Code of Federal Regulations Title 42. Public Health § 42.3.310 Responsibilities of respondents

(1) A respondent must permit access by the Secretary during normal business hours to its facilities, books, records, accounts, and other sources of information, including patient safety work product, that are pertinent to ascertaining compliance with the applicable confidentiality provisions. If the Secretary determines that exigent circumstances exist, such as when documents may be hidden or destroyed, a respondent must permit access by the Secretary at any time and without notice.

(2) If any information required of a respondent under this section is in the exclusive possession of any other agency, institution, or person, and the other agency, institution, or person fails or refuses to furnish the information, the respondent must so certify and set forth what efforts it has made to obtain the information.