| (a) Routine inspections. The Department of State Health Services (department) may conduct an inspection of each hospital prior to the issuance or renewal of a hospital license. (1) A hospital is not subject to routine inspections subsequent to the issuance of the initial license while the hospital maintains: (A) certification under Title XVIII of the Social Security Act, 42 United States Code (USC), §§1395 et seq; or (B) accreditation by a Centers for Medicare and Medicaid Services-approved organization. (2) The department may conduct an inspection of a hospital exempt from an annual licensing inspection under paragraph (1) of this subsection before issuing a renewal license to the hospital if the certification or accreditation body has not conducted an on-site inspection of the hospital in the preceding three years and the department determines that an inspection of the hospital by the certification or accreditation body is not scheduled within 90 days. (b) Complaint investigations. (1) Complaint investigations are conducted if the department finds that reasonable cause exists to believe that the hospital has violated provisions of the Act, this chapter, special license conditions, or orders of the commissioner of state health services (commissioner). (2) Complaints received by the department concerning abuse and neglect, or illegal, unprofessional, or unethical conduct will be conducted in accordance with §133.47(d) of this title (relating to Abuse and Neglect Issues). (3) Complaint investigations may be coordinated with the federal Centers for Medicare and Medicaid Services and its agents responsible for the inspection of hospitals to determine compliance with the conditions of participation under Title XVIII of the Social Security Act, (42 USC, §§1395 et seq), so as to avoid duplicate investigations. (4) Complaint investigations are unannounced. (5) Following the investigation of a complaint, the department shall notify the complainant if the complaint was substantiated and if regulatory violations were identified. (c) Reinspection. (1) Reinspections may be conducted by the department if a hospital applies for the reissuance of its license after the suspension or revocation of the hospital's license, the assessment of administrative or civil penalties, or the issuance of an injunction against the hospital for violations of the Act, this chapter, a special license condition, or an order of the commissioner. (2) A reinspection may be conducted to ascertain compliance with either health or construction requirements or both. (d) General. (1) The department may make any inspection, survey, or investigation that it considers necessary. A representative of the department may enter the premises of a hospital at any reasonable time to make an inspection or an investigation to ensure compliance with or prevent a violation of the Act, the rules adopted under the Act, an order or special order of the commissioner, a special license provision, a court order granting injunctive relief, or other enforcement procedures. Ensuring compliance includes permitting photocopying of any records or other information by or on behalf of the department as necessary to determine or verify compliance with the statute or rules adopted under the statute, except that the department may not photocopy, reproduce, remove or dictate from any part of the root cause analysis or action plan required under §133.48 of this title (relating to Patient Safety Program). (2) The department or a representative of the department is entitled to access to all books, records, or other documents maintained by or on behalf of the hospital to the extent necessary to enforce the Act, this chapter, an order or special order of the commissioner, a special license provision, a court order granting injunctive relief, or other enforcement procedures. The department shall maintain the confidentiality of hospital records as applicable under federal or state law. (3) By applying for or holding a hospital license, the hospital consents to entry and inspection or investigation of the hospital by the department or a representative of the department in accordance with the Act and this chapter. (e) Inspection and investigation protocol. (1) The department surveyor(s) shall hold a conference with the hospital administrator or designee before beginning the on-site inspection or investigation to explain the nature, scope, and estimated time schedule of the inspection or investigation. (2) Department surveyor(s) may conduct interviews with any person with knowledge of the facts. (3) The department surveyor(s) shall inform the hospital administrator or designee of the preliminary findings of the inspection or investigation and shall give the person a reasonable opportunity to submit additional facts or other information to the department's authorized representative in response to those findings. (4) Following an inspection or investigation of a hospital by the department, the department surveyor(s) shall hold an exit conference with the hospital administrator or designee and other invited staff and provide the following to the hospital administrator or designee: (A) the specific nature of the inspection or investigation; (B) any alleged violations of a specific statute or rule; (C) identity of any records that were duplicated; (D) the specific nature of any finding regarding an alleged violation or deficiency; (E) if the deficiency is alleged, the severity of the deficiency; and (F) if there are no deficiencies found, a statement indicating this fact. (5) If deficiencies are cited, the department surveyor(s) shall obtain either at the time of the exit conference or within 10 days of the hospital's receipt of the statement of deficiencies a plan of correction which is provided by the hospital and indicates the date(s) by which correction(s) will be made and any other written comments, if any, by the hospital administrator or designee concerning the inspection or investigation. Additional facts, written comments, or other information provided by the hospital in response to the findings shall be made a part of the record of the inspection or investigation for all purposes. (6) The department surveyor(s) shall obtain the signature of the hospital administrator or designee acknowledging the receipt of the statement of deficiencies and plan of correction form. (7) The department surveyor(s) shall inform the administrator or designee of the hospital's right to an informal administrative review when there is disagreement with the surveyor's findings and recommendations or when additional information bearing on the findings is available. (8) If deficiencies are cited and the plan of correction is not acceptable, the department shall notify the hospital in writing and request that the plan of correction be resubmitted within 10 calendar days of the hospital's receipt of the department's written notice. Upon resubmission of an acceptable plan of correction, written notice shall be sent by the department to the hospital acknowledging same. (9) Responses to the department may be submitted by facsimile. (10) The hospital shall come into compliance by the completion date provided on the statement of deficiencies and plan of correction form. (11) The department shall verify the correction of deficiencies either by mail or by an on-site inspection or investigation. (12) Acceptance of a plan of correction does not preclude the department from taking enforcement action under §133.121 of this title (relating to Enforcement Action). (f) Release of information by the department. (1) Upon written request, the department shall provide information on the identity, including the signature, of each department representative conducting, reviewing, or approving the results of the inspection or investigation, and the date on which the department representative acted on the matter. (2) Upon written request, the department shall release inspection documents in accordance with state and federal law. |
