Independent Health Facilities

Transcription

1 Independent Health Facilities Assessment Protocol for Pulmonary Function Studies INSTRUCTIONS: Please complete ( ) the attached protocol during the assessment. Ensure that all the questions have been answered, please do not leave any questions blank. A space has been provided at the bottom of each section for your comments.

2 FACILITY NAME/NO.: Date: STAFF s s with Recommendations 1. Do the physicians providing interpreting services meet the qualifications as outlined on Pg 5 of the CPPs&FS? 2. Do the medical staff ensure: The safe, accurate and reliable performance of those tests which the physician will be interpreting? Prompt communication of test results to the referring physician? Assistance is provided to the Quality Advisor to perform other responsibilities that may be assigned to a physician who has had appropriate training? Preparation of written reports for the Quality Advisor detailing any concerns the physician may have as to the safe and proper conduct of the facility? 3. Do the technologists meet the qualifications as outlined on pg 6 of the CPPs & FS? 4. Is there a Chief Technologist appointed? If appointed, does the Chief Technologist meet the qualifications as outlined on pg 6 of the CPPs & FS? 5. Do the Technologists: Ensure they are current with the changing technical trends in the cardiopulmonary field by attending conferences, meetings or other forms of continuing education and reading current relevant literature? Arrange patient appointments and staff work schedules? Distribute to referring physicians and agencies the test requisition and the completed test reports? Maintain proper policies & procedures? Maintain records of equipment calibration, maintenance and repair procedures? Maintain copies of test observations and reports? N/A Comments

3 STAFF s s with Recommendations Maintain administrative records? Ensure that safety policies and the equipment and facilities necessary for their implementation are in place and in working order? Ensure the safe and reliable performance of tests? Observe and follow documented infection control measures? Maintain all necessary facility supplies? Ensure safe and accurate performance of testing procedures? Implement current policies & procedures? Provide assistance to the Quality Advisor? 6. Are written job descriptions available for all staff? 7. Are continuing professional development activities documented by technologists and physicians? 8. Is all staff certified and current in BCLS? N/A Comments POLICIES AND PROCEDURES s s with Recommendations Are there written policies/procedures guidelines for the following? Description of the proper methodology for performing each test offered by the facility, including criteria to ensure that the results obtained is reliable? The predicted normal values for each test offered by the facility including the references from which these values were obtained? Procedures to be followed to maintain proper infection control/body substance precautions as described in the CPSO Guidelines Infection Control in the Physicians Office 2004? Procedures to be followed for each test to ensure that the test is performed only on those patients for whom it can be performed safely? meet N/A Comments Independent Health Facilities Pulmonary Function Protocol 3

4 POLICIES AND PROCEDURES CONT D s s with Recommendations General safety precautions to be followed in operating the facility and performing the tests to prevent adverse health effects from occurring in the facility? Specific first aid measures to be followed in the event of adverse health effect including a description of the arrangement made to transfer patients to an acute care facility when required? A list of safety equipment and medications with expiry dates to be maintained by the facility? Routine maintenance procedures to be followed to ensure reliable and accurate testing equipment? Documentation of regular routine calibration and validation measures on test equipment? Patient consent based on scope of practice in the facility in compliance with the Health Care Consent Act? Latex anaphylaxis? Material Safety Data Sheets (MSDS) current within 3 years for all chemicals maintained in the facility A copy of the Workplace Hazardous Materials Information Systems (WHMIS) manual? Fire safety including fire prevention; classes of fires and extinguishers, steps on discovery of fires, plans for reporting fires, fire evacuation plans and maps? 2. Are policies/procedures reviewed annually and dated accordingly? 3. Is there evidence that the staff know the policy or where to look for the policy if needed? 4. Is there evidence that the policy and procedures are implemented? *Assessor may select staff at random to ask of knowledge or use of policies meet N/A Independent Health Facilities Pulmonary Function Protocol 4

5 QUALITY CONTROL ACTIVITIES s s with Recommendations 1. Are Quality Control Activities implemented: Oxygen Saturation by Oximetry Calibration performed according to manufacturer s recommendations? Biological controls monitored and documented at least monthly? Carbon Monoxide Diffusing Capacity Spirometer volume calibrated to an accuracy of ± 3.5% of the syringe volume (3 ±.105L)? For peumotachometers, varying flow rates (2-12 L/sec) must be injectedusing a 3 L syringe to check for the same recovered volume accuracy range For continuous real-time gas analysis, a 2-point calibration of the infrared analyzer using zero and test gas concentration to within ± 0.5% of the test gas prior to each test For gas chromatography analysis, separation of the test gas concentration into its component gases and detection by a thermal conductivity analyzer to g single chromatograph tracing with a Ne and CO peak is required before each test. For infrared CO analyzers with electronic linearization, and He analyzers, a linear response is established for each test (i.e., the analyzer is adjusted to zero and full scale using the test gas concentration). Linearity check using a minimum of 3 serial gases or primary standards (with a maximum error of ±0.0015%) is completed every 3 months. Time is checked for accuracy within ±1% over 10 sec every 3 months. Biological controls monitored and documented at least monthly? FRC by Closed Circuit Helium Dilution Spirometer calibrated every three months over the full range of the instrument and accurate over 7 L to ± 3.5% of the volume added. A daily 3 L volume calibration (verification) and leak check is performed. Independent Health Facilities Pulmonary Function Protocol 5 N/A Comments

6 QUALITY CONTROL ACTIVITIES CONT D s s with Recommendations Two point (zero to full scale) calibration of the helium analyzer performed daily Biological controls monitored and documented at least monthly FRC by Nitrogen Washout Spirometer calibrated every three months over the full range of the instrument and accurate over 7 L to ± 3.5% of the volume added. Daily 3 L volume check and leak check Accuracy and linearity of the N2 analyzer checked before each patient by performing a 2 point calibration using 0 and 80% Nitrogen. A 3-point linear check is required initially and every 6 months thereafter (0%, 40% and 80% Nitrogen). If Nitrogen is derived from deductions of CO 2 and O 2, the respective analyzers must be checked according to the manufacturer. The pneumotach must be calibrated using room air for the inhaled check and O 2 for the exhaled check. Biological controls monitored and documented at least monthly FRC and Airways Resistance by Body Plethysmography Transducers are calibrated initially and checked every six months for noise and drift interference FRC and Airways Resistance by Body Plethysmography Box pressure transducer calibrated using a cc piston pump at 2 Hz Mouth pressure transducer calibrated using a water or mercury manometer and rotameter for flow Linearity is checked over the entire range of use Physical calibration is performed monthly Biological controls monitored and documented at least monthly Does N/A Independent Health Facilities Pulmonary Function Protocol 6

7 QUALITY CONTROL ACTIVITIES CONT D s s with Recommendations Non-specific Bronchial Provocative Test A new nebulizer s output must be determined by full calibration prior to use. The corresponding flow rate required to deliver the appropriate output must be recorded and used consistently. Checks of nebulizer output every 6 months need only test the output at that flow rate. If it varies by more than 10% during verification, a full calibration must be performed. Spirometer volume calibrated to an accuracy of ± 3.5% of the syringe volume (3 ±.105L). For peumotachometers, varying flow rates (2-12 L/sec) must be injected using a 3 L syringe to check for the same recovered volume accuracy range. Methacholine/provomethacholine and histamine stored according to the parameters and standards (refrigerated at 4 degrees Celsius for no more than 3 months). Stage 1 Exercise Testing Are mechanical bicycles tested for accuracy using known weights at least yearly? Are electronic bicycles calibrated with physical balance such as a torque calibrator at least yearly? Is the treadmill s belt velocity and grade tested yearly? Is each gas analyzer calibrated (2 point with range 0-7% for CO 2 and 0-100% for 0 2 with accuracy of ± 0.03%) prior to use? Three point calibration for O 2 analyzers using 0% O 2, 16% O 2, and 100% O 2 with an accuracy of ± 0.03% and five point calibration for CO2 between0-7% quarterly If the system has a linearizing algorithm a 2 point gas calibration is adequate Spirometer volume calibrated to an accuracy of ± 3.5% of the syringe volume (3 ±.105L)? Does N/A Independent Health Facilities Pulmonary Function Protocol 7

8 QUALITY CONTROL ACTIVITIES CONT D s s with Recommendations For peumotachometers, varying flow rates (2-12 L/sec) must be injected using a 3 L syringe to check for the same recovered volume accuracy range Is the respiratory circuit checked for leaks weekly Are biologic controls performed at least quarterly? Maximal Inspiratory and Expiratory Pressure Check the calibration by applying 100 cmh20 for both positive and negative pressures daily. The measured reading should be within 5% of the expected value. Is at least a 2 point calibration done with a water or mercury manometer over the pressure range used at least quarterly? ARTERIAL BLOOD GASES Is there a one point calibration performed every 30 minutes or at least prior to the patient sample? For ph is a one-point calibration is performed using the calibration solution with normal ph to determine the status of the electrode? Is a two-point calibration is performed every 8 hours using 2 ph buffer solutions (e.g., 7.4 and 6.8) to determine the sensitivity of the electrode? For PCO 2 is a one-point calibration is performed using a precision CO 2 gas mixture (e.g. 5%) to determine the status of the electrode? Is a two-point calibration is performed using 2 precise mixtures of CO 2 concentrations (e.g., 5% and 10%) to determine the sensitivity of the electrode? For PO 2 is a zero point value performed using 0% O 2? Is a one-point calibration performed using one O 2 concentration (e.g., 20%) to determine the sensitivity? Is the spectrophotometer calibrated over the fixed wavelengths using a water sample to determine the zero point and the drift? Is a thg calibration performed every 3 months? Does N/A Comments Independent Health Facilities Pulmonary Function Protocol 8

9 ENVIRONMENT, EQUIPMENT AND SUPPLIES s s with Recommendations 1. Is the facility clean? 2. Is all equipment used in the facility CSA approved? 3. Are electrical cords, plugs, outlets routinely checked for damage? 4. Are gas cylinders Properly labeled and secured to a wall or placed in a stationary cart whether or not they are in use? 5. Are the physicians and staff familiar with the current recommendations of the ATS/ERS regarding pulmonary function standards?* 6. Is mandatory compliance with the minimal recommendations for spirometry, lung diffusion and lung volumes as published in 2005 by the joint publications of the ATS/ERS Task Force be adhered to by staff? 7. Are the physicians and staff familiar with the Clinical Practice Parameters and Facility Standards? 8. In rooms where pharmacological challenge testing is done: Is there adequate ventilation? Are filters used on the expiratory circuit of the mouthpiece apparatus? 9. Are all tubings and valves sterilized after each use? 10. Are clean mouthpieces and noseclips used for each patient? 11. Are disposable bacterial filters used unless the circuitry is changed after each patient? 12. Is equipment that cannot be subjected to heat or chemicals sterilized using a cold sterilizing solution? 13. Does the facility follow manufacturer s recommendations for disinfecting and sterilization equipment? 14. Is the following equipment available in facilities performing exercise testing and bronchoprovocative testing? Sphygmomanometer and stethoscope Wheelchair O 2 source with mask Independent Health Facilities Pulmonary Function Protocol 9 N/A Comments

10 ENVIRONMENT, EQUIPMENT AND SUPPLIES s s with Recommendations Connective tubing Resuscitation equipment Airway management equipment Appropriate drugs 15. Are all resuscitation equipment, drugs and sterile equipment checked monthly for expiry dates? Is this activity documented? 16. Are fire evacuation plans/maps posted throughout the facility? 17. Are fire extinguishers easily accessible and checked each month and replaced if outdated or used? 18. Is the fire evacuation plan practiced periodically? Is fire safety plan activities documented? N/A Independent Health Facilities Pulmonary Function Protocol 10

11 RECORDS s s with Recommendations 1. Are written requisitions completed for all pulmonary function tests? 2. When an order for a test(s) has been dictated over the telephone, is the following written on the requisition by the person to whom the order was dictated? Test(s) Name of requisitioning physician Date and time of order Signature of person receiving the order 3. Does the report contain the following information? Personal data sufficient to identify the patient, the patient s age, height and weight; the referring and reporting physicians, the name of the facility performing the test and the test date? The technologist s comments as to the reliability of the patient s performance during the test, where necessary A summary of the original data obtained, the calculations made during the test and graphic records The reporting physician s interpretation of the original data as well as where appropriate comments as to the relevance of the results to the patient s presenting problem or suggestions as to patient management arising from the results 4. Does the facility maintain a log of activities that include but are not limited to: All maintenance, repair and calibration procedures performed (including biologic controls), results obtained, and where appropriate, corrective action taken 5. Are copies of all reports retained with the requisition and original data for the period of time as specified by the IHFA Regulations? N/A Comments Independent Health Facilities Pulmonary Function Protocol 11

12 QUALITY MANAGEMENT PROGRAM s s with Recommendations 1. Has a Quality Advisory Committee been established as outlined in the IHF Act? 2. Do quality management activities include the following? Establishing a mechanism for periodic review of selected original data for all types of tests performed by the facility to establish that tests are properly performed and reliable Regular review of calibration and validation data on equipment, noting any deviations from accepted norms and recording corrective action taken, if required Reporting and review of all adverse health effects occurring during testing, the action taken, the outcome achieved and documentation of recommendations made for future prevention, if required Establishing a mechanism for periodic review of the pattern of tests that the facility is requested to perform. This review includes but is not limited to: Whether the tests ordered are appropriate to the presenting clinic problem Whether effective use of the facility is being made in assessing these various clinical problems Whether results of these reviews are used to further educate referring physicians and facility staff? Periodic review of reports issued to ensure that: Test results are issued within two weeks accurately? Physicians interpret the studies accurately? Periodic surveys of patients to determine their satisfaction with the services Periodic surveys of referring physicians to determine their satisfaction and whether results have influenced patient outcomes. Independent Health Facilities Pulmonary Function Protocol 12 N/A Comments

13 QUALITY MANAGEMENT PROGRAM s s with Recommendations 3. Do staff participate in planning strategies to overcome any deficiencies and to continuously improve the services provided? 4. Based on the information above, has the facility established a quality management program appropriate for its volume and types of services provided? N/A QUALITY ADVISOR s s with Recommendations 1. Is there a designated Quality Advisor? 2. Is there a formal written agreement for the Quality Advisor to advise the facility owner/operator with respect to the quality of services provided? 3. Does the Quality Advisor fulfill the responsibilities of the appointed role which include but are not limited to the following: The qualifications and work performed by other physicians employed in the facility? The qualifications and work performed by pulmonary function technologists employed in the facility and where the nature and size of the facility warrants the appointment of a chief technologist and office support staff? The accuracy and reliability of the equipment used in performing pulmonary function tests? Whether the tests performed by the facility are done accurately and reliably? Whether the tests performed by the facility are conducted safely, and whether procedures and equipment are available within the facility to manage any adverse reaction that may occur? The appropriate design, staffing, and equipping of the facility so as to ensure patient comfort and safety and the proper performance and reporting of pulmonary function tests? The proper design of pulmonary function test requisitions and reports? The maintenance of all necessary records? Independent Health Facilities Pulmonary Function Protocol 13 N/A Comments

14 QUALITY ADVISOR s s with Recommendations Whether the pulmonary function test results are properly interpreted and promptly communicated to the referring physician? The establishment of a quality assurance program for the facility, including matters related to maintenance of a safe work environment? 4. Based on the information above, has the Quality Advisory fulfilled his/her role as Quality Advisor for the facility? N/A Independent Health Facilities Pulmonary Function Protocol 14

15 FACILITY NAME/NO. PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 7. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 15

16 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 16

17 FACILITY NAME/NO. PULMONARY FUNCTION STUDIES CHART REVIEW FORM PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 8. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 17

18 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 18

19 FACILITY NAME/NO. PULMONARY FUNCTION STUDIES CHART REVIEW FORM PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 9. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 19

20 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 20

21 FACILITY NAME/NO. PULMONARY FUNCTION STUDIES CHART REVIEW FORM PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 10. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 21

22 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 22

23 FACILITY NAME/NO. PULMONARY FUNCTION STUDIES CHART REVIEW FORM PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 11. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 23

24 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 24

25 FACILITY NAME/NO. PULMONARY FUNCTION STUDIES CHART REVIEW FORM PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 12. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 25

26 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 26

27 FACILITY NAME/NO. PULMONARY FUNCTION STUDIES CHART REVIEW FORM PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 13. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 27

28 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 28

29 FACILITY NAME/NO. PULMONARY FUNCTION STUDIES CHART REVIEW FORM PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 14. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 29

30 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 30

31 FACILITY NAME/NO. PULMONARY FUNCTION STUDIES CHART REVIEW FORM PATIENT IDENTIFIER (e: either a chart # or patient initials) Date of Test: Tests Ordered by Referring Physician (please check as applicable) : Oxygen Saturation by Oximetry (J323, J332, J334) Non-specific Bronchial Provocative Test (J333) Carbon Monoxide Diffusing Capacity (J309, 310) MIPs & MEPs (J340) Function Residual Capacity (J311, 307) Stage 1 Exercise Testing(J315, E450, E451) Exercise Challenge Testing for Asthma (J330) Other TESTING GUIDELINES s s with 1. Does the requisition include: patient demographics; clinical information; working diagnosis or reason for test; referring physician s name and signature 2. Are the clinical indications for the procedure in compliance with those listed in the parameters? 3. Are these studies directly related to the patient s clinical condition? 4. Are these confirmed by the information documented in the patient s chart? 5. Was informed consent obtained from the patient based on the test being performed? 6. Are the pre-requisites met: Is spirometry properly performed? Are spirometry results known prior to the test? 15. Are the test results reproducible as outlined in the parameters and standards for: J323, J332, J334 J333 J309, J310 J340 J311, J307 J315, E450, E451 J For J309,310 -Do the acceptable tests reported meet ATS standards for reproducibility; collection volumes; breath hold time; inspiratory volume; inspiratory & expiratory times? 8. For J315, J330, E450, E451 Is a resting ECG done and results known? (exception young healthy individuals) 9. For J330, J315, E450, E451: Is blood pressure taken at 1-2 minute intervals during exercise & recovery from exercise? Are flow-volume loops pre-and post exercise properly performed and reported.? Is a physician in attendance at all times during the test? Independent Health Facilities Pulmonary Function Protocol 31

32 REPORTING GUIDELINES s s with 10. Does the report include the following: Patient demographics Interpretation of the data, and where appropriate comments as to the relevance of the results to the patient s presenting problem For J323, J332, J334 Interpretation of the data taking into account the limitations of the study For J333 Results of baseline spirometry Summary of the data and calculations made If the study is positive, provision of some quantification of hyperactivity For J309, J310 Technologist s comments as to the reliability of patient s performance where necessary Summary of the original data and calculations made during test and where feasible, of the graphical records. For J340 Results of baseline spirometry Technologists comments as to the reliability of patient s performance where necessary Comparison of patient measurement to predicted normal value as to patient management For J311, J307 Results of baseline spirometry Comparison of patient measurement to predicted normal values In the case of abnormal results, type of ventilatory abnormality expected For J330, J315, E450,E451 Description of the exercise study protocol completed or when and why the test was stopped prematurely. Symptoms reported by patients Presence or absence of clinically significant changes in BP or heart rate or rhythm Evaluation of exercise performance and the ventilatory response to exercise Precise identification of the factor(s) that limit(s) exercise performance Results of baseline spirometry and changes seen Comments: Independent Health Facilities Pulmonary Function Protocol 32