Quality Assurance - Revision history

Nugenta: /* II. Variance Reporting / Process Improvement */

2018-08-18T19:16:39Z

II. Variance Reporting / Process Improvement

← Older revision		Revision as of 15:16, 18 August 2018
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	::::r. Exit Acq.		::::r. Exit Acq.

	=== ~~II. Variance~~ Reporting / Process Improvement ===		== Problem Reporting and Process Improvement ==
	'''The Variance / QA-QI Reporting process integrates both proactive and reactive mechanisms of risk management and the safety program while serving as a vehicle for quality improvement / process improvement initiatives.'''

			::The problem reporting system is intended to enhance safety, increase the quality of data collection, and improve user support.
⚫	====~~= A. Variance~~ Reporting =====
	'''The Variance report

		⚫	====Problem Reporting====
	* [[Image:word.png ]] [[Media:Variance_Form.docm \|Variance Form (MS Word (docm)]]
	* [[Image:pdf.png ]] [[Media:Variance_Form.pdf \|Variance Form (Adobe pdf)]]

			::1. The problem report form (under construction) is used to report, track, evaluate / assess, and manage: ::::a. Equipment malfunction and/or failure
	will be used to report, track, evaluate / assess, and manage occurrences (equipment malfunction / failure, adverse events, near-misses, close calls, hazardous conditions, injuries and sentinel events) and departures from normal operations, policies, procedures, and practices involving staff, users, subjects / patients and/or equipment. The objective of the variance reporting process is to determine the factors contributing to the occurrence in order to implement practices and systems to prevent any recurrence. A Variance Report can be initiated by users, subjects / patients and staff if there is:'''
			::::b. Adverse events, near-misses, close calls, hazardous conditions, injuries and sentinel events
			::::c. Departures from normal operations
			::::d. Non-compliance with policies, procedures, and practices involving staff, users, subjects / patients and/or equipment.
			::2. The objective of the problem reporting process is to determine the factors contributing to the occurrence in order to implement practices and systems to prevent any recurrence.
			::3. A Problem Report can be initiated by users, subjects / patients and staff.
			::4. The Problem Report is not a substitute for reporting of events to other authorities, including the IRB, institute clinical director, PI, etc.
			::5. Problems/issues can be submitted anonymously
			::6. If unsure whether to report, err on the side of reporting

		⚫	====Quality Improvement / Suggestions ====
	::::::::::• Equipment failure,
	::::::::::• Equipment that is inoperable,
	::::::::::• Defective equipment,
	::::::::::• Broken equipment,
	::::::::::• An occurrence or
	::::::::::• Variation to normal operations, policies, procedures, and practices.

			::1. Users are encouraged to make suggestions and provide feedback to MEG staff, by directly contacting the staff scientist (Tom Holroyd) and director (Allison Nugent).

			::2. Anonymous suggestions for quality improvement can be made through the Problem Report Form (under construction)
	The Principal Investigator (PI) or the experimenter conducting the study will be responsible for any medical complications or incidents involving a patient / subject. In addition, he/she will be responsible for initiating:
	:::::::::- all variances via the MEG Variance Reporting System,
	:::::::::- any adverse events via the Clinical Center’s Occurrence Reporting System,
	:::::::::- any unsafe conditions and safety related incidents to the Clinical Center’s Safety Committee, and
	:::::::::- all equipment / medical device malfunctions, with and without injury to the manufacturer and/or the Food & Drug Administration (FDA).
	<div align="center">*Refer to Adverse Event / Safety / Medical Device Reporting, Policy & Procedure 10.92.</div>

	In the absence of the PI, the person conducting the study / observing the variance will be responsible for completing a Variance Report and notifying MEG Core staff of all incidents or safety related issues.

	<br>

⚫	====~~= B.~~ Quality Improvement / Suggestions =====
	'''The Quality Improvement / Quality Assurance Report

	*[[Image:word.png ]] [[Media:Quality_and_Process_Improvement_Form.docm \|Quality Improvement Form (MS Word docm)]]
	*[[Image:pdf.png ]] [[Media:Quality_and_Process_Improvement_Form.pdf \|Quality Improvement Form (Adobe pdf)]]

	will serve as an instrument whereby recommendations for improvement and innovation can be initiated, in addition unsafe or unhealthful conditions may be reported by subjects / patient, users or staff as a part of the ongoing quality assurance / process improvement program. A Quality Assurance / Process Improvement report can be initiated by users, subjects / patients and staff in order to:'''

	::::::::::• Make recommendations,
	::::::::::• Provide suggestions or
	::::::::::• Give feedback to MEG Core staff


	<br>

Nugenta: /* Magnetic Phantom Measurement */

2018-08-18T19:06:48Z

Magnetic Phantom Measurement

← Older revision		Revision as of 15:06, 18 August 2018
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	::1. '''Magnetic Phantom Setup:'''		::1. '''Magnetic Phantom Setup:'''
	::::a. Place the platform board on the MEG chair under the Dewar.		::::a. Place the platform board on the MEG chair under the Dewar.

	::::b. Position the Magnetic Phantom (the one with the flat white top) on platform. The energizing cable should be right of center and the Blue Head Coil center.		::::b. Position the Magnetic Phantom (the one with the flat white top) on platform. The energizing cable should be right of center and the Blue Head Coil center.

	::::c. Connect the 3 head coils (Red –right; Green –left; Blue –center) to the magnetic phantom.		::::c. Connect the 3 head coils (Red –right; Green –left; Blue –center) to the magnetic phantom.

	::::d. Plug the energizing cable from the phantom into the MEG jack box spare slot.		::::d. Plug the energizing cable from the phantom into the MEG jack box spare slot.

	::::e. Raise chair so that the phantom is under the helmet.		::::e. Raise chair so that the phantom is under the helmet.

	::::f. Position all the cables so that they hang straight down and do not touch each other.		::::f. Position all the cables so that they hang straight down and do not touch each other.

	::2. '''Running the Calibrate Program from the ACQ Computer:'''		::2. '''Running the Calibrate Program from the ACQ Computer:'''
	::::a. Type “Acq”.		::::a. Type “Acq”.

	::::b. Select Study Type “Calibrate”.		::::b. Select Study Type “Calibrate”.

	::::c. Select Magnetic Phantom.		::::c. Select Magnetic Phantom.

	::::d. Might get an error message here. Select NO.		::::d. Might get an error message here. Select NO.

	::::e. Acquire data.		::::e. Acquire data.

	::::f. Click on Localize Head.		::::f. Click on Localize Head.

	::::g. OK to start localization.		::::g. OK to start localization.

	::::h. Continue.		::::h. Continue.

	::::i. Start.		::::i. Start.

	::::j. Click on Continue.		::::j. Click on Continue.

	::::k. Click on OK.		::::k. Click on OK.

	::::l. Tools menu. Data Editor. Select a set of channels. Expand scale. Drag to pick (pick peak with bar). Display map to check (Select Topograph).		::::l. Tools menu. Data Editor. Select a set of channels. Expand scale. Drag to pick (pick peak with bar). Display map to check (Select Topograph).

	::::m. To perform calculation - Select Tools; Magnetic Dipole Fit; Display LaunchApp.		::::m. To perform calculation - Select Tools; Magnetic Dipole Fit; Display LaunchApp.
	::::::::{\| class="wikitable"		::::::::{\| class="wikitable"
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	::::n. Magnetic Dipole Fit		::::n. Magnetic Dipole Fit

	::::o. Position should be 0, 0, and 0 .05		::::o. Position should be 0, 0, and 0 .05

	::::p. File. Exit.		::::p. File. Exit.

	::::q. File. Close Window.		::::q. File. Close Window.

	::::r. Exit Acq.		::::r. Exit Acq.

Nugenta: /* EEG Gain Calibration */

2018-08-18T19:06:12Z

EEG Gain Calibration

← Older revision		Revision as of 15:06, 18 August 2018
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	::1. Touch the gold static button before removing the head box and before inserting the shorting plug.		::1. Touch the gold static button before removing the head box and before inserting the shorting plug.

	::2. If applicable, remove the EEG jack box.		::2. If applicable, remove the EEG jack box.

	::3. Mount the green EEG Gain Calibration Card (also called the Shorting Plug) on the amplifier.		::3. Mount the green EEG Gain Calibration Card (also called the Shorting Plug) on the amplifier.

	::4. Run Acq for EEG calibration.		::4. Run Acq for EEG calibration.
	::::a. Select - Calibrate.		::::a. Select - Calibrate.
	::::b. Select - EEG.calib		::::b. Select - EEG.calib

	::5. At the query “Would you like to save the protocol as the default for the study?” enter NO.		::5. At the query “Would you like to save the protocol as the default for the study?” enter NO.

	::6. Click on the WINDOWS menu.		::6. Click on the WINDOWS menu.

	::7. EEG channel (highlight 64 EEG channels).		::7. EEG channel (highlight 64 EEG channels).

	::8. Select Null Offset.		::8. Select Null Offset.

	::9. Select Cal gain.		::9. Select Cal gain.

	::10. At Warning click OK.		::10. At Warning click OK.

	::11. Save.		::11. Save.

	::12. Exit Acq; NO (do not save rp file).		::12. Exit Acq; NO (do not save rp file).

	::13. Dsqsetup (To write values to the database).		::13. Dsqsetup (To write values to the database).

	::14. File.		::14. File.

	::15. Save as: Type (“today’s date”. rack).		::15. Save as: Type (“today’s date”. rack).

	::16. Click OK.		::16. Click OK.

	::17. Select Exit.		::17. Select Exit.

	::18. Record Values in the database. Type “. /recordcaib.py –w” (write to database).		::18. Record Values in the database. Type “. /recordcaib.py –w” (write to database).

Nugenta: /* Magnetic Phantom Measurement */

2018-08-18T19:05:36Z

Magnetic Phantom Measurement

← Older revision		Revision as of 15:05, 18 August 2018
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	::::::::{\| class="wikitable"		::::::::{\| class="wikitable"
	\|-		\|-
	\| '''''*Always disassemble the Magnetic Phantom before performing a noise collection.'''''		\| '''*Always disassemble the Magnetic Phantom before performing a noise collection.'''
	\|}		\|}

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	::::f. Position all the cables so that they hang straight down and do not touch each other.		::::f. Position all the cables so that they hang straight down and do not touch each other.

	::2. Running the Calibrate Program from the ACQ Computer:'''		::2. '''Running the Calibrate Program from the ACQ Computer:'''
	::::a. Type “Acq”.		::::a. Type “Acq”.

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	::::r. Exit Acq.		::::r. Exit Acq.


	=== II. Variance Reporting / Process Improvement ===		=== II. Variance Reporting / Process Improvement ===

Nugenta: /* EEG Gain Calibration */

2018-08-18T19:05:10Z

EEG Gain Calibration

← Older revision		Revision as of 15:05, 18 August 2018
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	====EEG Gain Calibration====		====EEG Gain Calibration====
	::~~'''~~EEG Calibration procedures will be performed for quality assurance whenever necessary to evaluate the performance of the MEG / EEG system and / or if EEG results are in doubt.~~'''~~		::EEG Calibration procedures will be performed for quality assurance whenever necessary to evaluate the performance of the MEG / EEG system and / or if EEG results are in doubt.

	::::::::{\| class="wikitable"		::::::::{\| class="wikitable"

Nugenta: /* Head Coil Calibration */

2018-08-18T19:04:48Z

Head Coil Calibration

← Older revision		Revision as of 15:04, 18 August 2018
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	::::n. To accept frequency values for coils hit ENTER.		::::n. To accept frequency values for coils hit ENTER.

		⚫	::6.''' Starting Data Collection #1'''
	<br>
⚫	::6.'''. ~~<u>~~Starting Data Collection #1'''
	::::a. Hit ENTER to launch Acq to start Data Collection #1.		::::a. Hit ENTER to launch Acq to start Data Collection #1.
	::::b. Hit ENTER to select turn reference channels off.		::::b. Hit ENTER to select turn reference channels off.

Nugenta: /* Calibration Procedures */

2018-08-18T19:04:09Z

Calibration Procedures

← Older revision		Revision as of 15:04, 18 August 2018
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	\| '''CALIBRATION PROCEDURE:''' \|\| '''''PERFORM WHENEVER:'''''		\| '''CALIBRATION PROCEDURE:''' \|\| '''''PERFORM WHENEVER:'''''
	\|-		\|-
	\| '''[[Quality Assurance#MEG Noise Collection\|MEG Noise Collection]]''' \|\| '''''There is line frequency noise'''''		\| '''[[Quality Assurance#MEG Noise Collection\|MEG Noise Collection]]''' \|\| '''There is line frequency noise'''
	\|-		\|-
	\| '''[[Quality Assurance#Head Coil Calibration\|Head Coil Calibration]]''' \|\| '''''Head localization results / accuracy is in doubt'''''		\| '''[[Quality Assurance#Head Coil Calibration\|Head Coil Calibration]]''' \|\| '''Head localization results / accuracy is in doubt'''
	\|-		\|-
	\| '''[[Quality Assurance#EEG Gain Calibration\|EEG Gain Calibration]]''' \|\| '''''EEG results are uncertain'''''		\| '''[[Quality Assurance#EEG Gain Calibration\|EEG Gain Calibration]]''' \|\| '''EEG results are uncertain'''
	\|-		\|-
	\| '''[[Quality Assurance#Magnetic Phantom Measurement\|Magnetic Phantom Measurement]]''' \|\| '''''The performance of the MEG system is in question'''''		\| '''[[Quality Assurance#Magnetic Phantom Measurement\|Magnetic Phantom Measurement]]''' \|\| '''The performance of the MEG system is in question'''
	\|}		\|}


	==== A. MEG Noise Collection ====		====MEG Noise Collection====
	::Noise collection calibration procedures will be performed for quality assurance whenever necessary to evaluate the performance of the MEG system. Noise collection is performed to determine the noise level of each individual channel. Data is collected with no subject and all noise sources are removed from the immediate vicinity of the MEG system.		::Noise collection calibration procedures will be performed for quality assurance whenever necessary to evaluate the performance of the MEG system. Noise collection is performed to determine the noise level of each individual channel. Data is collected with no subject and all noise sources are removed from the immediate vicinity of the MEG system.

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	::::::::{\| class="wikitable"		::::::::{\| class="wikitable"
	\|-		\|-
	\| '''''*Disassemble the Magnetic Phantom before performing any noise collection.'''''		\| '''*Disassemble the Magnetic Phantom before performing any noise collection.'''
	\|}		\|}

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	::::::::{\| class="wikitable"		::::::::{\| class="wikitable"
	\|-		\|-
	\| '''''Note: The distance should be 51.49 cm for the Omega-275 System.'''''		\| '''Note: The distance should be 51.49 cm for the Omega-275 System.'''
	\|}		\|}

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	::::::::{\| class="wikitable"		::::::::{\| class="wikitable"
	\|-		\|-
	\| '''''Note: a typical coil moment is 1.7e+11 to 1.8e+11 (fT*cm3)/A. Our range is: 1.6e+11 to 1.8e+11.'''''		\| '''Note: a typical coil moment is 1.7e+11 to 1.8e+11 (fT*cm3)/A. Our range is: 1.6e+11 to 1.8e+11.'''
	\|}		\|}

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	::::::::{\| class="wikitable"		::::::::{\| class="wikitable"
	\|-		\|-
	\| '''''*Disassemble the Magnetic Phantom before performing gain calibration.'''''		\| '''*Disassemble the Magnetic Phantom before performing gain calibration.'''
	\|}		\|}

	::1.Touch the gold static button before removing the head box and before inserting the shorting plug.		::1. Touch the gold static button before removing the head box and before inserting the shorting plug.

	::2.If applicable, remove the EEG jack box.		::2. If applicable, remove the EEG jack box.

	::3.Mount the green EEG Gain Calibration Card (also called the Shorting Plug) on the amplifier.		::3. Mount the green EEG Gain Calibration Card (also called the Shorting Plug) on the amplifier.

	::4. Run Acq for EEG calibration.		::4. Run Acq for EEG calibration.

Nugenta: /* Calibration Procedures */

2018-08-18T19:02:27Z

Calibration Procedures

← Older revision		Revision as of 15:02, 18 August 2018
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	\| '''CALIBRATION PROCEDURE:''' \|\| '''''PERFORM WHENEVER:'''''		\| '''CALIBRATION PROCEDURE:''' \|\| '''''PERFORM WHENEVER:'''''
	\|-		\|-
	\| '''[[Quality Assurance#MEG Noise Collection\|A. MEG Noise Collection]]''' \|\| '''''There is line frequency noise'''''		\| '''[[Quality Assurance#MEG Noise Collection\|MEG Noise Collection]]''' \|\| '''''There is line frequency noise'''''
	\|-		\|-
	\| '''[[Quality Assurance#Head Coil Calibration\|B. Head Coil Calibration''' \|\| '''''Head localization results / accuracy is in doubt'''''		\| '''[[Quality Assurance#Head Coil Calibration\|Head Coil Calibration]]''' \|\| '''''Head localization results / accuracy is in doubt'''''
	\|-		\|-
	\| '''[[Quality Assurance#EEG Gain Calibration\| C. EEG Gain Calibration''' \|\| '''''EEG results are uncertain'''''		\| '''[[Quality Assurance#EEG Gain Calibration\|EEG Gain Calibration]]''' \|\| '''''EEG results are uncertain'''''
	\|-		\|-
	\| '''[[Quality Assurance#Magnetic Phantom Measurement\| D. Magnetic Phantom Measurement''' \|\| '''''The performance of the MEG system is in question'''''		\| '''[[Quality Assurance#Magnetic Phantom Measurement\|Magnetic Phantom Measurement]]''' \|\| '''''The performance of the MEG system is in question'''''
	\|}		\|}

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	==== B. Head Coil Calibration ====		====Head Coil Calibration====

	::1. '''Head Coil Calibration''' will be performed for quality assurance as part of the maintenance and calibration procedures whenever		::1. '''Head Coil Calibration''' will be performed for quality assurance as part of the maintenance and calibration procedures whenever

Nugenta: /* Calibration Procedures */

2018-08-18T19:01:02Z

Calibration Procedures

← Older revision		Revision as of 15:01, 18 August 2018
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	<br>		<br>

	~~::::~~::::{\| class="wikitable"		::::{\| class="wikitable"
	\|-		\|-
	\| '''CALIBRATION PROCEDURE:''' \|\| '''''PERFORM WHENEVER:'''''		\| '''CALIBRATION PROCEDURE:''' \|\| '''''PERFORM WHENEVER:'''''

Nugenta at 19:00, 18 August 2018

2018-08-18T19:00:48Z

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