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What Every USAF Laboratorian Should Know

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What Every USAF Laboratorian Should Know AGENDA (Part I) AFIOH SURVEILLANCE DIRECTORATE CLIP BASICS CAP LAB ACCREDITATION & PROFICIENCY TESTING CPT 101 SENIOR ... – PowerPoint PPT presentation

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Title: What Every USAF Laboratorian Should Know


1
What Every USAF Laboratorian Should Know
2
AGENDA(Part I)
  • AFIOH SURVEILLANCE DIRECTORATE
  • CLIP BASICS
  • CAP LAB ACCREDITATION PROFICIENCY TESTING
  • CPT 101
  • SENIOR ENLISTED PERSPECTIVES (CMSGT MOORE)
  • BREAK (1500-1530)

3
AGENDA(Part II)
  • LRN (DR. ELIZABETH MACIAS, PH D)
  • PANDEMIC INFLUENZA UPDATE (DR. ELIZABETH MACIAS,
    PH D)
  • M1M/JBAIDS PT (DR. KETAN PATEL, PH D)
  • CLMI AF LAB STAFFING MODEL
  • Q A

4
CLIP BASICS
  • LABORATORY
  • (as defined in 42 CFR 493 and AFIP Pamphlet
    40-24)
  • A facility for the biological, microbiological,
    serological, chemical, immunohematological,
    hematological, biophysical, cytological,
    pathological, or other examination of materials
    derived from the human body for the purpose of
    providing information for the DIAGNOSIS,
    PREVENTION, or TREATMENT of any disease or
    IMPAIRMENT of, or the ASSESSMENT of health in
    human beings.
  • Note Facilities only collecting or preparing
    specimens (or both) or serving as a mailing
    service and not performing testing are not
    considered laboratories.

5
CLIP BASICS
  • CLIP does not apply to
  • Forensic laboratories
  • Research labs that DO NOT report patient specific
    results for the diagnosis, prevention or
    treatment of any disease or impairment of, or the
    assessment of, the health of individual patients
  • Labs regulated by DoDI 1010.16 or are certified
    by the National Laboratory Certification Program
    (NLCP) of the Substance Abuse and Mental Health
    Services Administration of HHS in which drug
    testing is performed which meets HHS guidelines
    and regulations.
  • Medical units that may perform limited human
    testing in a field environment for military
    training purposes

6
CLIP BASICS
  • Deployable medical units must meet the following
    minimum requirements
  • Maintain verification of training and competency
    or personnel
  • Maintain a standard operating procedure/operating
    instruction for each test performed
  • Maintain and document quality control, quality
    assurance, and maintenance programs
  • Validate all procedures with the supporting MTF
    laboratory
  • Participate in continuing education offered by
    the supporting MTF

7
CLIP BASICS
  • Types of CLIP Certificates
  • Certificate of Registration
  • Certificate for Minimal Complexity Testing
  • Certificate for Provider-Performed Microscopy
  • Certificate of Compliance
  • Certificate of Accreditation

8
CLIP BASICS
  • Renewal of CLIP Certificates
  • Not automatic for AF sites
  • Submit renewal application 1-3 months before
    expiration date
  • Certificate of Registration is not renewable
  • Report changes in the following within 30 days
  • Name
  • Location
  • Director
  • Report changes in test methodologies NLT 6 months
    (applies to sites with Certificate of
    Accreditation)
  • For minimal and PPM certificates, report changes
    in testing menu that will affect the type of
    certificate before performing the tests
  • CLIP registration form located in www.afip.org

9
CLIP Basics
Complexity Army Army Navy Navy Air Force Air Force
Certs Sites Certs Sites Certs Sites
High 97 138 84 139 83 90
Moderate 77 118 51 65 33 40
PPM 142 220 57 137 97 206
Waived 323 694 57 243 150 381
Svc Tot 639 1170 249 584 363 717
Source LJWG Meeting, 29 Jan 08, Col Harms
10
CLIP BASICS
  • Laboratory director qualifications for sites
    performing MODERATE complexity tests
  • Pathologist
  • Physician (MD or DO) w/ 1 yr directing/supervising
    non-waived lab or 20 CMEs in lab practice or lab
    training during medical residency (e.g.,
    hematology or hematology/oncology)
  • PhD (certified by ABMM, ABCC, ABB, ABMLI)
  • Masters degree in chemical, physical or clinical
    lab science or medical technology w/ 1 yr lab
    training/experience or both in non-waived testing
    and 2 yrs supervisory experience in non-waived
    testing
  • Bachelors degree in chemical, physical or
    clinical lab science or medical technology w/ 2
    yrs lab training/experience or both in non-waived
    testing and 2 yrs supervisory experience in
    non-waived testing

11
CLIP BASICS
  • Required personnel for sites performing MODERATE
    complexity tests
  • Technical consultant
  • Pathologist,
  • Physician w/ 1 yr lab training/experience
  • PhD or masters degree w/ 1 yr lab
    training/experience
  • Bachelors degree w/ 2 yrs training/ experience
  • Clinical consultant
  • Must be qualified to be a lab director
  • Physician (MD, DO or Podiatric Medicine)
  • Testing personnel
  • MD, DO, PhD, Masters/Bachelors/Associates
    degrees
  • Medical Lab Specialists (Military)
  • HS diploma w/ documentation of training for
    testing performed
  • Note The director, if qualified, may perform
    all duties above, or delegate to personnel
    meeting qualifications

12
CLIP BASICS
  • Laboratory director qualifications for sites
    performing HIGH complexity tests
  • Pathologist
  • Physician (MD or DO) w/ 1 yr lab training during
    medical residency (e.g., hematology or
    hematology/oncology) or 2 yrs directing/supervisin
    g high complexity testing
  • PhD certified by appropriate board (certified by
    ABMM, ABCC, ABB, ABMLI)

13
CLIP BASICS
  • Required personnel for sites performing HIGH
    complexity tests
  • Technical supervisor
  • Pathologist
  • Physician or PhD w/ 1 yr lab training/experience
    (minimum of 6 months high complexity
    bacteriology, mycobacteriology, mycology,
    parasitology, anatomic pathology, etc.)
  • Masters degree w/ 2 yrs training/experience
    (Virologyminimum of 6 months experience w/in
    subspecialty)
  • Bachelors degree w/ 4 yrs training/experience
    (Virologyminimum of 6 months experience w/in
    subspecialty)
  • Military unique (may not be recognized by
    accrediting agency) Commissioned officer with
    BS degree and 3 years of lab training/experience
    and appropriate certification

14
CLIP BASICS
  • Required personnel for sites performing HIGH
    complexity tests
  • Clinical consultant (essentially same as lab
    director)
  • General supervisor
  • Same as lab director or technical supervisor or
  • Physician or have appropriate doctoral, masters
    or bachelors degree w/ 1 yr lab
    training/experience in high complexity testing or
  • Qualify as testing personnel w/ 2 yrs lab
    training/experience in high complexity testing)
  • Testing personnel
  • MD, DO, PhD, Masters/Bachelors degrees
  • Associates degree w/ qualifying number of
    semester hours and lab training from accredited
    organization or 3 months documented lab training
    in appropriate specialty
  • Note The director, if qualified, may perform
    all other previous duties, or delegate to
    personnel meeting qualifications

15
CAP LAB DIRECTOR REQUIREMENTS
  • (1) For laboratories that perform high complexity
    testing (as defined under CLIA-88), or for
    laboratories performing only moderately complex
    and/or waived testing whose annual test volume
    exceeds 500,000, the qualifications for the
    director are equivalent to the requirements for
    directors of high complexity laboratories under
    CLIA-88, as follows
  • The director must
  • Be an M.D. or D.O. licensed to practice (if
    required) in the jurisdiction where the
    laboratory is located
  • Be certified in anatomic or clinical pathology,
    or both, by the American Board of Pathology or
    American Osteopathic Board of Pathology, or
    possess qualifications equivalent to those
    required for certification
  • OR

16
CAP LAB DIRECTOR REQUIREMENTS
  • Be an M.D., D.O. or D.P.M. licensed to practice
    (if required) in the jurisdiction where the
    laboratory is located
  • Have at least one year of laboratory training
    during residency, or at least two years of
    experience supervising high complexity testing
  • OR
  • Hold an earned doctoral degree in a chemical,
    physical, biological or clinical laboratory
    science from an accredited institution
  • Be certified and continue to be certified by a
    board approved by HHS

17
CAP LAB DIRECTOR REQUIREMENTS
  • (2) Laboratories in which high-complexity testing
    is limited to a particular specialty (e.g.,
    hematology, dermatopathology, oral pathology,
    neuromuscular pathology, ophthalmic pathology)
    may be directed by an M.D. or D.O. who is
    certified in that specialty by one of the
    following boards, or who possesses qualifications
    equivalent to those required for certification
  • A board that is a member of the American Board of
    Medical Specialties
  • The American Board of Oral and Maxillofacial
    Pathology
  • An American Osteopathic board
  • Specific requirements under CLIA-88 for
    neuromuscular pathology may be found in
    42CFR493.1273(c) (http//www.phppo.cdc.gov/clia/re
    gs/subpart_k.aspx493.1273).

18
CAP LAB DIRECTOR REQUIREMENTS
  • (3) For laboratories in which the annual test
    volume does not exceed 500,000, and in which
    testing is limited to moderately complex tests
    alone (including provider-performed microscopy
    PPM, as defined by U.S. federal regulations),
    or with waived tests, the director must
  • Be qualified as in paragraph (1), OR
  • Be an M.D., D.O. or D.P.M., licensed to practice
    in the jurisdiction where the laboratory is
    located (if required), with at least 20 hours of
    continuing medical education credit hours in
    laboratory medicine, or equivalent training
    during medical residencyor with at least one
    year of experience supervising nonwaived
    laboratory testing, OR
  • Be a doctoral scientist with at least one year of
    experience supervising nonwaived laboratory
    testing

19
CAP LAB DIRECTOR REQUIREMENTS
  • (4) For laboratories in which the annual test
    volume does not exceed 500,000, and in which
    testing is limited to waived tests and
    provider-performed microscopy (PPM) (as defined
    by U.S. federal regulations), the director must
  • Be qualified as in paragraphs (1), (2) or (3), OR
  • Be an M.D. or D.O., or D.P.M., licensed to
    practice in the jurisdiction in which the
    laboratory is located, if required.
  • Additional qualifications for grandfathered
    individuals and for the subspecialty of oral
    pathology may be found in the CLIA-88 regulations
  • BOTTOMLINE Lab Director on CAPs and CCLMs
    records NEED TO MATCH

20
CAP LABORATORY ACCREDITATION AND PROFICIENCY
TESTING
  • AF contract with CAP
  • FA7014-07-D-0002
  • Period of performance
  • Proficiency testing orders
  • Customer Satisfaction Questionnaire
  • Electronic access and submission of data
  • Contract modifications

21
CAP LABORATORY ACCREDITATION PROGRAM
  • CAP Unannounced Inspections
  • 6-month inspection window changed to 3
  • Key Dates
  • Purpose
  • Key events
  • 1-hr security notice
  • Expect more rigorous inspections

22
CAP LABORATORY ACCREDITATION PROGRAM
DoD Consolidated CAP Inspection Outcome CY07
  Phase I Phase I   Phase II Phase II
Section of Questions Correct of Questions Correct
Lab General 19,210 99.5 58,303 99.3
Hematology Coagulation 5,949 99.6 14,964 99.6
Chemistry Toxicology 5,653 99.9 34,542 99.8
Urinalysis 960 99.8 5,579 99.7
Microbiology 9,836 99.7 27,553 99.7
Transfusion Medicine 2,954 99.9 19,968 99.7
Diagnostic Immunology 1,809 100 6,709 99.7
Flow Cytometry 171 98.8 780 100
Molecular Pathology 436 100 1,842 100
Limited Services Lab 14,322 99.9 48,724 99.5
POCT 255 100 7,371 99.0
Source CCLM Briefing at LJWG Meeting, 29 Jan
08, COL Harms
23
CAP LABORATORY ACCREDITATION PROGRAM
DoD Consolidated CAP Inspection Outcome CY07
  Phase I Phase I   Phase II Phase II
Section of Questions Correct of Questions Correct
Anatomic Pathology 3,703 99.8 8,159 99.7
Cytopathology 813 99.6 3,689 99.7
Cytogenetics 19 100 78 100
Clinical Histocompatibility 17 100 195 100
TOTALS 66,107 99.7 238,456 99.5
Note CAP inspections are focused on compliance with established performance standards and quality improvement. CAP divides their standards into two groups Phase I and Phase II. Deficiencies on Phase I standards do not seriously affect the quality of patient care or significantly endanger the welfare of a laboratory worker. Deficiencies on Phase II standards may seriously affect the quality of patient care or the health and safety of hospital or laboratory personnel. Note CAP inspections are focused on compliance with established performance standards and quality improvement. CAP divides their standards into two groups Phase I and Phase II. Deficiencies on Phase I standards do not seriously affect the quality of patient care or significantly endanger the welfare of a laboratory worker. Deficiencies on Phase II standards may seriously affect the quality of patient care or the health and safety of hospital or laboratory personnel. Note CAP inspections are focused on compliance with established performance standards and quality improvement. CAP divides their standards into two groups Phase I and Phase II. Deficiencies on Phase I standards do not seriously affect the quality of patient care or significantly endanger the welfare of a laboratory worker. Deficiencies on Phase II standards may seriously affect the quality of patient care or the health and safety of hospital or laboratory personnel. Note CAP inspections are focused on compliance with established performance standards and quality improvement. CAP divides their standards into two groups Phase I and Phase II. Deficiencies on Phase I standards do not seriously affect the quality of patient care or significantly endanger the welfare of a laboratory worker. Deficiencies on Phase II standards may seriously affect the quality of patient care or the health and safety of hospital or laboratory personnel. Note CAP inspections are focused on compliance with established performance standards and quality improvement. CAP divides their standards into two groups Phase I and Phase II. Deficiencies on Phase I standards do not seriously affect the quality of patient care or significantly endanger the welfare of a laboratory worker. Deficiencies on Phase II standards may seriously affect the quality of patient care or the health and safety of hospital or laboratory personnel. Note CAP inspections are focused on compliance with established performance standards and quality improvement. CAP divides their standards into two groups Phase I and Phase II. Deficiencies on Phase I standards do not seriously affect the quality of patient care or significantly endanger the welfare of a laboratory worker. Deficiencies on Phase II standards may seriously affect the quality of patient care or the health and safety of hospital or laboratory personnel.
Source CCLM Briefing at LJWG Meeting, 29 Jan
08, COL Harms
24
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE ITOP ACCREDITATION INSPECTION CITATIONS
    (AF)
  • HEM.23430 Are there checks of patient reports
    for correct INR calculations, patient values, and
    reference ranges under the following
    circumstances (as listed in checklist)?
  • GEN.20370 Is there evidence of improvement in
    objective measures of the laboratorys quality in
    the preceding 2 years?
  • TRM.40850 Is there documentation that the
    transfusion service medical director actively
    participates in establishing criteria for
    transfusion, reviewing cases not meeting
    transfusion audit criteria, and monitoring
    transfusion practices?

25
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE ITOP ACCREDITATION INSPECTION CITATIONS
    (AF)
  • GEN.20372 Does the laboratory have a procedure
    for reporting device-related adverse patient
    events, as required by the FDA?
  • GEN.70824 Does the laboratory have a policy to
    protect personnel from excessive noise levels?
  • HEM.22830 Are there documented guidelines for
    detection and special handling of specimens with
    elevated hematocrits?

26
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE IITOP ACCREDITATION INSPECTION CITATIONS
    (AF)
  • HEM.36003 Does the method protocol include
    adequate controls, normal ranges, and proper
    reporting procedures?
  • TRM.42250 Do the procedures for therapeutic
    apheresis/phlebotomy provide adequate protection
    for the patient?
  • TRM.42300 Is there a documented request from
    the patients physician for therapeutic
    apheresis/phlebotomy procedures, and are records
    maintained of all the following elements (as
    listed in the checklist)?

27
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE IITOP ACCREDITATION INSPECTION CITATIONS
    (AF)
  • GEN.20368 - Is the QM program appraised at least
    annually for effectiveness?
  • LSV.00425 For tests for which CAP does not
    require PT, does the laboratory at least
    semiannually 1) participate in external PT, or 2)
    exercise an alternative performance assessment
    system for determining the reliability of
    analytic testing?
  • GEN.55500 Has the competency of each person to
    perform his/her assigned duties been assessed?

28
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE ITOP ACCREDITATION INSPECTION CITATIONS
    (Other Services)
  • FLO.50100 Is there adequate space for technical
    work (bench space)?
  • FLO.50700 Is temperature and humidity control
    adequate?
  • TRM.43612 Does the facility have a plan to
    implement ISBT 128 that is in accordance with its
    blood supplier?
  • GEN.72075 Are supplies of acids and bases
    stored in separate cabinets near floor level?
  • GEN.20369 Is there evidence of improvement in
    objective measures of the laboratorys quality in
    preceding years?

29
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE ITOP ACCREDITATION INSPECTION CITATIONS
    (Other Services)
  • LSV.37195 Are there documented guidelines for
    detection and special handling of specimens with
    elevated hematocrits?
  • LSV.38675 Is there a system to periodically
    measure the actual platelet concentration of the
    usual platelet poor plasma used for many
    coagulation tests?
  • HEM.35851 Does the laboratory have a documented
    system to ensure consistency of morphologic
    observations among all personnel performing
    microscopic morphologic classification of sperm
    and other cells?
  • HEM.37925 If D-Dimer method is used in the
    evaluation of venous thrombo-embolism, has the
    method been validated for this purpose?

30
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE ITOP ACCREDITATION INSPECTION CITATIONS
    (Other Services)
  • HEM.22707 Is there a documented policy
    regarding clearing (flushing) of the volume of
    intravenous lines before drawing samples for
    hemostasis testing?
  • GEN.41340 When critical results are
    communicated verbally or by phone, is there a
    policy that laboratory personnel ask for a
    verification read back ofthe results?
  • GEN.20371 Does the laboratory have a procedure
    for reporting device-related adverse patient
    events, as required by FDA?
  • GEN.70824 Does the laboratory have a policy to
    protect personnel from excessive noise levels?

31
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE IITOP ACCREDITATION INSPECTION CITATIONS
    (Other Services)
  • POC.08800 For QUANTITATIVE tests, are control
    materials at more than one concentration (level)
    used for all tests at least daily?
  • POC.07568 If the laboratory/POCT program uses
    more than one instrument to test for a given
    analyte, are the instruments checked against each
    other at least twice a year for correlation of
    patient results?
  • HEM.20143 Is there documentation of corrective
    action when control results exceed defined
    acceptability limits?
  • GEN.55500 Has the competency of each person to
    perform his/her assigned duties been assessed?

32
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE IITOP ACCREDITATION INSPECTION CITATIONS
    (Other Services)
  • LSV.00700 Is there evidence of ongoing
    evaluation of records of controls, instrument
    maintenance and function, temperature, etc., for
    all procedures as required?
  • LSV.00200 Does the laboratory integrate all PT
    samples within the routine workload, and are
    those samples analyzed by personnel who routinely
    test patient samples, using the same primary
    method systems as for patient samples?
  • POC.08700 If the lab/POCT program uses more
    than one instrument to test for a given analyte,
    are the instruments checked against each other at
    least twice a year for correlation of patient
    results?

33
CAP LABORATORY ACCREDITATION PROGRAM
  • PHASE IITOP ACCREDITATION INSPECTION CITATIONS
    (Other Services)
  • TRM.42250 Do the procedures for therapeutic
    apheresis/phlebotomy provide adequate protection
    for the patient?
  • GEN.26791 Does the laboratory have a policy
    that addresses compliance with CAP terms of
    accreditation?
  • LSV.01800 Is there documentation of at least
    annual review of all procedures by the current
    laboratory director or designee?
  • GEN.55500 Has the competency of each person to
    perform his/her assigned duties been assessed?
  • TLC.10400 If the laboratory director delegated
    some functions (e.g., review of QC data,
    procedure manuals, proficiency testing
    performance, etc.) to others, is there
    documentation of which individuals are authorized
    to act on his/her behalf for specific activities?

34
CAP LABORATORY ACCREDITATION PROGRAM
  • CLSI Reference on CAP Checklists
  • (See MSWord Document)

35
CAP PROFICIENCY TESTING
  • DoD Proficiency Testing Statistics

of PT Challenges of Correct Responses of Incorrect Responses Percentage of Correct Responses
Army 99,203 95,526 3,677 96.3
Navy 73,557 70,529 3,028 95.9
Air Force 80,658 76,372 4,196 94.7
Total 253,418 242,427 10,901 95.7
Note CAP generally recognizes a PT challenge score of 80 or better as being acceptable laboratory performance. Note CAP generally recognizes a PT challenge score of 80 or better as being acceptable laboratory performance. Note CAP generally recognizes a PT challenge score of 80 or better as being acceptable laboratory performance. Note CAP generally recognizes a PT challenge score of 80 or better as being acceptable laboratory performance. Note CAP generally recognizes a PT challenge score of 80 or better as being acceptable laboratory performance.
36
CAP PROFICIENCY TESTING
  • Air Force CY07 Instances of Unsuccessful
    Performance (where 2nd or 3rd failure occurred in
    CY07)

2 out of 3 failures 3 out of 4 failures Analyte Identified Cause
X Bacteriology Sample mix-up
X Bacteriology Technical error
X PT Reagent error
X CK Transcription error
X LD Transcription error
X Myoglobin Technical problem
X Bilirubin, Direct Calculation error
37
CAP PROFICIENCY TESTING
  • Air Force CY07 Instances of Unsuccessful
    Performance (where 2nd or 3rd failure occurred in
    CY07)

2 out of 3 failures 3 out of 4 failures Analyte Identified Cause
X Chloride Technical problem
X Cholesterol Technical problem
X CK Transcription error
38
CAP PROFICIENCY TESTINGREPORTED CAUSES OF PT
ERRORSOURCE SAFMLS CAP BRIEFING, FEB 07
NO EXPLANATION
OTHER
PT MATERIALS
METHODOLOGICAL
CLERICAL
TECHNICAL
39
CAP PROFICIENCY TESTING
  • Clerical Errors
  • Postanalytic phase
  • Same importance as testing errors
  • Examples
  • Transcription
  • Method/reagent/instrument codes
  • Missing information (TNP, etc.)
  • SOURCE SAFMLS CAP BRIEFING, FEB 07

40
CAP PROFICIENCY TESTING
  • Technical Issues--directly attributable to human
    actions
  • Reconstitution/pipetting/dilution errors
  • Specimen mix-up
  • Improper specimen handling
  • Incorrect instrument set-up
  • Failure to follow testing kit instructions
  • Morphologic misinterpretation
  • SOURCE SAFMLS CAP BRIEFING, FEB 07

41
CAP PROFICIENCY TESTING
  • Mechanical difficulties
  • Instrument software problems
  • Frequency of calibration
  • Inadequate reagent performance
  • Inadequate maintenance/function checks
  • Other instrument malfunction (intermittent
    electric problems)
  • SOURCE SAFMLS CAP BRIEFING, FEB 07

42
CAP PROFICIENCY TESTING
  • Issues with PT testing materials
  • Hemolyzed, contaminated
  • Unstable PT materials
  • Perceived bias
  • Matrix effect incompatible with method
  • Late shipment
  • SOURCE SAFMLS CAP BRIEFING, FEB 07

43
Evaluating Proficiency Testing Failures
  • Evaluate for precision error is evaluated using
    your internal quality control and calculating the
    coefficient of variation
  • CV Standard Deviation divided by the Mean
  • The greater the CV the greater the Precision
    Error
  • Review the survey plots and assess for bias error
  • Bias (Accuracy) error is the difference between
    your mean and the True Mean
  • For PT the True Mean is defined as the Target
    Mean
  • Is more than one results outside the /- 50
    range?
  • Review the survey plots for the last three
    surveys. Is
  • there more than one survey exceeding the /-
    50 limits?
  • Evaluate for developing trends
  • If the answer is yes to any of the above, this
    may identify a gradual long-term trend and
    potential test instability

44
Evaluating Proficiency Testing Failures
45
Evaluating Proficiency Testing Failures
  • Review the CAP survey for discrepant results,
    identified by the X sign. Evaluate the survey
    for
  • Transcription, transposition, dilution, method
    code, or computer entry errors
  • If none of these conditions exist, look for
    specimen handling problems, misinterpretation of
    results, or reporting of results outside the QC
    range
  • Document and take action to prevent recurrence

46
Evaluating Proficiency Testing Failures
  • If the reason for the discrepant results is still
    not apparent, evaluate the test system.
  • Are only high or low results affected? Look for
    a linearity or calibration problem
  • Is the problem limited to one test on the same
    instrument?
  • Are more than one test on same instrument
    affected?
  • Are several tests affected from the same PT
    sample? -- Could be a problem with the specimen
    reconstitution or integrity

47
Evaluating Proficiency Testing Failures
  • Evaluate the status of the discrepant test(s) at
    the time the survey was performed and also
    evaluate the present status.
  • Was instrument maintenance performed
    appropriately?
  • Were controls in range? Were there shifts or
    trends developing?
  • Was the instrument calibrated on schedule?
  • Were reagents and controls in date?

48
Evaluating Proficiency Testing Failures
  • If possible, retest PT specimens. After
    rerunning, you find the results are now in range,
    and
  • One test or specimen was affected, the error
    probably was due to "random analytical error"
    (i.e., aliquot evaporation, pipetting or dilution
    error, or instrument instability)
  • Two or more discrepant results for the same
    analyte were biased in the same direction, the
    error could have been due to "short term
    systematic analytical error" (i.e., improper
    instrument maintenance, reagent deterioration, or
    improper calibration)

49
Evaluating Proficiency Testing Failures
  • If all of the PT errors were explained by the
    previous points
  • Evaluate patient results during this time period
  • Document all corrective actions taken
  • Take steps to prevent recurrence
  • Multiple PT failures over several surveys for
    random or systematic errors could still impact
    patient results
  • Take action to prevent systematic or random
    errors
  • Include retraining personnel on proper techniques

50
Evaluating Proficiency Testing Failures
  • If the results of the retest are not in range
  • Test a new sample of the PT material
  • If necessary perform split sample testing on
    several patients
  • If the new specimens are in range
  • Problem may be PT material itself (i.e.,
    bacterial or fungal contamination, damage in
    shipment due to temperature, hemolysis of the
    specimen, matrix effect, evaporation of the
    specimen, reconstitution dilution error, or delay
    in testing)
  • Note Some of these errors are within control of
    the laboratory

51
Evaluating Proficiency Testing Failures
  • If the results of this retest are out of range,
    the problem is most likely "long term systematic
    errors."
  • Incorrect calibration - Recalibrate
  • Repetitive procedural error - Examine technique
    and retrain staff on proper testing techniques
  • Infrequent performance of the test - Consider
    sending out
  • Instrument problem - Get the manufacturer
    involved
  • Document all actions taken
  • Review patient results performed during this
    period

52
Evaluating Proficiency Testing Failures
  • Repetitive PT failures for the same analytes,
    even though explained through the steps taken
    above are reason for concern.
  • Conduct a thorough review of the testing
    processes
  • Eliminate source of random or systematic errors
  • Seek outside consultation as necessary to
    evaluate the complete process, from specimen
    handling to testing and reporting.

53
CPT 101
  • 7-Digit Code
  • Base Code is 5 Digits
  • Pathology is 80000 Series
  • Last 2 Digits Designates Modifier (Suffix)
  • 00 - Ordered and Performed In-House
  • 26 - Pathologist Interpretation Report
  • 32 - Referred In From Outside Facility
  • 90 - Referred Out to Reference Lab

54
CPT 101
  • AMA CPT Book
  • Organized By Specific Sections
  • Example From Book
  • Indentions
  • New Code Designated by Dot
  • Unlisted Procedures
  • Codes Ending in 99
  • Use Sparingly
  • To Order Call (800) 621-8335 or
  • Visit the AMA Website
  • http//www.ama-assn.org/
  • https//catalog.ama-assn.org/Catalog/home.jsp

55
CPT 101
  • 2008 CPT Update
  • Additions
  • 80047--BASIC METABOL PANEL (CA,IONIZED) THIS
    PANEL MUST INCLD CA,IONIZED (82330) CARBON
    DIOXIDE (82374) CHLORIDE (82435) CREATININE
    (82565) GLUCOSE (82947) K (84132) NA (84295) UREA
    NITROG (BUN) (84520)
  • 82610--CYSTATIN C
  • 83993--CALPROTECTIN, FECAL
  • 86356--MONONUCLEAR CELL ANTIGEN, QUANTITATIVE
    (EG, FLOW CYTOMETRY), NOT OTHERWISE SPECIFIED,
    EACH ANTIGEN
  • 86486--SKIN TEST UNLISTED ANTIGEN, EACH
  • 87500--INFECTIOUS AGENT DETECTION BY NUCLEIC ACID
    (DNA OR RNA) VANCOMYCIN RESISTANCE (EG,
    ENTEROCOCCUS SPECIES VAN A, VAN B), AMPLIFIED
    PROBE TECHNIQUE
  • 87809--INFECTIOUS AGENT ANTIGEN DETECTION BY
    IMMUNOASSAY WITH DIRECT OPTICAL OBSERVATION
    ADENOVIRUS
  • 88381--MICRODISSECTION (IE, SAMPLE PREPARATION OF
    MICROSCOPICALLY IDENTIFIED TARGET) MANUAL
  • 89322--SEMEN ANALYSIS VOLUME, COUNT, MOTILITY,
    AND DIFFERENTIAL USING STRICT MORPHOLOGIC
    CRITERIA (EG, KRUGER)
  • 89331--SPERM EVALUATION, FOR RETROGRADE
    EJACULATION, URINE (SPERM CONCENTRATION,
    MOTILITY, AND MORPHOLOGY, AS INDICATED)

56
CPT 101
  • 2008 CPT Changes
  • Deletion
  • 86586 UNLISTED ANTIGEN, EACH
  • Modifications
  • 80048--BASIC METABOLIC PANEL (CALCIUM, TOTAL)
    THIS PANEL MUST INCLUDE THE FOLLOWING CALCIUM
    (82310) CARBON DIOXIDE (82374) CHLORIDE (82435)
    CREATININE (82565) GLUCOSE (82947) POTASSIUM
    (84132) SODIUM (84295) UREA NITROGEN (BUN)
    (84520)
  • 82272--BLOOD, OCCULT, BY PEROXIDASE ACTIVITY (EG,
    GUAIAC), QUALITATIVE, FECES, 1-3 SIMULTANEOUS
    DETERMINATIONS, PERFORMED FOR OTHER THAN
    COLORECTAL NEOPLASM SCREENING
  • 83898--MOLECULAR DIAGNOSTICS AMPLIFICATION,
    TARGET, EACH NUCLEIC ACID SEQUENCE
  • 83900--MOLECULAR DIAGNOSTICS AMPLIFICATION,
    TARGET, MULTIPLEX, FIRST TWO NUCLEIC ACID
    SEQUENCES
  • 83901--MOLECULAR DIAGNOSTICS AMPLIFICATION,
    TARGET, MULTIPLEX, EACH ADDITIONAL NUCLEIC ACID
    SEQUENCE BEYOND 2 (LIST SEPARATELY IN ADDITION TO
    CODE FOR PRIMARY PROCEDURE)
  • 83908--MOLECULAR DIAGNOSTICS AMPLIFICATION,
    SIGNAL, EACH NUCLEIC ACID SEQUENCE

57
CPT 101
  • 2008 CPT Changes
  • Modifications
  • 86885--ANTIHUMAN GLOBULIN TEST (COOMBS TEST)
    INDIRECT, QUALITATIVE, EACH REAGENT RED CELL
  • 86886--ANTIHUMAN GLOBULIN TEST (COOMBS TEST)
    INDIRECT, EACH ANTIBODY TITER
  • 88380--MICRODISSECTION (IE, SAMPLE PREPARATION OF
    MICROSCOPICALLY IDENTIFIED TARGET) LASER CAPTURE
  • 89320--SEMEN ANALYSIS VOLUME, COUNT, MOTILITY,
    AND DIFFERENTIAL
  • 89321--SEMEN ANALYSIS SPERM PRESENCE AND
    MOTILITY OF SPERM, IF PERFORMED

58
CPT 101
  • Validation
  • Validate Monthly Workload Reports
  • Verify Test Files Have Correct CPT Codes
  • REMEMBER Data Is Used for DoD Decisions Through
    MEPRS and the CLMI Report

59
CLINICAL LABORATORY MANAGEMENT INDICATORS (CLMI)
  • Why CLMI?
  • It Provides tools to
  • Evaluate operational and financial performance
  • Improve utilization of services, productivity,
    and cost effectiveness
  • Data Requirements

60
Manpower Standard for AF Clinical Labs
  • Formula X Y (R/1100) Authorizations
  • Reportable Test (R) 1 authorization for every
    1100 reportable tests per month.
  • Base Cost (X)
  • Peer 1a Facilities (lt/ 12000 enrollees) 2
    requirements (open door cost)
  • Peer 1b Facilities (gt/12000 enrollees) 3
    requirements (open door cost)
  • Peer 2 Facilities (ASU) 4 requirements
  • Peer 3 Facilities (small hospital) 5
    requirements
  • Peer 4 Facilities (large hospital) 7
    requirements

61
Manpower Standard for AF Clinical Labs
  • Additives (Y)  
  • Overseas 1 authorization (overseas readiness
    manpower additive)
  • Isolation/BAT 1 authorization (Biological
    Augmentation Team)--deploys to theater of ops and
    performs bio-defense testing for the area war
    fighters. Facilities with an HLD and a
    non-deployable BAT will be given only 1
    authorization (i.e., Kunsan, Osan)
  • HLD 1 authorization
  • Split Operations In-house 1 authorization (open
    door cost), maximum of 2 labs

62
Manpower Standard for AF Clinical Labs
  • Additives (Y)  
  • Shared Ops 1 authorization (tech commitment to
    sharing facility)
  • Free Standing Lab 2 authorizations (open door
    cost - outside main MTF), maximum of 4 labs
  • Consultant/Flt CC/Grp Supt 1 authorization
    (activities must consume gt50 of time), maximum
    1/MTF
  • Phase II Student Training Program Utilize the
    historically, validated Phase II student training
    program formula of -25.02 16.91 (X)/(MAF)
  • Where X maximum student load MAF Man-hour
    Availability factor. This formula accounts for
    the maximum student load, as well as course
    hours. The first requirement earned is the
    course supervisor, subsequent requirements are
    course instructors.

63
CLMI
  • Phase II Additive Applies to MTFs with Phase II
    Program with 8 or More Students
  • Standard Equation
  • Yc -25.02 16.91(X)
  • Yc Man-hours
  • X Maximum Student Load (Source Phase II
    Medical Training Quarterly Status Report)
  • Phase II Trainers Yc/MAF
  • MAF Man-hour availability factor. (Avg number
    of hours a troop is available in a pay period.
    Determined by AF. Currently 163 hours.)

64
BREAK (1500-1530)
65
WHAT EVERY USAF LABORATORIAN SHOULD KNOW (Part II)
66
CCLM PROJECTS IN PROGRESS
  • Newborn Metabolic Screen (DoD)
  • Feasibility of centrally-funded CLSI Membership
    (AF)
  • Electronic requirements on CAP contract (AF)
  • Lab Director Inter-Service Sharing Agreements
    (DoD)

67
WEBSITES EVERY USAF LABORATORIAN SHOULD BOOKMARK
  • 1. CLIP
  • www.afip.org
  • 2. CLIA
  • www.cms.hhs.gov/CLIA/--CLIA Overview
  • wwwn.cdc.gov/clia/regs/top.aspx--CLIA Regulations
  • 3. KX
  • https//kx.afms.mil/kxweb/home.do-- Kx Homepage
  • 4. FDA
  • www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/
    search.cfm--Test Complexity/Categorization
    Database
  • 5. CAP
  • www.cap.org

68
WEBSITES EVERY USAF LABORATORIAN SHOULD BOOKMARK
  • 6. JCAHO
  • www.jointcommission.org--Main page
  • www.jcrinc.com-- Joint Commission Resources
  • 7. CDC
  • www.bt.cdc.gov/lrn--LRN Information
  • www.cdc.gov/od/sap/index.htm--CDC Select Agent
    Program
  • www.bt.cdc.gov/agent/agentlist-category.asp--Biote
    rrorism Agents and Diseases by Category
  • www.phppo.cdc.gov/nltn/--National Laboratory
    Training Network
  • www.phppo.cdc.gov/nltn/selfstudy.aspx--National
    Laboratory Training Network Self-Study Courses
  • 8. ASM
  • www.asm.org/Policy/index.asp?bid6342--Sentinel
    Level Clinical Microbiology Laboratory Guidelines
  • 9. AAAHC
  • www.aaahc.org/eweb/StartPage.asp

69
Contact Information
  • Maj Imelda M. Catalasan
  • DSN 662-2582
  • DSN FAX 662-6022
  • Commercial 202 782-2582
  • Commercial FAX 202 782-6022
  • E-mail imelda.catalasan_at_afip.osd.mil
  • Alternate E-mail cclmaf_at_afip.osd.mil

70
Contact Information
  • MSgt Gary S. Brown
  • DSN 662-2585
  • DSN FAX 662-6022
  • Commercial 202 782-2585
  • Commercial FAX 202 782-6022
  • E-mail gary.brown2_at_afip.osd.mil
  • Alternate E-mail cclmaf_at_afip.osd.mil

71
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