Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

GK > CLIA > Flashcards

CLIA Flashcards

1
Q

What are lab/facility exceptions to CLIA standards?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What are the 7 criteria used by FDA to determine test complexity and categorize tests?

A

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 well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

How is testing categorized between moderate and high complexity with the scorecard?

A

7 criteria scored from 1-3 with 1 being lowest
7 scores added together

12 OR LESS = moderate complexity

ABOVE 12 = high complexity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

List the 5 CLIA certificates

A

1) Registration
2) Waiver
3) PPM procedures
4) Compliance
5) Accreditation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

For how long are CLIA certificates valid?

A

2 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Which level of complexity in labs requires registration certificate?

A

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 well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

How complex are PPM procedures considered?

A

Moderate complexity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

List examples of accreditation programs approved by HHS

A

CAP, COLA, JCAHO

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Do labs with several locations require separate applications for CLIA certificates? What are the exceptions?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

What are the time limits for reporting changes to CMS?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

What are characteristics of waived tests?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q

Who can perform PPM procedures?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What are main specifications of PPM procedures?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

what are examples of PPM procedures?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q

What are the requirements of PPM labs?

A

PT, patient test management, quality control, personnel and quality assurance

subject to inspection

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

What is considered satisfactory performance on PT testing?

A

80% correct for each analyze in most specialities

some immunohematology procedures and compatibility testing require 100% accuracy

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

What is considered Unsatisfactory PT performance?

A

failure to attain minimum satisfactory score for an analyte, test or subspecialty for testing event and requires remedial actions

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
18
Q

What is considered unsuccessful PT?

A

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 well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

How long must documentation of PT records be maintained

A

minimum of 2 years from proficiency testing event

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

Is PT required for all test methods, systems or examinations during PT event?

A

NO only required for primary method used in patient testing

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
21
Q

How should PT samples be tested?

A

With regular workload by personnel who routinely perform testing and with routine methods

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

For which specialities and subspecialties is satisfactory performance on PT considered 80% correct for each analyte you are being tested on?

A

microbiology (bacteriology, mycobacteriology, mycology, parasitology, virology)

diagnostic immunology (syphilis serology, general immunology)

chemistry (routine chemistry, endocrinology, toxicology)

hematology (no subspecialties defined here)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

What is considered satisfactory PT performance in immunohematology subspecialties?

A

ABO/RHO 100%
Unexpected Antibody 80%
Compatibility testing 100%
Antibody identification 80%

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

What is considered satisfactory performance for most PT testing?

A

80% correct for each analyze you are being tested on ( 4/5 right per testing event)

Testing involves multiple samples of the same analyte

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

What is the number of samples and frequency of challenge for the subspecialties?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

What does failure to return PT results to PT program before deadline result in?

A

UNSATISFACTORY performance

score of 0 for testing event

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

How should the lab respond to PT failure?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
28
Q

What is unsuccessful PT performance?

A

failure to achieve an overall testing event score of satisfactory performance for 2 consecutive events or 2/3 consecutive events

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
29
Q

How are the pathology PT program requiremnts different?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
30
Q

What are the facility administration requirements for non waived testing from CLIA?

A

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 well did you know this?
1
Not at all
2
3
4
5
Perfectly
31
Q

How long must records of QC, patient tests, quality assessment and PT be retained?

A

2 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
32
Q

How long must records of test system performance specifications be retained?

A

for the period of time lab uses the test system but NOT LESS THAN 2 YEARS

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
33
Q

How long must cytology slide preparations be retained

A

5 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
34
Q

How long must original reports be retained?

A

2 years after date of reporting

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
35
Q

What should the lab do with records if it ceases operation?

A

must take provisions to ensure all records and applicable slides, blocks and tissues are maintained and available for time frames specified

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
36
Q

List major components of the quality systems required for non-waived testing

A

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 well did you know this?
1
Not at all
2
3
4
5
Perfectly
37
Q

how often must analyte not offered by CMS-approved PT program be assessed?

A

at least twice annually

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
38
Q

Are oral requests permitted for laboratory tests?

A

Only if lab requests written authorization for testing within 30 DAYS. Lab must maintain written authorization or attempts to obtain

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
39
Q

How long must records of test requisitions or authorizations be retained?

A

minimum of 2 years

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
40
Q

can the patient’s chart or medial record be used as test requisition?

A

Yes but must be available to lab at time of testing and to HHS upon request

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
41
Q

What are the required elements of the test requisition or authorization?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
42
Q

What are the required components of policies and procedures for specimen submission and handling?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
43
Q

Are oral explanations of instructions to patients allowed?

A

Oral explanation for specimen collection including patient preparation may be used as a supplement to written instructions where applicable

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
44
Q

Can textbooks be used in lieu of laboratory written procedures for testing or examining specimens?

A

No, can be used as supplement only

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
45
Q

List components that must be included in the procedure manual

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
46
Q

Can manufacturer package inserts or operator manuals be used?

A

Can be used to meet requirements and any items not provided by manufacturers must be provided by lab

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
47
Q

How should discontinued procedures be handled?

A

Filed separately from active

retained for 2 years after discontinuance

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
48
Q

List the conditions that the lab must define that ensure proper storage of reagents and accurate/relaibel test system operation and result reporting

A

Water quality

humidity

temperature

protection of equipment and instrumentation from fluctuations and interruptions in electrical current

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
49
Q

What are the required elements on reagent, materials, supplies, solutions labels?

A

1) Identity and titer/strength/concentration when significant
2) Recommended storage requirements
3) Preparation and expiration date
4) Other pertinent information for proper use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
50
Q

Prior to reporting patient test results lab must verify or establish for each method performance specifications. What are these characteristics?

A

1) accuracy and precision
2) Sensitivity and specificity if applicable
3) reportable range
4) reference range
5) any other applicable performance characteristic

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
51
Q

What is different about moderate or high complexity test methods in use prior to April 24 2003?

A

for tests in use prior to this date :
Labs NOT required to verify or establish performance specifications for moderate/high complexity

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
52
Q

What is the purpose of calibration and verification?

A

Substantiate continued accuracy of test method throughout lab’s reportable range for patient test results

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
53
Q

What is calibration?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
54
Q

what is calibration verification?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
55
Q

What is the reportable range of patient test results?

A

Range of known test values over which the laboratory can establish or verify the accuracy of the instrument, kit or test system measurement response

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
56
Q

What values must be included in the labs established reportable range?

A

Must include at least a minimal (zero) value, midpoint value and maximum value at the upper limit of that range

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
57
Q

How often must calibration verification procedures be performed?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
58
Q

Is calibration verification always required when changing reagent lots?

A

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 well did you know this?
1
Not at all
2
3
4
5
Perfectly
59
Q

How often must control procedures be performed?

A

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

60
Q

What controls are needed for qualitiative tests?

A

Positive and negative control with each run of patient specimens

61
Q

What controls are needed for quantitative tests?

A

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

62
Q

What controls are required for electrophetic determinations?

A

at least one control sample must be used in each cell

control sample must contain fractions representative of those routinely reported in patient specimens

63
Q

What controls are required for direct antigen systems?

A

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

64
Q

When must control material be tested before resuming patient testing?

A

complete change of reagents

preventative maintenance

any critical component replaced

65
Q

Can calibration material be used as control? are any additional steps required?

A

Use calibration material from DIFFERENT LOT than what’s used to establish cut off values or calibration

66
Q

What guidelines must be met by media in order to be acceptable for media quality control?

A

National Committee for Clinical Laboratory Standards ( NCCLS)

67
Q

What information must be included in the test report?

A

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

68
Q

originally to whom could test results be released according to CLIA?

A

Authorized individuals/ individuals using test results and lab that initially requested the test

69
Q

According to HIPAA 1996, who is allowed to receive test results according to CLIA regulations?

A

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

70
Q

Do CLIA labs that are NOT HIPAA covered entities need to provide patients direct access to laboratory test reports?

A

NO. they have discretion to provide patients subject to applicable state laws

71
Q

How are panic value or imminent life-threatening test results handled?

A

lab must alert individual or entity requesting the test or responsible for test results immediately

72
Q

Do labs alwasy have to notify individuals about delayed testing?

A

Must determine based on urgency of tests requested the need to notify about the delay

73
Q

What individuals are required for PPM testing?

A

1) Director
2) Testing Personnel

74
Q

What are the required qualifications of PPM Director?

A

1) State license as lab director if required
2) Lab director must be
a) Physician
b) State authorized midlevel practitioner
c) Dentist

75
Q

What are the PPM Director responsibilities?

A

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

76
Q

What are the PPM testing personnel requirements?

A

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

77
Q

What are the personnel responsibilties of PPM testing personnel?

A

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

78
Q

What are the required personnel for moderate complexity testing?

A

1) Director
2) TEchnical consultant
3) Clinical consultant
4) testing personnel

79
Q

What degrees/specialties/level of schooling are allowed to be moderate complexity director with enough experience or training?

A

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

80
Q

What are the training and experience requirements for a doctor to be qualified as a moderate complexity director?

A

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

81
Q

What are the education, training and experience requirements for doctoral degree to be qualified as moderate complexity director?

A

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

82
Q

What are the education, experience, training requirements for individual with master’s degree to be moderate complexity laboratory director?

A

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

83
Q

What are the requirements for bachelor’s degree to be moderate complexity laboratory director?

A

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

84
Q

List some of the moderate complexity director responsibilites

A

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

85
Q

Can the lab director perform the duties of all personnel required for non-waived testing?

A

YES lab directory may perform duties of technical consultant, clinical consultant and testing personnel or delegate

86
Q

What are the moderate complexity technical consultant qualifications?

A

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

87
Q

What are the moderate complexity technical consultant responsibilties?

A

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

88
Q

What are the procedures for evaluating competency?

A

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

89
Q

How often is competency evaluated?

A

at least semiannually during first year then at least annually

UNLESS test methodology or instrumentation changes then its prior to reporting patient test results

90
Q

What are the moderate complexity clinical consultant qualifications?

A

1) Qualified laboratory director
2) Licensed physician

91
Q

What are the responsibilities of moderate complexity clinical consultant?

A

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

92
Q

What are the moderate complexity testing personnel qualifications?

A

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

93
Q

what are the personnel required for high complexity testing?

A

1) Director
2) Clinical Consultant
3) Technical supervisor
4) General Supervisor
5) Testing Personnel

94
Q

What are the requirements for doctors of medicine or osteopathy to qualify as high complexity lab director?

A

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

95
Q

What are the requirements for DOCTORAL individuals to be qualified as high complexity lab director?

A

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

96
Q

What are the requirements for non doctoral individuals to qualify as high complexity laboratory director

A

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

97
Q

What are the requirements for high complexity technical supervisor?

A

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

98
Q

Which specialties don’t require 6 months experience in high complexity testing within the subspecialty to qualify as technical supervisor?

A

chemistry, diagnostic immunology and hematology

99
Q

Which specialties and subspecialties have stricter qualifications for technical supervisor?

A

cytology, histopathology, oral pathology, histocompatibility, clinical cytogenetics and immunohematology

100
Q

What are the responsibilities of high complexity technical supervisor?

A

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

101
Q

What are the unique requirements of cytology technical supervisor?

A

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

102
Q

What are the high complexity clinical consultant qualifications

A

1) qualified as lab director
OR
2) licensed physician

103
Q

What are responsibilities of high complexity clinical consultant?

A

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

104
Q

What are the high complexity general supervisor qualifications?

A

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

105
Q

What are responsibilties of high complexity general supervisor?

A

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

106
Q

Which responsibilities may be delegated by the technical supervisor or director to the GENERAL SUPERVISOR

A

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

107
Q

What are the high complexity testing personnel qualifications?

A

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

108
Q

High school graduates can be qualified as which types of personnel?

A

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

109
Q

Is direct onsite supervision of high complexity testing by testing personnel required?

A

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

110
Q

What are the main goals of HHS or designees during inspections?

A

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

111
Q

How must laboratories handle and what is permitted for HHS inspection?

A

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

112
Q

What results from failure to permit an announced or unnannounced inspection by HHS or designee?

A

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

113
Q

For which labs and when can HHS inspect clinical laboratories?

A

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

114
Q

What happens when laboratories are out of compliance with one or more conditions for medicare coverage?

A

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

115
Q

What are some possible sanctions by HHS for labs out of compliance?

A

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

116
Q

What are CMS decision to impose sanctions based on?

A

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

117
Q

What factors are considered by CMS when choosing sanctions

A

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

118
Q

If labs participation in PT is unsuccesful, what may CMS require?

A

training of personnel or necessary technical assisstance or both in order to meet requirements of PT program

119
Q

What actions by lab owner, operator or employee may cause CMS to initiate adverse action to suspend, limit or revoke CLIA certificate?

A

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

120
Q

What information is made available to physicians and general public by CMS once a year about laboratory performance?

A

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

121
Q

What is the purpose of the Clinical Laboratory Improvement Advisory Committee?

A

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

122
Q

What does the Clinical Laboratory Improvement Advisory Committee review and recommend?

A

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

123
Q

Which records must be retained for 10 years?

A

Immunohematology records

blood and blood product records

transfusion records

pathology test reports

histopathology slides

124
Q

Which records must be retained for 5 years?

A

Cytology slide preparations

125
Q

How long must pathology test reports and histopathology slides be kept?

A

10 years

126
Q

How long must cytology slide preparations be kept?

A

5 years

127
Q

How long must immunohematology records, blood and blood products and transfusion records be kept?

A

no less than 10 years after records of processing are completed

or 6 months after latest expiration date for individual product, whichever is later

128
Q

How long must pathology specimen blocks and cytology specimen blocks be kept?

A

2 years

129
Q

How long must quality system assessment records be kept?

A

2 years

130
Q

How long must PT testing records be kept?

A

2 years

131
Q

How long must test system performance specifications and records be kept?

A

2 years

132
Q

How long must analytic systems records (QC) be kept?

A

2 years

133
Q

How long must test reports be kept?

A

2 years

134
Q

How long must test proecdures be kept?

A

2 years

135
Q

How long must test requisitions be kept?

A

2 years

136
Q

List the 20 Quality Systems for Nonwaived Testing

A

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

137
Q

What are the CLIA requirements for facility administration for nonwaived testing?

A

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

138
Q

What are the general laboratory quality systems requirements?

A

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

139
Q

What are the requirements for General Laboratory Systems Quality Assessment?

A

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.

140
Q

Test Requisition Requirements

A

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.

141
Q

Specimen submission, handling, referral requirements

A

(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

142
Q

Procedure Manual Requirements

A

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).

143
Q

What verification of performance specifications is required for FDA-cleared or approved method?

A

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.

144
Q

What performance specifications must be verified or established for new methods or devices introduced into the laboratory?

A

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.

145
Q
A
146
Q
A

GK (15 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions