what every usaf laboratorian should know

What Every USAF Laboratorian Should Know

2I n t e g r i t y - S e r v i c e - E x c e l l e n c e

AGENDA(Part I)

AFIOH SURVEILLANCE DIRECTORATE

CLIP BASICS

CAP LAB ACCREDITATION & PROFICIENCY TESTING

CPT 101

SENIOR ENLISTED PERSPECTIVES (CMSGT MOORE)

BREAK (1500-1530)


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


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.


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


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


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


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


CLIP Basics

Complexity Army Navy 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


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 non-waived 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 non-waived testing


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

performedNote: The director, if qualified, may perform all duties above, or

delegate to personnel meeting qualifications


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)


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


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


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



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



(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).



(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



(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


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


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



Phase I 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

DoD Consolidated CAP Inspection Outcome CY07

Source: CCLM Briefing at LJWG Meeting, 29 Jan 08, COL Harms



DoD Consolidated CAP Inspection Outcome CY07

Phase I 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.

Source: CCLM Briefing at LJWG Meeting, 29 Jan 08, COL Harms



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?



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?



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)?



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?



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?




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?




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?



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?





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?




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?


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?



CLSI Reference on CAP Checklists

(See MSWord Document)


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.



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



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


CAP PROFICIENCY TESTINGREPORTED CAUSES OF PT ERROR

SOURCE: SAFMLS CAP BRIEFING, FEB 07

51%

24%

12%

7%5% 1%

CLERICAL

NO EXPLANATION

PT MATERIALS

METHODOLOGICAL

TECHNICAL

OTHER



Clerical Errors Postanalytic phase Same importance as testing errors Examples:

Transcription Method/reagent/instrument codesMissing information (TNP, etc.)




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




Mechanical difficulties Instrument software problems Frequency of calibration Inadequate reagent performance Inadequate maintenance/function checks Other instrument malfunction (intermittent

electric problems)




Issues with PT testing materials Hemolyzed, contaminated Unstable PT materials Perceived bias Matrix effect incompatible with method Late shipment



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



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



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



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?



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)



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



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



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



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.


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


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


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)

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

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

CPT 101


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


Why CLMI? It Provides tools to: Evaluate operational and financial performance Improve utilization of services, productivity, and cost

effectiveness Data Requirements

CLINICAL LABORATORY MANAGEMENT INDICATORS (CLMI)


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



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



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.


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.)


BREAK (1500-1530)


WHAT EVERY USAF LABORATORIAN SHOULD KNOW (Part II)


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)


WEBSITES EVERY USAF LABORATORIAN SHOULD BOOKMARK

1. CLIPwww.afip.org

2. CLIAwww.cms.hhs.gov/CLIA/--CLIA Overviewwwwn.cdc.gov/clia/regs/top.aspx--CLIA Regulations

3. KXhttps://kx.afms.mil/kxweb/home.do-- Kx Homepage

4. FDAwww.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm--

Test Complexity/Categorization Database

5. CAPwww.cap.org


WEBSITES EVERY USAF LABORATORIAN SHOULD BOOKMARK

6. JCAHO www.jointcommission.org--Main pagewww.jcrinc.com-- Joint Commission Resources

7. CDCwww.bt.cdc.gov/lrn--LRN Informationwww.cdc.gov/od/sap/index.htm--CDC Select Agent Programwww.bt.cdc.gov/agent/agentlist-category.asp--Bioterrorism Agents and

Diseases by Categorywww.phppo.cdc.gov/nltn/--National Laboratory Training Networkwww.phppo.cdc.gov/nltn/selfstudy.aspx--National Laboratory Training

Network Self-Study Courses

8. ASMwww.asm.org/Policy/index.asp?bid=6342--Sentinel Level Clinical

Microbiology Laboratory Guidelines

9. AAAHCwww.aaahc.org/eweb/StartPage.asp


Contact Information

Maj Imelda M. Catalasan

DSN: 662-2582DSN FAX: 662-6022Commercial: 202 782-2582Commercial FAX: 202 782-6022

E-mail: [email protected] E-mail: [email protected]


Contact Information

MSgt Gary S. Brown

DSN: 662-2585

DSN FAX: 662-6022

Commercial: 202 782-2585

Commercial FAX: 202 782-6022

E-mail: [email protected]

Alternate E-mail: [email protected]

Questions?

what every usaf laboratorian should know

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