- Towards Spirometry Excellence
- Why a Spirometry Program Needs a Written Standard Operating Procedure Manual
- Patients should have a Spirometry test before Exubera is prescribed.
- 2005 ATS/ERS Spirometry Standard: Key Changes to Equipment and Test Procedures
- Small decreases in FEV1 may raise lung cancer risk
- News from the NIOSH Course Directors Meeting
- Spirometry - The Forgotten Test
- Why Spirometry Training is Necessary
- Spirometry and Fainting
- Spirometry Certification Need Not Be Painful
- Spirometry's Role In Risk Management
- Managing the psychological factors that control Spirometry test validity
- Why perform 3 Spirometry trials in any test session?
- Why Quality Control?
- Coaching With Style
- The Power Of Spirometry in Medical Surveillance Programs
- Spirometry Refresher Training Does Make a Difference in Spirometry Data Quality
Links to other information:
Towards Spirometry Excellence: Part 1
In the last newsletter the need for a “Standard Operating Procedure” (SOP) manual was discussed. This statement details the contents of a useable SOP:
1. Prescreening Questions
These questions must be asked by the technician prior to performing the spirometry test and is meant to identify any conditions that might be present that would falsely elevate or depress the spirometry test measurements, thereby leading to a false positive or negative.
2. Respiratory Symptom Questionnaire
When subjects present at a clinic with respiratory complaints, specific symptoms need to be elicited and organized in such a way that the over reading physician has key information that explains the spirometry results. Symptoms of cough, phlegm production, and minor wheezing occur early in the course of COPD, and are non specific symptoms that are often of no concern to the subject. The most important symptom from the subject’s point of view is dyspnea on exertion (Mayo Airflow Update Vol 2, No 2 1984)
Symptoms can point to specific lung diseases such a chronic bronchitis, emphysema, 1 asthma, or occupationally related restrictive lung diseases such as asbestosis or
silicosis. The instrument of choice is the American Thoracic Society Questionnaire on Respiratory Symptoms (abridged version). This questionnaire can be filled out in advance of the clinic visit and given to the spirometry technician at the time of testing.
The Prescreening Questionnaire and the Respiratory Symptom Questionnaire can be found in the course manual of those personnel who have completed the NIOSH Spirometry Training Course.
3. Blood Pressure
Because the spirometric test increases intro-thoracic pressures which can aggravate existing cardio vascular conditions such as hypertension, the clinic Medical Director should set a Blood Pressure threshold. When exceeded, the technician clears with the attending physician before proceeding with the test (AARC Spirometry 1995 Update).
In the next newsletter the correct test procedure steps will be described. For those who do not want to create their own SOP, Palmer Associates provides this service which can be discussed by calling 650-726-2973.
Towards Spirometry Excellence: Part 2
In the last newsletter we looked at the first three components of a spirometry Standard Operating Procedures manual (SOP). These included the Prescreening Questionnaire, the Respiratory Symptom Questionnaire, and the criteria for a prescreening Blood Pressure measurement. Besides these, there are ten other components required for a complete SOP.
- A list of the key measurements that the medical director would want to see, along with their definitions. For example, the commonly used measurements are the Forced Vital Capacity (FVC), the Forced Expiratory Volume at one second (FEV1), the flow rate in the middle 50% of the FVC (FEF25-75%), the Peak Flow Rate (PFR), and the % FEV1 (ratio of FEV1/FVC).
- A list of the contraindications to performing a spirometry test that the physician and/or technician should look for: hemoptysis, pneumothorax, unstable cardiovascular status, thoracic, abdominal, or cerebral aneurysms, recent eye surgery, and recent surgeries of the thorax or abdomen.
- Hazards of performing spirometry: dizziness or syncope, chest or back pain, coughing,and bronchospasm.
- Spirometer calibration procedures: these should be detailed depending on whether or not a volume or flow spirometer is used. Procedures for each type of spirometer differ, but must be performed with the periodicity as stated by the OSHA enforced ATS/ERS Standard. This section would include the archiving of records and trouble shooting when calibration falls outside established limits.
- Spirometry program setup steps:
- Establish whether or not the test will be done in the sitting or standing position. Sitting may be safer should a subject faint; however, FEV1 values are smaller in the sitting position. Whether sitting or standing, there are established exceptions to the rule which must be documented and followed.
- Setup should also establish procedures to follow accepted conventions to round height measurements up or down in a manner which prevents bias.
- Setup calls for appropriate selection of prediction equations to calculate percent of predicted value. Currently ATS and ACOEM recommend the NHANES III equations. If your spirometer does not offer this option, use the 1983 Knudsen equations.
- Select which size graphs you want for the printout, large (Validations size) or small (Diagnostic size). The generally accepted rule is that if the spirometer is a hand held unit with limited record storage, use large size graphs since these are required for all SSA disability exams and all legal cases. Computer driven spirometers can generate graphs in either size on demand, so graph size is optional.
The remaining six components of an SOP will be discussed in the next newsletter.
Towards Spirometry Excellence. Part 3
In the previous newsletters we have discussed seven of 13 components of a complete Standard Operations Procedure Manual (SOP). The following one of six remaining components is given.
4. Test Procedure and Instructions
Spirometry testing is simple but fraught with technical pitfalls that can invalidate the pulmonary function measurements. Failure to obtain full understanding, cooperation and effort from a subject during any part of the test usually results in an underestimation of the true pulmonary function. Poorly maintained spirometers also affect the accuracy of observed spirometric values. Such erroneous measurements may cause a normal, healthy subject to be mislabeled as impaired or lead to incorrect assessment of impaired subjects.
In occupational medicine, the consequences of such misinterpretations can go beyond simply making an inaccurate diagnosis. Decisions regarding fitness for duty, workplace accommodation, and compensation for work-related illness may also be affected. Furthermore, since occupational spirometry tests are often conducted in the regulatory and medical-legal arenas, the validity of the spirometry test is likely to be scrutinized. Therefore, it is critical for both clinical and administrative purposes that occupational medicine physicians understand the need for standardization in performing the test.
(ACOEM Spirometry Position Paper, 2000)
A full understanding of what needs to be conveyed to the subject is vital to achieve the maximum response. A maximal inhalation is rapidly taken from room air before placing the mouthpiece in the mouth. Prompt the inhalation with statements such as “Take a deep breath. More, more. All you can hold.” Then prompt the exhalation with: “Now BLAST out hard and fast!” Continue by saying “PUSH, PUSH!” The technician should be a cheerleader with constant, enthusiastic coaching. You need not shout, but have intensity in your voice and good body language.
To insure that test instructions are fully understood, the elements of the instruction are given in six steps.
- Establish rapport.
- Gather pre-test data: Pre-screen questionnaire, B.P., height, BMI.
- Briefly explain test and mouthpiece position.
- Demonstrate mouthpiece position and have test subject demonstrate proper mouthpiece placement. Demonstrate maneuver with maximal effort blast.
- Administer test: Chin up and chair behind if standing, torso upright, mouthpiece off to one side, actively coach to full inspiration and full expiration.
- Look for acceptability and repeatability. (See component 6 in next newsletter)
The test can be repeated up to eight times in order to achieve three acceptable trials, of which the two best FVC and FEV1 values are within 150ml.
In the next newsletter Quality Control requirements will be discussed as well as the remaining elements of the SOP.
Standard Operating Procedures (SOP s) provide a blue print for standardizing the test preparation steps; test procedures and data disposition to be followed by all trained and certified technicians performing spirometry. Not only is it a good idea to have such a manual, but it is now a requirement by the new 2005 ATS/ERS Spirometry Standard. Specifically, the Standard states: In any quality control program, an important element is a manual of procedures that contains the following: calibration procedures, test-performance procedures, calculations, criteria, reference values source, and action to be taken when panic (unusual) values are observed.
An SOP manual not only standardizes test procedures between testing personnel, but also between multiple clinics or facilities within the same organization. Each person performing spirometry testing should have their own copy and refer to it when questions of procedure arises Such SOP s, when rigorously followed, increase the sensitivity and specificity of this important test. Remember, spirometry is the only test available to primary care physicians for the early detection of Chronic Obstructive Pulmonary Diseases, (COPD) such as chronic bronchitis and emphysema. Although coughing, sputum production, and minor wheezing may occur early in the course of COPD, these symptoms are non-specific and of no concern to the subject.
All medical personnel performing spirometry should successfully complete a NIOSH approved spirometry training course as required by NIOSH and ACOEM. As part of that training, students learn of the required elements for an SOP manual and will have enough information to write one. Additional information for preparing an SOP manual can be obtained from the ATS website www.thoracic.org/education/labmanual.asp. Another alternative is to have Palmer Associates Inc. prepare a manual for you, customized for your facility and equipment.
Pfizer has introduced Exubera a new form of insulin delivery! Exubera is the first diabetes treatment that you can inhale. Patients should have a spirometry test before Exubera is prescribed. This opens up a whole new market for spirometry and should help convince those on the fence PCPs.
Exubera is now available in pharmacies. Below is an excerpt from the Exubera prescribing information document:
Because of the effect of Exubera on pulmonary function, all patients should have spirometry (FEV1) assessed prior to initiating therapy with Exubera. Assessment of DLCO should be considered. The efficacy and safety of Exubera in patients with baseline FEV1 or DLCO <70% predicted have not been established and the use of Exuber in this population is not recommended.
Assessment of pulmonary function (e.g., spirometry) is recommended after the first 6 months of therapy, and annually thereafter, even in the absence of pulmonary symptoms. In patients who have a decline of 20% in FEV1 from baseline, pulmonary function test should be repeated. If the 20% decline from baseline FEV1 is confirmed, Exubera should be discontinued. The presence of pulmonary symptoms and lesser declines in pulmonary functions may require more frequent monitoring of pulmonary function and consideration of discontinuation of Exubera.
However, it is more important to note that Exubera should not be used for those who smoke or are ex-smokers of less than 6 months, also those with existing COPD (emphysema, or chronic bronchitis) and asthma. A review of effects show a decline in the FEV1 (-20% in 1.5% of the test group), also for the DLCO, in those receiving treatment. You can find out more about Exubera at www.Exubera.com, since the increased prescribing of this medication may impact your facilities respiratory testing program.
The new 2005 ATS/ERS Spirometry Standard is in effect and we want to highlight key changes to equipment and test procedures to keep you updated.
Equipment Performance Specifications: All are unchanged except for:
PEF: Accuracy + 10% of reading or + .40 L/sec, whichever is greater.
(used to be .20 L/sec). Precision: + 5% or 150ml
Quarterly Chart recorder s time scale to be checked and must fall within 2% of set speed (used to be 1%).
Calibration: The procedure for establishing the relationship between sensor-determined values of Flow and Volume and actual Flow and Volume.
Calibration Check: Validates that the device is within calibration limits (+ 3%). If check fails, a new calibration or maintenance procedure must be undertaken.
The 3 Liter calibration syringe must be accurate to + 15 ml or 0.5%.
Note: A dropped calibration syringe should be considered out of calibration until checked.
Calibration Check for Flow Spirometers:
Volume accuracy of the spirometer to be checked daily using a 3L syringe using 3 Flow ranges (between 0.5L/sec to 12L/sec i.e. 1 sec, 3sec and 6sec). Required accuracy is based upon the combined spirometer and syringe accuracy(+ 3% spirometer plus syringe accuracy of + 0.5 %, or a total of 3.5%). This results in an acceptability window of 3.11 L to 2.90 L.
This is a change from the old standard where only the spirometer accuracy of 3% was considered
Check Linearity of Spirometer Weekly:
This new procedure requires that a 3 liter syringe be used to deliver 3 constant flows at a low flow rate, 3 at mid-range flows, and 3 at high flows. All flows must result in 3 L readings with an accuracy of +3.5%.
Note: When using disposable sensors, a new sensor from the supply source should be tested each day as part of the calibration check.
Daily Calibration Check for Volume Spirometer:
Check volume using a single discharge of 3L. This may need to be repeated several times a day when testing high volumes of people and when the ambient temperature is changing.
Leak tests to be conducted daily. Accomplished by occluding the spirometer outlet and applying a constant positive pressure of 3cm/H2O). A volume loss of >30 ml after 1 minute indicates a leak.
Quarterly Range Calibration:
A volume calibration test must be completed over the entire spirometer range using 1 Liter increments.
Note: Spirometer accuracy must be maintained under BTPS conditions for up to 8 consecutive FVC maneuvers performed within a 10 minute period.
These are now presented for computer screens and for hard copy records.
Computer Screens: Volume: 5mm/L, Flow: 2.5mm/L/sec, Time: 10mm/sec.
Hard Copy: Volume: 10mm/L, Flow: 5mm/L/sec, Time: 20mm/sec. The aspect ratios for Flow Volume Curves are 2 units of Flow to 1 unit of Volume.
The hard copy time requirements can be relaxed in that the time base can be reduced to 10mm/sec when a Flow-Volume curve accompanies the Time-Volume curve.
Test Procedure Updates:
- Well fitting false teeth should not be removed.
- Although not required, a nose clip is recommended.
- It is recommended to sit for the test.
- End of Test (EOT) for adults is 6 seconds with 1 second plateau. For children under 10 years, it is 3 seconds.
The maximum pause between reaching full inspiration and beginning the expiratory effort should not exceed 1 to 2 seconds; otherwise the FVC can be falsely reduced.
Acceptable versus Usable Tests
Acceptable Tests must meet the following 8 Criteria:
- Good Start (no back extrapolation error).
- No cough during the first second.
- No early termination.
- No valsalva maneuver.
- No leak.
- No obstruction of mouthpiece.
- No extra breaths.
- Achieves a one second plateau after a 6 second or greater blow.
An acceptable test meets all 8 criteria listed. This is to be considered the gold standard .
Useable trials are those that only meet criteria 1 and 2. When this occurs, repeat testing up to 8 trials in an effort to obtain 3 Acceptable trials. If only Usable tests are obtained, report results based on the 3 best Usable trials with observed limitations.
An ideal test session requires that 3 Acceptable tests be recorded with the two largest FVC and FEV1 Values reproducing within 150 ml. (Note, the old criteria was 200ml.
Slow Vital Capacity Reproducibility:
When using the Slow Vital Capacity maneuver, the subject must wear a nose clip. Conduct a maximum of 4 trials with a 1 minute rest between trials. The 2 largest VC values should reproduce within + 150 ml.
These changes should be incorporated into your written Standard Operating Procedure (SOP) manuals and rigorously followed during testing in order to st
Jul 14, 2005 - Canadian scientists have
found a significant link between small decreases in lung function and an
elevated risk of lung cancer, with a stronger association in women than men.
Individuals with severely impaired lung function have an increased risk of lung cancer. Whether milder reductions in FEV1 also increase the risk of lung cancer is controversial, say S Wasswa-Kintu (University of British Columbia, Vancouver) and colleagues.
They add: Moreover, there is little consensus on whether men and women have similar risks for lung cancer for similar decreases in FEV1.
To investigate this issue, the researchers reviewed all prospective, population-based studies conducted between 1966 and 2005 that involved at least 5000 participants and examined the relationship between FEV1 and lung cancer, adjusting for smoking status.
Reporting in the journal Thorax, the team identified 28 abstracts, although six of these did not report FEV1, and eight failed to adjust for smoking.
Analysis of four of these studies that reported FEV1 in quintiles revealed that the risk of lung cancer increased as FEV1 decreased. Specifically, there were 2.23 and 3.97-fold increased risks for men and women, respectively, with FEV1 in the lowest quintile (less than 70% of predicted) compared with the highest quintile (100% of predicted).
Notably, the authors report that even relatively small decrements in FEV1 increased the risk of lung cancer, with a 10% FEV1 drop increasing a person s lung cancer risk by 30% in men and 2.64-fold in women.
Wasswa-Kintu et al summarize that reduced FEV1 is strongly associated with lung cancer.
Even a relatively modest reduction in FEV1 is a significant predictor of lung cancer, especially among women, they add.
Thorax 2005; 60: 570 575
We were extremely pleased with our meetings at the AHOC conference in Atlanta, despite the constant tornado warnings, flooding streets, and thunderstorms rarely seen in California. We got to meet the new person in charge of the NIOSH approved spirometry courses, LuAnn Beeckman. She is enthusiastic about fresh resources within NIOSH which will allow more structure and monitoring to ensure top quality courses. There is also talk about a standardized exam, so that anyone completing the course will have covered the same points successfully. We also heard that an updated ATS Standard is in the works which will harmonize the ATS Standard with the European (ERS) Standard. It is anticipated that this standard will be available sometime this Fall. Dr. Beeckman also stated that there are 53 NIOSH courses currently registered in the US; however only 21 are active. And of these only a few offer more than two to three courses per year. Those institutions who do not offer at least one course a year will be suspended.
The course audit program in which NIOSH inspectors will make spot visits, will be reinstituted next year, and courses not meeting minimum standards will be either put on probation or suspended. The good news is that Palmer Associate courses have a good reputation with NIOSH and receive many NIOSH referrals. It was exciting to see such interest in more widespread use of spirometry testing.
We visited the exhibit hall to see if anything new was available in the spirometry field. MEDI seems to be up on the latest models, so we came back with no news along those lines. For us it was like old home week as we saw many colleagues we ve worked with over the years, plus some of our former students. Spirometry is coming into its own and being utilized as never before.
By Dr. Alan Palmer
Spirometry is the only test available to the primary care physician for the early detection of COPD, when it is most amenable to treatment and perhaps reversal. If this statement is true, why is it not being used more? Dr. Charles Irvin of the Vermont Lung Center asked this question in his paper entitled "To Blow or Not to Blow - That is the question" (Respiratory Care Journal 10.02). He states there are four perceived problems that keep physicians from using spirometry:
- Spirometry is a poor test. This criticism reflects the lack of education on the part of the physician community. The National Lung Health Program's recent paper states that spirometry is one of the best clinical tests available for detection of lung disease and is better than Blood Pressure as a predictor for heart disease. Cleary, Spirometry is not only a good test, but an outstanding test.
- The equipment is bulky and expensive. This may have been true at one time, but not now. With the introduction of flow and ultra sonic spirometers that are comparatively smaller and meet all performance specifications; there is no excuse for not offering this test coupled with the fact that equipment is now available for less than $2000. Therefore, the bulkiness issue and cost barriers are gone.
- Spirometry is a hard test to administer. It does require that those administering the test undergo spirometry training so that they can give and quality control the test correctly. It also requires a reasonable amount of cooperation from the subject being tested, yet it only takes about 10 minutes to perform.
- Doctors don't understand what the test numbers mean. Since physicians receive little instruction in spirometry during their medical training, this criticism may be factual. Where they may order and review the electrocardiogram test with confidence, they are reticent to order spirometry testing because of their lack of understanding when doing the interpretation. Because mortality during lung disease is ranked #4 and COPD is under-diagnosed, there is a need to educate the physician community on the value of the test.
Dr. Alan Palmer
Spirometry training provides the student with the basic knowledge and skills to correctly perform the test and obtain meaningful data. There needs to be a complete understanding of the three phases of the spirogram curve and what happens to them when acceptability errors are detected or abnormal data is present and how to identify sub maximal efforts and provided re-instruction as required. Without training testers don't know what to look for, and miss the opportunity to correct the problem as they occur. The ACOEM position paper on Spirometry summarizes this training need:
Spirometry is simple but fraught with technical pitfalls that can invalidate the pulmonary function measurements. Failure to obtain full understanding, cooperation and effort from a subject during any part of the test usually results in an underestimation of the true pulmonary function. Poorly maintained spirometers also affect the accuracy of observed spirometric values. Such erroneous measurements may cause a normal, healthy subject to be mislabeled as 'impaired' or lead to incorrect assessments of impaired subjects. When evaluating changes over time, small decrements in pulmonary function may be lost in the noise of the measurements if testing equipment and/or testing technique are not as accurate, precise, rigorous, and standardized as possible. For analysis of group data, small differences between groups, which may be scientifically important, can be obscured by poor quality data caused be inadequate testing technique
In occupational medicine, the consequences of such misinterpretations can go beyond simply making an inaccurate diagnosis; decisions regarding fitness for duty, workplace accommodation, and compensation for work related illness may be affected. Furthermore, since occupational spirometry tests are often conducted in the regulatory and medical-legal arenas, the validity of the spirometry test is likely to be scrutinized. therefore, it is critical for both clinical and administrative purposes that occupational medicine physicians understand the need for standardization and quality control in spirometry.
(ACOEM Spirometry Positions Paper. 2000)
Fainting is the most common complication of Spirometry. Although it rarely results in injury, it is disturbing to both subject and technician and may be hazardous in some instances. For safety of the subject, piece of mind of the technician or nurse, and for optimal test quality, it helps to understand fainting and how to prevent it.
The Forced Vital Capacity (FVC) maneuver, the basic maneuver performed during Spirometry, requires an inhalation to total lung capacity following by a maximal blasting effort which is then sustained to blowout all of the subject's air as rapidly and completely as possible. This maneuver is demonstrated with the flow volume curve. The initial blast produces the sharp peak at the beginning of the maneuver; continued effort causes expulsion of air at the maximal achievable flow
Rate. Sustained effort results in complete exhalation. If you monitor the pressure in the chest during the FVC maneuver, you will find a very high intra‑
Thoracic pressure during the earliest part of the maneuver. Some subjects may sustain this at a high level. The effect of this increased intra‑thoracic pressure is to form a large pressure gradient for blood, which is returning to the heart through the veins. If the intra‑thoracic pressure is high enough, it can markedly reduce venous return to the heart, which results in a fall in cardiac output and blood pressure. The reduced blood pressure or cardiac output can cause a drop in
Blood supply to the brain and other organs. This drop in blood pressure, if large enough and sustained long enough, can cause a loss of consciousness or fainting.
Why doesn't this happen all of the time? Although it is necessary to develop a high intra‑thoracic pressure to achieve peak flow, it is not necessary to maintain such a high pressure to maintain maximal flow during the latter phase of the expiratory effort. For most subjects, intra‑thoracic pressure is high for only 13 seconds. After that, pressure falls to a low value during the late ~ expiratory effort. In some subjects, particularly muscular subjects with airways obstruction
(Chronic bronchitis, emphysema, and asthma) the presence of airflow obstruction prevents the fall in intra‑thoracic pressure. The more muscular subjects are capable of maintaining a high pressure for a prolonged period of time. These are the subjects who are prone to fainting. How can you prevent fainting? Since a high intrathoracic pressure is needed only for the first 13 seconds of the maneuver, it is possible to coach subjects to avoid lightheadedness or fainting. For
Subjects who have had previous experience with lightheadedness, or in whom you see evidence that they might faint, you can coach them to do a more relaxed expiratory effort during the latter phase of the forced vital capacity maneuver (e.g. "O.K. BLAST!" "Now keep blowing, keep blowing...o.k. Now keep blowing but not so hard, keep blowing but not so hard...) With practice you can coach your subjects through this maneuver without lightheadedness and fainting. How can you be sure you are getting good results? Since maximal flow is limited during most of the expiratory maneuver, a less forceful effort in late expiration can still produce maximal flow. You can compare the flow volume curves of sequential efforts to be sure that maximal flow has been reached (the flow volume curve, FVC and FEV1 should be very comparable). In summary, fainting is due to high intrathoracic pressure during the forced vital capacity maneuver. It occurs most commonly in muscular subjects with airflow obstruction. Cautiously observing your subject and coaching them to do a slightly less forceful, but can avoid it
Still sustained, effort during the late portion of the forced vital capacity maneuver.
Courtesy, Mayo Foundation.
(Palmer Associates Inc.' Teaching Philosophy)
"Hello, Students. So your employer sent you for our two day course at this
nice hotel so you can earn a certificate by passing an exam tomorrow
afternoon"? Feeling a little pressure? Who wouldn't?
Over the years we've become extremely sensitive to the burden many students bring to the classroom. What if I fail the test after the company spent so much to get me here? That's a valid concern and one we try to diffuse right up front with the following statement:
"Text anxiety is detrimental to the learning process and therefore not allowed. You will learn a lot of information in two days, but in a relaxed, supportive atmosphere with one-on-one sessions if required. If you don't do well, we take it as a personal failure. So the goal is to have you all excel."
Every course we have several students admit to suffering from test anxiety, but somehow talking about it helps the cause. We've all struggled with teachers who seem to take special glee in dragging students down with ploys of trick questions, spot quizzes or verbal put-downs. How edifying is that?
We like to see the light bulbs pops on above student heads as they relax and learn, free of nervous hindrances. Although we have not changed our exam over the years, the test scores have soared since we began addressing test jitters and offering reassurance during the introductory session.
To switch an old maxim: Less pain, more gain.
Back to the top
Because Spirometry requires a maximum cooperation from the subject, and anything less than maximum can result in an invalid test or a false negative or positive, wouldn't it be useful if there were a mechanism available to help you, the technician, determine the type of cooperation to expect from any given subject? Such a mechanism would in turn allow you to adopt an appropriate attitude and tailor the test instructions to better meet the subject's needs.
The first step in developing this mechanism was to examine the scope of problems encountered by technicians while testing. This was accomplished by reviewing 6897 Spirometry records collected over a 21 month period at a large corporation. Attending technicians and nurses were encouraged to enter personal comments into each record concerning the degree of cooperation achieved during the test and their perception of the test quality. All of the medical professionals performing the Spirometry tests had undergone NIOSH approved Spirometry training and followed strict written Standard Operating Procedure guidelines which were developed by the company to govern the test quality.
A review of all comments revealed that of the 6897 records 432 subjects (6.3%) had qualifying comments that included reasons why the test was either not done at all, not completed or done incorrectly, as well as any observable subject attitudes which may have accounted for the problems. An examination of the reported comments demonstrated two factors to be operative. The first was motivation, or willingness to follow test instructions; the second was comprehension, or the ability to follow test instructions.
The following figure shows how a quadrant can be formed using Comprehension as the vertical scale and Motivation as the horizontal scale. Four classifications are possible using this approach, acknowledging the fact that there may be varying degrees of homogeneity within each group. Subjects falling into the high motivation-comprehension quadrant (93.7% of the total group) were those who produced an acceptable test record with routine instruction and guidance from the technician. These subjects were labeled Spiro-competents. The remaining group of 432 people were distributed between the other three quadrants. Those in the high motivation-low comprehension quadrant were called Spiro-incompetents, because they tried hard but were unable to produce an acceptable effort without a great deal of effort on the part of the technician and many repeated tests.
Spiro-apathetics were those with low motivation and low comprehension. They did not want to be bothered to do the test and made little attempt to understand or follow directions. Spiro-antagonistics, on the other hand, were high in comprehension and quite capable of producing an acceptable test, but low in motivation. They exhibited overt hostility to performing the test either due to an anti-management stance or fear of test results. Regardless of the reason, they refused either to perform the test or to follow directions, thereby producing unacceptable test data.
The following table distributes the reasons for test failure as observed in the nurses' comments and the appropriate corresponding quadrant.
TECHNICIAN COMMENTS FOR SPIROMETRY TEST FAILURE
Could not follow test instructions
Could not complete test due to coughing
Refused to continue with test
Totally hostile to test with no cooperation
Became dizzy during the test
Pain during the procedure (headache, chest pain, back pain, nosebleeds)
Apathetic about the test (lack of testing maturity)
Refused the test
Existing allergies exacerbated
Learning to deal with all types of subjects of various levels of motivation and comprehension is a learned skill that is equally as important to the technician as knowing how to perform the test correctly. Once technicians can gauge the cooperation which can be expected from a subject, they can adjust their test instruction presentation and thereby enhance the chances of obtaining a successful test. This assessment mechanism helps the technician take the appropriate approach based on subject behavior and attitude for this highly stimulus-response oriented test.
The 1994 ATS Spirometry Standard is recommended by OSHA as the basis for providing NIOSH approved spirometry training. (See OSHA Standards and Compliance letter 3/5/90.) On page 1119 of the ATS Standard, under the paragraph entitled "Subject Instruction and Maneuver Performance", it states: "Volume-Time or Flow-Volume curves from the best three FVC maneuvers must be retained. Further on Page 1121 of the Standard under the paragraph entitled "Measurement Procedure" it states: "Spirometric variables should be measured from a series of at least three acceptable forced expiratory curves.
A valid record, therefore, requires that there be a minimum of 3 Acceptable curves (acceptable means the absence of acceptability errors), of which the two best FVC and FEV1 meet the 5% or 200ml Reproducibility criteria (see page `1121 and 1122 of the Standard). When this criteria is met, it gives confidence to the reader that the best effort was obtained and the values measured represent the truth of lung function.
Although an invalid record can show a subject to be in the normal range, it could be a false negative, or if in the abnormal range, a false positive. When using spirometry data in a surveillance program where data is trended to determine if function is declining at an abnormal rate, even though the data may yet still be in the "normal" range, it is vital to get the absolute true values, which is represented by a valid test. Otherwise, the trends may be obscured.
To encourage testers to continue testing until valid data is obtained, the Standard states on page 1121 under the paragraph entitled "Maximum number of maneuvers" that the test may be repeated up to a maximum of eight times in any one test session.
The ATS 1994 Update recommends that spirometry data collection programs be subject to a Quality Control review to insure the continued collection of valid data. The basis for this recommendation stems from the National Lung Health Study which demonstrated that a consistently applied quality Control program resulted in a significantly higher yield of valid data.
Since data validity results in increased test sensitivity and specificity, it follows that any screening and surveillance program using Quality Control will reduce its risk of obtaining false positive and negative data. The program requires a sample of spirometry records be sent to Palmer Associates Inc. Overread Center on a periodic basis for review and evaluation. Consistent procedural errors that invalidate the data can be identified with corrective measures suggested to that technician.
A graphic performance report is sent to each person submitting records. Summary performance records by person and by site are submitted to management along with performance trend graphs. Companies using this service have improved their data quality Success Rates significantly, for example by going from 78.3% to 95.6%.
The basic document around which all Quality Control decisions are made is a written Standard Operating Procedure Manual (SOP). This document, along with a video showing the steps to be followed, provides a blueprint for standardizing test procedures between personnel and various sites. Such guidelines increase the sensitivity and specificity of the program. Employees appreciate the easy to follow format of these SOP manuals, definitely user friendly.
Steps Required To Implement A Quality Control Program
- Since this program requires a minimum of 10 records to create the Quality Control statistics for each nurse, the monthly testing volume will need to be established.
- Identify those nurses who will be collecting spirometry data. Verify training.
- Identify the make and model of spirometers that will be used to collect data.
- Establish the spirometer program criteria that will be used for all spirometers in use.
- Establish testing criteria with Corporate Medical Director.
- Develop a written Standard
Operating Procedure manual that all nurses must follow when performing the
test. The manual will detail each step of the test procedure:
- Spirometer - initial setup programming.
- Calibration procedures and periodicity.
- Testing : preparation and test procedure.
- Quality Control checks.
- Cleaning and sterilization procedures and frequency.
- Avoiding cross contamination.
- Who should be tested.
- Record keeping requirements.
- Establish procedures for mailing in records on a monthly basis.
In spirometry testing, you may have noticed that the players don’t just step up to the mound and perform their best. They need firm and consistent coaching from the sidelines to give that maximal effort needed for a valid test. The spirometry game becomes a partnership arrangement between the subject and technician due to the stimulus's-response nature of the test. A wimpy coach illicit a wimpy action. A vigorous, enthusiastic coach gets the best results.
Does this coaching need to be of the brow beating category, in which the subject is shouted at throughout the test? Absolutely not. The most effective coaching can actually be whispered, but with such voice intensity, eye contact and body language that the subject knows you mean business. Keep control from start to finish, rave a bit for a good test, reinstruct for the unacceptable tests, and stay vitally interested in performance. Remember, you are looking for 3 Acceptable tests, of which the two best FEV1's and FVC’s reproduce within 200 ml (new Standard Update) or 5%. Enjoy the Game!
Stand by for some grim statistics. Chronic Respiratory Diseases (COPD) in the U.S. is reaching epidemic proportions. An estimated 28 million are affected, and in addition, 400,00 workers develop occupationally related disorders annually. The associated costs total $61.2 billion annually - 22.2 billion incurred for treatment and care and 39 billion due to losses in industrial output due to morbidity and mortality of skilled workers.
Since spirometry is the only test available to the primary care physician for the early detection of COPD (early being defined as “before significant symptoms occur”), this test can be considered an important element in a company’s risk management program.
If one is to define Risk Management as “the identification, evaluation and control of threats to the business enterprise such as: competition, new technology, restrictive legislation, government interference and fines, loss of skilled workers due to morbidity or mortality, increased worker compensation and health care, insurance costs, and increased risk of litigation by workers,” then an effective Respiratory Health Surveillance Program is mandatory.
The success of such a program is dependent on:
- Spirometry equipment that meets the ATS-OSHA performance specifications
- Technicians and nurses who perform spirometry being certified by attending a NIOSH approved training course
- Use of written Standard Operating Procedures (SOP’s)
Data to be read by knowledgeable overreaders trained in spirometry interpretation
Sound like a big order? Nothing compared to playing catch-up after the fact with lawsuits, stiff audit penalties, even the old red tag cease and desist order. Front end preparation saves some nightmare rear end disasters.
According to NIOSH, the number one cause of work related disease and injury in the workplace is Occupational Lung Diseases. This fact, along with the increasing incidence of disabling lung diseases due to cigarette smoking may be sufficient reason for companies to establish an effective spirometry - respiratory surveillance system as part of an overall risk management program. A companies surveillance program should be designed to track the four critical points in the course of a disease.
Primary prevention is an intervention before biologic onset of the disease. An example is prevention of occupational lung disease by use of protective devices (respirators) to reduce levels of dust to which workers are exposed, or the use of OSHA approved dosimeters and spirometry equipment as part of a surveillance system.
Secondary prevention is an intervention when disease can be detected at a stage before it is symptomatic. This is accomplished by using spirometry test data surveillance information for individual or group trend analysis to detect dynamic changes before they become abnormal.
Tertiary prevention or Control is used to define intervention after the onset of identifiable symptoms through entry into the health care system in order to delay, arrest or reverse the course of COPD. An example is discouragement of smoking for individuals, a measure that will arrest or even reverse condition.
An effective respiratory screening and surveillance program can result in significant health cost savings to a business. It has been shown that the yearly costs to identify and treat workers with moderately advanced CRD is four fold greater than if the condition had been detected in its mild state, and eleven fold greater when identified in its severely advanced state. Given the average 14 year life span remaining to those diagnosed with severe CRD, the accumulated health care costs alone are impressive.
A complete program of respiratory screening requires both a test of lung function, spirometry, (the only test available to primary care physicians for the early detection of COPD,) and a rigorous Respiratory symptom Questionnaire which elicits important symptoms of respiratory dysfunction, smoking habits and previous work history. This spectrum of information, when used knowledgably, allows for the early detection of Chronic Respiratory Disease.
The Success of such a screening program and any subsequent surveillance is dependant upon:
- Use of accurate and precise spirometry equipment, approved for use by OSHA
- Development of written Standard Operating Procedures and their enforcement in the field.
- Use of technicians who have undergone NIOSH approved training and certification.
- Standardization of measurement procedures and data categorization
- Continuing quality control of data acquisition procedures in the field and resultant data records
- Knowledgeable interpretation of individual data for clinical care and group data analysis for epidemiological studies
Both the ATS and ACOEM stress the importance of Spirometry refresher training, since it has been observed that test performance by well trained technicians can decay over a period of time resulting in an increasing prevalence of poor quality data. Poor quality data invariably results in an increase in false positive and sometimes false negative interpretations. It would appear that the reason for this downward trend in technician performance can be related to one of the following reasons:
- Increased work pressure (not enough time allocated to the test procedure) thereby prompting technicians to take shortcuts in procedure to save time
- Boredom, resulting in careless work caused by having to perform too many tests each day
The need for periodic retraining of those conducting spirometry testing is supported by a paper written by Dr William Edmonson, writing in the Medical Journal 'Chest' (publication of the American College of Chest Physicians) where he reports on a study conducted to document the effects of periodic retraining of technicians and the resultant improvement in their performance by collecting a higher prevalence of valid data
Does Periodic Technician Training Affect Spirometry Quality?
William R. Edmonson MD, Anywhere University
PURPOSE:Pulmonary function testing is an integral part of clinical decision making. In order to accurately assess disease status, the physician must have a test that is both reproducible and interpretable. The American Thoracic Society (ATS) has published standards for spirometry, lung volumes, and diffusing capacity which give us guidance for having tests which are of acceptable quality. Our study examines the effect of technician education on the quality of spirometry.
METHODS:Using ATS guidelines, we retrospectively analyzed spirometric tests performed by 5 technicians in a large hospital affiliated with an academic institution throughout a 7 month period. Initial on-site training was performed prior to the beginning of the study with a repeat session given 6 months later. Tests were compared throughout the 7 month period for meeting ATS requirements. Tests were considered to meet ATS guidelines if the Forced Vital Capacity, Forced Expired Volume in 1 second, and the Peak Expired Flow were reproducible; in addition, the best test met the ATS criteria for individual trial as follows: 1) initial extrapolation of expiration < 5%; 2) end of test plateau; and 3) expiratory time 6 seconds or greater. _ square analysis was used to test whether there are differences among the three testing periods. Bonferroni correction was used for multiple comparisons. This study was approved by the Institutional Review Board.
RESULTS:After initial training, 71% of spirometry performed met ATS criteria. Two months later, without further training, the percentage of spirometry meeting ATS criteria dropped to 48% (p<0.01). The percentage of tests meeting ATS criteria for the next 4 months remained between 48-51% (p>0.99). Training was then reinitiated with an improvement to 67% of tests meeting ATS standards (p<0.01) which returned results to their previous quality (p>0.99).
CONCLUSION:Decline in quality was statistically significant after 2 months of the initial training session. This trend persisted until repeat training was performed. Periodic technician training improved the percentage of spirometry meeting ATS criteria and, thus, the quality of the tests performed. Periodic training should be considered at least every 2 months for all technicians performing spirometric testing.
CLINICAL IMPLICATIONS:Improved spirometry quality will assist clinicians in making more accurate assessments of their patients' disease status. Cost of medical care may improve if additional testing can be avoided on patients with inaccurate or uninterpretable spirometric tests.
DISCLOSURE:W. R. Edmonson, None.