4/5/2018. Quality Control: systematic use of methods to ensure the device conforms to standards. Quality Assurance: does the device

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1 Procedures for James P. Sullivan, BA, RPFT Pulmonary Diagnostic Laboratories Memorial Sloan Kettering Cancer Center New York, New York QA, QC and QI: what s the difference? Quality Control: systematic use of methods to ensure the device conforms to standards. Quality Assurance: does the device meet requirements? Quality Improvement: programs to improve or enhance the performance of a device or procedure. Continuous Quality Improvement: ongoing QI programs. Why is QA and QI Important? If it moves air, we can get a number 1

2 The People vs. the Machines Equipment Procedures Calibration vs. Control Mechanical Simulator Devices Technologist Procedures Human Biologic Standard (HBS, or Bio-QC) Self, Peer and Administrative Review The Machines: Calibration Syringes: Can be used for both calibration and control for flow-volume, gas dilution and DL CO. Mechanical Simulator Devices: For flow, VTG and DL CO The People: Human Biologic Standard (HBS): Also referred to as bio-qc Also referred to as bio QC Should be healthy non-smokers asthmatics need not apply 2

3 The People: pros Requires no additional equipment or set-up time. Works on all measurements. Checks the entire system. The absolute best way to really learn how to instruct your patients and operate your system. Almost all labs have a suitable HBS QC subject. The People: cons Not as reproducible and consistent; 5% variance is acceptable, which is not good enough Not all technologists are suitable subjects for HBS QA Diurnal variations limit reliability Technologist resistance The Machines: pros All labs have a calibration syringe. Highly reproducible and consistent. 3

4 The Machines: cons May be costly and complicated. May not check the entire system. What if the device is faulty? The ideal QA program will be a combination of both human and mechanical controls. Calibration Syringes: 3-L is the common standard. All labs should have at least two 3-L syringes, one to calibrate and one to verify. 5-L is very desirable, because this volume more closely approximates more patients. 7-L is best. Syringes should be serviced (cleaned, lubricated and calibrated) as per manufacturer s recommendations. Syringe connectors should be replaced regularly. 4

5 Calibration Syringes: FVC: perform FVL at clinically-relevant flows; should return syringe volume +/- 3%, i.e., L using 3 L syringe. FRC-He or N 2 : perform FRC measurement with different volumes; should return syringe volume plus deadspace. D L co: D L co should be essentially zero; this procedure essentially checks for leaks in the system. VA should be syringe volume plus deadspace. Mechanical Devices: Hans Rudolph Calibration Syringes D L co Simulator Flow-Volume Simulator Resistance Standards Morgan Scientific VTG Simulator SensorMedics VTG Simulator Hans Rudolph D L co Simulator: 5

6 Hans Rudolph Flow-Volume Simulator: Hans Rudolph Flow Resistance Standards: Morgan Scientific VTG Simulator: 6

7 SensorMedics Plethysmograph Simulator Metal box containing calibrated volume and sinusoidal pump. Easy to use, although heavy. One volume only, can be used only on SensorMedics equipment. Will not detect problems in patient circuit. Reference Literature All pulmonary laboratories should have various reference literature available, including, but not limited to: Department policy and procedure manuals Vendors operating manuals All installation records, including initial control studies Corrective action logs ATS/ERS Statements and Lab Manual AARC CPGs Recent pulmonary diagnostics text (Ruppel, Wanger, etc.) 7

8 Human Biologic Standard Controls Collect 20 sets of ATS-compliant data for each control parameter. To be done on properly maintained and functioning analyzer after a full calibration. Usual control parameters are FVC, FEV 1, FRC, TLC, DL CO and VA. Attempt to perform these at the same time of day to minimize diurnal variations. Human Biologic Standard Controls Calculate mean and SD for each parameter. Enter data onto spreadsheet for calculation and graphing. In a normal data distribution: 65% of data will be within ± 1 SD of the mean, 95% of data will be within ± 2 SD of the mean, 99% of data will be within ± 3 SD of the mean. Human Biologic Standard Controls Use Westgard s rules to establish QA responses: When one value exceeds ± 2 SD, a warning condition exists. When one value exceeds ± 3 SD, an out of control condition exists. When two consecutive values exceeds ± 2 SD, an out of control condition exists. 8

9 Human Biologic Standard Controls Use Westgard s rules to establish QA responses: When four consecutive values exceed ± 1 SD in the same direction, an out of control condition exists. When ten consecutive values fall on same side of mean, an out of control condition exists. Human Biologic Standard Controls General QA Rules: ± 2 SD are considered warning limits. Values between 2 and 3 SD indicate an error and the procedure should be repeated. Values beyond ± 3 SD are unacceptable and troubleshooting procedures should commence. 9

10 Peer Review Staff Review Administrative Review Self Review Peer-Review Steps: Quick review of final report Check Order Management System Check demographics Review post-test test comments Confirm calibrations successfully completed Check order studies were performed in Review all FVC trials and graphics Review all SVC/VTG trials and graphics Review all DLCO trials and graphics Check for Hgb adjustment Check for technologist approval Questions? Thank You! 10

11 James P. Sullivan, BA, RPFT Supervisor, Pulmonary Diagnostic Laboratories Memorial Sloan Kettering Cancer Center New York, New York (212)