What Every USAF Laboratorian
Should Know
AGENDA
(Part I)

AFIOH SURVEILLANCE DIRECTORATE

CLIP BASICS

CAP LAB ACCREDITATION & PROFICIENCY
TESTING

CPT 101

SENIOR ENLISTED PERSPECTIVES (CMSGT
MOORE)

BREAK (1500-1530)
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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
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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.
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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
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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
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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
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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
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CLIP Basics
Complexity
Army
#
Certs
Navy
#
Sites
#
Certs
Air Force
# 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
639
1170
249
584
363
717
Svc Tot
Source: LJWG Meeting, 29 Jan 08, Col Harms
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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)

Master’s 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 nonwaived testing

Bachelor’s 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 nonwaived testing
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CLIP BASICS

Required personnel for sites performing MODERATE complexity
tests

Technical consultant
 Pathologist,
 Physician w/ 1 yr lab training/experience
 PhD or master’s degree w/ 1 yr lab training/experience
 Bachelor’s 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, Master’s/Bachelor’s/Associate’s 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
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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/supervising
high complexity testing
 PhD certified by appropriate board (certified by ABMM,
ABCC, ABB, ABMLI)
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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.)
 Master’s degree w/ 2 yrs training/experience (Virology—
minimum of 6 months experience w/in subspecialty)
 Bachelor’s degree w/ 4 yrs training/experience (Virology—
minimum 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
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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, master’s or bachelor’s
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, Master’s/Bachelor’s degrees
 Associate’s 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
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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
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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
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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/regs/subpart_k.aspx#493.1273).

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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 residency;or 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
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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 CAP’s and CCLM’s
records NEED TO MATCH
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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
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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
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CAP LABORATORY ACCREDITATION
PROGRAM
DoD Consolidated CAP Inspection Outcome CY07
Phase I
Section
# of Questions
Lab General
Phase II
% Correct
# of Questions
% Correct
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
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
255
100
7,371
99.0
Urinalysis
POCT
Source: CCLM Briefing at LJWG Meeting, 29 Jan 08, COL Harms
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CAP LABORATORY
ACCREDITATION PROGRAM
DoD Consolidated CAP Inspection Outcome CY07
Phase I
Section
# of Questions
Anatomic Pathology
Phase II
%
Correct
# of Questions
% Correct
3,703
99.8
8,159
99.7
813
99.6
3,689
99.7
Cytogenetics
19
100
78
100
Clinical Histocompatibility
17
100
195
100
66,107
99.7
238,456
99.5
Cytopathology
TOTALS
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
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CAP LABORATORY ACCREDITATION
PROGRAM

PHASE I—TOP 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 laboratory’s 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?

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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE I—TOP 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?

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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE II—TOP 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
patient’s physician for therapeutic
apheresis/phlebotomy procedures, and are records
maintained of all the following elements (as listed in
the checklist)?

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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE II—TOP 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?
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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE I—TOP 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 laboratory’s quality in preceding years?
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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE I—TOP 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?
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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE I—TOP 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?

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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE II—TOP 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?

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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE II—TOP 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?
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CAP LABORATORY
ACCREDITATION PROGRAM

PHASE II—TOP 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?
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CAP LABORATORY
ACCREDITATION PROGRAM
CLSI Reference on CAP Checklists
(See MSWord Document)
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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
253,418
242,427
10,901
95.7
Total
Note: CAP generally recognizes a PT challenge score of 80% or better as being acceptable laboratory performance.
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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
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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
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CAP PROFICIENCY TESTING
REPORTED CAUSES OF PT ERROR
SOURCE: SAFMLS CAP BRIEFING, FEB 07
NO EXPLANATION
7%
5% 1% OTHER
PT MATERIALS
12%
METHODOLOGICAL
51% CLERICAL
24%
TECHNICAL
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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
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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
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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
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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
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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
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Evaluating Proficiency Testing Failures
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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
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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
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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?


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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)
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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
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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
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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
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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.
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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
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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
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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)
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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
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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
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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
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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
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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 (</= 12000 enrollees): 2
requirements (open door cost)
 Peer 1b Facilities (>/=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
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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 nondeployable 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
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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 >50% 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.
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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.)
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BREAK (1500-1530)
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WHAT EVERY USAF LABORATORIAN
SHOULD KNOW (Part II)
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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)
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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
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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--Bioterrorism 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?bid=6342--Sentinel Level Clinical
Microbiology Laboratory Guidelines
9. AAAHC
www.aaahc.org/eweb/StartPage.asp
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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@afip.osd.mil
Alternate E-mail: cclmaf@afip.osd.mil
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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@afip.osd.mil
Alternate E-mail: cclmaf@afip.osd.mil
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Questions?