[Code of Federal Regulations] [Title 42, Volume 3] [Revised as of October 1, 2005] From the U.S. Government Printing Office via GPO Access [CITE: 42CFR485.641] [Page 611-612] TITLE 42--PUBLIC HEALTH CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 485_CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS--Table of Contents Subpart F_Conditions of Participation: Critical Access Hospitals (CAHs) Sec. 485.641 Condition of participation: Periodic evaluation and quality assurance review. (a) Standard: Periodic evaluation--(1) The CAH carries out or arranges for a periodic evaluation of its total program. The evaluation is done at least once a year and includes review of-- (i) The utilization of CAH services, including at least the number of patients served and the volume of services; (ii) A representative sample of both active and closed clinical records; and (iii) The CAH's health care policies. (2) The purpose of the evaluation is to determine whether the utilization of services was appropriate, the established policies were followed, and any changes are needed. (b) Standard: Quality assurance. The CAH has an effective quality assurance program to evaluate the quality and appropriateness of the diagnosis and treatment furnished in the CAH and of the treatment outcomes. The program requires that-- (1) All patient care services and other services affecting patient health and safety, are evaluated; (2) Nosocomial infections and medication therapy are evaluated; (3) The quality and appropriateness of the diagnosis and treatment furnished by nurse practitioners, clinical nurse specialists, and physician assistants at the CAH are evaluated by a member of the CAH staff who is a doctor of medicine or osteopathy or by another doctor of medicine or osteopathy under contract with the CAH; [[Page 612]] (4) The quality and appropriateness of the diagnosis and treatment furnished by doctors of medicine or osteopathy at the CAH are evaluated by-- (i) One hospital that is a member of the network, when applicable; (ii) One QIO or equivalent entity; or (iii) One other appropriate and qualified entity identified in the State rural health care plan; and (5)(i) The CAH staff considers the findings of the evaluations, including any findings or recommendations of the QIO, and takes corrective action if necessary. (ii) The CAH also takes appropriate remedial action to address deficiencies found through the quality assurance program. (iii) The CAH documents the outcome of all remedial action. [58 FR 30671, May 26, 1993, as amended at 62 FR 46037, Aug. 29, 1997; 63 FR 26359, May 12, 1998]