Part 3 - Patient Safety Organizations and Patient Safety Work Product  


Subpart A - General Provisions
§ 3.10 - Purpose.
§ 3.20 - Definitions.
Subpart B - PSO Requirements and Agency Procedures
§ 3.102 - Process and requirements for initial and continued listing of PSOs.
§ 3.104 - Secretarial actions.
§ 3.106 - Security requirements.
§ 3.108 - Correction of deficiencies, revocation, and voluntary relinquishment.
§ 3.110 - Assessment of PSO compliance.
§ 3.112 - Submissions and forms.
Subpart C - Confidentiality and Privilege Protections of Patient Safety Work Product
§ 3.204 - Privilege of patient safety work product.
§ 3.206 - Confidentiality of patient safety work product.
§ 3.208 - Continued protection of patient safety work product.
§ 3.210 - Required disclosure of patient safety work product to the Secretary.
§ 3.212 - Nonidentification of patient safety work product.
Subpart D - Enforcement Program
§ 3.304 - Principles for achieving compliance.
§ 3.306 - Complaints to the Secretary.
§ 3.308 - Compliance reviews.
§ 3.310 - Responsibilities of respondents.
§ 3.312 - Secretarial action regarding complaints and compliance reviews.
§ 3.314 - Investigational subpoenas and inquiries.
§ 3.402 - Basis for a civil money penalty.
§ 3.404 - Amount of a civil money penalty.
§ 3.408 - Factors considered in determining the amount of a civil money penalty.
§ 3.414 - Limitations.
§ 3.416 - Authority to settle.
§ 3.418 - Exclusivity of penalty.
§ 3.420 - Notice of proposed determination.
§ 3.422 - Failure to request a hearing.
§ 3.424 - Collection of penalty.
§ 3.426 - Notification of the public and other agencies.
§ 3.504 - Hearings before an ALJ.
§ 3.506 - Rights of the parties.
§ 3.508 - Authority of the ALJ.
§ 3.510 - Ex parte contacts.
§ 3.512 - Prehearing conferences.
§ 3.514 - Authority to settle.
§ 3.516 - Discovery.
§ 3.518 - Exchange of witness lists, witness statements, and exhibits.
§ 3.520 - Subpoenas for attendance at hearing.
§ 3.522 - Fees.
§ 3.524 - Form, filing, and service of papers.
§ 3.526 - Computation of time.
§ 3.528 - Motions.
§ 3.530 - Sanctions.
§ 3.532 - Collateral estoppel.
§ 3.534 - The hearing.
§ 3.538 - Witnesses.
§ 3.540 - Evidence.
§ 3.542 - The record.
§ 3.544 - Post hearing briefs.
§ 3.546 - ALJ's decision.
§ 3.548 - Appeal of the ALJ's decision.
§ 3.550 - Stay of the Secretary's decision.
§ 3.552 - Harmless error.