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1 Perform Quality Control Procedures Timothy R. Myers MBA, RRT-NPS Perform Quality Control Procedures For 1. Blood gas analyzers, co-oximeters 2. Gas analyzers 3. Point-of-care analyzers 4. Pulmonary function equipment 5. Mechanical ventilators 6. Gas metering devices e.g., flowmeter 7. Noninvasive monitors e.g., transcutaneous 8. Record & monitor QC data using accepted statistical methods

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Page 1: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Perform Quality Control Procedures

Timothy R. Myers MBA, RRT-NPS

Perform Quality Control Procedures For �  1. Blood gas analyzers, co-oximeters �  2. Gas analyzers �  3. Point-of-care analyzers �  4. Pulmonary function equipment �  5. Mechanical ventilators �  6. Gas metering devices e.g., flowmeter �  7. Noninvasive monitors e.g., transcutaneous �  8. Record & monitor QC data using accepted statistical methods

Page 2: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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What is Quality Control? � Refers to all those processes and procedures designed

to ensure that the results of laboratory analysis or medical technology are consistent, comparable, accurate and within specified limits of precision

� Typically enacted into routine laboratory or departmental operations by introduction of known standards or manufacturer recommendations

Quality Control Procedures Blood gas analyzers, Co-oximeters

�  Measurement of pH and blood gas parameters assumes critical importance in the care of seriously ill patients; the quality of results is crucial1

�  States and federal government have laws and regulations that govern quality control and aspects specific for blood gases

�  The Joint Commission

�  Clinical Laboratory Improvement Act (CLIA)

1Elser RC. Respir Care 1986: 31

Page 3: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Blood Gas and COx Analyzers

Key Points in QC Blood gas analyzers, Co-oximeters

�  Properly designed protocol or process of quality control measures, documentation and analysis

�  Established to monitor routine, daily or on an as-needed basis

�  QC data permit assessment of correctness for system and subsequent patient data

�  Multiple-level quality control that uses two control levels for pH, PCO2, PO2 and four components of Hb (oxy, deoxy, met and carboxy)

Page 4: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Quality Control of Gas and POC Analyzers

�  Not as stringent requirements as exist for other analyzers

�  Policy and procedures need to be established for appropriate quality control of gas analyzers

�  Should be established from manufacturer’s guidelines �  Two-Point QC for O2 analyzers (100 and 21%)

�  Documented according to Policies & Procedures

Specialty Gas Analyzers

Page 5: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Quality Control Procedures Pulmonary Diagnostic Equipment

� No state or federal government regs

� Policy and procedures need to be established for appropriate pulmonary diagnostic equipment

� Should be established from manufacturer’s guidelines

� Documented according to Policies & Procedures

� Should follow ATS/ERS Guidelines

ATS/ERS Statement

Page 6: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Pulmonary Diagnostic

Quality Control Procedures Pulmonary Diagnostic Equipment

�  Ensures laboratory is consistently meeting appropriate standards

�  Manual of procedures that contains the following: �  calibration procedures �  test-performance procedures �  calculations �  criteria �  reference �  values source

Page 7: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Quality Control Procedures Ventilation Equipment

�  While there are no regulatory mandates for a ventilation quality control process or procedure, high quality and patient safety require a formal process at the department level

�  All ventilation devices require some type of operational verification process (OVP) at the beginning of ventilation and with most equipment restarts �  3rd and 4th generation ventilation devices log OVPs

Ventilation Devices

Page 8: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Quality Control Procedures Ventilation Equipment

�  Most ventilator manufacturers will also track and document programs that provide preventative maintenance and software/option package upgrades

�  Manufacturer recommendations for maintenance, upgrades, OVP and analyzer calibrations should be followed

�  A maintenance and repair log for every ventilation device should be maintained by respiratory care department or biomedical engineering

Quality Control Procedures Ventilation Equipment

�  A strong departmental audit program should be initiated and maintained that includes policies & procedures and documentation on: �  FiO2 analysis �  Alarm settings within acceptable limits �  Accurate documentation of vent/patient checks �  Appropriate frequency, pressure and volume settings �  Accidental extubation and VAP rates �  Weaning parameters and processes �  Iatrogenic problems or conditions

Page 9: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Quality Control Procedures Gas Metering Devices

�  Gas metering devices run the gamut of instruments and delivery devices and include: �  Oxygen blenders �  Flowmeters �  Flow restrictors �  Regulators �  Oxygen Concentrators �  Pulse-dose delivery systems �  Fixed performance device (e.g. venturi masks)

Oxygen Metering Devices

Page 10: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Quality Control Procedures Gas Metering Devices

�  There are no regulations that govern the oversight on the quality control of gas metering devices, but there are specific processes that should be followed: �  Always maintain, store, calibrate and utilize per manufacturer’s

recommendations and guidelines �  A periodic maintenance and testing program should be established with

biomedical engineering or a 3rd party source to validate the accuracy and precision of the gas delivered from the device based on manufacturer specifications

Quality Control Procedures Non-Invasive Monitors

�  Non-Invasive monitors for respiratory care encompass numerous devices and include: �  Pulse Oximeters �  Capnography (End-Tidal CO2) Monitors �  Transcutaneous Devices �  Respiratory Mechanics Devices �  Cardiovascular Monitors �  Apnea Monitors �  Calorimetry �  Special Gas Monitors

Page 11: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Non-Invasive Monitors

Quality Control Procedures Non-Invasive Monitors

�  There are no regulations that govern the oversight on the quality control of non-invasive monitors, but there are specific processes that should be followed:

�  These devices are variable from manufacturer to manufacturer, and from device type to type

�  Many of the devices require specific OVPs or calibration processes to ready them for use or after a specific period of use �  Transcutaneous monitors, Pneumotachs, etc…

�  Always maintain, store, calibrate and utilize per manufacturer’s recommendations and guidelines

Page 12: Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or biomedical engineering Quality Control Procedures Ventilation Equipment ! A strong departmental

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Quality-Control Cycle � Consists of four steps: � Quality planning: consists of defining measurable

outcome � Quality objectives: specific to the product or

service and to the phase in their life cycle � Data collection � Data analysis and implementation

Establishing Control Limits � General principle for establishing control limits is to

estimate the expected variability of the respective characteristic in samples of the size we are about to take �  estimates are then used to establish the control limits on the

chart.

� Although often arbitrarily determined when to declare a process out of control (that is, outside the UCL-LCL range), it is common practice to apply statistical principles to do so

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Quality Control Example