Quality Improvement Put into Practice

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Quality Improvement Put into Practice

• Carl Mottram, BA RRT RPFT FAARC
• Director - Pulmonary Function Labs
  Rehabilitation
• Assistant Professor of Medicine - Mayo Clinic
  College of Medicine

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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

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Case Presentation

• CXR
• Spirometry DLCO
• Pre Post Pred
• FVC 2.10 2.11 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

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Case Presentation

• LMD Action Plan
• Orders a CT scan
• Referred to Mayo Clinic for further evaluation

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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
  PFTs

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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

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PFT results affect people!!!

• Further testing
• Labeling (COPD, Asthma, etc)
• Medicine
• Disability

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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

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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

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Guidelines and Standards

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

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CLSIs Quality System In Respiratory Care HS4-A2
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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 116416-423

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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

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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

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Quality Improvement Put into Practice - Quality
Assurance

• Systematic approach of monitoring and
  evaluating quality.

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Quality Improvement Put into Practice - Quality
Assurance

• CLSIs Path of workflow Model
• Pre-test
• Testing session
• Post-test

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Quality Improvement Put into Practice Pre-test
Quality Assurance

• Pre-test instructions
• Appropriate order
• Questionnaire
• Height and weight
• Networked systems
• Equipment quality assurance program

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Quality Improvement Put into Practice Pre-test
Quality Assurance

• Equipment quality assurance
• Validation/Verification
• Preventive maintenance
• Documentation and records (logbooks)

• Mechanical models
• Biological models

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Quality Improvement Put into Practice Pre-test
Quality Assurance

• 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
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Quality Improvement Put into Practice Pre-test
Quality Assurance

• 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
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Quality Improvement Put into Practice Pre-test
Quality Assurance

• 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
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Quality Improvement Put into Practice Pre-test
Quality Assurance

• Mechanical Models DLCO
• Syringe DLCO weekly or whenever problems occur
• VA BTPS 3.3L
• DLCO Simulator or BioQC

2005 ATS/ERS Standards Standardization of DLCO
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Quality Improvement Put into Practice Pre-test
Quality Assurance

• Biological Model
• Normal laboratory subjects
• Two individuals (13)
• Establish mean and SD (minimum 20 samples)

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Quality Improvement Put into Practice Pre-test
Quality Assurance

• 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
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Quality Improvement Put into Practice Pre-test
Quality Assurance

• 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
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Quality Improvement Put into Practice Pre-test
Quality Assurance

• 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
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Quality Improvement Put into Practice Pre-test
Quality Assurance

• 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
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Quality AssuranceBiological 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

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Quality AssuranceBiological Quality Control -
DLCO
Model A versus B Mean difference 0.5
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Quality AssuranceSubject comparisons DLCO
Model A versus B - Mean difference 1.5
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Quality Improvement Put into Practice Test
Quality Assurance

• Testing room environment
• Environmental interference
• Technologists performance training - QSE
  Personnel
• Second technologist
• Meeting ATS/ERS acceptability and repeatability
  criteria (new guidelines)

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Quality Improvement Put into Practice Test
Quality Assurance - QSE Personnel

• Technologists
• Job qualifications
• Job descriptions
• Orientation
• Training
• Competency assessment
• Continuing education
• Performance appraisal

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Quality Improvement Put into Practice Test
Quality Assurance - QSE Personnel

• Competence Assessment
• Training and on-going performance evaluations
• NIOSH Spirometry Training Course
• cdc.gov/NIOSH/topics/spirometry
• AARCs Spirometry Training
• National Board for Respiratory Care
• CPFT and RPFT exams

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Quality Improvement Put into Practice Test
Quality Assurance

• Lung volumes - DLCO VA 500 ml larger than TLC -
  ???
• Technologist Driven Protocols
• Reference equations

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Quality Improvement Put into Practice Test
Quality Assurance

• Technologist Driven Protocols
• Flowcharting the process

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Quality Improvement Put into Practice Post-Test
Quality Assurance

• Maneuver selection
• Quality review by second technologist
• While in-house training may achieve the desired
  goals, laboratory directors should strongly
  consider the benefits of formal training programs
  from outside providers.
• Feedback to the technicians concerning their
  performance should be provided on a routine basis

2005 ATS/ERS Standards General Laboratory
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Technician Training and Feedback Improve Test
Quality
GPA
Year
Lung Health StudyEnright Am Rev Respir Dis
1431215, 1991
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Quality Improvement Put into Practice Post-Test
Quality Assurance

• Turn-around time
• Average TRT lt1 day (15), 1-2 d (30), 3-4 d
  (27), 5-6 d (15), gt7 d (3)
• ATS PFL Registry Abstract AARC 2005, OF-05-037
• Electronic Medical Record

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Quality Improvement Put into Practice Does it
Work?

• Retrospective review of 18,000 consecutive pts.
  at Mayo Clinic
• Ninety percent of the patients were able to
  reproduce FEV1 within 120 ml (6.1), FVC within
  150 ml (5.3), and PEF within 0.80 L (12).
• Enright PL. Beck KC. Sherrill DL. Repeatability
  of spirometry in 18,000 adult patients. American
  Journal of Respiratory Critical Care Medicine.
  169(2)235-8, 2004 Jan 15.

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This is fine as far as it goes. From here on,
its who you know.