review
– Spend your time on what best assesses competency
• Positive cultures
• Results from critical specimens
• Worksheets from culture types with complicated work ups
– Remember that supervisor review of QC records, PT results and PM records is already being performed to meet other accreditation requirements
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Direct Observation of Performance of Instrument Maintenance and Function Checks
– Observation of performance of maintenance procedures and checks of instruments
– Direct observation is required – cannot assess by alternative method
– Assessment required for each piece of equipment person is trained to operate
• Automated ID/AST system
• Molecular diagnostic instrumentation
• Blood culture instrumentation
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Assessment of Test Performance Through Testing Previously Analyzed Specimens
– Blind retesting
• Split sample analysis
• Previously analyzed specimens
• Internal blind testing samples
• External proficiency testing samples
– Useful assessment tool
• Culture set up
• Organism identification
• Appropriate serology results
• Testing and reporting of susceptibility results
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Assessment of Problem Solving Skills
– Examples
• Employee responds orally or in writing to simulated technical/procedural problem
– Case study
– Written test
• Employee documents actual problem solving of issues they have encountered
– Encourage documentation of situations as they occur
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• Define your Test System
– CLIA = instructions and all of the instrumentation, equipment, reagents, and supplies needed to perform and assay/examination and generate test results
– Combine analytes performed on same testing platform
– Determine if there are unique procedures, problems, etc.
• No – separate competency not required
• Yes – separate competency IS required
– Cannot lump together broad categories
• Serology
• Immunology
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• Molecular Microbiology Test Systems
–
–
–
–
–
–
–
–
–
• Mycology Test Systems
–
–
–
–
–
Roche AmpliPrep/TaqMan
GenMark Respiratory
GenMark HCV Genotyping
Verigene
GeneXpert
Panther
BD Max
FOCUS CMV
FOCUS HSV
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C. albicans Screen
Calcofluor Smear
Culture Work up
Lactophenol Cotton Blue
Yeast AST
• Determine who can perform assessment
– Moderate complexity testing
• Technical Consultant* – At least a bachelor’s degree and 2 years of laboratory experience/training with non‐waived testing
– High complexity testing
• Technical Supervisor* – A bachelor’s degree and 4 years of laboratory experience/training in high complexity testing
• May delegate IN WRITING to General Supervisor* –
Associate’s degree and 2 years of laboratory experience/training in high complexity testing
* Required education and experience NOT a title
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• Determine methods and documentation
– Don’t reinvent the wheel – integrate into what you do already
• Reviewing results, QC, PT, etc.
• Performing testing
• Checking maintenance on instruments
• Problem solving – we do it everyday !
– Perform assessment year round
– Involve testing personnel
• Shared responsibility
• Personal accountability
• Utilize schedule and set expectations
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• Documentation
– Components
• Who/What was evaluated
• When/How was it evaluated
• What was done if problems were identified
– Paperwork accessibility (binder)
– Resources
• Online training and competency assessment
www.medtraining.org
• ASM Clinical Microbiology Portal
https://clinmicro.asm.org/index.php/lab‐management/laboratory‐
management/362‐personnel‐competency
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• Remediation
– Address unacceptable performance immediately
– Should be educational in nature improving performance
– Analyze the problem
• System issue?
– Is the procedure inadequate/unclear?
– Is the assessment tool unclear or inconsistently applied?
• Technologist issue?
– Methodology – performing the test correctly? [Following procedure]
– Understand purpose/principle of test? [Problem solving related to test]
– Understand test components/instrumentation/QC?
– Report results correctly?
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• Remediation
– Initiate appropriate remedial action
• Discuss procedure with employee
• Procedure review
• Observe another employee performing procedure
• Practice with known specimens
• Reinstitute formal training
– Reassess competency
– Plan if you cannot establish competency
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Year ____
Annual __ Semi‐Annual__ AREA OF FOCUS: BACTERIOLOGY – Culture Work Up
EMPLOYEE: TITLE: DEPT/LOCATION: HOW COMPETENCY IS MEASURED:
1. Direct Obs/Testing ‐ Direct observation of test performance including specimen processing and testing
2. Test reporting ‐ Monitoring the recording and reporting of test results
3. Records ‐ Review of immediate test results or worksheets, QC records, proficiency testing results and preventive maintenance records
4. Direct Obs/Maintenance ‐ Direct observation of performance of instrument maintenance and function checks
5. Blind sample/PT ‐ Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing
6. Problem Solving ‐ Assessment of problem solving skills
Competent –
Assessment Assessor’s Name Yes (Y)
Element Method of Assessment Date
& Signature
Re‐training needed (R)
E
L
E
M
E
N T
1,2 1
2
2,3
3
4
Direct observation of culture/test work up, according to current scope of practice. Total # of observed events to be at least 15 and will represent a broad cross section of the types of cultures/tests performed. (Attach completed Bacteriology Observation Form)
Duplicate reading of susceptibility testing by assessor.
MIC#___________ KB#___________ E‐test# ________
Supervisor ongoing review of corrected test results.
Random sampling of 5 reported test results. (Attach completed Bacteriology Records Review Form)
Review of completed QC records and proficiency testing results. (Attach completed Bacteriology records review form)
Review the VITEK 2 Maintenance work instruction. Demonstrate daily maintenance functions and where to document. Discuss process for cleaning the optics. Demonstrate knowledge of how to contact Technical Service.
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Assess‐
Element
ment date
Assessor’s Competent –
Name & Yes (Y) Signature Re‐training needed (R)
Method of Assessment 4
Demonstrate how to take the Fyrite reading on the CO2 incubator
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Accurately read 10 Gram stain unknowns (attach results)
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Identification and testing of unknowns (attach results)
Complete all six modules of the Bioterrorism Preparedness Training for LRN Sentinel Laboratories (due by July; http://www.oregon.train.org (attached documentation of completion)
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Complete UW Med Training Microbiology CA twice / year www.medtraining.org; 80% pass rate (attach results)
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Complete UW Med training GS CA twice / year
www.medtraining.org; 80% pass rate (attach results)
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Successful completion of the Bacteriology problem solving assessment (attach documentation of completion)
REVIEWED BY
Employee:
(signature) ________________________________________________________________________
Date:
___
Supervisor or Manager
(signature)
______________________________________________________________________
Date:
___
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Name: __________________ Bacteriology Observation Form
Direct Observation of Testing
Antibiotic Culture Date Assessor Accurately Identification Susceptibilities Type / works up and Accession culture Susceptibility Reviewed and Cascaded Number per SOP testing Correctly
performed (15)
(A/U)
according to (A/U)
SOP
(A/U)
Test Reporting
All culture documentation
entered in LIS accurately (to include prelim/ final reports and
billing codes)
(A/U)
All appropriate reports and any necessary email/phone reporting completed
(A/U)
Notes / details of observed testing
1 Urine
2 CSF
3 Tissue
4 Wound
5 Blood
6 BAL
7 Sputum
8 QBAL
9 Throat
10 Genital
11 CF
12 Sterility
13 Stool
14 MRSA
15 Fluid
A=ACCEPTABLE;
U=UNACCEPTABLE (note the reason; attached paperwork as necessary);
N/A=NOT APPLICABLE
Employee: _______________________
Name: _____________ Bacteriology Records Review
TYPE Date
(KB /Vitek / E‐test / MicroScan)
Set up
(A/U)
Read
(A/U)
A/U
Susceptibility QC Assessor
Notes
A/U
Reagent QC Assessor
Notes
A/U
Proficiency Testing Assessor
Notes
1
2
3
4
TYPE Date
Set up
(A/U)
Read
(A/U)
1
2
3
4
Survey Date
Sample #
Tests done
1
2
3
4
Random Review of Reported Culture Results Type of test Date Accession Documenta‐
A/U
Assessor
tion #
complete?
1
2
Notes
3
4
A=ACCEPTABLE;
U=UNACCEPTABLE (note the reason – attach paperwork as necessary)
N/A=NOT APPLICABLE
SPECIMEN #
1
SOURCE
Blood
2
Peritoneal fluid
3
Bronchial washing
4
Sputum
5
6
Tissue – posterior spine (OR specimen)
Blood
7
CSF
8
Superficial Wound – Right thigh/groin
Deep Wound – exposed bone, right 2nd toe
BAL – right lower lobe
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RESULT
Results Acceptable: YES / NO Supervisor: ____________________ Date: ___________
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Set-up, read and record (below) disk diffusion test results on this E.
coli isolate.
Date/Time Set: _______
Date/Time Read: _______
The CLSI M100-S25 has an interpretive category of SDD for
Cefepime. Briefly, what is the definition of SDD as described in the
CLSI document?
_____________________________________________________
_____________________________________________________
Antibiotic
Amox/Clav (AMC)
Cefazolin (CZ)
Cefepime (FEP)
Ceftriaxone (CRO)
Trimeth/Sulfa (T/S)
Meropenem (MER)
Gentamicin(GM)
Zone (mm)
Interpretation
This unknown organism was recovered from a throat culture.
Sub the isolate to BAP/CHOC and perform manual testing needed to provide identification (Do not set up VITEK)
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This unknown organism was recovered from a throat culture.
Sub the isolate to BAP/CHOC and perform manual testing needed to provide identification (Do not set up VITEK)
Arcanobacterium hemolyticum
Gram stain
Reverse CAMP test
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Year: ______
Annual _____ Semi-Annual_____
AREA OF FOCUS: Parasitology ‐ Cryptosporidium/Giardia DFA
EMPLOYEE: E
L
E
M
E
N T
TITLE: DEPT/LOCATION: HOW COMPETENCY IS MEASURED:
1. Direct Obs/Testing ‐ Direct observation of test performance including specimen processing and testing
2. Test reporting ‐ Monitoring the recording and reporting of test results
3. Records ‐ Review of immediate test results or worksheets, QC records, proficiency testing results and preventive maintenance records
4. Direct Obs/Maintenance ‐ Direct observation of performance of instrument maintenance and function checks
5. Blind sample/PT ‐ Assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing
6. Problem Solving ‐ Assessment of problem solving skills
Date of Assess‐ Element
ment
1
2
3
4
5
5
6
Assessor’s Competent –
Yes (Y) or Re‐training Name &
Signature needed (R)
Method of Assessment Direct observation of specimen processing and smear preparation.
Review of results reported in LIS. Appropriate reports and phone/fax reporting completed. (Review sampling of reported results and attach)
Review of applicable records (QC, PT, test results/worksheets) (Attach Parasitology record review form)
Microscope maintenance performed by contracted vendor.
Identification and testing of O&P unknowns.
(Attach results)
Identification and testing of Insect / Worm unknowns. (Attach results)
Completion of the Parasitology problem solving assessment. (Attach
results)
N/A
REVIEWED BY:
Employee: ____________________________________________________________________________________________
Supervisor:____________________________________________________________________________________________
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N/A
Date:
Date:
Bacteriology Problem Solving Assessment
Name: ______________
Date: ____________
1. A non‐pigmented Enterococcus species is isolated from a sterile knee joint fluid. Vancomycin susceptibility testing results are 2µg/mL and the VITEK identifies the isolate as E. gallinarum. What would you do next and why?
______________________________________________
_____________________________________________
__________________________
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January
February
March
Processing
AST
Serology
April
May
June
Bacteriology
Biochemicals
Bacteriology
Plate Reading
July
August
September
Parasitology
AFB
October
November
December
Mycology
Molecular
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• Know the CLIA regulations – Required elements of assessment and who can perform assessments
• Don’t reinvent the wheel – utilize what you are already doing
• document, Document, DOCUMENT!
• Keep up to date with annual/semi‐annual evaluations
– New employees
– New tests and technologies
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