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;
   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 19 CSR 30-20

on-site in accordance with Chapter 197, RSMo and 19 CSR 30-20.021(3);

1. (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
2. (P) Assurance that the applicant presented the 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 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 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. (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 department 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.
4. (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.
5. (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.

6. (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 19 CSR 30-20

of its review/inspection for the resumption of licensed hospital services at the hospital. (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 192.005.2 and 197.040, RSMo 1994.* 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. *Original authority: 192.005.2, RSMo 1985, amended 1993 and 197.040, RSMo 1953. compliance with the reporting requirements in section 383.133, RSMo. (B) Administration, Chief Executive Officer. 1. The chief executive officer shall be the direct representative of the governing body and shall be responsible for management of the hospital commensurate with the authority delegated by the governing body in its bylaws. 2. The chief executive officer shall be responsible for maintaining liaison among the governing body, medical staff and all departments of the hospital. 3. The chief executive officer shall organize the administrative functions of the hospital through appropriate departmentalization and delegation of duties and shall establish a system of authorization, record procedures and internal controls. 4. The chief executive officer shall be responsible for the recruitment and employment of qualified personnel to staff the various departments of the hospital and shall insure that written personnel policies and job descriptions are available to all employees. 5. The chief executive officer shall be responsible for the development and enforcement of written policies and procedures governing visitors to all areas of the hospital. 6. The chief executive officer shall be responsible for establishing effective security measures to protect patients, employees and visitors. 7. The chief executive officer shall maintain policies protecting children admitted to or discharged from the hospital. Policies shall provide for at least the following: A. A child shall not be released to anyone other than the child’s parent(s), legal guardian or custodian; B. The social work service personnel shall have knowledge of available social services for unmarried mothers and for the placement of children; C. Adoption placements shall comply with section 453.010, RSMo; and D. The reporting of suspected inci- dences of child abuse shall be made to the Division of Family Services as established under section 210.120, RSMo. 8. The chief executive officer shall be responsible for developing a written emergency preparedness plan. The plan shall include procedures which provide for safe and orderly evacuation of patients, visitors and personnel in the event of fire, explosion or other internal disaster. The plan shall also include procedures for caring for mass casualties resulting from any external disaster in the region. 9. The emergency plan in paragraph (2)(B)8. of this rule shall be readily available to all personnel. The chief executive officer is responsible for ensuring all employees shall be instructed regarding their responsibilities during an emergency. Drills for internal disasters, such as fires, shall be held at least quarterly for each shift and shall include the simulated use of fire alarm signals and simulation of emergency fire conditions. Annual drills for external disasters shall be held in coordination with representatives of local emergency preparedness offices. The movement of hospital patients is not required as a part of the drills. 10. The chief executive officer shall be responsible for carrying out policies of the governing body to ensure that patients are admitted to the hospital only by members of the medical staff and that each patient’s general medical condition shall be the primary responsibility of a physician member of the medical staff. 11. The chief executive officer shall bring to the attention of the chief of the medical staff and governing body failure by members of that staff to conform with established hospital policies regarding administrative matters, professional standards or the timely preparation and completion of each patient’s clinical record. 12. The chief executive officer shall be responsible for developing and maintaining a hospital environment which provides for efficient care and safety of patients, employees and visitors. 13. The chief executive officer shall be responsible for the development and enforcement of written policies which prohibit smoking throughout the hospital except specific designated areas where smoking may be permitted. Lobbies and dining rooms having an area of at least one thousand (1,000) square feet which are enclosed and separated from the access to exit corridor systems may have a designated smoking area. This designated smoking area may not exceed twenty percent (20%) of the total area of the room and shall be located to minimize the spread of smoke into the nonsmoking areas. Lobbies, dining rooms and other rooms of less than one thousand (1,000) square feet which are enclosed and separated from the access to exit corridor systems may be designated smoking areas provided one hundred percent (100%) of the air supplied to the room is exhausted. Individual patients may be permitted to smoke in their rooms with the consent of any other patients occupying the room and with the permission of his/her attending physician. If a patient is confined to bed or classified as not being responsible, smoking is permitted only 19 CSR 30-20 under the direct supervision of an authorized individual. Modification of the patient room ventilation system is not required to permit occasional authorized smoking by a patient. 14. An annual licensing survey for each fiscal year shall be filed with the department on the survey document provided by the Department of Health. The survey shall be due within two (2) months after the hospital’s receipt of the survey. 15. The chief executive officer shall be responsible for establishing and implementing a mechanism which will assure that patient services provide care or an appropriate referral that is commensurate with the patient’s needs. If services are provided by contract, the contractor shall furnish services that permit the hospital to comply with all applicable hospital licensing requirements. 16. The chief executive officer shall be responsible for establishing and implementing a mechanism to assure that all equipment and physical facilities used by the hospital to provide patient services, including those services provided by a contractor, comply with applicable hospital licensing requirements. 17. The chief executive officer shall be responsible for establishing and implementing a mechanism to assure that patients’ rights are protected. At a minimum, the mechanism shall include the following: A. The patient has the right to be free from abuse or neglect; B. The patient has the right to be treated with consideration and respect; C. The patient has the right to protec- tive oversight while a patient in the hospital; D. The patient or his/her designated representative has the right to be informed regarding the hospital’s plan of care for the patient; E. The patient or his/her designated representative has the right to be informed, upon request, regarding general information pertaining to services received by the patient; F. The patient or his/her designated representative has the right to review the patient’s medical record and to receive copies of the record at a reasonable photocopy fee; G. The patient or his/her designated representative has the right to participate in the patient’s discharge planning, including being informed of service options that are available to the patient and a choice of agencies which provide the service; H. When a patient has brought per- sonal possessions to the hospital, s/he has the right to have these possessions reasonably protected; I. The patient has the right to accept medical care or to refuse it to the extent permitted by law and to be informed of the medical consequences of refusal. The patient has the right to appoint a surrogate to make health care decisions on his/her behalf to the extent permitted by law; and J. The patient, responsible party or designee has the right to participate in treatment decisions and the care planning process. (C) Medical Staff. 1. The medical staff shall be organized, shall develop and, with the approval of the governing body, shall adopt bylaws, rules and policies governing their professional activities in the hospital. 2. Medical staff membership shall be limited to physicians, dentists, psychologists and podiatrists. They shall be currently licensed to practice their respective professions in Missouri. The bylaws of the governing body and medical staff shall include the procedure to be used in processing applications for medical staff membership; approving or disapproving appointments; and determining the privileges available to physicians, dentists, psychologists and podiatrists. 3. No application for membership on the medical staff shall be denied based solely upon the applicant’s professional degree or the school or health care facility in which the practitioner received medical, dental, psychology or podiatry schooling, postgraduate training or certification, if the schooling or postgraduate training for a physician was accredited by the American Medical Association or the American Osteopathic Association, for a dentist was accredited by the American Dental Association’s Commission on Dental Accreditation, for a psychologist was accredited with accordance to Chapter 337, RSMo and for a podiatrist was accredited by the American Podiatric Medical Association. Each application for staff membership shall be considered on an individual basis with objective criteria applied equally to each applicant. 4. Each physician, dentist, psychologist or podiatrist requesting staff membership shall submit a written application to the chief executive officer of the hospital on a form approved by the governing body. Each application shall be accompanied by evidence of education, training, professional qualifications, license and standards of performance. 5. The governing body, acting upon rec- ommendations of the medical staff, shall approve or disapprove appointments. Written criteria shall be developed for privileges extended to each member of the staff. A formal mechanism shall be established for recommending to the governing body delineation of privileges, curtailment, suspension or revocation of privileges and appointments and reappointments to the medical staff. The mechanism shall include an inquiry of the National Practitioner Data Bank. 6. Any applicant for medical staff mem- bership who is denied membership or whose completed application is not acted upon in ninety (90) calendar days or a medical staff member whose membership is terminated, curtailed or diminished in any way shall be given in writing the reasons for the action or lack of action. The reasons shall relate to, but not be limited to, standards of patient care, patient welfare, the objectives of the institution or the conduct or competency of the applicant or staff member. 7. Initial appointments to the medical staff shall not exceed twelve (12) months. Reappointments, which may be processed and approved at the discretion of the governing body on a monthly or other cyclical pattern, shall not exceed two (2) years. 8. The medical staff bylaws shall pro- vide for—an outline of the medical staff organization; designation of officers, their duties and qualifications and methods of selecting the officers; committee functions; and an appeal and hearing process. 9. The medical staff bylaws shall pro- vide for an active staff and other categories as may be designated in the governing body bylaws. The medical staff bylaws shall describe the voting rights, attendance requirements, eligibility for holding offices or committee appointments, and any limitations or restrictions identified with location of residence or office practice for each category. 10. The organized medical staff shall meet at intervals necessary to accomplish its required functions. A mechanism shall be established for monthly decision-making by or on behalf of the medical staff. 11. Written minutes shall be signed and permanently filed on a confidential basis in the hospital. 12. The medical staff as a body or through committee shall review and evaluate the quality of clinical practice of the staff throughout the hospital at least once each quarter. Review and evaluation shall include selected deaths, unimproved cases, tissue, infections, complications, errors in diagnosis and results of treatment. 13. The medical staff shall establish in its bylaws or rules criteria for the content of patients’ records provisions for their timely completion and disciplinary action for noncompliance. 14. Bylaws of the medical staff shall require that at all times at least one (1) physician member of the medical staff shall be on duty or available within a reasonable period of time for emergency service. (3) Required Patient Care Services. Each hospital shall provide the following: central services, dietary services, emergency services, medical records, nursing services, pathology and medical laboratory services, pharmaceutical services, radiology services, social work services and an inpatient care unit. (A) Central Services. 1. Central services shall be organized and integrated with patient care services in the hospital. 2. The director of central services shall be qualified by education, training and experience in aseptic technique, principles of sterilization and disinfection and distribution of medical/surgical supplies. The director shall be responsible to an administrative officer or a qualified designee. 3. Sufficient supervisory and support staff shall be assigned as related to the scope of services provided. 4. Sufficient space and equipment shall be provided for the safe and efficient operation of the services as determined by the scope of hospital services delivered. 5. Policies and procedures shall define the activities of all services provided. Sterilization and disinfection standards of practice shall be established. The principles of the Association for Practitioners in Infection Control, Association of Operating Room Nurses, Center for Disease Control and Prevention, American Society for Healthcare Central Service Personnel, Association for the Advancement of Medical Instrumentation, and others may be utilized to establish facility standards of practice for central services. 6. Written procedures shall specify how items stored in central services can be obtained when central services is considered closed. 7. Reprocessed packaged item(s) shall be identified as to content, show evidence of sterilization and be labeled indicating the sterilizer used and the load/cycle number. A policy on the shelf life of a packaged sterile item shall be established in accordance with acceptable standards of sterilization and dependent on the quality of the packaging material, storage conditions and the amount of handling of the item. 8. Central services shall maintain docu- mentation from the manufacturer that packaging material utilized for reprocessing is appropriate for this use. Expiration dates shall comply with the packaging material utilized. 9. Sterile medical-surgical packaged items shall be handled only as necessary and stored in vermin-free areas where controlled ventilation, temperature and humidity are maintained. The integrity of sterile items shall be maintained throughout reprocessing, storage, distribution and transportation. 10. Preventive maintenance of equip- ment shall be done as recommended by the manufacturer or as specified by hospital policy. Records shall be maintained as specified by hospital policy. Records shall include documentation that items processed by steam have undergone sufficient time, temperature and pressure and that items processed by ethylene oxide have undergone sufficient time, temperature, gas concentration and humidity to obtain pathogenic microbial kill. 11. Ethylene oxide sterilized items shall be aerated as specified by hospital policy based on the manufacturer’s recommendations to eliminate the hazards of toxic residue for both patient and staff. 12. Principles of sterilization and disin- fection as approved by the hospital’s infection control committee shall apply throughout the hospital when central services activities are decentralized. (B) Dietary Services. 1. The hospital shall have a full-time employee designated who— A. Serves as director of dietary ser- vices; B. Is responsible for the daily man- agement of the dietary services; C. Is qualified by education, training and experience in food service management and nutrition through an approved course for certification by the Dietary Managers Association or registration by the Commission on Dietetic Registration of the American Dietetic Association, or an associate degree in dietetics or food systems management; and D. Has documented evidence of annu- al continuing education. 2. When the director is not a qualified dietitian, a qualified dietitian shall be employed on a part-time or consultant basis. The dietitian shall make visits to the facility to assist in meeting the nutritional needs of the patients and the scope of services offered. 3. The qualified dietitian shall ensure that high quality nutritional care is provided to patients in accordance with recognized dietary practices. When the services of a qualified dietitian are used on a part-time or consultant basis, the following services shall be provided on the premises on a regularly scheduled basis: A. Continuing liaison with the ad- ministration, medical staff and nursing staff; B. Approval of planned, written menus, including modified diets; and C. Evaluation of menus for nutrition- al adequacy. 4. The consultant or part-time dietitian shall assist the director of dietary services to ensure— A. Patient and family counseling and diet instructions; B. Nutritional screening within three (3) days of admission to identify patients at nutritional risk. The hospital shall develop criteria to use in conducting the nutritional screening and staff who conduct the screening shall be trained to use the criteria; C. Comprehensive nutritional as- sessments within twenty-four (24) hours after screens on patients at nutritional risk, including height, weight and pertinent laboratory tests; D. Documentation of pertinent in- formation in patient’s records, as appropriate; E. Participation in committee activi- ties concerned with nutritional care; and F. Planned, written menus for regu- lar and modified diets. 5. The director of dietary services or his/her designee shall be responsible for— A. Representing the dietary service in interdepartmental meetings; B. Recommending the quantity and quality of food purchased; C. Participating in the selection, ori- entation, training, scheduling and supervision of dietary personnel; D. Interviewing the patients for food preferences and tolerances and providing appropriate substitutions; E. Monitoring adherence to the writ- ten planned menu; and F. Scheduling dietary services meet- ings. 6. When the qualified dietitian serves as a consultant, written reports shall be submitted to and approved by the chief executive officer or designee concerning the services provided. 7. The director of dietary services shall be responsible for developing and implementing written policies and procedures and for monitoring to assure they are followed. Policies and procedures shall be kept current and approved by the chief executive officer or designee. 8. Dietary services shall be staffed with a sufficient number of qualified personnel. 9. Menus shall be planned, written and followed to meet the nutritional needs of the patients as determined by the recommended dietary allowances (RDA) of the Food and Nutrition Board of the National Research 19 CSR 30-20 Council, National Academy of Sciences or as modified by physician’s order. 10. Diets shall be prescribed in accor- dance with the diet manual approved by the qualified dietitian and the medical staff. The diet manual shall be available to all medical, nursing and food service personnel. 11. At least three (3) meals or their equivalent shall be served approximately five (5) hours apart with supplementary feedings as necessary. There shall not be more than fourteen (14) hours between a substantial evening meal and breakfast. 12. Dietary records shall be maintained which include: food specifications and purchase orders; meal count; standardized recipes; menu plans; nutritional evaluation of menus; and minutes of departmental and inservice education meetings. 13. The dietary services shall comply with 19 CSR 20-1.010 Sanitation of Food Services Establishments. Foods shall be prepared by methods that conserve nutritive value, flavor and appearance and shall be attractively served at acceptable temperatures. Potentially hazardous foods shall be served at temperatures specified in 19 CSR 20- 1.010(4)(I) and (J), (5)(B)1.–3. and (H). 14. When there is a contract to provide dietary services to a hospital, the hospital is responsible for assuring that contractual services comply with rules concerning dietary services in hospitals. (C) Emergency Services. 1. Each hospital providing general ser- vices to the community shall provide an easily accessible emergency area which shall be equipped and staffed to ensure that ill or injured persons can be promptly assessed and treated or transferred to a facility capable of providing needed specialized services. In multiple-hospital communities where written agreements have been developed among the hospitals in accordance with an established community-based hospital emergency plan, individual hospitals may not be required by the Department of Health to provide a fully equipped emergency service. 2. A hospital shall have a written hospi- tal emergency transfer policy and written transfer agreements with one (1) or more hospitals within its service area which provide services not available at the transferring hospital. Transfer agreements shall be established which reflect the usual and customary referral practice of the transferring hospital, but are not intended to cover all contingencies. 3. Hospital emergency services shall be under the medical direction of a qualified staff physician who is board-certified or board-admissible in emergency medicine and maintains a knowledge of current ACLS and ATLS standards or a physician who is experienced in the care of critically ill and injured patients and maintains current verification in ACLS and ATLS. In pediatric hospitals, PALS shall be substituted for ACLS. With the explicit advanced approval of the Department of Health, a hospital may contract with a qualified consultant physician to meet this requirement. A. That physician shall be responsible for implementing rules of the medical staff relating to patient safety and privileges and to the quality and scope of emergency services. B. A qualified registered nurse shall supervise and evaluate the nursing and patient care provided in the emergency area by nursing and ancillary personnel. Supervision may be by direct observation of staff or, at a minimum, the nurse shall be immediately available in the institution. C. Any person assigned to the emer- gency services department administering medications shall be a licensed physician, registered nurse, EMT-paramedic or appropriately licensed or certified allied health practitioner and shall administer medications only within his/her scope of practice except for students who are participating in a training program to become physicians, nurses, emergency medical technician-paramedics who may be allowed to administer medication under the supervision of their instructors as a part of their training. Trained individuals from the respiratory therapy department may be allowed to administer aerosol medications when a certified respiratory therapy assistant is not available. 4. Any hospital which provides emer- gency services and does not maintain a physician in-house twenty-four (24) hours a day for emergency care shall have a call roster which lists the name of the physician who is on call and available for emergency care and the dates and times of coverage. A physician who is on call and available for emergency care shall respond in a manner which is reasonable and appropriate to the patient’s condition after being summoned by the hospital. 5. Any hospital with surgical services that also provide emergency surgical services shall have a general surgical call roster which lists the name of the general surgeon who is on call for emergency surgical cases, and the dates and times of coverage. The surgeon who is on call for emergency surgical cases shall arrive at the hospital within thirty (30) minutes of being summoned. Patients arriving at a hospital that does not provide emergency surgical services and are found upon examination to require emergency surgery shall be immediately transferred to a hospital with the necessary services. 6. All patients admitted to the emergen- cy service shall be assessed prior to discharge by a physician or registered professional nurse. 7. If discharged from the emergency department, other than to the inpatient setting, the patient or responsible person shall be given written instructions for care and an oral explanation of those instructions. Documentation of these instructions shall be entered on the emergency service medical record. 8. There shall be a quality improvement program for the emergency service which includes, but is not limited to, the collection and analysis of data to assist in identification of health service problems, and a mechanism for implementation and monitoring appropriate actions. The quality improvement program shall include the periodic evaluation of at least the following: length of time each patient is in the emergency room, appropriateness of transfers, physician response time, provision for written instructions, timeliness of diagnostic studies, appropriateness of treatment rendered, and mortality. 9. Written policies shall be adopted to assure that notification procedures are implemented concerning the significant exposure of prehospital emergency personnel to communicable diseases as required in 19 CSR 30- 40.047. 10. The emergency service medical record shall contain patient identification, time and method of arrival, history, physical findings, treatment and disposition and shall be authenticated by the physician. These records, including an ambulance report when applicable, shall be filed under supervision of the medical records department. 11. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of emergency services. (D) Medical Records. 1. The director of the medical record services shall be appointed by the chief executive officer or chief operating officer. This director may be a qualified registered record administrator, an accredited record technician or an individual with demonstrated competence and knowledge of medical record department activities supervised by a qualified consultant who is a registered record administrator or accredited record technician. 2. Patient care by members of the medi- cal staff, nursing staff and allied health professionals shall be entered in the patient’s medical record in a timely manner. Documentation shall be legible, dated, authenticated and recorded in ink, typewritten or recorded electronically. 3. All orders shall be dated and authen- ticated by the ordering practitioner and shall be kept in the patient’s medical record. Verbal orders shall be authenticated by the prescribing practitioner or attending physician within the time frame that is defined by the medical staff in cooperation with nursing and administration. Authentication shall include written signatures, initials, computer-generated signature codes or rubber stamp signatures by the medical members and authorized persons whose signatures the stamp represents. The use of rubber stamps is discouraged, but where authorized, a signed statement shall be maintained in the administrative offices with a copy in the medical records department stating that the medical staff member whose stamp is involved is the only one who has the stamp and is the only one authorized to use it. The duplication of signature stamps and the delegation of their use by others is prohibited. 4. Only abbreviations and symbols approved by the medical staff may be used in the medical records. Each abbreviation or symbol shall have only one (1) meaning and an explanatory legend shall be available for use by all concerned. 5. The medical record of each patient shall be maintained in order to justify admission and continued hospitalization, support the diagnosis, describe the patient’s progress and response to medications and services and to facilitate rapid retrieval and utilization by authorized personnel. 6. Medical records are the property of the hospital and shall not be removed from the hospital premises except by court order, subpoena, for the purposes of microfilming or for off-site storage approval by the governing body. 7. Written consent of the patient or the patient’s legal representative is required for access to or release of information, copies or excerpts from the medical record to persons not otherwise authorized to receive this information. 8. Patient records shall be considered complete for filing when the required contents are assembled and authenticated. Hospital policy shall define circumstances in which incomplete medical records may be filed permanently by order of the medical record committee. 9. An inpatient’s medical record shall include: a unique identifying record number; pertinent identifying and personal data; history of present illness or complaint; if injury, how the injury occurred; past history; family history; physical examination; admitting diagnosis; medical staff orders; progress notes; nurses’ notes; discharge summary; final diagnosis; and evidence of informed consent. Where applicable, medical records shall contain reports such as clinical laboratory, X-ray, consultation, electrocardiogram, surgical procedures, therapy, anesthesia, pathology, autopsy and any other reports pertinent to the patient’s care. 10. Admission forms shall be designed to record pertinent identifying and personal data. 11. A certificate of live birth shall be prepared for each child born alive and shall be forwarded to the local registrar within seven (7) 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. 12. 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. 13. 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. 14. The State Anatomical Board shall be notified of an unclaimed dead body. A record of this notification shall be maintained. 15. The patient’s medical records shall be maintained to safeguard against loss, defacement 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 twenty-third birthday, whichever occurs later. Preservation of medical records may be extended by the hospital for clinical, educational, statistical or administrative purposes. 16. There shall be a mechanism for the review and evaluation on a regular basis of the quality of medical record services. 17. Should the hospital cease to be licensed, arrangements for disposition of the patient medical records shall be made with nearby hospitals, the patient’s physician or a reliable storage company. Notification of the disposition is to be provided to the department. 18. A history and physical examination shall be completed on each inpatient within twenty-four (24) hours of admission, or a history and physical examination shall have been completed within the seven (7) days prior to admission. 19. A patient’s records shall be com- pleted within thirty (30) days of discharge. (E) Nursing Services. 1. The nursing service shall be integrat- ed and identified within the total hospital organizational structure. 2. The nursing service shall have a writ- ten organizational structure that indicates lines of authority, accountability and communication. 3. The organization of the nursing ser- vice shall conform with the variety of patient care services offered and the range of nursing care activities. 4. Nursing policies and standards of practice describing patient care shall be in writing and be kept current. 5. Policies shall provide for the collabo- ration of nursing personnel with members of the medical staff and other health care disciplines regarding patient care issues. 6. Nursing service policies shall estab- lish an appropriate committee structure to oversee and assist in the provision of quality nursing care. The purpose and function of each committee shall be defined and a record of its activities shall be maintained. 7. Policies shall make provision for nursing personnel to be participants of hospital committees concerned with patient care activities. 8. The nursing service shall be admin- istered and directed by a qualified registered professional nurse with appropriate education, experience and demonstrated ability in nursing practice and management. 9. The nursing service administrator shall be responsible to the chief executive officer or chief operating officer. 10. 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. 11. The nursing service administrator shall participate in the formulation of hospital policies and the development of longrange plans relating to patient care. 12. The nursing service administrator, or designee, shall represent nursing at all appropriate meetings of the medical staff and governing board of the hospital. 13. The nursing service administrator shall be accountable for the selection, promotion and termination of all nursing personnel under the authority of nursing service. 14. The nursing service administrator shall have sufficient time to perform the nec- 19 CSR 30-20 essary managerial duties and functions of the position. 15. A qualified registered professional nurse shall be designated and authorized to act in the absence of the nursing service administrator. 16. Nursing personnel shall hold a valid and current license in accordance with sections 335.011–335.096, RSMo. 17. There shall be a job description for each classification of nursing personnel which delineates the specific qualifications, licensure, certification, authority, responsibilities, functions and performance standards for that classification. Job descriptions shall be reviewed annually and revised as necessary to reflect current job requirements. 18. There shall be scheduled annual evaluations of job performance for all classifications of nursing personnel. 19. All nursing personnel shall be ori- ented to the hospital, nursing services and to their position classification. The orientation shall be of sufficient length and content to prepare nursing personnel for their specified duties and responsibilities. Competency shall be validated prior to assuming independent performance in actual patient situation. 20. For specialized nursing units and those units providing specific clinical services, written policies and procedures, including standards of practice, shall be available and current. 21. Nursing personnel meetings shall be conducted at intervals necessary for leadership and to communicate management information. Separate meetings for the various job classifications of personnel may be conducted. Minutes of all meetings shall be maintained and reflect attendance, scope of discussion and action(s) taken. The minutes shall be filed according to hospital policy. 22. Each facility shall develop and uti- lize a methodology which ensures adequate nurse staffing that will meet the needs of the patients. At a minimum, on duty at all times there shall be a sufficient number of registered professional nurses to provide patient care requiring the judgment and skills of a registered professional nurse and to supervise the activities of all nursing personnel. 23. There shall be sufficient licensed and ancillary nursing personnel on duty on each nursing unit to meet the needs of each patient in accordance with accepted standards of nursing practice. 24. Patient care assignments shall be consistent with the qualifications of the nursing personnel and the identified patient needs. 25. Documentation in the patient’s med- ical record shall reflect use of the nursing process in the delivery of care throughout the patient’s hospitalization. 26. A registered professional nurse shall assess the patient’s needs for nursing care in all settings where nursing care is provided. A nursing assessment shall be completed within twenty-four (24) hours of admission as an inpatient. The registered professional nurse may be assisted in the process by other qualified nursing staff members. 27. Patient education and discharge needs shall be addressed and appropriately documented in the medical records. 28. The necessary types and quantities of supplies and equipment shall be available to meet the current needs of each patient. Reference materials pertinent to patient care shall be readily accessible. (F) Pathology and Medical Laboratory Services. 1. Provision shall be made, either on the premises or by contract with a reference laboratory, for the prompt performance of adequate examinations in the fields of hematology, clinical chemistry, urinalysis, microbiology, immunology, anatomic pathology, cytology and immunohematology. 2. The director of the pathology and medical laboratory services shall be a physician who is a member of the medical staff and appointed by the governing body. If the director is not a pathologist, a pathologist shall be retained on a part-time basis as a consultant on-site. Consultation shall be provided no less than monthly. A written report of the consultant’s evaluation and recommendations shall be submitted after each visit. 3. Pathology and medical laboratory services shall be integrated with other hospital services. The pathologist(s) shall have an active role in in-service educational programs and in medical staff functions, the laboratory quality assurance program and shall participate in committees that review tissue, infection control and blood usage. 4. Laboratory technologists shall have graduated from a medical technology program approved by a nationally recognized body or have documented equivalent education, training and experience. There shall be sufficient qualified laboratory technologists and supportive technical staff currently competent in their field to perform the tests required. Laboratory personnel shall have the opportunity for continuing education. 5. The laboratory shall perform tests and examine specimens from hospital inpatients only on the order of a medical staff member. The laboratory shall perform tests and examine specimens from any other source only on written request. Test requests received by the laboratory shall clearly identify the patient, the source of the request, the tests required and the date. Requests for examinations of surgical specimens shall contain necessary clinical information. 6. The laboratory shall maintain com- plete written instructions for specimen collection and processing, storage, testing and reporting of results. The instructions shall include, but not be limited to, a step-by-step description of the testing procedure, reagent use and storage, control and calibration procedures and pertinent literature references. 7. Dated reports of all laboratory exam- inations shall become a part of the patient’s medical record. If the original report from a reference laboratory is not part of the patient’s record, the original shall be retained and retrievable for a period of not less than two (2) years. Dated reports of tests on outpatients and from referring laboratories shall be sent promptly to the individual or facility ordering the test. Copies of all laboratory tests and examinations shall be retained and retrievable for at least two (2) years. 8. Instruments and equipment shall be evaluated to insure that they function properly at all times. Records shall be maintained for each piece of equipment, showing the date of inspection, calibration, performance evaluation and action taken to correct deficiencies. Temperatures shall be recorded daily for all temperature-controlled instruments. 9. Each section of the pathology and medical laboratory shall have a written quality control program to verify accuracy, measure precision and detect error. Quality control results shall be documented and retained for at least two (2) years. 10. The hospital laboratory shall suc- cessfully participate in a proficiency testing program covering all anatomical and clinical specialties in which the laboratory performs tests and in which proficiency testing is available. Records of proficiency testing shall be maintained for at least two (2) years. 11. All specimens, except for teeth and foreign objects, removed during a surgical, diagnostic, or other procedure shall be submitted for pathologic examination, except for specimens that have been previously determined to be exempt. Specimens submitted for pathological examination shall be accompanied by pertinent clinical information. Specimens exempted from pathologic examination shall be those for which examination does not add to the diagnosis, treatment or prognosis, shall be determined by the medical staff in consultation with the pathologist, and shall be documented in writing. When the specimen is not submitted for pathological examination, a report of the removal must be present in the patient’s medical record. Specimens requiring only a gross description and diagnosis shall be determined by the medical staff in consultation with the pathologist and shall be documented in writing. 12. An autopsy service shall be available to meet the needs of the hospital. Each autopsy shall be performed by, or under the supervision of, a pathologist or a physician whose credentials document his/her qualifications in anatomical pathology. All microscopic interpretations shall be made by a pathologist who is qualified in anatomical pathology. 13. At all times there shall be an estab- lished procedure for obtaining a supply of blood and blood components. Facilities for the safekeeping and safe administration of blood and blood products shall be provided. Positive patient identification shall be provided through an armband that displays a number or other unique identifying symbol. This armband shall be on the patient before or at the time of drawing the first tube of blood used for transfusion preparation. The refrigerator used for the routine storage of blood for transfusion shall maintain a temperature between one degree and six degrees Celsius (1°—6° C) and this temperature shall be verified by an outside recording thermometer. This refrigerator shall be constantly monitored by an audible and visible alarm that is located in an area that is staffed at all times. The alarm shall be battery-operated or powered by a circuit different from the one supplying the refrigerator. This refrigerator shall be on the power line supplied by the emergency generator. 14. The hospital shall provide safety equipment for laboratory employees that includes, but is not limited to, gloves. No food, drink, tobacco or personal care items shall be in the laboratory testing area. (G) Pharmacy Services. 1. Pharmacy services shall be identified and integrated within the total hospital organizational plan. Pharmacy services shall be directed by a pharmacist who is currently licensed in Missouri and qualified by education and experience. The director of pharmacy services shall be responsible for the provision of all services required in subsection (4)(G) of this rule and shall be a participant in all decisions made by pharmacy services or committees regarding the use of medications. With the assistance of medical, nursing and administrative staff, the director of pharmacy services shall develop standards for the selection, distribution and safe and effective use of medications throughout the hospital. 2. Additional professional and support- ive personnel shall be available for services provided. Pharmacists shall be currently licensed in Missouri and all personnel shall possess the education and training necessary for their responsibilities. 3. Support pharmacy personnel shall work under the supervision of a pharmacist and shall not be assigned duties that by law must be performed by a pharmacist. Interpreting medication orders, selecting, compounding, packaging, labeling and the dispensing of medications by pharmacy staff shall be performed by or under the supervision of a pharmacist. Interpretation of medication orders by support personnel shall be limited to order processing and shall not be of a clinical nature. 4. Hours shall be established for the provision of pharmacy services. A pharmacist shall be available to provide required pharmacy services during hours appropriate for necessary contact with medical and nursing staff. A pharmacist shall be on call at all other times. 5. Space, equipment and supplies shall be available according to the scope of pharmacy services provided. Office or other work space shall be available for administrative, clerical, clinical and other professional services provided. All areas shall meet standards to maintain the safety of personnel and the security and stability of medications stored, handled and dispensed. 6. The pharmacy and its medication storage areas shall have proper conditions of sanitation, temperature, light, moisture, ventilation and segregation. Refrigerated medication shall be stored separate from food and other substances. The pharmacy and its medication storage area shall be locked and accessible only to authorized pharmacy and supervisory nursing personnel. The director of pharmacy services, in conjunction with nursing and administration, shall be responsible for the authorization of access to the pharmacy by supervisory nursing personnel to obtain doses for administering when pharmacy services are unavailable. 7. Medication storage areas outside of the pharmacy shall have proper conditions of sanitation, temperature, light, moisture, ventilation and segregation. Refrigerated medications shall be stored in a sealed compartment separate from food and laboratory materials. Medication storage areas shall be locked and accessible only to authorized personnel. 8. The evaluation, selection, source of supply and acquisition of medications shall occur according to the hospital’s policies and procedures. Medications and supplies needed on an emergency basis and necessary medications not included in the hospital formulary shall be acquired according to the hospital’s policies and procedures. 9. Records shall be maintained of medi- cation transactions, including: acquisition, compounding, repackaging, dispensing or other distribution, administration and controlled substance disposal. Persons involved in compounding, repackaging, dispensing, administration and controlled substance disposal shall be identified and the records shall be retrievable. Retention time for records of bulk compounding, repackaging, administration, and all controlled substance transactions shall be a minimum of two (2) years. Retention time for records of dispensing and extemporaneous compounding, including sterile medications, shall be a minimum of six (6) months. 10. Security and recordkeeping proce- dures in all areas shall ensure the accountability of all controlled substances, shall address accountability for other medications subject to theft and abuse and shall be in compliance with 19 CSR 30-1.030(3). Inventories of Schedule II controlled substances shall be routinely reconciled. Inventories of Schedule III—V controlled substances outside of the pharmacy shall be routinely reconciled. Records shall be maintained so that inventories of Schedule III—V controlled substances in the pharmacy shall be reconcilable. 11. Controlled substance storage areas in the pharmacy shall be separately locked and accessible only to authorized pharmacy staff. Reserve supplies of all controlled substances in the pharmacy shall be locked. Controlled substance storage areas outside the pharmacy shall be separately locked and accessible only to persons authorized to administer them and to authorized pharmacy staff. 12. Authorization of access to controlled substance storage areas outside of the pharmacy shall be established by the director of pharmacy services in conjunction with nursing and administration. The distribution and accountability of keys, magnetic cards, electronic codes or other mechanical and electronic devices shall occur according to the hospital’s policies and procedures. 13. All variances involving controlled substances—including inventory, security, recordkeeping, administration and disposal— shall be reported to the director of pharmacy services for review and investigation. Loss, diversion, abuse or misuse of medications shall be reported to the director of pharmacy services, administration, and local, state and federal authorities as appropriate. 14. The provision of pharmacy services in the event of a disaster, removal from use of medications subject to product recall and reporting of manufacturer drug problems 19 CSR 30-20 shall occur according to the hospital’s policies and procedures. 15. Compounding and repackaging of medications in the pharmacy shall be done by pharmacy personnel under the supervision of a pharmacist. Those medications shall be labeled with the medication name, strength, lot number, expiration date and other pertinent information. Recordkeeping and quality control, including end-product testing when appropriate, shall occur according to the hospital’s policies and procedures. 16. Compounding, repackaging or rela- beling of medications by nonpharmacy personnel shall occur according to the hospital’s policies and procedures. Medications shall be administered routinely by the person who prepared them, and preparation shall occur just prior to administration except in circumstances approved by the director of pharmacy, nursing and administration. Labeling shall include the patient’s name, where appropriate, medication name, strength, expiration date, identity of the person preparing and other pertinent information. 17. Compounded sterile medications shall be routinely prepared in a suitably segregated area in a Class 100 environment by pharmacy personnel. Preparation by nonpharmacy personnel shall occur only in specific areas or in situations when immediate preparation is necessary and pharmacy personnel are unavailable and shall occur according to policies and procedures. All compounded cytotoxic/hazardous medications shall be prepared in a suitably segregated area in a Class II biological safety cabinet or vertical airflow hood. The preparation, handling, administration and disposal of sterile or cytotoxic/hazardous medications shall occur according to policies and procedures including: orientation and training of personnel, aseptic technique, equipment, operating requirements, environmental considerations, attire, preparation of parenteral medications, preparation of cytotoxic/hazardous medications, access to emergency spill supplies, special procedures/products, sterilization, extemporaneous preparations and quality control. 18. Radiopharmaceuticals shall be acquired, stored, handled, prepared, packaged, labeled, administered and disposed of according to the hospital’s policies and procedures and only by or under the supervision of personnel who are certified by the Nuclear Regulatory Commission. 19. A medication profile for each patient shall be maintained and reviewed by the pharmacist and shall be reviewed by the pharmacist upon receiving a new medication order prior to dispensing the medication. The pharmacist shall review the prescriber’s order or a direct copy prior to the administration of the initial dose, except in an emergency or when the pharmacist is unavailable, in which case the order shall be reviewed within seventy-two (72) hours. 20. Medications shall be dispensed only upon the order of an authorized prescriber and only by or under the supervision of the pharmacist. 21. All medications dispensed for administration to a specific patient shall be labeled with the patient name, drug name, strength, expiration date and, when applicable, the lot number and other pertinent information. 22. The medication distribution system shall provide safety and accountability for all medications, include unit of use and ready to administer packaging, and meet current standards of practice. 23. To prevent unnecessary entry to the pharmacy, a locked supply of routinely used medications shall be available for access by authorized personnel when the pharmacist is unavailable. Removal of medications from the pharmacy by authorized supervisory nursing personnel, documentation of medications removed, restricted and unrestricted medication removal, later review of medication orders by the pharmacist, and documented audits of medications removal shall occur according to the hospital’s policies and procedures. The nurse shall remove only amounts necessary for administering until the pharmacist is available. 24. Floorstock medications shall be lim- ited to emergency and nonemergency medications which are authorized by the director of pharmacy services in conjunction with nursing and administration. The criteria, utilization and monitoring of emergency and nonemergency floorstock medications shall occur according to the hospital’s policies and procedures. Supplies of emergency medications shall be available in designated areas. 25. All medication storage areas in the hospital shall be inspected at least monthly by a pharmacist or designee according to the hospital’s policies and procedures. 26. The pharmacist shall be responsible for the acquisition, inventory control, dispensing, distribution and related documentation requirements of investigational medications according to the hospital’s policies and procedures. A copy of the investigational protocol shall be available in the pharmacy to all health care providers who prescribe or administer investigational medications. The identity of all recipients of investigational medications shall be readily retrievable. 27. Sample medications shall be received and distributed by the pharmacy according to the hospital’s policies and procedures. 28. Dispensing of medications by the pharmacist to patients who are discharged from the hospital or who are outpatients shall be in compliance with 4 CSR 220. 29. Persons other than the pharmacist may provide medications to patients leaving the hospital only when prescription services from a pharmacy are not reasonably available. Medications shall be provided according to the hospital’s policies and procedures, including: circumstances when medications may be provided, practitioners authorized to order, specific medications and limited quantities, prepackaging and labeling by the pharmacist, final labeling to facilitate correct administration, delivery, counseling and a transaction record. Final labeling, delivery and counseling shall be performed by the prescriber or a registered nurse. 30. Current medication information resources shall be maintained in the pharmacy and patient care areas. The pharmacist shall provide medication information to the hospital staff as requested. 31. The director of pharmacy services shall be an active member of the pharmacy and therapeutics committee or its equivalent, which shall advise the medical staff on all medication matters. A formulary shall be established which includes medications based on an objective evaluation of their relative therapeutic merits, safety and cost and shall be reviewed and revised on a continual basis. A medication use evaluation program shall be established which evaluates the use of selected medications to ensure that they are used appropriately, safely and effectively. Followup educational information shall be provided in response to evaluation findings. 32. The pharmacist shall be available to participate with medical and nursing staff regarding decisions about medication use for individual patients, including: not to use medication therapy; medication selection, dosages, routes and methods of administration; medication therapy monitoring; provision of medication-related information; and counseling to individual patients. The pharmacist or designee shall personally offer to provide medication counseling when discharge or outpatient prescriptions are filled. The pharmacist shall provide requested counseling. 33. Medication orders shall be initiated or modified only by practitioners who have independent statutory authority to prescribe or who are legally given authority to order medications. That authority may be given through an arrangement with a practitioner who has independent statutory authority to prescribe and who is a medical staff member. The authority may include collaborative practice agreements, protocols or standing orders and shall not exceed the practitioner’s scope of practice. Practitioners given this authority who are not hospital employees shall be approved through the hospital credentialing process. When hospital-based agreements, protocols or standing orders are used, they shall be approved by the pharmacy and therapeutics or equivalent committee. 34. All medication orders shall be writ- ten in the medical record and signed by the ordering practitioner. When medication therapy is based on a protocol or standing order and a specific medication order is not written, a signed copy of the protocol or of an abbreviated protocol containing the medication order parameters or of the standing order shall be placed in the medical record. Telephone or verbal orders shall be accepted only by authorized staff, immediately written and identified as such in the medical record and signed by the ordering practitioner within a time frame defined by the medical staff. 35. Medication orders shall be written according to policies and procedures and those written by persons who do not have independent statutory authority to prescribe shall be included in the quality improvement program. 36. Automatic stop orders for all medi- cations shall be established and shall include a procedure to notify the prescriber of an impending stop order. A maximum stop order shall be effective for all medications which do not have a shorter stop order. Automatic stop orders are not required when the pharmacist continuously monitors medications to ensure that they are not inappropriately continued. 37. Medications shall be administered only by persons who have statutory authority to administer or who have been trained in each pharmacological category of medication they administer, and administration shall be limited to the scope of their practice. Persons who do not have statutory authority to administer shall not administer parenteral medications, controlled substances or medications that require professional assessment at the time of administration. A person who has statutory authority to administer shall be readily available at the time of administration. Training for persons who do not have statutory authority to administer shall be documented and administration by those persons shall be included in the quality improvement program. Medications shall be administrated only upon the order of a person authorized to prescribe or order medications. Administration by all persons shall occur according to the hospital’s policies and procedures. 38. Medications brought to the hospital by patients shall be handled according to policies and procedures. They shall not be administered unless so ordered by the prescriber and identified by the pharmacist or the prescriber. 39. Medications shall be self-adminis- tered or administered by a responsible party only upon the order of the prescriber and according to policies and procedures. 40. Medication incidents, including medication errors shall be reported to the prescriber and the appropriate manager. Medication incidents shall be reported to the appropriate committee. Adverse medication reactions shall be reported to the prescriber and the director of the pharmacy services. The medication administered and medication reaction shall be recorded in the patient’s medical record. Adverse medication reactions shall be reviewed by the pharmacy and therapeutics committee and other medical or administrative committees when appropriate. (H) Radiology Services. 1. Radiographic and fluoroscopic diag- nostic services shall be provided in each hospital. 2. The director of radiology services shall be a qualified physician member of the medical staff and appointed by the governing body. This physician shall be responsible for implementing the rules of the medical staff governing the quality and scope of radiology services and safety precautions to protect patients and personnel. 3. Radiotherapy services shall be admin- istered only under the supervision of a physician appropriately qualified by special training and experience. 4. Requests for radiology services shall be authenticated in the patient’s medical record by the attending physician, licensed house staff or other medical staff member authorized to request radiologic services. 5. A written interpretation, authenticat- ed by a radiologist or other medical staff member appropriately trained and qualified through the medical staff credentialing process, shall be made for all radiological diagnostic services. 6. Documentation of each radiotherapy treatment shall be authenticated and become a part of the patient’s medical record. 7. A qualified radiologic technologist shall be on duty or on call at all times. Emergency radiologic services shall be available at all times. 8. Protection from radiation to patients and personnel shall comply with 19 CSR 20- 10.010–19 CSR 20-10.190. 9. There shall be periodic inspection of equipment by a medical physicist qualified to furnish complete evaluation. Documentation shall be maintained and available for two (2) years. (I) Social Work Services. 1. The program shall include: a method of screening to determine the social service needs of the patient; a method of providing appropriate social work interventions, including discharge planning and counseling; and a mechanism for referrals to community agencies when appropriate. 2. The social service program shall be identified and integrated in the total hospital organizational plan. Social work services shall be provided under the direction of a qualified social services worker. When the individual is not a qualified social worker, a qualified social worker shall be employed on a part-time or consultant basis. 3. Social work services including dis- charge planning shall be integrated with other direct patient-care services of the hospitals. The social work assessment and plan of action shall be implemented for each patient who has need for social services. 4. Written policies and procedures relat- ing to the quality and scope of social work services shall be kept current. (J) Inpatient Care Unit. 1. A facility to be classified as a gener- al hospital shall provide inpatient care for medical or surgical patients, or both, and may include pediatric, obstetrical and newborn, psychiatric or rehabilitation patients. To be classified a specialized pediatric, psychiatric or rehabilitation hospital, a facility shall provide inpatient care in an exclusive specialty such as pediatrics, psychiatry or rehabilitation and shall have a medical staff and other professional or technical personnel especially qualified in the particular specialty for which the hospital is operated. (K) Fire Safety, General Safety and Operating Features. 1. Each hospital shall comply with the “Operating Features” requirements of Chapter 31 of NFPA 101, 1994. New hospitals or portions of hospitals constructed or remodeled after the effective date of this amendment shall be maintained so that the building and its various operating systems comply with NFPA 99, 1993 and NFPA 101, 1994. Existing hospital facilities constructed prior to the effective date of this amendment shall maintain and operate the building in compliance with the design and safety regulations in effect at the time of their construction. 19 CSR 30-20 2. Each hospital shall be maintained in good repair to facilitate the maintenance of an appropriate health care delivery environment and to minimize hazards. 3. Each hospital shall develop a mecha- nism for the identification and abatement of occupant safety hazards in their facilities. Any safety hazard or threat to the general safety of patients, staff or the public shall be corrected. 4. Each hospital shall develop and main- tain current a disaster plan which is specified to its facility for response to man-made or natural disasters. Annex 1 of NFPA 99, 1993 shall be used as a guide in the preparation and revision of the hospital’s health care disaster plan. (L) Orientation and Continuing Education. 1. There shall be an orientation and con- tinuing education program for the development and improvement of necessary skills and knowledge of the facility personnel. 2. The orientation program shall be of the scope and duration necessary to effectively prepare personnel new to a unit for their assigned duties and responsibilities based on job descriptions. Temporary personnel shall participate in an orientation prior to providing direct patient care. 3. Educational programs shall be con- ducted using internal or external resources and shall be planned and documented. Documentation on the topic, presenter, date/time of presentation and the program attendance shall be available. 4. Teaching material and suitable refer- ences shall be identified and supplied as needed for the staff of each department or unit that treats patients. 5. The orientation and continuing edu- cation program shall participate in the performance improvement process and shall provide evaluation opportunities appropriate to its goals and objectives. 6. The continuing education program shall include, as appropriate for the job, but not be limited to: A. Problems and needs of specific age groups, chronically ill, acutely ill and disabled patients; B. Prevention and control of infec- tions including universal precautions; C. Interpersonal relationships and communication skills; D. Fire prevention, safety and acci- dent prevention; E. Patient rights, dignity and privacy issues; F. Licensed nursing personnel train- ing on basic cardiac life support and choking prevention and intervention; and G. Any other educational need identi- fied through the quality improvement activities and those generated by advances made in health care science and technology. 7. Competency of all employees shall be evaluated annually based on job description and necessary job skills and knowledge. (M) Quality Improvement Program. 1. The governing body shall ensure the development and implementation of an effective, ongoing, systematic hospital-wide, patient-oriented performance improvement plan. 2. This plan shall be designed to mea- sure, assess and improve the quality of patient care as evidenced by patient health outcomes or improvement in processes, or both. 3. The performance improvement plan shall be written and shall include: A. Description of the plan purpose, objectives, organizations, scope, authority, responsibility, and mechanisms of a planned systematic, organization-wide approach to designing, measuring, assessing and improving performance; B. Assurance of collaborative partici- pation from appropriate departments and services, both clinical and nonclinical, including those services provided directly and under contract; C. Provision for assessment and coor- dination of quality improvement activities through an established oversight team that meets on an established periodic basis; D. Assurance of ongoing communica- tion, reporting and documentation of patientcare issues and quality improvement activities and their effectiveness to the governing body and medical staff at least quarterly; and E. Development of an annual assess- ment of the effectiveness of the plan. 4. At a minimum, the plan shall include: A. Organization-wide design, mea- surement, assessment and improvement of patient care and organizational functions; B. Review of care that includes out- comes of care provided by the medical and nursing staff and by other health care practitioners employed or contracted by the hospital; C. Measurements of quality of care which are outcomeor process-based, specific to the hospital, and to identified needs and expectations of the patients and staff; D. Review on a continuing basis of the processes that affect a large percentage of patients, that place patients at risk or that have caused or are likely to cause quality problems; and E. Review of all hospital specific data and state normative data provided by the Department of Health (DOH). The CEO or his/her designee shall respond to the DOH with a corrective plan when the hospital is directed to do so by the Bureau of Hospital Licensing and Certification. 5. The performance improvement plan shall be designed to review activity, actions initiated and reassessments. Documentation shall be maintained on these activities. (4) Optional Ancillary Services. (A) Ambulatory Care Services. 1. Ambulatory care services, if provided through an organized department of the hospital, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. This physician shall be responsible for implementing rules of the medical staff governing the quality and scope of ambulatory care services provided. 2. Ambulatory care services shall be integrated with other hospital services as required to meet the needs of the patient. 3. Nursing personnel assigned to the ambulatory care services shall be under the supervision of a qualified registered professional nurse with relevant education, experience and demonstrated current competency. 4. Approved written policies and proce- dures shall describe the scope of ambulatory care provided. Policies and procedures shall be reviewed at least annually and revised as necessary. 5. Ambulatory care services shall be staffed by personnel qualified by education, training and experience to provide safe patient care. 6. Patient’s medical records shall reflect ambulatory care and treatment provided. These records shall be filed and maintained under supervision of the medical records department. 7. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of ambulatory care services provided. (B) Anesthesia Services. 1. Anesthesia services, if provided, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. This physician shall be responsible for implementing the rules of the medical staff governing the quality and scope of anesthesia care provided. 2. Approved written policies and proce- dures shall include: patient and employee safety, preand post-anesthesia evaluation, care of equipment, storage of anesthesia agents and the administration of anesthesia. 3. Anesthesia shall be administered only by qualified anesthesiologists, physicians or dentists trained in anesthesia, certified nurse anesthetists or supervised students in an approved educational program. 4. An anesthesia record documenting the care given shall be a permanent part of the patient’s medical record. 5. The pre-anesthesia patient evaluation shall be accomplished by a physician and documented within forty-eight (48) hours before surgery and shall include the history and physical examination; anesthetic, drug and allergy history; essential laboratory data; and other diagnostic test results to establish potential anesthetic risks. These procedures may be waived in the event of a life threatening emergency, provided the surgeon so certifies on the patient medical record. 6. A post-anesthesia evaluation shall be documented in the patient’s medical record within twenty-four (24) hours after surgery. 7. The use of flammable anesthetic agents shall be limited to those areas of the hospital which comply with all applicable requirements of the Standard for Inhalation Anesthetics 1980 published by the National Fire Protection Association. 8. Prior to surgery, the patient’s medical record shall contain evidence that the patient has been advised regarding the surgical procedure(s) contemplated, the type of anesthesia to be administered and the risks involved with each. Evidence that informed consent has been given shall become a part of the patient’s medical record. 9. There shall be a mechanism for the review and evaluation on a regular basis of the quality and scope of anesthesia services. (C) Home-Care Services. 1. Home-care services, if provided, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. This physician shall be responsible for implementing rules of the medical staff governing the quality and scope of home-care services. 2. The objectives and description of home-care services shall be related to identifiable needs and shall include those services the hospital provides or those provided through participating community agencies. 3. There shall be written policies and procedures delineating administrative control, scope of services offered and the manner in which they are provided. These policies and procedures shall be reviewed annually and revised as necessary. 4. A medical record shall be maintained on every patient receiving home-care services. These records shall contain the overall care plan, physician’s orders, services provided, progress notes and disposition of the patient. Records shall be filed under supervision of the medical records department. 5. There shall be a mechanism for the review and evaluation on a regular basis of the quality and scope of home-care services provided. (D) Medical Services. 1. Medical services, if provided, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body as chief of the medical services. This director shall be responsible for implementing the rules of the medical staff governing medical privileges and the quality of medical care provided. 2. Medical services shall be responsible for the medical care of all patients except those under the care of physicians or other services as defined in the medical staff or governing body bylaws. 3. The activities of medical services shall be integrated with other services in the hospital. 4. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of medical services provided. (E) Obstetrical and Newborn Services. 1. Obstetrical services, if provided, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. This physician shall be responsible for implementing the rules of the medical staff governing obstetrical privileges, quality of obstetrical care and patient safety. 2. Obstetrical services shall be super- vised by a qualified registered professional nurse with relevant education, experience and demonstrated current competency. 3. The obstetrical nursing supervisor shall have the authority to implement and enforce hospital policies and procedures governing obstetrical services and shall have the responsibility for evaluating the competency of nursing personnel assigned to obstetrical services. 4. Facilities for obstetrical services shall be designed to prevent unauthorized traffic. 5. Undelivered patients receiving intra- venous oxytocin shall be under continuous observation by trained personnel. Induction or augmentation of labor with oxytocin may be initiated only after a qualified physician has evaluated the patient, determined that induction or augmentation is beneficial to the mother, fetus, or both, recorded the indication and established the plan of management. The physician initiating these procedures shall be readily accessible to manage complications that arise during infusion and a physician who has privileges to perform Caesarean deliveries shall be in consultation and readily accessible in order to manage any complications that require surgical intervention. 6. There shall be provision for isolation of infants with known or suspected infections or communicable diseases. Policies and procedures regarding isolation shall be integrated with the hospital infection control program. 7. Each newborn shall be identified by an acceptable method which includes the name, date and time of birth, the infant’s sex and the mother’s hospital number. 8. A delivery room record shall be maintained. 9. A nursery shall be provided for care of the newborn. 10. Hospitals with an obstetrical service shall have at least one (1) premature-care incubator by an independent testing laboratory. 11. All cases of acute infectious con- junctivitis (Ophthalmia neonatorum) shall be reported immediately to the individual(s) responsible for the infection control program and to the local or district health department in accordance with section 210.080, RSMo. 12. All cases of epidemic diarrhea of the newborn shall be reported immediately to the individual(s) responsible for the infection control program and the local or district health department. 13. Resuscitation, suction, oxygen, monitoring and newborn temperature control equipment shall be available for the care of newborn. Supplies for the proper care of newborn shall be available. 14. An incubator or bassinet with con- trolled temperature shall be available for each delivery room and for transport to the nursery. 15. Space shall be provided for the preparation or the handling and storage of formula. Separate refrigeration shall be provided for formula. 16. Eye care of newborn shall be in accordance with section 210.070, RSMo. 17. Written policies and procedures shall be established to provide safe transport of infants within the hospital or to another health-care facility. 18. Written policies and procedures gov- erning special care programs shall be approved by the medical staff and governing body. 19. There shall be a mechanism for the review and evaluation on a regular basis of the quality of obstetrical and newborn services provided. 19 CSR 30-20 (F) Pediatric Services. 1. The pediatric unit, if provided, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. This physician shall be responsible for implementing the rules of the medical staff governing the quality and scope of pediatric services. 2. The pediatric unit shall be supervised by a qualified registered professional nurse with relevant education, experience and demonstrated current competency. 3. The pediatric supervisor shall have the authority to implement and enforce hospital policies and procedures governing pediatric services and shall have the responsibility for evaluating the competency of nursing personnel assigned to pediatric services. 4. The pediatric unit shall be designed for specific needs of children and located apart from adult patients and the newborn. 5. The pediatric unit shall have at least one (1) room suitable for isolation. 6. Supplies and equipment required for emergencies shall be readily available in the pediatric unit. 7. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of pediatric services provided. (G) Post-Anesthesia Recovery Services. 1. Post-anesthesia recovery services, if provided, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. This director shall be responsible for implementing the rules of the medical staff governing post-anesthesia recovery services. 2. A qualified registered professional nurse shall direct and evaluate the nursing care provided by post-anesthesia recovery services. 3. A post-anesthesia recovery record documenting patient care shall be a permanent part of the patient’s medical record. 4. Patients receiving post-anesthesia recovery care shall be closely observed by qualified personnel until each patient is stabilized for safe transfer. Written procedures for discharge from the post-anesthesia recovery service shall be approved by the medical staff. 5. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of post-anesthesia recovery services provided. (H) Psychiatric Services—Emergency and Acute. 1. Emergency psychiatric care. A. If the hospital does not have a psy- chiatric unit, written policies and procedures shall be developed to provide for the safe management of patients requiring psychiatric services until they can be safely transferred to an appropriate facility. B. Written policies shall be estab- lished regarding the use of restraints or seclusion. These restraints or seclusion shall be used only on the order of a physician. In the absence of a physician, a registered professional nurse shall make the decision that the use of a physical restraint or seclusion is the least restrictive procedure appropriate at the time of the emergency situation. The physician shall be notified immediately and a physician’s order obtained as soon as possible after the occurrence of an emergency. Physicians’ orders for use of physical restraints or seclusion shall be rewritten every twenty-four (24) hours. A full record of any restriction of activity for any patient shall be recorded on the nurses’ notes and shall include the reason for restriction, the type of restriction used, the time of starting and ending the restriction and regular observations of the patient while restricted. 2. Acute psychiatric services. If a psy- chiatric unit is designed within the hospital, it shall comply with the following requirements as a minimum: A. Psychiatric services shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. The director shall be responsible for implementing rules of the medical staff governing psychiatric privileges, quality and scope of care and patient safety; B. Psychiatric services shall be super- vised by a qualified registered professional nurse with relevant education, experience and demonstrated current competency; C. The psychiatric nursing supervisor shall have the authority to implement and enforce hospital policies and procedures governing psychiatric care and shall have the responsibility for evaluating the competency of all nursing personnel assigned to psychiatric services; D. Appropriate registered nurse staffing patterns shall be developed to meet the care needs and activity demands of each patient in the psychiatric unit; E. New employees shall attend appro- priate orientation, in-service and staff development programs prior to being considered part of the staff required to meet the minimum standards of patient care; F. Written policies shall be estab- lished regarding the use of restraints or seclusion. These restraints or seclusion shall be used only on the order of a physician. In the absence of a physician, a registered professional nurse shall make the decision that the use of a physical restraint or seclusion is the least restrictive procedure appropriate at the time of the emergency situation. The physician shall be notified immediately and a physician’s order obtained as soon as possible after the occurrence of an emergency. Physician’s orders for use of physical restraints or seclusion shall be rewritten every twenty-four (24) hours. A full record of any restriction of activity for any patient shall be recorded on the nurses’ notes and shall include the reason for restriction, the type of restriction used, the time of starting and ending the restriction and regular observations of the patient while restricted; G. The social work services staff shall be available to participate as members of the treatment team, exchanging information and evaluations with the attending physician and other professional disciplines in order to insure a comprehensive treatment program for patients; H. Activity therapy services shall be available with the services provided under the direction of a qualified therapist. All therapy shall be given on the written order of a physician and documented in the patients’ clinical records; and I. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of psychiatric services provided. (I) Rehabilitation Services. 1. The rehabilitation services, if provid- ed, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. The director shall be responsible for implementing rules of the medical staff governing the quality and scope of rehabilitation services. 2. Rehabilitation services shall be super- vised by a qualified physician or a qualified therapist with relevant education and experience. 3. Rehabilitation services shall be inte- grated within the total organizational plan and the director shall assist in the formulation of policies and development of long-range planning affecting patient care. 4. Therapy shall be administered in accordance with a physician’s written orders and shall be documented in the patient’s medical record. 5. Rehabilitation services shall be pro- vided by qualified personnel. In-service shall be ongoing and documented. 6. Approved written policies and proce- dures which define and describe the scope and conduct of rehabilitative care shall be reviewed annually and revised as necessary. 7. The qualified therapist shall evaluate and reevaluate the therapy administered and this shall be documented in the patient’s medical record. 8. Space and equipment shall be provid- ed to meet the needs of rehabilitation services. Space, supplies and equipment shall be maintained to ensure patient safety. 9. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of rehabilitation services provided. (J) Respiratory Care Services. 1. Respiratory care services, if provid- ed, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. The director shall be responsible for implementing rules of the medical staff governing the quality and scope of respiratory care services. 2. Respiratory care services shall be integrated within the total hospital organizational plan. 3. Respiratory care services shall be administered under the direction of a qualified registered or certified respiratory therapist or a registered professional nurse with relevant education and experience. 4. Therapy shall be administered in accordance with a physician’s written orders and shall be documented in the patient’s medical record. 5. Respiratory care services shall be provided by qualified personnel. In-service shall be ongoing and documented. 6. Approved written policies and proce- dures which define and describe the scope and conduct of respiratory care shall be reviewed annually and revised as necessary. 7. A qualified registered or certified respiratory therapist or a registered professional nurse shall evaluate and reevaluate the therapy administered and this shall be documented in the patient’s medical record. 8. Space and equipment shall be provid- ed to meet the needs of respiratory care services. Space, supplies and equipment shall be maintained to ensure patient safety. 9. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of respiratory care services provided. (K) Special Patient Care Services. 1. Special care units, if provided, shall be under the medical direction of a qualified physician, member of the medical staff and appointed by the governing body. 2. Patient care in each special care unit shall be integrated with the other nursing services and supervised by a qualified registered professional nurse with relevant education, experience and demonstrated current competency. 3. Approved written policies and proce- dures shall define and describe the scope and conduct of each special patient-care service. These shall be reviewed annually and revised as necessary. 4. Qualifications of personnel for assignment to each special care unit shall be delineated in writing. Orientation, in-service training and continuing education shall be provided and documented. 5. Registered nurse staffing patterns shall be developed to meet the needs of each patient in special care units. 6. A multi-disciplinary committee, chaired by the director, shall develop protocols for the conduct of patient care in each special care unit. This committee shall meet at least quarterly and minutes shall be kept and filed on a confidential basis. 7. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of care provided in each special care area. (L) Surgical Services. 1. Surgical services, if provided, shall be under the medical direction of a qualified physician member of the medical staff and appointed by the governing body. This physician shall be responsible for implementing rules of the medical staff governing the quality and scope of surgical services. 2. Approved written policies and proce- dures shall define and describe the scope and conduct of surgical services. These shall be reviewed annually and revised as necessary. 3. The surgical suite shall be supervised by a qualified registered professional nurse with relevant education, experience and demonstrated current competency. This supervisor shall have the authority to implement hospital policies and procedures for the surgical suite and shall have the responsibility for evaluating all nursing personnel assigned to the surgical suite. 4. A qualified registered professional nurse shall be assigned circulating duties for surgical procedures performed. 5. Accepted standards of patient care, sterility and aseptic techniques shall be maintained. 6. Prior to surgery, the patient’s medical record shall contain evidence that the patient has been advised as to the surgical procedure(s) contemplated, the type of anesthesia to be administered and the risks involved with each. Evidence that informed consent has been given shall become a part of the patient’s medical record. 7. An operating room record document- ing the patient care provided shall become a part of the patient’s medical record. The record shall contain at least the name of the patient, the patient’s hospital number, the name of the surgeon, name of surgical procedure(s), the date, time surgery began and ended, names and titles of persons assisting with the procedure and the verification of countable materials. 8. There shall be a mechanism for the review and evaluation on a regular basis of the quality and appropriateness of surgical services. (5) Environmental and Support Services. Each hospital shall have an organized service which maintains a clean and safe environment. (A) Housekeeping Services. 1. The housekeeping services shall have a director who is qualified by education, training and experience in the principles of hospital housekeeping. This individual shall report to a designated administrative officer. 2. Approved written policies and proce- dures shall define and describe the scope and conduct of housekeeping services. These shall be reviewed in cooperation with the infection control program and kept current. 3. Space for housekeeping services shall provide for office(s), the storage of supplies and equipment and for equipment maintenance. 4. There shall be sufficient trained per- sonnel to meet the needs of housekeeping services. Housekeeping personnel shall be given the opportunity to participate in-service training or other relevant continuing educational programs. 5. All noninfectious wastes generated within the hospital shall be collected in appropriate containers for disposal. 6. There shall be a mechanism for the review and evaluation on a regular basis of the quality of housekeeping services provided. (B) Infection Control. 1. There shall be an active multidisci- plinary infection control committee responsible for implementing and monitoring the infection control program. The committee shall include, but not be limited to, a member of the medical staff, registered professional nursing staff and administration. This program shall include measures for preventing, identifying, investigating, reporting and controlling infections throughout the hospital, including the employee health program. 2. The infection control committee or its designated infection control practitioner shall conduct an ongoing review and analysis of nosocomial infection data and risk factors. The infection control practitioner shall be a 19 CSR 30-20 physician, registered nurse, have a bachelor’s degree in laboratory science or have similar qualifications and have additional training or education preparation in infection control, infectious diseases, epidemiology and principles of quality improvement. 3. Written policies and procedures out- lining infection control measures, aseptic techniques, cleaning, disinfection and sterilization and a mechanism for reporting and monitoring patient and employee infections shall be developed for all patient care and support departments in the hospital. 4. Orientation and ongoing education shall be provided to all patient care and patient-care support personnel on the cause, effect, transmission, prevention and elimination of infections. Records of employee attendance shall be retained and available for inspection. A mechanism for monitoring compliance with infection control policies and procedures shall be coordinated with administrative staff, personnel staff and the quality improvement program. 5. Infection control committee meetings shall be held quarterly. Minutes shall be retained. 6. There shall be an annual review and evaluation of the quality of the infection control program. (C) Laundry and Linen Services. 1. The hospital shall have organized ser- vices which ensure that adequate supplies of clean linens are available. There shall be specific written procedures for the processing, distribution and storage of linen. These shall be reviewed in cooperation with the infection control committee and kept current. 2. Soiled linen processing functions shall be physically separated from both clean linen storage and soiled linen holding areas. Only commercial laundry equipment shall be used to process hospital linen. 3. Clean linen shall be stored and dis- tributed to the point of use in a way that minimizes microbial contamination from surface contact or airborne particles. 4. Soiled linen shall be collected at the point of use and transported to the soiled linen holding room in a manner that minimizes microbial dissemination into the environment. 5. If a commercial laundry service is used, verification shall be provided to assure the hospital that the processing and handling of linen complies with paragraphs (5)(C)1.–4. of this rule. 6. There shall be a mechanism for the review and evaluation on a regular basis of the quality of laundry and linen services provided. (D) Infectious Waste Management. 1. Every hospital shall write an infec- tious waste management plan with an annual review identifying infectious waste generated on-site, the scope of the infectious waste program, and policies and procedures to implement the infectious waste program. The director of this program shall be qualified by education, training and experience in the principles of infectious waste management. The plan shall include at least the following: chief executive officer’s endorsement letter; introduction and purpose; objectives; phone number of responsible individuals; organizational chart; schematic(s) of waste disposal routes; definition of those wastes handled by the system; department and individual responsibilities; procedures for waste identification, segregation, containment, transport, treatment and disposal; emergency and contingency procedures; training and educational procedures; and appendices (rules and other applicable institutional policy statements). Any hospital exempt from infectious waste processing facility permit requirements of 10 CSR 80-7.010 and that accepts infectious waste from off-site shall include in its plan requirements for storage, processing and recordkeeping of this waste and the cleanup of potential spills in the unloading area. Manufacturers’ specifications for temperature, residence time and control devices for any infectious waste processing devices shall be included in the plan. A trained operator shall operate the equipment during any infectious waste treatment procedures. 2. Infectious waste shall be segregated from other wastes at the point of generation and shall be placed in distinctive, clearly marked, leakproof containers or plastic bags appropriate for the characteristics of the infectious waste. Containers for infectious waste shall be identified with the universal biological hazard symbol. All packaging shall maintain its integrity during storage and transport. Infectious waste shall not be placed in a gravity waste disposal chute. 3. Pending disposal, infectious waste shall be stored, separated from other wastes, in a limited-access enclosure posted with the biological hazard symbol. This enclosure shall afford protection from vermin, be a dry area and be provided with an impervious floor with a perimeter curb. The floor shall slope to a drain connected to the sanitary sewage system or collection device. If infectious waste is compacted, the mechanical device shall contain the fluids and aerosols and shall not release aerosols or fluids when opened and the container is removed. Provisions for waste stored seventy-two (72) hours or more shall be separately addressed in the infectious waste management plan. 4. Hospital infectious waste treated on site shall be rendered innocuous, using one (1) of the following methods: A. Sterilization of the waste in an autoclave is permitted, provided that the unit is operated in accordance with the manufacturer’s recommendations and that the autoclave’s effectiveness is verified at least weekly with a biological spore assay containing Bacillus Stearothermophilus. If the autoclave is used for other functions, the infectious waste management plan will develop specific guidelines for its use; B. Incineration in a multi-chamber incinerator designed to provide complete combustion of the type of waste introduced into the incinerator is permitted. The incinerator shall be operated in accordance with the manufacturer’s recommendations and shall comply with air pollution control laws and regulations. The incinerator shall achieve a minimum temperature of eighteen hundred degrees Fahrenheit (1,800°F) in the secondary chamber with a minimum retention time of one-half (1/2) second in the secondary chamber. The incinerator shall be equipped with continuous temperature recording charts for the secondary chamber and utilized during any infectious waste treatment process. Pathological wastes mixed with or contained in plastic materials shall be incinerated in a multi-chamber incinerator achieving a minimum temperature of eighteen hundred degrees Fahrenheit (1,800°F) in the secondary combustion chamber with one-half (1/2) second retention time; C. Decontamination of the infectious waste by other technologies in a manner acceptable to the Department of Health shall be permitted; D. Bulk blood, suctioned fluids, excretions and secretions may be carefully poured down a drain connected to a sanitary sewer; or E. Infectious waste rendered innocu- ous by the methods in subparagraphs (5)(D)4.A. or C. of this rule shall be disposed of in accordance with the requirements of 10 CSR 80-7.010. 5. An infectious waste treatment pro- gram shall include records of biological spore assay tests if required by treatment methods and the approximate amount of waste disinfected or incinerated per hour measured by weight per load. The program director shall maintain records demonstrating the proper operation of the disinfection or incineration equipment. 6. All infectious waste when transported off the premises of the hospital shall be packaged and transported as provided in sections 260.200–260.207, RSMo. 7. Any hospital which accepts infectious waste from small quantity generators as defined by 10 CSR 80-7.010 or from other Missouri hospitals—in quantities exceeding fifty percent (50%) of the total poundage of infectious waste generated on-site at the hospital—shall notify the Department of Natural Resources and comply with permitting requirements of sections 260.200—260.207, RSMo. The weight of infectious waste generated on-site shall be calculated by multiplying one and five-tenths (1.5) pounds per day times the number of beds complying with Department of Health standards for hospital licensure. Infectious waste generated off-site may be accepted by a hospital only if packaged according to 10 CSR 80- 7.010(2)(A)–(D). AUTHORITY: sections 192.005.2, RSMo 1994 and 197.080 and 260.225, RSMo Supp. 1997.* This rule was previously filed as 13 CSR 50-20.021 and 19 CSR 10-20.021. Original rule filed June 2, 1982, effective Nov. 11, 1982. Amended: Filed April 9, 1985, effective Sept. 28, 1985. Amended: Filed June 2, 1987, effective Sept. 11, 1987. Amended: Filed Nov. 16, 1987, effective March 26, 1988. Amended: Filed June 14, 1988, effective Oct. 13, 1988. Amended: Filed Aug. 16, 1988, effective Dec. 29, 1988. Amended: Filed Nov. 21, 1995, effective July 30, 1996. Amended: Filed Oct. 6, 1998, effective April 30, 1999. *Original authority: 192.005.2, RSMo 1985, amended 1993; 197.080, RSMo 1953, amended 1993, 1995; and 260.225, RSMo 1972, amended 1975, 1986, 1988, 1990, 1993, 1995.