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What Every USAF Laboratorian Should Know

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1 What Every USAF Laboratorian Should Know
UTCs 200

2 AGENDA (Part I) AFIOH SURVEILLANCE DIRECTORATE CLIP BASICS
CAP LAB ACCREDITATION & PROFICIENCY TESTING CPT 101 SENIOR ENLISTED PERSPECTIVES (CMSGT MOORE) BREAK ( )

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 (as defined in 42 CFR 493 and AFIP Pamphlet 40-24)
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 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

9 CLIP Basics # Certs # Sites High 97 138 84 139 83 90 Moderate 77 118
Complexity Army Navy Air Force # Certs # Sites High 97 138 84 139 83 90 Moderate 77 118 51 65 33 40 PPM 142 220 57 137 206 Waived 323 694 243 150 381 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) 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

11 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

12 CLIP BASICS Pathologist
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)

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.) 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

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, 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

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 42CFR (c) (

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 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

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 CAP’s and CCLM’s records NEED TO MATCH

20 CAP LABORATORY ACCREDITATION AND PROFICIENCY TESTING
AF contract with CAP FA 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 II Section # of Questions % Correct Lab General 19,210 99.5 58,303 99.3 Hematology & Coagulation 5,949 99.6 14,964 Chemistry & Toxicology 5,653 99.9 34,542 99.8 Urinalysis 960 5,579 99.7 Microbiology 9,836 27,553 Transfusion Medicine 2,954 19,968 Diagnostic Immunology 1,809 100 6,709 Flow Cytometry 171 98.8 780 Molecular Pathology 436 1,842 Limited Services Lab 14,322 48,724 POCT 255 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 II Section # of Questions % Correct Anatomic Pathology 3,703 99.8 8,159 99.7 Cytopathology 813 99.6 3,689 Cytogenetics 19 100 78 Clinical Histocompatibility 17 195 TOTALS 66,107 238,456 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

24 CAP LABORATORY ACCREDITATION PROGRAM
PHASE I—TOP ACCREDITATION INSPECTION CITATIONS (AF) HEM – Are there checks of patient reports for correct INR calculations, patient values, and reference ranges under the following circumstances (as listed in checklist)? GEN – Is there evidence of improvement in objective measures of the laboratory’s quality in the preceding 2 years? TRM – 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 I—TOP ACCREDITATION INSPECTION CITATIONS (AF) GEN – Does the laboratory have a procedure for reporting device-related adverse patient events, as required by the FDA? GEN – Does the laboratory have a policy to protect personnel from excessive noise levels? HEM – Are there documented guidelines for detection and special handling of specimens with elevated hematocrits?

26 CAP LABORATORY ACCREDITATION PROGRAM
PHASE II—TOP ACCREDITATION INSPECTION CITATIONS (AF) HEM – Does the method protocol include adequate controls, normal ranges, and proper reporting procedures? TRM – Do the procedures for therapeutic apheresis/phlebotomy provide adequate protection for the patient? TRM – 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)?

27 CAP LABORATORY ACCREDITATION PROGRAM
PHASE II—TOP ACCREDITATION INSPECTION CITATIONS (AF) GEN Is the QM program appraised at least annually for effectiveness? LSV – 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 – Has the competency of each person to perform his/her assigned duties been assessed?

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

29 CAP LABORATORY ACCREDITATION PROGRAM
PHASE I—TOP ACCREDITATION INSPECTION CITATIONS (Other Services) LSV – Are there documented guidelines for detection and special handling of specimens with elevated hematocrits? LSV – Is there a system to periodically measure the actual platelet concentration of the usual “platelet poor” plasma used for many coagulation tests? HEM – 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 – 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 I—TOP ACCREDITATION INSPECTION CITATIONS (Other Services) HEM – Is there a documented policy regarding clearing (flushing) of the volume of intravenous lines before drawing samples for hemostasis testing? GEN – 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 – Does the laboratory have a procedure for reporting device-related adverse patient events, as required by FDA? GEN – Does the laboratory have a policy to protect personnel from excessive noise levels?

31 CAP LABORATORY ACCREDITATION PROGRAM
PHASE II—TOP ACCREDITATION INSPECTION CITATIONS (Other Services) POC – For QUANTITATIVE tests, are control materials at more than one concentration (level) used for all tests at least daily? POC – 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 – Is there documentation of corrective action when control results exceed defined acceptability limits? GEN – Has the competency of each person to perform his/her assigned duties been assessed?

32 CAP LABORATORY ACCREDITATION PROGRAM
PHASE II—TOP ACCREDITATION INSPECTION CITATIONS (Other Services) LSV – Is there evidence of ongoing evaluation of records of controls, instrument maintenance and function, temperature, etc., for all procedures as required? LSV – 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 – 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 II—TOP ACCREDITATION INSPECTION CITATIONS (Other Services) TRM – Do the procedures for therapeutic apheresis/phlebotomy provide adequate protection for the patient? GEN – Does the laboratory have a policy that addresses compliance with CAP terms of accreditation? LSV – Is there documentation of at least annual review of all procedures by the current laboratory director or designee? GEN – Has the competency of each person to perform his/her assigned duties been assessed? TLC – 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.

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 Technical error PT Reagent error CK Transcription error LD Myoglobin Technical problem 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 Cholesterol CK Transcription error

38 CAP PROFICIENCY TESTING REPORTED CAUSES OF PT ERROR SOURCE: 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) or Visit the AMA Website

55 CPT 101 2008 CPT Update Additions
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) CYSTATIN C CALPROTECTIN, FECAL MONONUCLEAR CELL ANTIGEN, QUANTITATIVE (EG, FLOW CYTOMETRY), NOT OTHERWISE SPECIFIED, EACH ANTIGEN SKIN TEST; UNLISTED ANTIGEN, EACH INFECTIOUS AGENT DETECTION BY NUCLEIC ACID (DNA OR RNA); VANCOMYCIN RESISTANCE (EG, ENTEROCOCCUS SPECIES VAN A, VAN B), AMPLIFIED PROBE TECHNIQUE INFECTIOUS AGENT ANTIGEN DETECTION BY IMMUNOASSAY WITH DIRECT OPTICAL OBSERVATION; ADENOVIRUS MICRODISSECTION (IE, SAMPLE PREPARATION OF MICROSCOPICALLY IDENTIFIED TARGET); MANUAL SEMEN ANALYSIS; VOLUME, COUNT, MOTILITY, AND DIFFERENTIAL USING STRICT MORPHOLOGIC CRITERIA (EG, KRUGER) SPERM EVALUATION, FOR RETROGRADE EJACULATION, URINE (SPERM CONCENTRATION, MOTILITY, AND MORPHOLOGY, AS INDICATED)

56 CPT 101 2008 CPT Changes Deletion Modifications
UNLISTED ANTIGEN, EACH Modifications 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) BLOOD, OCCULT, BY PEROXIDASE ACTIVITY (EG, GUAIAC), QUALITATIVE, FECES, 1-3 SIMULTANEOUS DETERMINATIONS, PERFORMED FOR OTHER THAN COLORECTAL NEOPLASM SCREENING MOLECULAR DIAGNOSTICS; AMPLIFICATION, TARGET, EACH NUCLEIC ACID SEQUENCE MOLECULAR DIAGNOSTICS; AMPLIFICATION, TARGET, MULTIPLEX, FIRST TWO NUCLEIC ACID SEQUENCES MOLECULAR DIAGNOSTICS; AMPLIFICATION, TARGET, MULTIPLEX, EACH ADDITIONAL NUCLEIC ACID SEQUENCE BEYOND 2 (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE) MOLECULAR DIAGNOSTICS; AMPLIFICATION, SIGNAL, EACH NUCLEIC ACID SEQUENCE

57 CPT 101 2008 CPT Changes Modifications
ANTIHUMAN GLOBULIN TEST (COOMBS TEST); INDIRECT, QUALITATIVE, EACH REAGENT RED CELL ANTIHUMAN GLOBULIN TEST (COOMBS TEST); INDIRECT, EACH ANTIBODY TITER MICRODISSECTION (IE, SAMPLE PREPARATION OF MICROSCOPICALLY IDENTIFIED TARGET); LASER CAPTURE SEMEN ANALYSIS; VOLUME, COUNT, MOTILITY, AND DIFFERENTIAL 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 (</= 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

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 >50% of time), maximum 1/MTF Phase II Student Training Program: Utilize the historically, validated Phase II student training program formula of: (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 = (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 ( )

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 2. CLIA Overview wwwn.cdc.gov/clia/regs/top.aspx--CLIA Regulations 3. KX Kx Homepage 4. FDA Complexity/Categorization Database 5. CAP

68 WEBSITES EVERY USAF LABORATORIAN SHOULD BOOKMARK
6. JCAHO page Joint Commission Resources 7. CDC Information Select Agent Program Agents and Diseases by Category Laboratory Training Network Laboratory Training Network Self-Study Courses 8. ASM Level Clinical Microbiology Laboratory Guidelines 9. AAAHC

69 Contact Information Maj Imelda M. Catalasan DSN: DSN FAX: Commercial: Commercial FAX: Alternate

70 Contact Information MSgt Gary S. Brown DSN: DSN FAX: Commercial: Commercial FAX: Alternate

71 Questions?


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