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What Every USAF Laboratorian Should Know

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). AGENDA (Part II). LRN (DR. ELIZABETH MACIAS, PH D)

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What Every USAF Laboratorian Should Know

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  1. What Every USAF Laboratorian Should Know

  2. AGENDA(Part I) • AFIOH SURVEILLANCE DIRECTORATE • CLIP BASICS • CAP LAB ACCREDITATION & PROFICIENCY TESTING • CPT 101 • SENIOR ENLISTED PERSPECTIVES (CMSGT MOORE) • BREAK (1500-1530)

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

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

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

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

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

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

  9. CLIP Basics 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 • 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 42CFR493.1273(c) (http://www.phppo.cdc.gov/clia/regs/subpart_k.aspx#493.1273).

  18. CAP LAB DIRECTOR REQUIREMENTS • (3) For laboratories in which the annual test volume does not exceed 500,000, and in which testing is limited to moderately complex tests alone (including provider-performed microscopy [PPM], as defined by U.S. federal regulations), or with waived tests, the director must: • Be qualified as in paragraph (1), OR • Be an M.D., D.O. or D.P.M., licensed to practice in the jurisdiction where the laboratory is located (if required), with at least 20 hours of continuing medical education credit hours in laboratory medicine, or equivalent training during medical 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 • FA7014-07-D-0002 • Period of performance • Proficiency testing orders • Customer Satisfaction Questionnaire • Electronic access and submission of data • Contract modifications

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

  22. CAP LABORATORY ACCREDITATION PROGRAM DoD Consolidated CAP Inspection Outcome CY07 Source: CCLM Briefing at LJWG Meeting, 29 Jan 08, COL Harms

  23. CAP LABORATORY ACCREDITATION PROGRAM DoD Consolidated CAP Inspection Outcome CY07 Source: CCLM Briefing at LJWG Meeting, 29 Jan 08, COL Harms

  24. 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?

  25. 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?

  26. 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)?

  27. 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?

  28. 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?

  29. 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?

  30. 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?

  31. 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?

  32. 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?

  33. 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?

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

  35. CAP PROFICIENCY TESTING DoD Proficiency Testing Statistics

  36. CAP PROFICIENCY TESTING Air Force CY07 Instances of Unsuccessful Performance (where 2nd or 3rd failure occurred in CY07)

  37. CAP PROFICIENCY TESTING Air Force CY07 Instances of Unsuccessful Performance (where 2nd or 3rd failure occurred in CY07)

  38. CAP PROFICIENCY TESTINGREPORTED CAUSES OF PT ERRORSOURCE: SAFMLS CAP BRIEFING, FEB 07 NOEXPLANATION 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

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