Appendix B to Part 718 - Standards for Administration and Interpretation of Pulmonary Function Tests. Tables B1, B2, B3, B4, B5, B6.
20:4.0.2.2.6.4.74.7.2 : Appendix B
Appendix B to Part 718 - 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 § 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.
