20 CFR 718 Appendix B - Standards for Administration and Interpretation of Pulmonary Function Tests. Tables B1, B2, B3, B4, B5, B6.

• Section Number: 718 Appendix B
• Section Name: Standards for Administration and Interpretation of Pulmonary Function Tests. Tables B1, B2, B3, B4, B5, B6.

    The following standards are established in accordance with 
section 402(f)(1)(D) of the Act. They were developed in consultation 
with the National Institute for Occupational Safety and Health 
(NIOSH). These standards are promulgated for the guidance of 
physicians and medical technicians to insure that uniform procedures 
are used in administering and interpreting ventilatory function 
tests and that the best available medical evidence will be submitted 
in support of a claim for black lung benefits. If it is established 
that one or more standards have not been met, the claims adjudicator 
may consider such fact in determining the evidentiary weight to be 
given to the results of the ventilatory function tests.
    (1) Instruments to be used for the administration of pulmonary 
function tests shall be approved by NIOSH and shall conform to the 
following criteria:
    (i) The instrument shall be accurate within +/-50 ml or within 
+/-3 percent of reading, whichever is greater.
    (ii) The instrument shall be capable of measuring vital capacity 
from 0 to 7 liters BTPS.
    (iii) The instrument shall have a low inertia and offer low 
resistance to airflow such that the resistance to airflow at 12 
liters per second must be less than 1.5 cm H20/liter/sec.
    (iv) The instrument or user of the instrument must have a means 
of correcting volumes to body temperature saturated with water vapor 
(BTPS) under conditions of varying ambient spirometer temperatures 
and barometric pressures.
    (v) The instrument used shall provide a tracing of flow versus 
volume (flow-volume loop) which displays the entire maximum 
inspiration and the entire maximum forced expiration. The instrument 
shall, in addition, provide tracings of the volume versus time 
tracing (spirogram) derived electronically from the flow-volume 
loop. Tracings are necessary to determine whether maximum 
inspiratory and expiratory efforts have been obtained during the FVC 
maneuver. If maximum voluntary ventilation is measured, the tracing 
shall record the individual breaths volumes versus time.
    (vi) The instrument shall be capable of accumulating volume for 
a minimum of 10 seconds after the onset of exhalation.
    (vii) The instrument must be capable of being calibrated in the 
field with respect to the FEV1. The volume calibration shall be 
accomplished with a 3 L calibrating syringe and should agree to 
within 1 percent of a 3 L calibrating volume. The linearity of the 
instrument must be documented by a record of volume calibrations at 
three different flow rates of approximately 3 L/6 sec, 3 L/3 sec, 
and 3 L/sec.
    (viii) For measuring maximum voluntary ventilation (MVV) the 
instrument shall have a response which is flat within +/-10 percent 
up to 4 Hz at flow rates up to 12 liters per second over the volume 
range.
    (ix) The spirogram shall be recorded at a speed of at least 20 
mm/sec and a volume excursion of at least 10mm/L. Calculation of the 
FEVl from the flow-volume loop is not acceptable. Original tracings 
shall be submitted.
    (2) The administration of pulmonary function tests shall conform 
to the following criteria:
    (i) Tests shall not be performed during or soon after an acute 
respiratory illness.
    (ii) For the FEV1 and FVC, use of a nose clip is required. The 
procedures shall be explained in simple terms to the patient who 
shall be instructed to loosen any tight clothing and stand in front 
of the apparatus. The subject may sit, or stand, but care should be 
taken on repeat testing that the same position be used. Particular 
attention shall be given to insure that the chin is slightly 
elevated with the neck slightly extended. The subject shall be 
instructed to expire completely, momentarily hold his breath, place 
the mouthpiece in his mouth and close the mouth firmly about the 
mouthpiece to ensure no air leak. The subject will than make a 
maximum inspiration from the
instrument and when maximum inspiration has been attained, without 
interruption, blow as hard, fast and completely as possible for at 
least 7 seconds or until a plateau has been attained in the volume-
time curve with no detectable change in the expired volume during 
the last 2 seconds of maximal expiratory effort. A minimum of three 
flow-volume loops and derived spirometric tracings shall be carried 
out. The patient shall be observed throughout the study for 
compliance with instructions. Inspiration and expiration shall be 
checked visually for reproducibility. The effort shall be judged 
unacceptable when the patient:
    (A) Has not reached full inspiration preceding the forced 
expiration; or
    (B) Has not used maximal effort during the entire forced 
expiration; or
    (C) Has not continued the expiration for least 7 sec. or until 
an obvious plateau for at least 2 sec. in the volume-time curve has 
occurred; or
    (D) Has coughed or closed his glottis; or
    (E) Has an obstructed mouthpiece or a leak around the mouthpiece 
(obstruction due to tongue being placed in front of mouthpiece, 
false teeth falling in front of mouthpiece, etc.); or
    (F) Has an unsatisfactory start of expiration, one characterized 
by excessive hesitation (or false starts). Peak flow should be 
attained at the start of expiration and the volume-time tracing 
(spirogram) should have a smooth contour revealing gradually 
decreasing flow throughout expiration; or
    (G) Has an excessive variability between the three acceptable 
curves. The variation between the two largest FEV1's of the three 
acceptable tracings should not exceed 5 percent of the largest FEV1 
or 100 ml, whichever is greater. As individuals with obstructive 
disease or rapid decline in lung function will be less likely to 
achieve this degree of reproducibility, tests not meeting this 
criterion may still be submitted for consideration in support of a 
claim for black lung benefits. Failure to meet this standard should 
be clearly noted in the test report by the physician conducting or 
reviewing the test.
    (iii) For the MVV, the subject shall be instructed before 
beginning the test that he or she will be asked to breathe as deeply 
and as rapidly as possible for approximately 15 seconds. The test 
shall be performed with the subject in the standing position, if 
possible. Care shall be taken on repeat testing that the same 
position be used. The subject shall breathe normally into the 
mouthpiece of the apparatus for 10 to 15 seconds to become 
accustomed to the system. The subject shall then be instructed to 
breathe as deeply and as rapidly as possible, and shall be 
continually encouraged during the remainder of the maneuver. Subject 
shall continue the maneuver for 15 seconds. At least 5 minutes of 
rest shall be allowed between maneuvers. At least three MVV's shall 
be carried out. (But see Sec. 718.103(b).) During the maneuvers the 
patient shall be observed for compliance with instructions. The 
effort shall be judged unacceptable when the patient:
    (A) Has not maintained consistent effort for at least 12 to 15 
seconds; or
    (B) Has coughed or closed his glottis; or
    (C) Has an obstructed mouthpiece or a leak around the mouthpiece 
(obstruction due to tongue being placed in front of mouthpiece, 
false teeth falling in front of mouthpiece, etc.); or
    (D) Has an excessive variability between the three acceptable 
curves. The variation between the two largest MVVs of the three 
satisfactory tracings shall not exceed 10 percent.
    (iv) A calibration check shall be performed on the instrument 
each day before use, using a volume source of at least three liters, 
accurate to within +/-1 percent of full scale. The volume 
calibration shall be performed in accordance with the method 
described in paragraph (1)(vii) of this Appendix. Accuracy of the 
time measurement used in determining the FEV1 shall be checked using 
the manufacturer's stated procedure and shall be within +/-3 percent 
of actual. The procedure described in the Appendix shall be 
performed as well as any other procedures suggested by the 
manufacturer of the spirometer being used.
    (v)(A) The first step in evaluating a spirogram for the FVC and 
FEV1 shall be to determine whether or not the patient has performed 
the test properly or as described in (2)(ii) of this Appendix. The 
largest recorded FVC and FEV1, corrected to BTPS, shall be used in 
the analysis.
    (B) Only MVV maneuvers which demonstrate consistent effort for 
at least 12 seconds shall be considered acceptable. The largest 
accumulated volume for a 12 second period corrected to BTPS and 
multiplied by five or the largest accumulated volume for a 15 second 
period corrected to BTPS and multiplied by four is to be reported as 
the MVV.