1 / 57

Quality Systems in the Pulmonary Function Laboratory

Quality Systems in the Pulmonary Function Laboratory. Carl Mottram, BA RRT RPFT FAARC Director - Pulmonary Function Labs & Rehabilitation Associate Professor of Medicine - Mayo Clinic College of Medicine. Case Presentation. 31 y.o. female History of present illness

Anita
Download Presentation

Quality Systems in the Pulmonary Function Laboratory

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Quality Systems in the Pulmonary Function Laboratory Carl Mottram, BA RRT RPFT FAARC Director - Pulmonary Function Labs & Rehabilitation Associate Professor of Medicine - Mayo Clinic College of Medicine

  2. Case Presentation • 31 y.o. female • History of present illness • Non-specific cough, tightness in throat and episodic shortness of breath following URI • No wheezing noted by patient or on exam • Exam normal other than obesity (BMI 38) • LMD orders CXR and spirometry with diffusing capacity

  3. Case Presentation • CXR • Spirometry & DLCO Pre Post %Pred FVC 2.102.11 62% FEV1 0.89 1.36 31% Ratio 42.4 64.5 DLCO 8.0 30% Impression: Severe obstruction with a severe reduction in DLCO. Some improvement with BD

  4. Case Presentation • LMD Action Plan • Orders a CT scan • Referred to Mayo Clinic for further evaluation

  5. Case Presentation • Outside CT negative • Pulmonary, ENT, and GI consults scheduled • Pulmonary physician • Negative exam • Lungs clear, patient had coughing spell during exam, no wheezing or stridor noted • Questioned outside spirometry results and orders PFT’s

  6. Case Presentation • Spirometry & DLCO Pre Post %Pred FVC 2.55 2.48 75% FEV1 2.27 2.25 79% Ratio 89 90.7 DLCO 24.2 99% Impression: Borderline restriction most likely 2 to obesity with no evidence of airflow obstruction or BD response

  7. PFT results affect people!!! • Further testing • Labeling (COPD, Asthma, etc) • Medicine • Disability

  8. Guidelines and Standards • American Thoracic Society • 1987 Revised Spirometry Standards • 1991 Reference Values & Interpretation • 1994 Revised Spirometry Standards • 1995 Diffusing Capacity • 1999 Guidelines for Methacholine and Exercise Challenge Testing • ATS/ERS 2005 Series; General Laboratory, Spirometry, Diffusing Capacity, Lung volumes, and Interpretation

  9. Guidelines and Standards • American Association of Respiratory Care (AARC) • Clinical Practice Guidelines (52) • Spirometry • Static lung volumes • Plethysmography • Diffusing Capacity • Infant/Toddler Pulmonary Function Tests

  10. Guidelines and Standards • American Thoracic Society • ATS Pulmonary Function Laboratory Management and Procedure Manual • Updated 2005 • www.thoracic.org • Education • Education Products

  11. Patient Patientassessment Clinicalinterpretation application Path of workflow QSE CLSI’s Quality System In Respiratory Care – HS4-A2

  12. Evidence of Quality Testing • Spirometry in Primary Care Practice* • 30 primary care clinics, 15 trained group /15 usual group • 3.4% in usual group and 13.5% in trained group met ATS acceptability and reproducibility criteria • 1,012 pt. tests, 2,928 blows (2.89) • * Eaton et al, Chest 1999; 116:416-423

  13. Evidence of Quality Testing • Improving the Quality of Bedside Spirometry • Audit of testing outside the PF lab - Cleveland Clinic • 15% - ATS acceptability/reproducibility criteria • CI Project - 63.5% acceptability/reproducibility • Stoller JK. Orens DK. Hoisington E. McCarthy K. Bedside spirometry in a tertiary care hospital: The Cleveland Clinic experience. Respiratory Care. 47(5):578-82, 2002 May

  14. Evidence of Quality Testing • Wanger J, Irvin C Resp Care 36 (12): 1991 • 13 hospitals, 7 different systems, 5 Bio-QC (3 men, 2 women) • DLCO CV 11.5 - 18.6 with the largest diff. 24 units

  15. Evidence of Quality Testing Certification of DLCO Measurements for Clinical Trials Results of the initial DLco simulation tests from 125 pulmonary laboratories 94 (75.2%) Passed with coaching; no hardware 24 (19.2%) Failed. Passed after servicing 6 (4.8%) Failed. Passed with new equipment 1 (0.8%) Site dropped 1 R.L. Jensen, PhD., R.O. Crapo, M.D., P.Y. Berclaz, M.D., Ph, C. Zimmer, B.S., D.M. ATS abstract 2007

  16. Evidence of Quality Testing Results from a surveyof PFT labs in Europe and Latin America Enright, Blonshine, Harris 2007 ERS abstract

  17. Quality Systems in the PFLQuality Assurance “Systematic” approach of monitoring and evaluating quality.

  18. Quality Systems in the PFLQuality Assurance • CLSI’s “Path of workflow” Model • Pre-test • Testing session • Post-test

  19. Quality Systems in the PFLPre-test • Pre-test instructions • Appropriate order • Questionnaire • Height* and weight • Networked systems • Equipment quality assurance program

  20. Quality Systems in the PFLPre-test • Subject preparation • Activities that should preferably be avoided prior to lung function testing. • Smoking within 1 hours of testing • Consuming alcohol within 4 hours of testing • Performing vigorous exercise within 30 minutes of testing • Wearing clothing that substantially restricts full chest and abdominal expansion • Eating a large meal within 2 hours of testing • Deviations recorded 2005 ATS/ERS Standards General Laboratory

  21. Quality Systems in the PFLPre-test • Height and weight • Measured in indoor clothes without shoes • Patients with deformities of the thoracic cage should have their arm span measured • Regression equations • Ht = arm span/1.06 2005 ATS/ERS Standards General Laboratory

  22. Equipment quality assurance Validation/Verification Preventive maintenance Documentation and records (logbooks) Mechanical models Biological models Quality Systems in the PFLPre-test

  23. Quality Systems in the PFLPre-test • Mechanical Model • 3-liter syringe • 0.5, 1-2, 6 second flows • Leak checked • Stored and used in such a way as to maintain the same temperature and humidity of the testing site • Validated based on manufacturer recommendations 2005 ATS/ERS Standards Standardization of Spirometry

  24. Quality Systems in the PFLPre-test Mechanical Model - Plethysmography • Validation using a known volume should be performed periodically • Model lung with thermal mass to simulate isothermal conditions of the lung. • Accuracy 50 ml or 3% 2005 ATS/ERS Standards Standardization of Lung Volumes

  25. Quality Systems in the PFLPre-test • Mechanical Model – Dilution techniques • Analyzer accuracy and linearity • N2 washout: Monthly, exhalation volumes should be checked with the syringe filled with room air, and inhalation volumes with the syringe filled with 100% O2. 2005 ATS/ERS Standards Standardization of Lung Volumes

  26. Quality Systems in the PFLPre-test • Mechanical Models – DLCO • Syringe DLCO weekly or whenever problems occur • VA,VC BTPS ~ 3.2- 3.3L • DLCO Simulator or BioQC 2005 ATS/ERS Standards Standardization of DLCO

  27. Quality Systems in the PFLPre-test • Biological Model • Normal laboratory subjects • Two individuals (13) • Establish mean and SD (minimum 20 samples) 2005 ATS/ERS Standards General Laboratory

  28. Quality Systems in the PFLPre-test Biological Control - Plethysmography • At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested 2005 ATS/ERS Standards - Standardization of Lung Volumes

  29. Quality Systems in the PFLPre-test Biological Control – N2 washout • At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested 2005 ATS/ERS Standards - Standardization of Lung Volumes

  30. Quality Systems in the PFLPre-test Biologic Control – He dilution • At least monthly or whenever errors are suspect 2 reference subjects (biologic controls) should be tested 2005 ATS/ERS Standards - Standardization of Lung Volumes

  31. Quality Systems in the PFLPre-test Biologic Control – Diffusing Capacity • At least weekly • Or whenever errors are suspect • Or whenever a calibration tank is replaced 2005 ATS/ERS Standards - Standardization of DLCO

  32. Quality Systems in the PFLBiological Quality Control - PF Lab • Results “Out of range” • Repeat with another technologist • Second tech is within limits - record out of range data • Second tech out of range - trouble-shoot and document BioQC1: ULN LLN SD CV FEV1 2.95 2.73 0.05 0.02 FVC 3.62 3.35 0.07 0.02 TLC (Pleth) 6.09 5.65 0.11 0.02 DLCO 24.5 21.5 0.75 0.04

  33. Quality Systems in the PFLBiological Quality Control - DLCO Model A versus B: Mean difference 0.5

  34. Quality Systems in the PFLSubject comparisons: DLCO Model A versus B - Mean difference 1.5

  35. Abnormal Study: Mild airway obstruction with a significant response to bronchodilator. Lung volumes suggest hyperinflation. DLCO is within normal limits.

  36. Quality Counts Test performed

  37. “This is fine as far as it goes. From here on, it’s who you know.”

  38. Quality Systems in the PFLTest • Testing room environment • Environmental interference • Technologist’s performance & training - QSE: Personnel • Second technologist • Meeting ATS/ERS acceptability and repeatability criteria (new guidelines)

  39. Quality Systems in the PFLTest - QSE: Personnel • Technologists • Job qualifications • Job descriptions • Orientation • Training • Competency assessment • Continuing education • Performance appraisal

  40. Quality Systems in the PFLTest - QSE: Personnel • Competence Assessment • Training and on-going performance evaluations • NIOSH Spirometry Training Course • cdc.gov/NIOSH/topics/spirometry • AARC’s Spirometry Training • National Board for Respiratory Care • CPFT and RPFT exams

  41. ATS/ERS Standards Standardization of Spirometry Between Maneuver Evaluation • Minimum of 3 maneuvers • Acceptable repeatabilityis achieved when the difference between the largest and the next largest FVC is 0.150 L or less AND the difference between the largest and next largest FEV1 is 0.150 L or less. • For those with an FVC of 1.0 L or less both these values are 0.100 L.

  42. ATS/ERS Standards Standardization of DLCO • Should be at least two acceptable tests that meet the repeatability criteria: • Within 3 mL/min/mmHg-1 (or 1 mmol/min/kPa) of each other • or within 10% of the highest value. • Report average of at least two acceptable tests

  43. ATS/ERS Standards Standardization of Lung Volumes Measurement technique - Plethysmography • Quiet breathing until a stable end-expiratory level is achieved • Close shutter at or near FRC • Approx 2-3 seconds • Gentle pants + 10 cmH2O • 0.5 to 1 Hz (30-60 breaths per minute) • > 1.5 Hz may lead to errors • < 0.5 Hz may cause problems with the controlled leak

  44. ATS/ERS Standards Standardization of Lung Volumes Measurement technique – Plethysmography (cont) • 3-5 technically satisfactory panting maneuvers • Patient then performs an ERV maneuver followed by a slow IVC (preferred method) • “Linked” maneuvers

  45. ATS/ERS Standards Standardization of Lung Volumes A. B. Shutter closure Shutter closure Shutter closure • Preferred method • Secondary preferred method

  46. ATS/ERS Standards Standardization of Lung Volumes • Alternative method • Patient then performs an IC followed by a slow exp. VC Shutter closure Shutter closure

  47. Pant prior to shutter closure Target: < 200 mls switch-in error

  48. ATS/ERS Standards Standardization of Lung Volumes Reporting (Preferred method) • Repeatability: Obtain > 3 FRCpleth values that agree within 5% • Largest FRC – smallest FRC mean FRC • Reported FRC is the mean of the technically satisfactory measurements linked to the technically satisfactory ERV and IVC maneuvers used for calculating RV and TLC. • Reported TLC is the reported value for RV plus the largest of the technically acceptable IVC’s

  49. ATS/ERS Consensus StatementsSummary

  50. Quality Systems in the PFLTestQuality Assurance • Lung volumes - DLCO VA 500 ml larger than TLC - ??? • Technologist Driven Protocols • Reference equations • NHANES III

More Related