Administration of the Hospital Licensing Program

PURPOSE: This rule formalizes the hospital licensing policies being carried out by the Department of Health. It prescribes procedures for the review of hospital records, acceptance of plans of deficiency correction and suspension of a hospital license. PUBLISHER’S NOTE: The secretary of state has determined that the publication of the entire text of the material which is incorporated by reference as a portion of this rule would be unduly cumbersome or expensive. This material as incorporated by reference in this rule shall be maintained by the agency at its headquarters and shall be made available to the public for inspection and copying at no more than the actual cost of reproduction. This note applies only to the reference material. The entire text of the rule is printed here. (1) Persons intending to operate a hospital shall submit information to the Department of Health and Senior Services, as set out in the application form (MO 580-0007(8-18)) which is included herein. Within thirty (30) days after receipt of the application, the applicant will be notified of any omitted information or documents. After sixty (60) days any incomplete application is null. The department may deny a license application in any case which it finds that there has been a substantial failure to comply with the requirements for hospitals in Chapter 197, RSMo, and the regulations promulgated thereunder. Each application for license to operate a hospital shall be accompanied by the appropriate licensing fee, except applications from governmental units, required by section 197.050, RSMo. (2) Each license shall be issued only for the premises identified on the application for hospital license and entity named in the application. All locations included in the hospital application for hospital license shall meet the definition of “premises” as stated in 19 CSR 30-20.011. No license shall be issued unless the applicant is in substantial compliance with Chapter 197, RSMo and the regulations promulgated thereunder. A license, unless sooner revoked, shall be issued for a period of up to a year. If during the period in which a license is in effect, a licensed operator which is a partnership, limited partnership, or corporation undergoes any of the following changes, whether by one (1) or by more than one (1) action, the operator shall within fifteen (15) working days of such change apply for a new license: (A) With respect to a partnership, a change in the majority interest of general partners; (B) With respect to a limited partnership, a change in the general partner or in the majority interest of limited partners; (C) With respect to a corporation, a change in the persons who own, hold, or have the power to vote the majority of any class of securities issued by the corporation. If the corporation does not have stock, a change of owner occurs when the emerging entity has a new federal tax number; or (D) The board of directors with management control is an entity other than the licensed operator. (3) The operator of a licensed hospital shall notify the department in writing within fifteen (15) days of— (A) A change of ownership of the hospital; or (B) Any extensive modification, modification, or reconstruction of the licensed premises, as identified in the life safety code standards in 42 CFR Part 482 (2018) and 42 CFR Part 485 (2018), which are incorporated by reference in this rule. The Code of Federal Regulations is published by the U.S. Government and is available by calling toll-free (866) 512-1800 or going to https://bookstore.gpo.gov/. The address is: U.S. Government Publishing Office, U.S. Superintendent of Documents, Washington, DC 20402-0001. This rule incorporates later amendments and additions to 42 CFR Part 482 (2018) and 42 CFR Part 485 (2018). (4) An operator of two (2) or more licensed hospitals may submit an initial application to the Department of Health and Senior Services to operate the hospitals as a single licensed hospital. The two (2) or more licensed hospitals may be separated by a distance which can be traveled in no more than one (1) hour by customary ground transportation in normal weather conditions. The operator shall designate a permanent hospital base from which the one- (1-) hour travel distance is determined. If the application is approved, the hospitals may be named on the licensure application and a single license issued. Before the Department of Health and Senior Services approves the application, the applicant shall submit an operational proposal to the director of the Department of Health and Senior Services for approval. At a minimum the proposal shall include: (A) Approval from the Certificate of Need program if a Certificate of Need is required under sections 197.300–197.367, RSMo; (B) Assurance that the applicant presented the initial proposal at a public hearing within the community where the currently licensed hospital(s) is located. The proposal shall provide evidence that the entire community was adequately notified at least two (2) weeks in advance, of the public hearings. The written record of the hearings, including the community response to the proposal, shall be submitted to the Department of Health and Senior Services as a part of the applicant’s proposal. The Department of Health and Senior Services shall be given two (2) weeks advance notice of the public hearings. The Department of Health and Senior Services may consider the information presented as part of the determination process; and (C) Assurance that the initial applicant is in compliance with Chapter 197, RSMo, and the regulations promulgated SENIOR SERVICES thereunder. The above criteria is for initial application for single hospital licensure. The annual renewal for the single licensed hospitals will follow the annual licensure process. (5) The license shall state the maximum licensed bed capacity, the hospital name, issue date, expiration date, and additional information, such as a specialty hospital designation, that the department may require. At least forty-five (45) days prior to the expiration date of an existing license, the department shall notify the operator that the license application is due for renewal. An annual application shall be submitted no more than ninety (90) days and not less than thirty (30) days prior to the expiration date of the existing license. Each application for license, except application from governmental units, shall be accompanied by a licensing fee in accordance with section 197.050, RSMo. (6) Appointed representatives of the Department of Health and Senior Services, Bureau of Hospital Standards shall be allowed to review patient medical records and hospital employee personnel records in the course of conducting an investigation of allegations against an employee or previous employees of a hospital or allegations of substandard care regarding a patient. (7) The nursing service administrator shall be a full-time employee and shall have the authority and be accountable for assuring the provision of quality nursing care for those patient areas delineated in the organizational structure. (8) Survey Process. (A) The department shall conduct licensure compliance surveys of hospitals as required by section 197.100, RSMo. Initial surveys shall be announced. Complaint investigations shall be unannounced. (B) Interviews with staff, patients, and visitors shall be conducted in private, unless otherwise requested by the person being interviewed. Staff serving as a witness to an interview or an observation shall only observe and not participate. (C) Survey findings shall be provided to the hospital in accordance with procedures and time lines designated by Chapter 197, RSMo. (D) In addition to the powers to deny, suspend, or revoke a license in the case of a substantial failure to comply provided in section 197.070, RSMo, the department shall use the standards for enforcing hospital licensure regulations in section 197.293, RSMo. (9) Plan of Correction. (A) If the facility believes that deficiencies are not applicable or are not based upon laws or rules, a request for review may be submitted to the office of the director of the department. If a request for reconsideration is submitted, the request shall contain a rationale or documentation to provide evidence that the deficiency should not have been cited. Failure of the facility to submit a plan of correction or a request for reconsideration of the deficiency acceptable to the director of the department or designee—within the time frame specified—shall be grounds for the department to take disciplinary action against the facility’s license if there remains a substantial failure to comply with the requirements for hospitals established under Chapter 197, RSMo and regulations promulgated thereunder. The operator has the right to appeal the department’s decision in accordance with section 197.071, RSMo. (B) Upon receipt of the required plan of correction for achieving licensure compliance, the department shall review the plan to determine the appropriateness of the corrective action. If the plan is acceptable, the department shall notify the chief executive officer or designee, in writing, and indicate that implementation of the plan should proceed. If the plan is not acceptable, the department shall notify the chief executive officer or designee, in writing, and indicate the reasons why the plan is not acceptable. Within ten (10) calendar days from the receipt of the notice, a revised, acceptable plan of correction shall be provided to the department. (10) Follow-up Surveys. (A) Upon expiration of the target dates for correction of deficiencies specified in the approved plan of correction, the department may make a follow-up survey to determine whether the required corrective measures have been acceptably accomplished. If the follow-up survey, conducted in accordance with 197.080, RSMo, if applicable, finds the facility fails to comply with the requirements for hospitals in Chapter 197, RSMo, and regulations promulgated thereunder, the department may deny, suspend, or revoke a license in the case of a substantial failure to comply. The operator has the right to appeal the department’s decision in accordance with section 197.071, RSMo. (B) The powers to deny, suspend, or revoke a license in the case of a substantial failure to comply in section 197.070, RSMo, are in addition to the standards the department shall use for enforcing hospital licensure regulations in section 197.293, RSMo. (11) If, for a period in excess of fourteen (14) days, a facility ceases to provide patient care or to otherwise operate as a hospital within the definition of section 197.020.2, RSMo, except in the case of a strike, an act of God, manmade disaster or written approval of the department, the facility shall surrender its license to the department. The facility shall not operate again as a hospital until an application for a hospital license is submitted with assurance that the facility complies with the requirements for hospitals in Chapter 197, RSMo, and regulations promulgated thereunder and the Department of Health and Senior Services issues a license. (12) Requested Suspension of License. If any hospital wishes to cease operation for a period of time but retain its current hospital license, the Department of Health and Senior Services, upon written request from the licensed operator, may grant approval for suspension of the hospital’s license for a specified time. (A) Not less than fourteen (14) days prior to cessation of patient services at the hospital, the licensed operator shall submit to the department a written request for continuance. (B) The written request for the suspension of the license shall include the reasons for cessation of patient services, the anticipated length of cessation of patient services, what safeguards the hospital will institute to provide security to the institution, the preventive maintenance measures used to assure that all equipment will be kept in good working order and evidence that the hospital is financially solvent to meet the conditions of the request and will remain so throughout the period of cessation of patient services. (C) Approval may be granted only for the suspension of a hospital’s current license if the cessation of patient services is for one (1) of the following reasons: 1. The renovation of the hospital’s facility to upgrade to current licensure standards and to correct licensure or federal certification physical plant deficiencies; 2. The transfer of the operation of the hospital to a new operator to allow sufficient time for the new operator to obtain a new license; or 3. Other reasons which will not result in a deterioration of the hospital physical plant or its programs and which will be in the best interest of the citizens it serves. (D) The suspension of a hospital’s current license shall not exceed ninety (90) days beyond the date of cessation of patient services for ownership transfer. The suspension of a hospital’s current license shall not exceed one hundred eighty (180) days beyond the date of cessation of patient services for renovation construction. The department may not grant more than one (1) suspension to a hospital’s licensed operator within any twelve- (12-) month period and shall grant no suspension for a period of more than one hundred eighty (180) days from the date of cessation of inpatient services. (E) No inpatients shall be housed within the hospital from the initial date of cessation of inpatient services until operation of the hospital is restored with Department of Health and Senior Services approval. (F) No inpatient services shall be provided in the hospital during the period of time that inpatient services are discontinued. (G) When suspension of the license is requested for a renovation or construction proposal, the licensed operator shall submit plans for the renovation to the department for review and shall have received the department’s approval of those plans prior to the date of cessation of inpatient services at the hospital. (H) The licensed operator shall notify the department no less than fourteen (14) days prior to the resumption of inpatient services that the hospital is ready for review/inspection for approval to reoccupy the hospital with inpatients. (I) Within ten (10) working days of notification, the department shall respond in writing to the licensed operator with the findings of its review/inspection for the resumption of licensed hospital services at the hospital. (13) A certificate of live birth shall be prepared for each child born alive and shall be forwarded to the local registrar, or as otherwise directed by the state registrar within five (5) days after the date of delivery. If the physician or other person in attendance does not certify to the facts of birth within five (5) days after the birth, the person in charge of the institution shall complete and sign the certificate. (14) When a dead fetus is delivered in an institution, the person in charge of the institution or his/her designated representative shall prepare and, within seven (7) days after delivery, file a report of fetal death with the local registrar or as otherwise directed by the state registrar. (15) Medical records of deceased patients shall contain the date and time of death, autopsy permit, if granted, disposition of the body, by whom received and when. (16) The State Anatomical Board shall be notified of an unclaimed dead body. A record of this notification shall be maintained. (17) The patient’s medical records shall be maintained to safeguard against loss, defacement, unauthorized access, and tampering and to prevent damage from fire and water. Medical records shall be preserved in a permanent file in the original, on microfilm, or other electronic media. Patients’ medical records shall be retained for a minimum of ten (10) years, except that a minor shall have his/her record retained until his/ her twentieth birthday, whichever occurs later. Preservation of medical records may be extended by the hospital for clinical, educational, statistical, or administrative purposes. (18) Requests for variance from the requirements of 19 CSR 30-20 shall be in writing to the Department of Health and Senior Services. Department determinations in response to variance requests shall be in writing and both requests and determinations shall be made a part of the Department of Health and Senior Services permanent records for the facility. (A) Requests shall contain at a minimum— 1. The section number and text of the rule in question; 2. Specific reasons why compliance with the rule would impose an undue hardship on the operator, including an estimate of any additional cost which might be involved; 3. An explanation of the extenuating factors which may be relevant; 4. A complete description of the individual characteristics of the facility or patients or any other factors which would fulfill the intent of the rule in question to safeguard the health, safety, and the welfare of the patient, staff, or public if the variance from the requirement is granted; and 5. A length of time the variance is being requested. (19) The department’s written determination shall identify a variance expiration date, if approved. The facility may re-apply for a variance up to ninety (90) days prior to the expiration of a department-approved variance. (20) Any facility granted a variance by the department shall inform the department in writing if the conditions warranting the variance change. This written notification to the department shall be made within thirty (30) days of the change affecting the variance. The department may revoke the granted variance if the changes in conditions detrimentally impact the health, safety, and the welfare of the patient, staff, or public, as determined by the department. (21) All previously approved variances shall be submitted at the time of annual licensure renewal. SENIOR SERVICES SENIOR SERVICES AUTHORITY: sections 192.006, 197.065, and 197.297, RSMo 2016, and section 197.080, RSMo Supp. 2019.* This rule was previously filed as 13 CSR 50-20.015. Original rule filed April 9, 1985, effective July 11, 1985. Amended: Filed Nov. 4, 1992, effective June 7, 1993. Amended: Filed Nov. 21, 1995, effective July 30, 1996. Amended: Filed Oct. 6, 1998, effective April 30, 1999. Amended: Filed June 28, 2001, effective Feb. 28, 2002. Amended: Filed April 30, 2004, effective Dec. 30, 2004. Amended: Filed March 20, 2019, effective Nov. 30, 2019. ** *Original authority: 192.006, RSMo 1993, amended 1995; 197.065, RSMo 2004, amended 2017; 197.080, RSMo 1953, amended 1993, 1995, 2017; and 197.297, RSMo 2000. **Pursuant to Executive Order 21-07, 19 CSR 30-20.015, subsection (8)(A) was suspended from April 2, 2020 through August 31, 2021. Pursuant to Executive Order 21-09, 19 CSR 30-20.015, sections (2) and (5) was suspended from March 20, 2020 through December 31, 2021.