Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or...
Transcript of Perform Quality Control Procedures - Amazon S3 · maintained by respiratory care department or...
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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
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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
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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)
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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
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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
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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
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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
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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
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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
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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
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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
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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