42 CFR § 37.95 - Specifications for performing spirometry tests.

§ 37.95 Specifications for performing spirometry tests.

(a) Persons administering spirometry tests. Each person administering spirometry tests for the Coal Workers' Health Surveillance Program must successfully complete a NIOSH-approved spirometry training course and maintain a valid certificate by periodically completing NIOSH-approved spirometry refresher training courses, identified on the NIOSH Web site at http://www.cdc.gov/niosh/. A copy of the certificate of completion from a NIOSH-approved spirometry training or refresher course, with validation dates printed on the document, must be available for inspection. NIOSH will assign each person administering spirometry tests a unique identification number, which must be entered into the spirometry system computer whenever instrument quality assurance or miner testing is done or on the Spirometry Results Notification Form (CDC/NIOSH 2.15).

(b) Spirometer specifications. Spirometry testing equipment must meet the 2005 ATS/ERS Standardisation of Spirometry specifications for spirometer accuracy and precision and real-time display size and content, pp. 331-333, including Table 2 on p. 322 and Table 6 on p. 332 (incorporated by reference, see § 37.98). Facilities must make available for inspection written verification from a third-party testing laboratory (not the manufacturer or distributor) that the model of spirometer being used has successfully passed its validation checks as required by the Standardization of Spirometry; 1994 Update protocol, Appendix B pp. 1126-1134, including Table C1 (incorporated by reference, see § 37.98). Facilities may request such documentation from spirometer manufacturers. For each forced expiratory maneuver submitted for a miner under this part, the spirometry data file must retain a record of the parameters defined in the 2005 ATS/ERS Standardisation of Spirometry, p. 335 including Table 8 (incorporated by reference, see § 37.98). Spirometers that provide electronic transfer of spirometry data results files must use the format, content, and data structure specified by the 2005 ATS/ERS Standardisation of Spirometry, p. 335, or a procedure for data transfer that is approved by NIOSH.

(c) Spirometry procedures. Administration of spirometry must include the following:

(1) Miner Identification Document. The Miner Identification Document (CDC/NIOSH (M)2.9), described in § 37.20, must be completed for each miner at the facility where spirometry is performed.

(2) Pre-test checklist. The Spirometry Pre-Test Checklist portion of the Spirometry Results Notification Form (CDC/NIOSH 2.15) must be completed prior to each spirometry session to identify possible contraindications to testing, or factors that might affect results.

(3) Respiratory Assessment Form. A standardized Respiratory Assessment Form (CDC/NIOSH 2.13) must be completed at the initial spirometry and repeated at each spirometry testing procedure.

(4) Collection of anthropometric and demographic information. The miner's standing height must be measured in stocking feet using a stadiometer (or equivalent device) each time the miner performs spirometry. The miner's weight must also be measured (in stocking feet). The miner's birth date, race, and ethnicity must also be recorded. These data will be entered into the spirometry system computer and transmitted with the spirometry data file or, if required under the facility's approval, on the Spirometry Results Notification Form (CDC/NIOSH 2.15).

(5) Test procedures. Spirometry will be conducted in accordance with test procedures defined in the 2005 ATS/ERS Standardisation of Spirometry, pp. 323-326, and the Standardisation of Lung Function Testing, Replies to Readers, pp. 1496-1498 (both incorporated by reference, see § 37.98).

(i) The technician must be able to view real-time testing display screens as specified in the 2005 ATS/ERS Standardisation of Spirometry, p. 322 (incorporated by reference, see § 37.98).

(ii) A miner will be tested in the standing position, but may be seated if he or she experiences lightheadedness or other signs or symptoms that raise a safety concern relating to the standing position during the spirometry test.

(d) Records retention. On-site records of the results will include spirometry test reports and retention of all spirometry sessions, pre-test checklists, and standardized respiratory assessment results in electronic or printed format until notification to delete or render the information inaccessible, as described in § 37.100(b)(6)(ii), is received from NIOSH.

[81 FR 73287, Oct. 24, 2016]

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