California Code of Regulations › Title 8 - Industrial Relations › Division 1 - Department of Industrial Relations › Chapter 4 - Division of Industrial Safety › Subchapter 7 - General Industry Safety Orders › Group 16 - Control of Hazardous Substances › Article 109 - Hazardous Substances and Processes › Appendix D - Pulmonary Function Standards for Cotton Dust Standard

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The spirometric measurements of pulmonary function
						  shall conform to the following minimum standards, and these standards are not
						  intended to preclude additional testing or alternate methods which can be
						  determined to be superior.
I. Apparatus
a. The instrument shall be accurate to within ±
						  50 millimeters or within ± 3 percent of reading, whichever is
						  greater.
b. 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.
c. 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.
d. The zero time point for the purpose of timing the
						  FEV1 shall be determined by extrapolating the steepest
						  portion of the volume time curve back to the maximal inspiration volume
						  (1,2,3,4) or by an equivalent method.
e. Instruments incorporating measurements of airflow to
						  determine volume shall conform to the same volume accuracy stated in (a) of
						  this section when presented with flow rates from at least 0 to 12 liters per
						  second.
f. 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.
g. The instrument used shall provide a tracing or
						  display of either flow versus volume or volume versus time during the entire
						  forced expiration. A tracing or display is necessary to determine whether the
						  patient has performed the test properly. The tracing must be stored and
						  available for recall and must be of sufficient size that hand measurements may
						  be made within requirement of paragraph (a) of this section. If a paper record
						  is made, it must have a paper speed of at least 2 cm/sec and a volume
						  sensitivity of at least 10.0 mm of chart per liter of volume.
h. The instrument shall be capable of accumulating
						  volume for a minimum of 10 seconds and shall not stop accumulating volume
						  before (1) the volume change for a 0.5 second interval is less than 25
						  milliliters, or (2) the flow is less than 50 milliliters per second for a 0.5
						  second interval.
i. The forced vital capacity (FVC) and forced
						  expiratory volume in 1 second (FEV1.0) measurements
						  shall comply with the accuracy requirements stated in paragraph (a) of this
						  section. That is, they should be accurately measured to within ± 50 ml
						  or within ± 3 percent of reading, whichever is greater.
j. The instrument must be capable of being calibrated
						  in the field with respect to the FEV1 and FVC. This
						  calibration of the FEV1 and FVC may be either directly
						  or indirectly through volume and time base measurements. The volume calibration
						  source should provide a volume displacement of at least 2 liters and should be
						  accurate to within ± 30 milliliters.
II. Technique for Measurement of Forced Vital Capacity
						  Maneuver
a. Use of a nose clip is recommended but not 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, but care should be taken on repeat testing that the same
						  position be used and, if possible, the same spirometer. Particular attention
						  shall be given to insure that the chin is slightly elevated with the neck
						  slightly extended. The patient shall be instructed to make a full inspiration
						  from a normal breathing pattern and then blow into the apparatus, without
						  interruption, as hard, fast, and completely as possible. At least three forced
						  expirations shall be carried out. During the maneuvers, the patient shall be
						  observed for compliance with instruction. The expirations shall be checked
						  visually for reproducibility from flow-volume or volume-time tracings or
						  displays. The following efforts shall be judged unacceptable when the
						  patient:
1. has not reached full inspiration preceding the
						  forced expiration,
2. has not used maximal effort during the entire forced
						  expiration,
3. has not continued the expiration of at least 5
						  seconds or until an obvious plateau in the volume time curve has
						  occurred,
4. has coughed or closed his glottis,
5. 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.),
6. has an unsatisfactory start of expiration, one
						  characterized by excessive hesitation (or false starts), and therefore not
						  allowing back extrapolation of time 0 (extrapolated volume on the volume time
						  tracing must be less than 10 percent of the FVC),
7. has an excessive variability between the three
						  acceptable curves. The variation between the two largest FVC's and
						  FEV1's of the three satisfactory tracings should not
						  exceed 10 percent or ± 100 milliliters, whichever is greater.
b. Periodic and routine recalibration of the instrument
						  or method for recording FVC and FEV1.0 should be
						  performed using a syringe or other volume source of at least two liters.
III. Interpretation of Spirogram
a. The first step in evaluating a spirogram should be
						  to determine whether or not the patient has performed the test properly or as
						  described in II above. From the three satisfactory tracings, the forced vital
						  capacity (FVC) and forced expiratory volume in 1 second
						  (FEV1.0) shall be measured and recorded. The largest
						  observed FVC and largest observed FEV1 shall be used in
						  the analysis regardless of the curve(s) on which they occur.
b. The following guidelines are recommended by NIOSH
						  for the evaluation and management of workers exposed to cotton dust. It is
						  important to note that employees who show reductions in
						  FEV1/FVC ration below .75 or drops in Monday
						  FEV1 of 5 percent or greater on their initial screening
						  exam, should be reevaluated within a month of the first exam. Those who show
						  consistent decrease in lung function should be managed as recommended.
IV. Qualifications of Personnel Administering the
						  Test
Technicians who perform pulmonary function testing
						  should have the basic knowledge required to produce meaningful results.
						  Training consisting of approximately 16 hours of formal instruction should
						  cover the following areas.
a. Basic physiology of the forced vital capacity
						  maneuver and the determinants of airflow limitation with emphasis on the
						  relation to reproducibility of results.
b. Instrumentation requirements including calibration
						  procedures, sources of error and their correction.
c. Performance of the testing including subject
						  coaching, recognition of improperly performed maneuvers and corrective
						  actions.
d. Data quality with emphasis on
						  reproducibility.
e. Actual use of the equipment under supervised
						  conditions.
f. Measurement of tracings and calculations of
						  results.