Current through Register Vol. 49, No. 18, September 16, 2024
PURPOSE: This amendment describes the license
application, survey and reporting process for a hospital, as well as the
process for disciplining 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 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 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.
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*Original authority: 192.006, RSMo 1993, amended 1995;
197.080, RSMo 1953, amended 1993, 1995; and 197.293, RSMo
2000.
