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.

1. (1) Persons intending to operate a hospital shall submit information to the Department of Health’s Bureau of Hospital Licensing and Certification, as set out in the application form (MO 580-007, 12/87). Within thirty
2. (30) days after receipt of the application of any omitted information or documents. After sixty (60) days any incomplete application is null. Each application for license to operate a hospital shall be accompanied by the appropriate licensing fee required by section 197.050, RSMo. Each license shall be issued for the premises and persons named in the application.
3. (2) Each license shall be issued only for the premises and persons named in the application. 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

4. (1) or by more than one (1) action, the operator shall within fifteen (15) working days of such change apply for a new license:

   1. (A) With respect to a partnership, a change in the majority interest of general partners;
   2. (B) With respect to a limited partnership, a change in the general partner or in the majority interest of limited partners;
   3. (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 one (1) federal tax number; or
   4. (D) The board of directors with management control is an entity other than the licensed operator.

5. (3) An operator of two (2) or more licensed hospitals may submit application to the Department of Health 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. Also, an operator of a licensed hospital may submit a proposal to provide, at a minimum, all of the required patient care services at a geographical location which at the time of the proposal is not a part of the licensed hospital. The location shall be within a one (1)-hour travel distance by customary ground transportation in normal weather conditions. Before the Department of Health approves the application, the applicant shall submit an operational proposal to the director of the Department of Health for approval. At a minimum the proposal shall include:

   1. (A) A description of the patient care services that will be provided at each geographical location and how they will be integrated with patient care services at other geographical locations which will be operated under the single license. The description shall include justification to support the applicant’s allegation that the combined patient care hospital services will exceed the current benefits that are derived by the community(ies) where each individual currently licensed hospital is located. Or, if the operator currently is not providing the service within the geographical location contained in the proposal, there shall be evidence the service is needed in that location;
   2. (B) A description of the organizational structure of the proposed single licensed hospital;
   3. (C) Documentation of evidence that the hospital’s facilities in each geographical location named in the proposal will be owned or leased by the same operator and that the services are operated under common management;
   4. (D) Assurance that the hospital’s operation in each geographical location will be held out to the public under a common name;
   5. (E) Assurance the hospital’s services in each geographical location will be subject to the bylaws and operating decisions of the same governing body;
   6. (F) Assurance that members of the medical staff in each geographical location will be directed by a common medical director and will be subject to the same bylaws and operating decisions of a common medical staff;
   7. (G) Assurance the hospital’s operations in each geographical location will be administered by a common chief executive officer through appropriate delegation of duties; 19 CSR 30-20
   8. (H) Assurance the licensed hospital’s services in each geographical location will be integrated and, when services are provided at multiple locations, that they will be supervised by a common director who is provided with adequate assistance in supervision of the services;
   9. (I) Assurance that the single licensed hospital’s medical records department is integrated and the records are easily accessible to patient care staff;
   10. (J) Assurance the applicant’s proposal is not in violation of other federal, state and local regulations;
   11. (K) Assurance that the applicant, either separately at each geographical location or in combination, will provide all required patient care services, including emergency services, in accordance with Chapter 197, RSMo and 19 CSR 30-20.021(3) and in accordance with acceptable standards of practice;
   12. (L) Assurance that services and beds at one

6. (1) geographical location will not be reallocated to another geographical location prior to the operator requesting and obtaining approval from the Certification of Need program, whenever appropriate, and the Department of Health;

   1. (M) Approval from the Certificate of Need program if the operator’s proposal includes a request to provide a patient care service in a geographical location of the hospital which is not currently a part of the hospital’s license when the proposal is subject to the Missouri Certificate of Need law, sections 197.300— 197.365, RSMo;
   2. (N) Assurance that skilled nursing unit, intermediate care unit and residential care unit services provided within the licensed hospital are physically located at a geographical location of the hospital where all of the required patient care services are provided on-site in accordance with Chapter 197, RSMo and 19 CSR 30-20.021(3);
   3. (O) Assurance that the applicant’s proposal will not jeopardize the health and safety of individuals who reside within the geographical locations which will be served by the single licensed hospital. The applicant shall demonstrate that the proposal contains provision for services which exceed or are comparable to the services currently being provided to the community, or will provide adequate justification to convince the Department of Health the service is no longer needed within the geographical location where the service is currently provided; and
   4. (P) Assurance that the applicant presented the proposal at a public hearing within the SENIOR SERVICES

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 as a part of the applicant’s proposal. The Department of Health shall be given two (2) weeks advance notice of the public hearings.

1. (4) The license shall state the maximum licensed bed capacity, the person(s) to whom granted and the date and 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. A relicensure 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 197.210, RSMo.
2. (5) Appointed representatives of the Department of Health shall be allowed to inspect a hospital as required in section 197.100, RSMo. The chief executive officer or designee shall grant access to information requested by the department for the purpose of evaluating compliance with hospital licensing requirements. Requested records may include, but are not limited to, incident reports, quality of care reports, peer review reports, committee minutes, policies and procedures, training records, medical records or any other documents which are necessary to complete the inspection. All information and reports obtained by the Department of Health shall be kept confidential as required in section 197.477, RSMo.
3. (6) Appointed representatives of the Department of Health’s Bureau of Hospital Licensing and Certification 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 transferred to the hospital from another licensed facility. The representatives shall first provide written assurance that information obtained from the patient’s medical record or from the employee’s personnel record will be maintained confidential.

4. (7) The operator shall have a written policy pertaining to employees reporting mismanagement of violations of applicable laws and rules. At a minimum the policy shall include the following provisions:

   1. (A) No supervisor or individual with hiring or firing authority in a licensed hospital shall prohibit any of its employees from discussing the operations of the hospital, either specifically or generally, with any representatives of the department; and

   2. (B) No supervisor or individual with authority to hire and fire in a licensed hospital shall prohibit his/her employees from disclosing information which the employee reasonably believes evidences a violation of any applicable state or federal law or regulation. This subsection shall not be construed as—

      1. 1. Permitting an employee to leave

his/her assigned work areas during normal work hours without following applicable rules and policies pertaining to leaves, unless the employee is requested by the Department of Health to officially appear before department representatives;

1. 2. Authorizing an employee to represent

the employee’s personal opinions as the opinions of his/her employer; or

1. 3. Precluding the operator from taking

appropriate disciplinary actions against any employee.

1. (8) Inspection. The department shall conduct licensure compliance inspections of hospitals as required by section 197.100, RSMo. Inspections will normally be announced to the facility at least seventy-two (72) hours in advance. Complaint investigations may be unannounced.

2. (9) Inspection Findings.

   1. (A) Whenever an authorized representative of the department finds, during an inspection, that a hospital is not in compliance with the provisions of the Hospital Licensing Law, sections 197.010–197.120, RSMo, the chief executive officer or designee shall be informed of the general nature of findings in an exit conference conducted prior to the representative’s departure from the premises. Within ten (10) working days after each licensing inspection, a written report shall be prepared by the department detailing the specifics of each deficiency. A copy of the report and a written correction order shall be sent to the hospital’s chief executive officer or designee. The report shall state each deficiency separately and shall reference the specific statute or administrative rule violated. 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.
   2. (B) Should the findings of the inspection constitute an immediate and serious threat to the safety or health of the patients, public or hospital staff, a condition of substantial noncompliance shall be considered to exist. The department representative shall verbally convey any determination of substantial noncompliance to the chief executive officer or designee at the exit conference. Findings of substantial noncompliance shall be documented in the normal reporting method described in subsection (9)(A) of this rule.

   3. (C) The following guidelines, applicable to the inspection, shall be used by the licensing representative to determine if a finding during an inspection constitutes an immediate and serious threat to the health and safety of one (1) or more patients. The guidelines used to determine immediate and serious threat serve only as guides for authorized department representatives to use when making the determination.

      1. 1. Failure to protect from abuse—

         1. A. Serious injuries such as head trau-

ma or fractures;

1. B. Non-consensual sexual interac-

tions; e.g., sexual harassment, sexual coercion or sexual assault;

1. C. Unexplained serious injuries that

have not been investigated;

1. D. Staff striking or roughly handling

an individual;

1. E. Staff yelling, swearing, gesturing

or calling an individual derogatory names;

1. F. Bruises around the breast or genital

area; or

1. G. Suspicious injuries; e.g., black

eyes, rope marks, cigarette burns, unexplained bruising.

1. 2. Failure to prevent neglect—

   1. A. Lack of timely assessment of indi-

viduals after injury;

1. B. Lack of supervision for individual

with known special needs;

1. C. Failure to carry out doctor’s

orders;

1. D. Repeated occurrences such as falls

which place the individual at risk of harm without intervention;

1. E. Access to chemical and physical

hazards by individuals who are at risk;

1. F. Access to hot water of sufficient

temperature to cause tissue injury;

1. G. Non-functioning call system with-

out compensatory measures;

1. H. Unsupervised smoking by an indi-

vidual with a known safety risk;

1. I. Lack of supervision of cognitively

impaired individuals with known elopement risk;

1. J. Failure to adequately monitor indi-

viduals with known severe self-injurious behavior;

1. K. Failure to adequately monitor and

intervene for serious medical/surgical conditions;

1. L. Use of chemical/physical restraints

without adequate monitoring;

1. M. Lack of security to prevent abduc-

tion of infants;

1. N. Improper feeding/positioning of

individual with known aspiration risk; or

1. O. Inadequate supervision to prevent

physical altercations.

1. 3. Failure to protect from psychological

harm—

1. A. Application of chemical/physical

restraints without clinical indications;

1. B. Presence of behaviors by staff such

as threatening or demeaning, resulting in displays of fear, unwillingness to communicate, and recent or sudden changes in behavior by individuals; or

1. C. Lack of intervention to prevent

individuals from creating an environment of fear.

1. 4. Failure to protect from undue adverse

medication consequences and/or failure to provide medications as prescribed—

1. A. Administration of medication to an

individual with a known history of allergic reaction to that medication;

1. B. Lack of monitoring and identifica-

tion of potential serious drug interaction, side effects, and adverse reactions;

1. C. Administration of contraindicated

medications;

1. D. Pattern of repeated medication

errors without intervention;

1. E. Lack of diabetic monitoring result-

ing or likely to result in serious hypoglycemic or hyperglycemic reaction; or

1. F. Lack of timely and appropriate

monitoring required for drug titration.

1. 5. Failure to provide adequate nutrition

and hydration to support and maintain health—

1. A. Food supply inadequate to meet

the nutritional needs of the individual;

1. B. Failure to provide adequate nutri-

tion and hydration resulting in malnutrition; e.g., severe weight loss, abnormal laboratory values;

1. C. Withholding nutrition and hydra-

tion without advance directive; or

1. D. Lack of potable water supply.
2. 6. Failure to protect from widespread

nosocomial infections; e.g. failure to practice standard precautions, failure to maintain sterile techniques during invasive procedures and/or failure to identify and treat nosocomial infections—

1. A. Pervasive improper handling of

body fluids or substances from an individual with an infectious disease;

1. B. High number of infections or con-

tagious diseases without appropriate reporting, intervention and care;

1. C. Pattern of ineffective infection

control precautions; or

1. D. High number of nosocomial infec-

tions caused by cross contamination from staff and/or equipment/supplies.

1. 7. Failure to correctly identify individu-

als—

1. A. Blood products given to wrong

individual;

1. B. Surgical procedure/treatment per-

formed on wrong individual or wrong body part;

1. C. Administration of medication or

treatments to wrong individual; or

1. D. Discharge of an infant to the

wrong individual.

1. 8. Failure to safely administer blood

products and safely monitor organ transplantation—

1. A. Wrong blood type transfused;
2. B. Improper storage of blood prod-

ucts;

1. C. High number of serious blood

reactions;

1. D. Incorrect cross match and utiliza-

tion of blood products or transplantation organs; or

1. E. Lack of monitoring for reactions

during transfusions.

1. 9. Failure to provide safety from fire,

smoke and environment hazards and/or failure to educate staff in handling emergency situations—

1. A. Nonfunctioning or lack of emer-

gency equipment and/or power source;

1. B. Smoking in high risk areas;
2. C. Incidents such as electrical shock,

fires;

1. D. Ungrounded/unsafe electrical

equipment;

1. E. Widespread lack of knowledge of

emergency procedures by staff;

1. F. Widespread infestation by

insects/rodents;

1. G. Lack of functioning ventilation,

heating or cooling system placing individuals at risk;

1. H. Use of non-approved space

heaters, such as kerosene, electrical, in resident or patient areas;

1. I. Improper handling/disposal of haz-

ardous materials, chemicals and waste; 19 CSR 30-20

1. J. Locking exit doors in a manner that

does not comply with NFPA 101;

1. K. Obstructed hallways and exits pre-

venting egress;

1. L. Lack of maintenance of fire or life

safety systems; or

1. M. Unsafe dietary practices resulting

in high potential for food-borne illnesses.

1. 10. Failure to provide initial medical

screening, stabilization of emergency medical conditions and safe transfer for individuals and women in active labor seeking emergency treatment—

1. A. Individuals turned away from

emergency room (ER) without medical screening exam;

1. B. Women with contractions not med-

ically screened for status of labor;

1. C. Absence of ER or obstetrical (OB)

medical screening records;

1. D. Failure to stabilize emergency

medical condition; or

1. E. Failure to appropriately transfer an

individual with an unstabilized emergency medical condition.

1. (10) Settlement Agreement.

   1. (A) Ten (10) working days following receipt of the written inspection report, the chief executive officer or designee shall provide the department with a written plan for correcting the cited deficiencies or a request for reconsideration of the deficiency. The plan of correction shall specify the means the hospital will employ for correcting the cited deficiencies and the date that each corrective measure will be completed. If a request for reconsideration is submitted, the request shall contain 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 suspend the facility’s license if there remains a substantial failure to comply with the requirements established under sections 197.010–197.120, RSMo and 19 CSR 30-20.011–19 CSR 30-20.070. The operator has the right to appeal the department’s decision in accordance with section 197.071, RSMo.
   2. (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 depart- SENIOR SERVICES

ment shall notify the chief executive officer or designee, in writing, and indicate the reasons why the plan is not acceptable. Within ten (10) working days from the receipt of the notice, a revised, acceptable plan of correction shall be provided to the department.

1. (11) Follow-up Inspections. Upon expiration of the target dates for correction of deficiencies specified in the approved plan of correction, the department may make a follow-up inspection to determine whether the required corrective measures have been acceptably accomplished. If the follow-up inspection finds the facility fails to comply with the provisions of the Hospital Licensing Law, sections 197.010–197.120, RSMo and 19 CSR 30-20.011–19 CSR 30-20.070, the department may take action to suspend or to revoke the operator’s license to operate the hospital. The operator has the right to appeal the department’s decision in accordance with section 197.071, RSMo.
2. (12) 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 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 in 19 CSR 30-20.030 and the Department of Health issues a license.

3. (13) 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, upon written request from the licensed operator, may grant approval for suspension of the hospital’s license for a specified time.

   1. (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.
   2. (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.

   3. (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. 1. The renovation of the hospital’s facil-

ity to upgrade to current licensure standards and to correct licensure or federal certification physical plant deficiencies;

1. 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

1. 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.

1. (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.
2. (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 approval.
3. (F) No inpatient services shall be provided in the hospital during the period of time that inpatient services are discontinued.
4. (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 patient services at the hospital.
5. (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.
6. (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.

1. (14) Involuntary Suspension or Revocation of the License.

   1. (A) Whenever the department determines that substantial noncompliance exists in a hospital, the department may immediately suspend or revoke the license of the facility or order cessation of use of any portion of the noncompliant services or buildings.
   2. (B) The department shall document its action in writing in addition to the report detailing the findings of the inspection. A copy shall be submitted to the hospital’s chief executive officer or designee.
   3. (C) The hospital shall expedite corrections required to relieve the involuntary suspension or revocation.
   4. (D) The operator may elect to seek appeal or relief from the Administrative Hearing Commission in accordance with section 197.071, RSMo, or the operator may elect to first request a review of the action by the office of the director of the department.

AUTHORITY: sections 192.006, 197.080, and 197.293, RSMo 2000.* 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.

*Original authority: 192.006, RSMo 1993, amended 1995; 197.080, RSMo 1953, amended 1993, 1995; and 197.293, RSMo 2000. SENIOR SERVICES