CLIA Flashcards
What are lab/facility exceptions to CLIA standards?
Forensic testing
research labs that don’t report patient results
NIDA certified labs which perform drug testing
*other testing at NIDA lab is subject to CLIA
What are the 7 criteria used by FDA to determine test complexity and categorize tests?
1) scientific/technical knowledge
2) training and experience required
3) reagents/materials preparation, stability, reliability
4) operational steps
5) calibration, QC, proficiency testing materials availability
6) test system troubleshooting and equipment maintenance
7) interpretation and judgment required to perform all 3 phases of testing
How is testing categorized between moderate and high complexity with the scorecard?
7 criteria scored from 1-3 with 1 being lowest
7 scores added together
12 OR LESS = moderate complexity
ABOVE 12 = high complexity
List the 5 CLIA certificates
1) Registration
2) Waiver
3) PPM procedures
4) Compliance
5) Accreditation
For how long are CLIA certificates valid?
2 years
Which level of complexity in labs requires registration certificate?
all labs performing moderate or high complexity or both
labs performing only WAIVED, PPM, or combination are NOT required to obtain registration certificate
only labs applying for compliance or accreditation cert will receive registration cert.
issued to labs performing non-waived testing until CLIA inspection occurs
Initially for all laboratories performing test procedures of moderate complexity (other than the subcategory of PPM procedures) or high complexity, or both; and
(2) For all laboratories that have been issued a certificate of waiver or certificate for PPM procedures that intend to perform tests of moderate or high complexity, or both, in addition to those tests listed in § 493.15(c) or specified as PPM procedures.
How complex are PPM procedures considered?
Moderate complexity
List examples of accreditation programs approved by HHS
CAP, COLA, JCAHO
Do labs with several locations require separate applications for CLIA certificates? What are the exceptions?
YES
exceptions: mobile units, health screening fairs, temporary testing locations can be covered under cert of primary site
not for profit fedreral, state or local government labs that perform limited public health testing (no more than combination of 15 moderately complex or waived tests per certificate
labs within a hospital with contiguous buildings on same campus and under common direction
What are the time limits for reporting changes to CMS?
30 days: ownership, name, location or director or technical supervisor
6 months: tests within specialty or subspecialty not included on compliance certificate
6 months: deletions or changes in test methodologies for tests included in specialty or subspecialty or both contained in compliance Cert
What are characteristics of waived tests?
1) fully automated or self-contained
2) use only unprocessed specimens
3) require no specimen manipulation before analytic phase
4) no operator intervention during analytic phase
5) direct readout of results - no calculations or conversions
6) contain fail-safe mechanisms that render no result when system malfunctions or initiates fail-safe mechanisms rendering no result when result is outside of reportable range
7) no invasive test system troubleshooting, electronic, or mechanical maintenance
8) instructions are written at 7th grade comprehension level
Who can perform PPM procedures?
physician,
midlevel practitioner under physician supervision or independent practice if state authorizes it
dentist
only during patient’s visit on specimen obtained from his patient or patient in group practice
What are main specifications of PPM procedures?
Moderate complexity
Instrument is bright-field/phase-contrast microscopy
specimen is labile
CONTROLS NOT AVAILABLE to monitor entire testing process
LIMITED specimen handling or processing required
what are examples of PPM procedures?
wet mount preparations for presence or absence of bacteria, fungi, parasites, human cellular elements
KOH preparations
pinworm examinations
fern tests
post coital, direct exams of vaignal or cervical mucous
urine sediment exams
nasal smears for granulocyts
fecal leukocyte
qualitative semen analysis
What are the requirements of PPM labs?
PT, patient test management, quality control, personnel and quality assurance
subject to inspection
What is considered satisfactory performance on PT testing?
80% correct for each analyze in most specialities
some immunohematology procedures and compatibility testing require 100% accuracy
What is considered Unsatisfactory PT performance?
failure to attain minimum satisfactory score for an analyte, test or subspecialty for testing event and requires remedial actions
What is considered unsuccessful PT?
unsatisfactory performance for SAME ANALYTE in 2 consecutive or 2/3 testing events
repeated unsatisfactory OVERALL testing event scores for 2 consecutive or 2/3 testing events for same specialty or subspecialty
unsatisfactory testing event score for those subspecialties not graded by analyte (Bacteriology, mycobacteriology, virology, parasitology, mycology, compatibility testing, unexpected antibody detection, antibody identification) for SAME subspecialty for 2 consecutive or 2/3 testing events
How long must documentation of PT records be maintained
minimum of 2 years from proficiency testing event
Is PT required for all test methods, systems or examinations during PT event?
NO only required for primary method used in patient testing
How should PT samples be tested?
With regular workload by personnel who routinely perform testing and with routine methods
For which specialities and subspecialties is satisfactory performance on PT considered 80% correct for each analyte you are being tested on?
microbiology (bacteriology, mycobacteriology, mycology, parasitology, virology)
diagnostic immunology (syphilis serology, general immunology)
chemistry (routine chemistry, endocrinology, toxicology)
hematology (no subspecialties defined here)
What is considered satisfactory PT performance in immunohematology subspecialties?
ABO/RHO 100%
Unexpected Antibody 80%
Compatibility testing 100%
Antibody identification 80%
What is considered satisfactory performance for most PT testing?
80% correct for each analyze you are being tested on ( 4/5 right per testing event)
Testing involves multiple samples of the same analyte
What is the number of samples and frequency of challenge for the subspecialties?
MYCOBACTERIOLOGY: 5 samples per testing event and 2 events per year
Immunohematology, microbiology, diagnostic immunology, chemistry and hematology = 3 times per year with 5 samples per testing event
What does failure to return PT results to PT program before deadline result in?
UNSATISFACTORY performance
score of 0 for testing event
How should the lab respond to PT failure?
Appropriate training and employ technical assistance necessary to correct problems associated with failure
remedial action must be taken and documented and maintained for 2 years
What is unsuccessful PT performance?
failure to achieve an overall testing event score of satisfactory performance for 2 consecutive events or 2/3 consecutive events
How are the pathology PT program requiremnts different?
More strict
to Participate successfully in cytology PT program for gynecological examinations
each indidivudal tested at least once per year and obtain a passing score
announced and unannounced testing will be done on site in each lab at least once a year
examination of 10 side test set
10 > 10 > 20
no more than 45 minutes to complete 10 slide test and not more than 90 for 20 slides
failure if scores less than 90% on 10 slide test set
if individual fails, lab must schedule retesting event to take place not more than 45 days after receipt of failure notification
What are the facility administration requirements for non waived testing from CLIA?
Facility: construction/arrangement/maintenance must ensure space, ventilation, utilities, minimizes contamination, unidirectional workflow
appropriate and sufficient equipment, instruments reagents, materials and supplies for volume of testing
comply with applicable federal, state and local requirements
safety precautions must be established, posted and observed
How long must records of QC, patient tests, quality assessment and PT be retained?
2 years
How long must records of test system performance specifications be retained?
for the period of time lab uses the test system but NOT LESS THAN 2 YEARS
How long must cytology slide preparations be retained
5 years
How long must original reports be retained?
2 years after date of reporting
What should the lab do with records if it ceases operation?
must take provisions to ensure all records and applicable slides, blocks and tissues are maintained and available for time frames specified
List major components of the quality systems required for non-waived testing
Confidentiality of patient information and specimen identification and integrity
complaint investigations
communications
personnel competency
Proficiency testing
General Lab systems assessment - monitor and correct problems and effectiveness
test requisition
specimen submission / handling
procedure manual
test systems, equipment, instrumentation, reagents, materials and supplies
Method performance specifications
Equipment maintenance and function checks
calibration and calibration verifications
Control procedures
Comparison of test reults
corrective actions
test records
test results
systems assessment
how often must analyte not offered by CMS-approved PT program be assessed?
at least twice annually
Are oral requests permitted for laboratory tests?
Only if lab requests written authorization for testing within 30 DAYS. Lab must maintain written authorization or attempts to obtain
How long must records of test requisitions or authorizations be retained?
minimum of 2 years
can the patient’s chart or medial record be used as test requisition?
Yes but must be available to lab at time of testing and to HHS upon request
What are the required elements of the test requisition or authorization?
Patient name OR other unique identifier
Sex AND Age/DOB
Name and Address of authorized person ordering test and if appropriate individual responsible for utilizing the test results OR name and address of lab submitting the specimen including contact for reporting panic values
Tests to be performed
Date and time of specimen collection
specimen source, if appropriate
For Pap smears Last menstrual period, age/DOB and indication whether previously had abnormal report/treatment/biopsy
any additional information relevant and necessary to a specific test to assure accurate and timely testing and reporting of results
What are the required components of policies and procedures for specimen submission and handling?
PREPARATION of patients
Specimen collection
Labelling
Preservation
Transportation
Processing
Acceptability and rejection
Referral
must assure positive ID and optimum integrity of patient specimens from time of collection until testing has been completed and results reported
Are oral explanations of instructions to patients allowed?
Oral explanation for specimen collection including patient preparation may be used as a supplement to written instructions where applicable
Can textbooks be used in lieu of laboratory written procedures for testing or examining specimens?
No, can be used as supplement only
List components that must be included in the procedure manual
Specimen collection, processing, rejection criteria
microscopic examinations, detection of inadequately prepared slides
steps to procedure including calculations and interpretation
preparation of slides, solutions, calibrators, controls reagents stains or other mateirals
calibration/calibration verification
reportable range as established or verified
control procedures
remedial action when calibration or control results unacceptable
limitations in methodologies (interfering substances included)
reference range (normal values)
imminent life threatening results /panic values
literature references
criteria for specimen storage and preservation to ensure specimen integrity until testing is completed
systems for reporting patient results including reporting of panic values
course of action if test system inoperable
criteria for referral of specimens including submission and handling
Can manufacturer package inserts or operator manuals be used?
Can be used to meet requirements and any items not provided by manufacturers must be provided by lab
How should discontinued procedures be handled?
Filed separately from active
retained for 2 years after discontinuance
List the conditions that the lab must define that ensure proper storage of reagents and accurate/relaibel test system operation and result reporting
Water quality
humidity
temperature
protection of equipment and instrumentation from fluctuations and interruptions in electrical current
What are the required elements on reagent, materials, supplies, solutions labels?
1) Identity and titer/strength/concentration when significant
2) Recommended storage requirements
3) Preparation and expiration date
4) Other pertinent information for proper use
Prior to reporting patient test results lab must verify or establish for each method performance specifications. What are these characteristics?
1) accuracy and precision
2) Sensitivity and specificity if applicable
3) reportable range
4) reference range
5) any other applicable performance characteristic
What is different about moderate or high complexity test methods in use prior to April 24 2003?
for tests in use prior to this date :
Labs NOT required to verify or establish performance specifications for moderate/high complexity
What is the purpose of calibration and verification?
Substantiate continued accuracy of test method throughout lab’s reportable range for patient test results
What is calibration?
testing and adjusting an instrument, kit or test system to provide a known relationship between the measurement response and value of the substance that is being measured by the test procedure
what is calibration verification?
assaying calibration materials in same manner as patient samples to confirm that calibration of instrument, kit or test system has remained stable through lab’s reportable range of patient test results
What is the reportable range of patient test results?
Range of known test values over which the laboratory can establish or verify the accuracy of the instrument, kit or test system measurement response
What values must be included in the labs established reportable range?
Must include at least a minimal (zero) value, midpoint value and maximum value at the upper limit of that range
How often must calibration verification procedures be performed?
at least once every 6 months
AND if the following occur:
complete change in reagents UNLESS changing reagent lot numbers does not affect range or controls
major preventative maintenance or replacement of critical parts that may influence test performance
controls reflect an unusual trend or shift or outside acceptable limits and other means of correcting the control values have failed
Labs established schedule for verifying reportable range requires more frequent verification
Is calibration verification always required when changing reagent lots?
If lab can demonstrate that changing reagent lot numbers does not affect reportable range and that control values are not affected
*if reagents are obtained from manufacturer and all reagents for a test are packaged together, lab is NOT required to perform calibration verification for each package of reagents if they are received in same shipment and contain same lot number
How often must control procedures be performed?
During a run of patients = interval within which accuracy and precision of testing system is expected to be stable but cannot be greater than 24 hours
OR less than frequency recommended by manufacturer
What controls are needed for qualitiative tests?
Positive and negative control with each run of patient specimens
What controls are needed for quantitative tests?
at least 2 samples of different concentrations of either calibration materials or control materials or both
with frequency of not less than once each run of patient specimens
What controls are required for electrophetic determinations?
at least one control sample must be used in each cell
control sample must contain fractions representative of those routinely reported in patient specimens
What controls are required for direct antigen systems?
each day of use lab must evaluate detection phase of direct antigen system using an appropriate positive and negative control material (organism or antigen extract)
When direct antigen systems include extraction phase, system must be checked each day of use using a positive organism
When must control material be tested before resuming patient testing?
complete change of reagents
preventative maintenance
any critical component replaced
Can calibration material be used as control? are any additional steps required?
Use calibration material from DIFFERENT LOT than what’s used to establish cut off values or calibration
What guidelines must be met by media in order to be acceptable for media quality control?
National Committee for Clinical Laboratory Standards ( NCCLS)
What information must be included in the test report?
1) EITHER patients name + identification number OR unique patient identifier + identificaition number (2 identifiers)
2) Name and address of laboratory where test was performed
3) Test report date
4) Test performed
5) specimen source, when appropriate
6) Test result and units of measurement if applicable OR interpretation
7) Any information regarding condition and disposition of specimens that do not meet labs criteria for acceptability
originally to whom could test results be released according to CLIA?
Authorized individuals/ individuals using test results and lab that initially requested the test
According to HIPAA 1996, who is allowed to receive test results according to CLIA regulations?
CLIA-certified labs that are also HIPAA covered entities must provide patient, representatives and disignated person with copies of completeed test reports upon request
DONT change role of providers in ordering tests and explaiing test reports to patients
Do CLIA labs that are NOT HIPAA covered entities need to provide patients direct access to laboratory test reports?
NO. they have discretion to provide patients subject to applicable state laws
How are panic value or imminent life-threatening test results handled?
lab must alert individual or entity requesting the test or responsible for test results immediately
Do labs alwasy have to notify individuals about delayed testing?
Must determine based on urgency of tests requested the need to notify about the delay
What individuals are required for PPM testing?
1) Director
2) Testing Personnel
What are the required qualifications of PPM Director?
1) State license as lab director if required
2) Lab director must be
a) Physician
b) State authorized midlevel practitioner
c) Dentist
What are the PPM Director responsibilities?
overal operation and administration including prompt, accurate and profiecient reporting of test results
1) no more than 5 labs
2) ensure that any PPM procedure is personally perfommred by an individual who meets the qualification requirements and in accordance with requirements
What are the PPM testing personnel requirements?
1) State license if required
2) Meet one of following
a) Be physician
b) state authorized midlevel practitioner under supervision of a physician or in independent practice if authorized by state
c) dentist
What are the personnel responsibilties of PPM testing personnel?
specimen processing, test performance and reporting of test results
PPM procedures must be perfomed by physician, supervised midlevel practitioner of dentist
Performed during patients visit on specimen obtained from own patient or from patient in medicaul group
performed using bright field or phase contrast microscope
What are the required personnel for moderate complexity testing?
1) Director
2) TEchnical consultant
3) Clinical consultant
4) testing personnel
What degrees/specialties/level of schooling are allowed to be moderate complexity director with enough experience or training?
Doctor of medicine/osteopathy/podiatry
Doctoral degree in chemical, physical, biological or clinical laboratory science
Master’s degree in chemical, physical, biological, clinical laboratory science or medical technology
Bachelor’s degree in chemical, physical, biological science or medical technology
What are the training and experience requirements for a doctor to be qualified as a moderate complexity director?
1) Must possess a current license as a laboratory director issued by the state if required AND
a) Be doctor of medicine or osteopathy licensed to practice medicine in state
certified in ANATAMIC OR CLINICAL PATHOLOGY or BOTH by American Board of Pathology of AMerican Osteopathic Board of Pathology OR possess qualifications that are EQUIVELANT to those required for such certifications
OR
b) Be doctor of medicine, osteopathy or podiatric medicine licensed to practice in state AND HAVE
1) 1 year experience directing or supervising non-waived tests OR
2) 20 CEUS in laboratory practice OR
3) Clinical laboratory training during residency
What are the education, training and experience requirements for doctoral degree to be qualified as moderate complexity director?
Doctoral degree in chemical, phsyical, biological or clinical laboratory science
a) Certified by American Board of Medical Microbiology, American Board of Clinical Chemistry, ABB, or AMerican Board of Medical Laboratory Immunology
OR
b) have had at least 1 year experience directing or supervising non-waived testing
What are the education, experience, training requirements for individual with master’s degree to be moderate complexity laboratory director?
Master’s degree in chemical, physical, biological or clinical laboratory science or medical technology
AND
a) Have at least 1 year of laboratory training or experience or both in non-waived testing
AND
b) at least 1 year supervisory experience in non-waived testing
What are the requirements for bachelor’s degree to be moderate complexity laboratory director?
Bachelor’s dgree in chemical, physical or biological science or medical technology
AND
a) at least 2 years lab training and experience or both in non-waived testing
AND
b) at least 2 years of supervisory lab experience in non-waived testing
List some of the moderate complexity director responsibilites
overall operation and administration of lab
employment of competent personnel
record/report test results promptly, accurately, profiecenlty
assuring compliance with applicable regulations
Ensure that all duties are perfomed
Acessible onsite, telephone or electronic consultation
direct no more than 5 labs
Ensure that testing systems for each tests provide quality services for all aspects of test performance
Ensure physical plant and environmental conditions are appropriate and safe
test methodologies can provide quality results for patient care
verification procedures ensure accuracy, precision and other characteristics
lab personnel are performing test methods as required
Enrolled in HHS approved PT program for each test performed
QC and QA are established and
maintained
Establishment and maintenance of acceptable levels of analytical performance for each test system
All remedial actions are taken and documented
Reports of test results include required information for interpretation
Consultation is available to lab’s clients on quality of test results reported and interpretation
Employ sufficient # of lab personnel with education and experience and training
Policies and procedures are established for monitoring individuals who perform testing for competency
Procedure manual is available to all personnel responsible for any aspect of testing process
Specify in writing responsibilies and duties of each consulatant and person engaged in performance of pre-analytic, analytic and post-analytic phases of testing
Can the lab director perform the duties of all personnel required for non-waived testing?
YES lab directory may perform duties of technical consultant, clinical consultant and testing personnel or delegate
What are the moderate complexity technical consultant qualifications?
1) state licensed if required
2) Must be
a) licensed and board certified pathologist
b) licensed physician
OR Doctoral
OR master’s degree in chemical, physical, biological or clinical laboratory science or medical technology
AND have 1 years experience or training in non-waived testing in designated specialty/subspecialty
c) bachelors degree in chem, phys or biol or medical tech
AND 2 years experience or training in non-waived testing in specialty/subspecialty
What are the moderate complexity technical consultant responsibilties?
Accessible to lab for onsite, electronic consultation as needed
S election of test methodology appropriate for clinical use of the test results
Verification of test procedures, establishment of test performance characteristics including preciesion and accuracy
enrollment participation in PT pgrogram
Establish QC program appropriate for testing performed, parameters for acceptable levels of analytic performance, levels are maintained
Resolving technical problems and esnuring remedial actions are taken
test results not reported until corrective actiosn have been taken and system is functioing
Identifying training needs and assuring each indivudal perforing tests recieved regular in service training, education
Evaluating competency of all testing personnel and assuring its maintained
Evaluating performance/competency at least semiannually during 1st year and then annually afterwards
What are the procedures for evaluating competency?
Must include but not limited to:
1) Direct observations of routine testing performance
2) monitoring recording and reporting
3) Intermediate test results or worksheets, QC records, PT testing results, PM records
4) Direct observation of instrument maintenance/function checks
5) Testing analyzed specimens, internal blind testing samples, exetrnal PT samples
6) Asses problem solving skills
How often is competency evaluated?
at least semiannually during first year then at least annually
UNLESS test methodology or instrumentation changes then its prior to reporting patient test results
What are the moderate complexity clinical consultant qualifications?
1) Qualified laboratory director
2) Licensed physician
What are the responsibilities of moderate complexity clinical consultant?
Provide clinical consultation to lab clients
Assist lab clients in ensuring appropriate tests are ordered to meet clinical expectations
ensure reports of tests results include information for interpretation
AND
Consultation with clients regarding QUALITY of test results reported and their intepretation concerning specific patient conditions
What are the moderate complexity testing personnel qualifications?
State license if required
one of the following:
a) licensed physician OR doctoral OR master’s OR biological degree
b) associate degree
c) high school graduate or equivelant AND copleted official military medical lab procedures course of at least 50 weeks duration AND held military enlisted occupational specialty of MLS MLT
OR
d) high school diploma or equivelant and have documentation of TRAINING approriate for testing performed that ensures they have the required skills for testing performance
what are the personnel required for high complexity testing?
1) Director
2) Clinical Consultant
3) Technical supervisor
4) General Supervisor
5) Testing Personnel
What are the requirements for doctors of medicine or osteopathy to qualify as high complexity lab director?
1) State issued license as lab director if required
AND
a) Doctor medicine / osteopathy licensed to practice in state AND CERTIFIED in anatomic or clinical pathology by Boards of Pathalogy or Osteopathic Board of Pathology or possess equal qualifications required for such
OR
b) Doctor of medicine, osteopathy or podiatry licensed to practice in state
AND have
1) At least 1 year lab training during residency OR
2) At least 2 years of experience directing or supervising high complexity testing
What are the requirements for DOCTORAL individuals to be qualified as high complexity lab director?
Doctoral degree in chemical, physical, biological or clinical laboratory science
AND
a) CERTIFIED by American Boards of Medical Microbiology/Clinical Chemistry/Bioanalysis/Medical Laboratory Immunology or OTHER BOARD deemed comparable by HHS
OR
b) Before February 24, 2003, must have been serving as director of lab performing high complexity testing AND:
1) 2 years of clinical lab training or experience AND
2) 2 years directing / supervising high complexity testing
What are the requirements for non doctoral individuals to qualify as high complexity laboratory director
Serving as director and must have previously qualified or could have qualified as lab director under regulations 42 CFR 493.1415 published March 14 1990 at 55 FR 9538 on or before February 28 1992
OR
on or before february 28, 1992 be qualified under state law to direct lab in state lab is located
OR
for subspecialty of oral pathology be CERTIFIED by American Board of Oral Pathology, Board of Pathology, Osteopathic Board of Pathology or possess equivalent qualifications
What are the requirements for high complexity technical supervisor?
1) Licensed board-certified pathologist
2) Licensed physician OR doctoral degree AND
a) 1 year clinical training / experience in high complexity testing within the specialty AND
b) 6 months experience in high complexity testing within subspecialty
3) Master’s degree AND
a) 2 years clinical lab training or experience or both in high complexity testing within specialty AND
b) 6 months experience in high complexity testing within the subspecialty
4) Bachelor’s degree AND
a) 4 years clinical lab training/experience/both in high complexity testing within specialty AND
b) 6 months experience in subspecialty
6 month experience in subspecialty not required for specialties of chemistry, diagnostic immunology and hematology
Which specialties don’t require 6 months experience in high complexity testing within the subspecialty to qualify as technical supervisor?
chemistry, diagnostic immunology and hematology
Which specialties and subspecialties have stricter qualifications for technical supervisor?
cytology, histopathology, oral pathology, histocompatibility, clinical cytogenetics and immunohematology
What are the responsibilities of high complexity technical supervisor?
accessible for onsite or electronic consultation
selection of appropriate test methodology for clinical use
verification of test procedures performed/establishment of test performance characteristics/precision/accuracy
HHS approved PT program
QC Program appropriate for testing and establishing acceptable levels of performance and maintainance of those levels
resolving technical problems, remedial actions
dont report patient results until corrective actions have been taken and system is functioning properly
indentify training needs, assure training of testing personnel and education
evaluate competency of all testing personnel and maintenance of competency
What are the unique requirements of cytology technical supervisor?
TS or qualified individual may perform duties of cytology general supervisor and cytotechnologist
must establish workload limit for each individual examining slides
reassess workload limit for each individual examining slides at leaset every 6 months
ensure each indidivdual examining gynecologic preparations participates in HHS-approved cytology PT and passes
if responsible for screening slide preparations must document number of slides screened in 24 hours and hours devoted during each 24 hr period to screening cytology slides
What are the high complexity clinical consultant qualifications
1) qualified as lab director
OR
2) licensed physician
What are responsibilities of high complexity clinical consultant?
1) provide consultation to clients
2) assist in ensuring appropriate tests are ordered by clients
3) Ensure reports include required information for interpretation
4) Consultation is available and communicated to labs clients regarding quality of test results reported and interpretation concerning specific patient conditions
What are the high complexity general supervisor qualifications?
1) State license if required
2) qualified as HCLD or TS
3) Licensed physician, doctoral, masters, BS AND 1 year of experience / training / both in high complexity testing
What are responsibilties of high complexity general supervisor?
ACCESSIBLE to testing personnel at all times testing is performed to provide on site or electronic consultation to resolve technical problems in accordance with policies and procedures established by lab director or technical supervisor
day-to-day supervision of high complexity test performance by qualified personnel
monitor test analysis and specimen examinations to ensure acceptable levels of analytic performance are maintained
Which responsibilities may be delegated by the technical supervisor or director to the GENERAL SUPERVISOR
Responsibility for:
Assuring all remedial actions are taken whenever test systems deviate from established performance specifications
Ensuring patient test results are not reported until all corrective actions have been taken and test system is functioning properly
providing orientation to all testing personnel AND
annually evaluating and documenting the performance of all testing personnel
What are the high complexity testing personnel qualifications?
licensed physician OR doctoral, masters, bachelors degree
associates degree in laboratory science/medical technology OR equivelant education and training
On or before april 24th 1995, be high school graduate and have specific clinical laboratory training
until september 1 1997, have high school diploma AND have specific clinical lab experience
AFTER september 1 1997, obtain associate degree
High school graduates can be qualified as which types of personnel?
Moderate complexity testing personnel with training and verification of skills, knowledge
high complexity testing personnel:
On or before april 24, 1995 high school GRADUATE
Until September 1 1997 high school DIPLOMA
After september 1, 1997 ASSOCIATE DEGREE
Is direct onsite supervision of high complexity testing by testing personnel required?
Testing personnel may only perform high complexity testing under direct supervision of a qualified general supervisor
EXCEPT: individuals who were performing high complexity testing on or before January 19 1993 IF all high complexity testing performed by the individual in absence of general supervisor is reviewed within 24hrs by general supervisor
What are the main goals of HHS or designees during inspections?
Assess compliance with applicable requirements
testing is performed in manner not pose imminent and serious risk to public health
evaluate complaints from public
whether lab is performing tests not certified for
performing tests in accodance with manufacturer instructions
How must laboratories handle and what is permitted for HHS inspection?
permit HHS/designee to interview all employees of the lab concerning compliance with applicable requirements
access to all areas of facility including procurement and proccessing areas, storage facilities, testing and reporting areas
observation of employees performing tests, data analysis and reporting
provide copies of all records and data to HHS or designee that agency requires under these regulations
must provide upon reasonable request all information/data needed by HHS for their determination of compliance with requirements of CLIA
What results from failure to permit an announced or unnannounced inspection by HHS or designee?
Suspension of medicare and medication payments to the lab OR termination of participation in medicare and medication for payment AND
suspension or action to revoke lab’s CLIA certificate
For which labs and when can HHS inspect clinical laboratories?
HHS or desginee may conduct unannounced or announced random validation inspections of any accredited or CLIA-exempt laboratory at any time during hours of operation
What happens when laboratories are out of compliance with one or more conditions for medicare coverage?
CLIA 88 provides for intermediate sanctions that may imposed on labs that perform clinical diagnostic tests on human specimens when they are out of compliance with one or more conditions for medicare coverage of their services
Requires Secretary of HHS to develop and implement a range of sanctions
What are some possible sanctions by HHS for labs out of compliance?
intermediate sanctions
suspension, limitation, revocation of certificate of lab out of compliance with one or more rquirements of certificate
civil suit for lab activity that constitutes significant hazard to public health
imprisonment or fine for any person convicted of intentional violation of CLIA requirements
administrative hearing and judicial review rights of laboratory sanctioned under CLIA
Secretary publishes annually list of all sanctioned laboratories during preceding year
What are CMS decision to impose sanctions based on?
Deficiencies identfied by CMS or its agents during inspections to certify or validate compliance with federal requirements or through review of materials submitted by the laboratory
unsuccessful participation in PT
What factors are considered by CMS when choosing sanctions
1) whether deficincies pose immediate jeopardy
2) nature, incidence, severity, duration of deficiencies or noncompliance
3) whether same condition level deficincies have been identified repeatedly
4) accuracy and extent of lab records (remedial action) in regard to noncompliance and availability to state, CMS, other agents
5) relationship of one deficiency or group of deficiencies to other deficiencies
6)overall compliance history of lab including periods of noncompliance
7) corrective and long-term compliance outcomes that CMS hopes to achieve through sanction
8) whether lab has made any progress toward improvement following reasonable opportunity to correct deficiencies
9) recommendation by state agency to which sanction
If labs participation in PT is unsuccesful, what may CMS require?
training of personnel or necessary technical assisstance or both in order to meet requirements of PT program
What actions by lab owner, operator or employee may cause CMS to initiate adverse action to suspend, limit or revoke CLIA certificate?
Misrepresentation in obtaining CLIA certificate
performed or represented the lab as entitled to perform exam or procedure that is not within the cateogry authorized by CLIA certificate
failed to comply with certificate requirements and performance standards
failed to comply with reasonable requests by CMS for any information or work on materials that CMS concludes are necessary to determine the laboratory;s eligbility for its CLIA certificate OR continued compliance with performance standards by CMS
refused reasonable request by CMS or agents for permission to inspect the. lab and its operation and records during hours of operation
violated or aided and abetted in the violation of any provisions of CLIA and its implementing regulations
failed to comply with an alternative sanction
within preceding 2 year period, owned or operated a lab that had its CLIA certificate revoked
if CMS determines lab has intentionally referrred its proficiency testing samples to another lab for analysis, CMS revokes CLIA certificate for at least 1 year and may impose civil money penalty
What information is made available to physicians and general public by CMS once a year about laboratory performance?
list of laboratories convicted under federal or state laws relating to fraud, abuse, false billing or kickbacks
list of labs that had CLIA certificates suspended, limited or revoked and reason
list of persons convicted of violating CLIA requirements and circumstances of each case and penalties imposed
list of laboratories on which alternative sanctions have been imposed- effective date, reasons, corrective actions, if and date of lab compliance
list of labs whose accreditation has been withdrawn or revoked and reasons
all appeals and hearing decisions
list of labs sued by CMS and reasons
list of labs that have been excluded from participation in medicare and medicaid and reasons
What is the purpose of the Clinical Laboratory Improvement Advisory Committee?
Established by HHS
advise and make recommendations on technical and scientific aspects of CLIA
comprised of individuals involved in provision of laboratory services, utilization, development of testing/methodology and others as approved by HHS
Meet as needed at least once each year
What does the Clinical Laboratory Improvement Advisory Committee review and recommend?
at request of HHS will recommend and review:
criteria for categorizing tests and examinations of moderate complexity (including subcategory) and high complexity
determination of waived tests
personnel standards
patient test management, QC, QA standards
PT Standards
Applicability to the standards of new technology
other issues relevant to part 493
Which records must be retained for 10 years?
Immunohematology records
blood and blood product records
transfusion records
pathology test reports
histopathology slides
Which records must be retained for 5 years?
Cytology slide preparations
How long must pathology test reports and histopathology slides be kept?
10 years
How long must cytology slide preparations be kept?
5 years
How long must immunohematology records, blood and blood products and transfusion records be kept?
no less than 10 years after records of processing are completed
or 6 months after latest expiration date for individual product, whichever is later
How long must pathology specimen blocks and cytology specimen blocks be kept?
2 years
How long must quality system assessment records be kept?
2 years
How long must PT testing records be kept?
2 years
How long must test system performance specifications and records be kept?
2 years
How long must analytic systems records (QC) be kept?
2 years
How long must test reports be kept?
2 years
How long must test proecdures be kept?
2 years
How long must test requisitions be kept?
2 years
List the 20 Quality Systems for Nonwaived Testing
Confidentiality of patient information
Specimen ID and Integrity
Complaint Investigations
Communications
Personnel Competency
Evaluation of PT performance
General Lab Systems Assessment
Test Requisition
Specimen Submission and Handling
Procedure Manual
Test Systems, Equipment, Instrumentation, Reagents, Materials and Supplies
Establishment and Verification of Method Performance Specifications
Equipment Maintenance and Function Checks
Calibration and Calibration Verification
Control Procedures
Comparison of Test Results
Corrective Actions
Test Records
Test Reports
Systems Assessment
What are the CLIA requirements for facility administration for nonwaived testing?
Constructed arranged and maintained to ensure space, ventilation and utilities necessary for conducting all phases of testing; minimize contamination; unidirectional workflow of molecular amplification procedures not contained in closed system
appropriate and sufficient equipment, instruments reagents, supplies for type and volume of testing
compliance with applicable federal, state and local laboratory requirements
Safety precautions established, posted, observed to ensure protection from physical, chemical, biochemical, electrical hazards, biohazardous materials
What are the general laboratory quality systems requirements?
Must establish and maintain written policies and procedures that implement and monitor quality systems (quality control) for all phases of the testing process AND general laboratory systems
Each quality system must include assessment component that ensures continuous IMPROVEMENT of performance and services
Improvement achieved through ongoing monitoring that identifies, evaluates and resolves problems
What are the requirements for General Laboratory Systems Quality Assessment?
the laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements
the general laboratory systems quality assessment must include a review of the effectiveness of corrective actions taken to resolve problems, revision of policies and procedures necessary to prevent recurrence of problems, and discussion of general laboratory systems quality assessment reviews with appropriate staff.
(c) The laboratory must document all general laboratory systems quality assessment activities.
Test Requisition Requirements
The laboratory must ensure the test requisition solicits the following information:
(1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values.
(2) The patient’s name or unique patient identifier.
(3) The sex and age or date of birth of the patient.
(4) The test(s) to be performed.
(5) The source of the specimen, when appropriate.
(6) The date and, if appropriate, time of specimen collection.
(7) For Pap smears, the patient’s last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy.
(8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable.
*The patient’s chart or medical record may be used as the test requisition or authorization but must be available to the laboratory at the time of testing and available to CMS or a CMS agent upon request.
Specimen submission, handling, referral requirements
(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable:
(1) Patient preparation.
(2) Specimen collection.
(3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source.
(4) Specimen storage and preservation.
(5) Conditions for specimen transportation.
(6) Specimen processing.
(7) Specimen acceptability and rejection.
(8) Specimen referral.
The laboratory must document the date and time it receives a specimen.
The laboratory must refer a specimen for testing only to a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by CMS.
If the laboratory accepts a referral specimen, written instructions must be available to the laboratory’s clients and must include, as appropriate, the information specified
Procedure Manual Requirements
A written procedure manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory’s written procedures for testing or examining specimens.
(b) The procedure manual must include the following when applicable to the test procedure:
(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in § 493.1242.
(2) Microscopic examination, including the detection of inadequately prepared slides.
(3) Step-by-step performance of the procedure, including test calculations and interpretation of results.
(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing.
(5) Calibration and calibration verification procedures.
(6) The reportable range for test results for the test system as established or verified in § 493.1253.
(7) Control procedures.
(8) Corrective action to take when calibration or control results fail to meet the laboratory’s criteria for acceptability.
(9) Limitations in the test methodology, including interfering substances.
(10) Reference intervals (normal values).
(11) Imminently life-threatening test results, or panic or alert values.
(12) Pertinent literature references.
(13) The laboratory’s system for entering results in the patient record and reporting patient results including, when appropriate, the protocol for reporting imminently life-threatening results, or panic, or alert values.
(14) Description of the course of action to take if a test system becomes inoperable.
(c) Manufacturer’s test system instructions or operator manuals may be used, when applicable, to meet the requirements of paragraphs (b)(1) through (b)(12) of this section. Any of the items under paragraphs (b)(1) through (b)(12) of this section not provided by the manufacturer must be provided by the laboratory.
(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use.
(e) The laboratory must maintain a copy of each procedure with the dates of initial use and discontinuance as described in § 493.1105(a)(2).
What verification of performance specifications is required for FDA-cleared or approved method?
Verification of performance specifications. Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results:
(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics:
(A) Accuracy.
(B) Precision.
(C) Reportable range of test results for the test system.
(ii) Verify that the manufacturer’s reference intervals (normal values) are appropriate for the laboratory’s patient population.
What performance specifications must be verified or established for new methods or devices introduced into the laboratory?
Establishment of performance specifications. Each laboratory that modifies an FDA-cleared or approved test system, or introduces a test system not subject to FDA clearance or approval (including methods developed in-house and standardized methods such as text book procedures), or uses a test system in which performance specifications are not provided by the manufacturer must, before reporting patient test results, establish for each test system the performance specifications for the following performance characteristics, as applicable:
(i) Accuracy.
(ii) Precision.
(iii) Analytical sensitivity.
(iv) Analytical specificity to include interfering substances.
(v) Reportable range of test results for the test system.
(vi) Reference intervals (normal values).
(vii) Any other performance characteristic required for test performance.
