Current through April 3, 2024
(1) Performance
Improvement.
(a) The hospital must ensure that
there is an effective, hospital-wide performance improvement program to
evaluate and continually improve patient care and performance of the
organization.
(b) The performance
improvement program must be ongoing and have a written plan of implementation
which assures that:
1. All organized services
including services furnished by a contractor, are evaluated (all departments
including engineering, housekeeping, and accounting need to show evidence of
process improvement.);
2.
Nosocomial infections and medication therapy are evaluated;
3. All medical and surgical services
performed in the hospital are evaluated as to the appropriateness of diagnosis
and treatment;
4. The competency of
all staff is evaluated at least annually; and
5. The facility shall develop and implement a
system for measuring improvements in adherence to the hand hygiene program,
central venous catheter insertion process, and influenza vaccination
program.
(c) The
hospital must have an ongoing plan, consistent with available community and
hospital resources, to provide or make available social work, psychological,
and educational services to meet the medically related needs of its patients
which assures that:
1. Discharge planning is
initiated in a timely manner; and
2. Patients, along with their necessary
medical information, are transferred or referred to appropriate facilities,
agencies or outpatient services, as needed, for follow-up or ancillary
care.
(d) The hospital
must develop and implement plans for improvement to address deficiencies
identified by the performance improvement program and must document the outcome
of the remedial action.
(e) The
hospital must demonstrate that the appropriate governing board or board
committee is regularly apprised of process improvement activities, including
identified deficiencies and the outcomes of remedial action.
(2) Medical Staff.
(a) The hospital shall have an organized
medical staff operating under bylaws adopted by the medical staff and approved
by the governing body, to facilitate the medical staff's responsibility in
working toward improvement of the quality of patient care.
(b) The hospital and medical staff bylaws
shall contain procedures, governing decisions or recommendations of appropriate
authorities concerning the granting, revocation, suspension, and renewal of
medical staff appointments, reappointments, and/or delineation of privileges.
At a minimum, such procedures shall include the following elements: A procedure
for appeal and hearing by the governing body or other designated committee if
the applicant or medical staff feels the decision is unfair or wrong.
(c) The governing body shall be responsible
for appointing medical staff and for delineating privileges. Criteria for
appointment and delineation of privileges shall be clearly defined and included
in the medical staff bylaws, and related to standards of patient care, patient
welfare, the objectives of the institution or the character or competency of
the individual practitioner. Independent patient admission privileges shall
only be granted to currently licensed doctors of medicine, osteopathy,
podiatry, or dentistry.
(d) The
medical staff must adopt and enforce bylaws to effectively carry out its
responsibilities and the bylaws must:
1. Be
approved by the governing body;
2.
Include a statement of the duties and privileges of each category of medical
staff;
3. Describe the organization
of the medical staff;
4. Describe
the qualifications to be met by a candidate in order for the medical staff to
recommend that the candidate be appointed by the governing body;
5. Include criteria for determining the
privileges to be granted to individual practitioners and a procedure for
applying the criteria to individuals requesting privileges; and
6. Include provisions for medical staff
appointments granting active, associate, or courtesy medical staff membership,
and/or provisions for the granting of clinical privileges. Such individuals
must practice within the scope of their current Tennessee license, and the
overall care of each patient must be under the supervision of a physician
member of the medical staff.
(e) To be eligible for staff membership, an
applicant must be a graduate of an approved program of medicine, dentistry,
osteopathy, podiatry, optometry, psychology, or nurse-midwifery, currently
licensed in Tennessee, competent in his or her respective field, and worthy in
character and in matters of professional ethics.
(f) The medical staff shall be composed of
currently licensed doctors of medicine, osteopathy, dentistry, and podiatry and
may include optometrists, psychologists, and nurse-midwives. The medical staff
must:
1. Periodically conduct appraisals of
its members;
2. Examine the
credentials of candidates for medical staff membership and make recommendations
to the hospital on the appointment of the candidates; and
3. Participate actively in the hospital's
process improvement plan implementation for the improvement of patient care
delivery plans.
(g) The
medical staff must be structured in a manner approved by the hospital or its
governing body, well-organized, and accountable to the hospital for the quality
of the medical care provided to the patient. Disciplinary action involving
medical staff taken by the hospital shall be reported to the appropriate
licensing board or professional society.
(h) If the medical staff has an executive
committee, a majority of the members of the committee must be doctors of
medicine or osteopathy.
(i) The
responsibility for organization and conduct of the medical staff must be
assigned only to an individual doctor of medicine or osteopathy, or a doctor of
dental surgery or dental medicine.
(j) All physicians and non-employee medical
personnel working in the hospital must adhere to the policies and procedures of
the hospital. The chief executive officer or his or her designee shall provide
for the adequate supervision and evaluation of the clinical activities of
non-employee medical personnel which occur within the responsibility of the
medical staff service.
(3) Infection Control.
(a) The hospital must provide a sanitary
environment to avoid sources and transmission of infections and communicable
diseases. There must be an active performance improvement program for the
prevention, control, and investigation of infections and communicable
diseases.
(b) The chief executive
officer or administrator shall assure that an infection control committee
including members of the medical staff, nursing staff and administrative staff
develop guidelines and techniques for the prevention, surveillance, control and
reporting of hospital infections. Duties of the committee shall include the
establishment of:
1. Written infection control
policies;
2. Techniques and systems
for identifying, reporting, investigating and controlling infections in the
hospital;
3. Written procedures
governing the use of aseptic techniques and procedures in all areas of the
hospital, including adoption of a standardized central venous catheter
insertion process which shall contain these key components:
(i) Hand hygiene (as defined in
0720-14-.06(3)(g));
(ii) Maximal barrier precautions to include
the use of sterile gowns, gloves, mask and hat, and large drape on
patient;
(iii) Chlorhexidine skin
antisepsis;
(iv) Optimal site
selection;
(v) Daily review of line
necessity; and
(vi) Development and
utilization of a procedure checklist;
4. Written procedures concerning food
handling, laundry practices, disposal of environmental and patient wastes,
traffic control and visiting rules in high risk areas, sources of air
pollution, and routine culturing of autoclaves and sterilizers;
5. A log of incidents related to infectious
and communicable diseases;
6. A
method of control used in relation to the sterilization of supplies and water,
and a written policy addressing reprocessing of sterile supplies;
7. Formal provisions to educate and orient
all appropriate personnel in the practice of aseptic techniques such as
handwashing and scrubbing practices, proper grooming, masking and dressing care
techniques, disinfecting and sterilizing techniques, and the handling and
storage of patient care equipment and supplies; and
8. Continuing education provided for all
hospital personnel on the cause, effect, transmission, prevention, and
elimination of infections, as evidenced by front line employees verbalizing
understanding of basic techniques.
(c) The administrative staff shall ensure the
hospital prepares, and has readily available on site, an Infection Control Risk
Assessment for any renovation or construction within existing hospitals.
Components of the Infection Control Risk Assessment may include, but are not
limited to, identification of the area to be renovated or constructed, patient
risk groups that will potentially be affected, precautions to be implemented,
utility services subject to outages, risk of water damage, containment
measures, work hours for project, management of traffic flow, housekeeping,
barriers, debris removal, plans for air sampling during or following project,
anticipated noise or vibration generated during project.
(d) The chief executive officer, the medical
staff and the chief nursing officer must ensure that the hospitalwide
performance improvement program and training programs address problems
identified by the infection control committee and must be responsible for the
implementation of successful corrective action plans in affected problem
areas.
(e) The facility shall
develop policies and procedures for testing a patient's blood for the presence
of the hepatitis B virus and the HIV (AIDS) virus in the event that an employee
of the facility, a student studying at the facility, or other health care
provider rendering services at the facility is exposed to a patient's blood or
other body fluid. The testing shall be performed at no charge to the patient,
and the test results shall be confidential.
(f) A hospital shall have an annual influenza
vaccination program which shall include at least:
1. The offer of influenza vaccination to all
staff and independent practitioners at no cost to the person or acceptance of
documented evidence of vaccination from another vaccine source or facility. The
hospital will encourage all staff and independent practitioners to obtain an
influenza vaccination;
2. A signed
declination statement on record from all who refuse the influenza vaccination
for reasons other than medical contraindications (a sample form is available at
https://www.tn.gov/content/dam/tn/health/documents/SampleIndividualFluForm.pdf);
3. Education of all employees about the
following:
(i) Flu vaccination,
(ii) Non-vaccine control measures,
and
(iii) The diagnosis,
transmission, and potential impact of influenza;
4. An annual evaluation of the influenza
vaccination program and reasons for non-participation; and
5. A statement that the requirements to
complete vaccinations or declination statements shall be suspended by the
administrator in the event of a vaccine shortage as declared by the
Commissioner or the Commissioner's designee.
(g) All hospitals shall each year from
October 1 through March 1 offer the immunization for influenza and pneumococcal
diseases to any inpatient who is sixty-five (65) years of age or older prior to
discharging. This condition is subject to the availability of the
vaccine.
(h) The facility and its
employees shall adopt and utilize standard precautions (per CDC) for preventing
transmission of infections, HIV, and communicable diseases, including adherence
to a hand hygiene program which shall include:
1. Use of alcohol-based hand rubs or use of
non-antimicrobial or antimicrobial soap and water before and after each patient
contact if hands are not visibly soiled;
2. Use of gloves during each patient contact
with blood or where other potentially infectious materials, mucous membranes,
and non-intact skin could occur and gloves changed before and after each
patient contact;
3. Use of either a
non-antimicrobial soap and water or an antimicrobial soap and water for visibly
soiled hands; and
4. Health care
worker education programs which may include:
(i) Types of patient care activities that can
result in hand contamination;
(ii)
Advantages and disadvantages of various methods used to clean hands;
(iii) Potential risks of health care workers'
colonization or infection caused by organisms acquired from patients;
and
(iv) Morbidity, mortality, and
costs associated with health care associated infections.
(i) All hospitals shall adopt
appropriate policies regarding the testing of patients and staff for human
immunodeficiency virus (HIV) and any other identified causative agent of
acquired immune deficiency syndrome.
(j) Each department of the hospital
performing decontamination and sterilization activities must develop policies
and procedures in accordance with the current editions of the CDC guidelines
for "Prevention and Control of Nosocomial Diseases" and "Isolation in
Hospitals".
(k) The central sterile
supply area(s) shall be supervised by an employee, qualified by education
and/or experience with a basic knowledge of bacteriology and sterilization
principles, who is responsible for developing and implementing written policies
and procedures for the daily operation of the central sterile supply area,
including:
1. Receiving, decontaminating,
cleaning, preparing, and disinfecting or sterilizing reusable items;
2. Assembling, wrapping, removal of outer
shipping cartons, storage, distribution, and quality control of sterile
equipment and medical supplies;
3.
Proper utilization of sterilization process monitors, including temperature and
pressure recordings, and use and frequency of appropriate chemical indicator or
bacteriological spore tests for all sterilizers; and
4. Provisions for maintenance of package
integrity and designation of event-related shelf life for hospital-sterilized
and commercially prepared supplies;
5. Procedures for recall and disposal or
reprocessing of sterile supplies; and
6. Procedures for emergency collection and
disposition of supplies and the timely notification of attending physicians,
general medical staff, administration and the hospital's risk management
program when special warnings have been issued or when warranted by the
hospital's performance improvement process.
(l) Precautions shall be taken to prevent the
contamination of sterile supplies by soiled supplies. Sterile supplies shall be
packaged and stored in a manner that protects the sterility of the contents.
Sterile supplies may not be stored in their outermost shipping carton. This
would include both hospital and commercially prepared supplies. Decontamination
and preparation areas shall be separated.
(m) Space and facilities for housekeeping
equipment and supply storage shall be provided in each hospital service area.
Storage for bulk supplies and equipment shall be located away from patient care
areas. Storage shall not be allowed in the outermost shipping carton. The
building shall be kept in good repair, clean, sanitary and safe at all
times.
(n) The hospital shall
appoint a housekeeping supervisor who is qualified for the position by
education, training and experience. The housekeeping supervisor shall be
responsible for:
1. Organizing and
coordinating the hospital's housekeeping service;
2. Acquiring and storing sufficient
housekeeping supplies and equipment for hospital maintenance;
3. Assuring the clean and sanitary condition
of the hospital to provide a safe and hygienic environment for patients and
staff. Cleaning shall be accomplished in accordance with the infection control
rules and regulations herein and hospital policy; and
4. Verifying regular continuing education and
competency for basic housekeeping principles.
(o) Laundry facilities located in the
hospital shall:
1. Be equipped with an area
for receiving, processing, storing and distributing clean linen;
2. Be located in an area that does not
require transportation for storage of soiled or contaminated linen through food
preparation, storage or dining areas;
3. Provide space for storage of clean linen
within nursing units and for bulk storage within clean areas of the hospital.
Linen may not be stored in cardboard containers or other containers which offer
housing for bugs; and,
4. Provide
carts, bags or other acceptable containers appropriately marked to identify
those used for soiled linen and those used for clean linen to prevent dual
utilization of the equipment and cross contamination.
(p) The hospital shall appoint a laundry
service supervisor who is qualified for the position by education, training and
experience. The laundry service supervisor shall be responsible for:
1. Establishing a laundry service, either
within the hospital or by contract, that provides the hospital with sufficient
clean, sanitary linen at all times;
2. Knowing and enforcing infection control
rules and regulations for the laundry service;
3. Assuring the collection, packaging,
transportation and storage of soiled, contaminated, and clean linen is in
accordance with all applicable infection control rules, regulations and
procedures;
4. Assuring that a
contract laundry service complies with all applicable infection control rules,
regulations and procedures; and,
5.
Conducting periodic inspections of any contract laundry facility.
(q) The physical environment of
the facility shall be maintained in a safe, clean and sanitary manner.
1. Any condition on the hospital site
conducive to the harboring or breeding of insects, rodents or other vermin
shall be prohibited. Chemical substances of a poisonous nature used to control
or eliminate vermin shall be properly identified. Such substances shall not be
stored with or near food or medications.
2. Cats, dogs or other animals shall not be
allowed in any part of the hospital except for specially trained animals for
the handicapped and except as addressed by facility policy for pet therapy
programs. The facility shall designate in its policies and procedures those
areas where animals will be excluded. The areas designated shall be determined
based upon an assessment of the facility performed by medically trained
personnel.
3. A bed complete with
mattress and pillow shall be provided. In addition, patient units shall be
provided with at least one chair, a bedside table, an over bed tray and
adequate storage space for toilet articles, clothing and personal
belongings.
4. Individual wash
cloths, towels and bed linens must be provided for each patient. Linen shall
not be interchanged from patient to patient until it has been properly
laundered.
5. Bath basin water
service, emesis basin, bedpan and urinal shall be individually
provided.
6. Water pitchers,
glasses, thermometers, emesis basins, douche apparatus, enema apparatus,
urinals, mouthwash cups, bedpans and similar items of equipment coming into
intimate contact with patients shall be disinfected or sterilized after each
use unless individual equipment for each is provided and then sterilized or
disinfected between patients and as often as necessary to maintain them in a
clean and sanitary condition. Single use, patient disposable items are
acceptable but shall not be reused.
(4) Nursing Services.
(a) The hospital must have an organized
nursing service that provides twenty-four (24) hour nursing services furnished
or supervised by a registered nurse, and have a licensed practical nurse or
registered nurse on duty at all times.
(b) The hospital must have a well-organized
service with a plan of administrative authority and delineation of
responsibilities for patient care. The chief nursing officer must be a licensed
registered nurse who is responsible for the operation of the service, including
determining the types and numbers of nursing personnel and staff necessary to
provide nursing care for all areas of the hospital.
(c) The nursing service must have adequate
numbers of licensed registered nurses, licensed practical nurses, and other
personnel to provide nursing care to all patients as needed. There must be
supervisory and staff personnel for each department or nursing unit to ensure,
when needed, the immediate availability of a registered nurse for bedside care
of any patient.
(d) There must be a
procedure to ensure that hospital nursing personnel for whom licensure is
required have valid and current licenses.
(e) A registered nurse must assess, supervise
and evaluate the nursing care for each patient.
(f) The hospital must ensure that an
appropriate individualized plan of care is available for each
patient.
(g) A registered nurse
must assign the nursing care of each patient to other nursing personnel in
accordance with the patient's needs and the specialized qualifications and
competence of the nursing staff available. All nursing personnel assigned to
special care units shall have specialized training and a program in-service and
continuing education commensurate with the duties and responsibilities of the
individual. All training shall be documented for each individual so employed,
along with documentation of annual competency skills.
(h) A registered nurse may make the actual
determination and pronouncement of death under the following circumstances:
1. The deceased was a patient at a hospital
as defined by T.C.A. §
68-11-201(27);
2. Death was anticipated, and the attending
physician has agreed in writing to sign the death certificate. Such agreement
by the attending physician must be present with the deceased at the place of
death;
3. The nurse is licensed by
the state; and
4. The nurse is
employed by the hospital providing services to the deceased.
(i) Non-employee licensed nurses
who are working in the hospital must adhere to the policies and procedures of
the hospital. The chief nursing officer must provide for the adequate
supervision and evaluation of the clinical activities of non-employee nursing
personnel which occur within the responsibility of the nursing service. Annual
competency and skill documentation must be demonstrated on these individuals
just as employees, if they perform clinical activities.
(j) All drugs, devices and related materials
must be administered by, or under the supervision of, nursing or other
personnel in accordance with federal and state laws and regulations, including
applicable licensing requirements, and in accordance with the approved medical
staff policies and procedures.
(k)
All orders for drugs, devices and related materials must be in writing and
signed by the practitioner or practitioners responsible for the care of the
patient. Electronic and computer-generated records and signature entries are
acceptable. When telephone or oral orders must be used, they must be:
1. Accepted only by personnel that are
authorized to do so by the medical staff policies and procedures, consistent
with federal and state law; and
2.
Signed or initialed by the prescribing practitioner according to hospital
policy.
(l) Blood
transfusions and intravenous medications must be administered in accordance
with state law and approved medical staff policies and procedures.
(m) There must be a hospital procedure for
reporting transfusion reactions, adverse drug reactions, and errors in
administration of drugs.
(5) Medical Records.
(a) The hospital shall comply with the
Tennessee Medical Records Act, T.C.A. §§
68-11-301, et seq. A hospital
shall transfer copies of patient medical records in a timely manner to
requesting practitioners and facilities.
(b) The hospital must have a medical record
service that has administrative responsibility for medical records. The service
shall be supervised by a Registered Health Information Administrator (RHIA), a
Registered Health Information Technician (RHIT), or a person qualified by work
experience. A medical record must be maintained for every individual evaluated
or treated in the hospital.
(c) The
organization of the medical record service must be appropriate to the scope and
complexity of the services performed. The hospital must employ adequate
personnel to ensure prompt completion, filing and retrieval of
records.
(d) The hospital must
maintain a medical record for each inpatient and outpatient. Medical records
must be accurate, promptly completed, properly filed and retained, and
accessible. The hospital must use a system of author identification and record
maintenance that ensures the integrity of the authentication and protects the
security of all record entries.
(e)
All medical records, either written, electronic, graphic or otherwise
acceptable form, must be retained in their original or legally reproduced form
for a minimum period of at least ten (10) years, or for the period of minority
plus one year for newborns, after which such records may be destroyed. Records
destruction shall be accomplished by burning, shredding or other effective
method in keeping with the confidential nature of its contents. The destruction
of records must be made in the ordinary course of business, must be documented
and in accordance with the hospital's policies and procedures, and no record
may be destroyed on an individual basis.
(f) When a hospital closes with no plans of
reopening, an authorized representative of the hospital may request final
storage or disposition of the hospital's medical records by the department.
Upon transfer to the department, the hospital relinquishes all control over
final storage of the records in the files of the Tennessee Department of
Finance and Administration and the files shall become property of the State of
Tennessee.
(g) The hospital must
have a system of coding and indexing medical records. The system must allow for
timely retrieval by diagnosis and procedure.
(h) The hospital must have a procedure for
ensuring the confidentiality of patient records. Information from or copies of
records may be released only to authorized individuals, and the hospital must
ensure that unauthorized individuals cannot gain access to or alter patient
records. Original medical records must be released by the hospital only in
accordance with federal and state laws, court orders or subpoenas.
(i) The medical record must contain
information to justify admission and continued hospitalization, support the
diagnosis, and describe the patient's progress and response to medications and
services.
(j) All entries must be
legible, complete, dated and authenticated according to hospital
policy.
(k) All records must
document the following:
1. Evidence of a
physical examination, including a health history, performed and/or updated no
more than forty-five (45) days prior to admission or within forty-eight (48)
hours following admission;
2.
Admitting diagnosis;
3. Results of
all consultative evaluations of the patient and appropriate findings by
clinical and other staff involved in the care of the patient;
4. Documentation of complications, hospital
acquired infections, and unfavorable reactions to drugs and
anesthesia;
5. Properly executed
informed consent forms for procedures and treatments specified by hospital
policy, or by federal or state law if applicable, as requiring written patient
consent;
6. All practitioners'
orders, nursing notes, reports of treatment, medication records, radiology, and
laboratory reports, and vital signs and other information necessary to monitor
the patient's condition;
7.
Discharge summary with outcome of hospitalization, disposition of case and plan
for follow-up care; and
8. Final
diagnosis with completion of medical records within thirty (30) days following
discharge.
(l)
Electronic and computer-generated records and signature entries are
acceptable.
(6)
Pharmaceutical Services.
(a) The hospital must
have pharmaceutical services that meet the needs of the patients and are in
accordance with the Tennessee Board of Pharmacy statutes and regulations. The
medical staff is responsible for developing policies and procedures that
minimize drug errors. This function may be delegated to the hospital's
organized pharmaceutical service.
(b) A full-time, part-time or consulting
pharmacist must be responsible for developing, supervising and coordinating all
the activities of the pharmacy services.
(c) Current and accurate records must be kept
of receipt and disposition of all scheduled drugs.
(d) Adverse drug events, both adverse
reactions and medication errors, shall be reported according to established
guidelines to the hospital performance improvement/risk management program and
as appropriate to physicians, the hospital governing body and regulatory
agencies.
(e) Abuses and losses of
controlled substances must be reported, in accordance with federal and state
laws, to the individual responsible for the pharmaceutical service, and to the
chief executive officer, as appropriate.
(f) Current reference materials relating to
drug interactions and information of drug therapy, side effects, toxicology,
dosage, indications for use, and routes of administration must be available to
the professional staff in the pharmacy and in areas where medication is
administered.
(g) Any unused
portions of prescriptions shall be either turned over to the patient only on a
written authorization including directions by the physician, or returned to the
pharmacy for proper disposition by the pharmacist.
(h) Whenever patients bring drugs into an
institution, such drugs shall not be administered unless they can be identified
and ordered to be given by a physician.
(7) Radiologic Services.
(a) The hospital must maintain, or have
available, diagnostic radiologic services according to the needs of the
patients. If therapeutic services are also provided, they, as well as the
diagnostic services, must meet professionally approved standards for safety and
personnel qualifications.
(b) The
radiologic services must be free from hazards for patients and
personnel.
(c) Patients, employees
and the general public shall be provided protection from radiation in
accordance with "State Regulations for Protection Against Radiation." All
radiation producing equipment shall be registered and all radioactive material
shall be licensed by the Division of Radiological Health of the Tennessee
Department of Environment and Conservation.
(d) Periodic inspections of equipment must be
made and hazards identified must be promptly corrected.
(e) Radiologic services must be provided only
on the order of practitioners with clinical privileges or of other
practitioners authorized by the medical staff and the governing body to order
the services.
(f) X-ray personnel
shall be qualified by education, training and experience for the type of
service rendered.
(g) All x-ray
equipment must be registered with the Tennessee Department of Environment and
Conservation, Division of Radiological Health.
(h) X-rays shall be retained for four (4)
years and may be retired thereafter provided that a signed interpretation by a
radiologist is maintained in the patient's record under T.C.A. §
68-11-305.
(i) Patients must not be left unattended in
pre- and post-radiology areas.
(8) Laboratory Services.
(a) The hospital must maintain, or have
available, either directly or through a contractual agreement, adequate
laboratory services to meet the needs of its patients. The hospital must ensure
that all laboratory services provided to its patients are performed in a
facility licensed in accordance with the Tennessee Medical Laboratory Act. All
technical laboratory staff shall be licensed in accordance with the TMLA and
shall be qualified by education, training and experience for the type of
services rendered.
(b) Emergency
laboratory services must be available 24 hours a day.
(c) A written description of services
provided must be available to the medical staff.
(d) The laboratory must make provision for
proper receipt and reporting of tissue specimens.
(e) The medical staff and a pathologist must
determine which tissue specimens require a macroscopic (gross) examination and
which require both macroscopic and microscopic examination.
(f) Laboratory services must be provided in
keeping with services rendered by the hospital. This shall include suitable
arrangements for blood and plasma at all times. Written policies and procedures
shall be developed in concert with the Standards of American Association of
Blood Banks. Documentation and record keeping shall be maintained for tracking
and performance monitoring.
(9) Food and Dietetic Services.
(a) The hospital must have organized dietary
services that are directed and staffed by adequate qualified personnel. A
hospital may contract with an outside food management company if the company
has a dietitian who serves the hospital on a fulltime, part-time, or consultant
basis, and if the company maintains at least the minimum standards specified in
this section and provides for constant liaison with the hospital medical staff
for recommendations on dietetic policies affecting patient treatment. If an
outside contract is utilized for management of its dietary services, the
hospital shall designate a full-time employee to be responsible for the overall
management of the services.
(b) The
hospital must designate a person, either directly or by contractual agreement,
to serve as the food and dietetic services director with responsibility for the
daily management of the dietary services. The food and dietetic services
director shall be:
1. A qualified dietitian;
or,
2. A graduate of a dietetic
technician or dietetic assistant training program, correspondence or classroom,
approved by the American Dietetic Association; or,
3. An individual who has successfully
completed in-person or online coursework that provided ninety (90) or more
hours of classroom instruction in food service supervision. If the course has
not been completed, this person shall be enrolled in a course and making
satisfactory progress for completion within the time limit specified by the
course requirement; or,
4. An
individual who is a certified dietary manager (CDM), or certified food
protection professional (CFPP); or,
5. A current or former member of the U.S.
military who has graduated from an approved military dietary manager training
program.
(c) There must
be a qualified dietitian, full-time, part-time, or on a consultant basis who is
responsible for the development and implementation of a nutrition care process
to meet the needs of patients for health maintenance, disease prevention and,
when necessary, medical nutrition therapy to treat an illness, injury or
condition. Medical nutrition therapy includes assessment of the nutritional
status of the patient and treatment through diet therapy, counseling and/or use
of specialized nutrition supplements.
(d) There must be sufficient administrative
and technical personnel competent in their respective duties.
(e) Menus must meet the needs of the
patients.
1. Individual patient nutritional
needs must be met in accordance with recognized dietary practices.
2. All patient diets, including therapeutic
diets, must be ordered by a practitioner responsible for the care of the
patient, or by a qualified dietitian to whom the physician who chairs the
hospital's medical executive committee has referred this task. The medical
staff and hospital's board of trustees shall decide the extent of ordering
privileges that a qualified dietitian shall have and a mechanism to ensure that
order writing by a qualified dietitian is coordinated with the responsible
practitioner's care of the patient and complies with Tennessee law governing
dietitians.
3. A current
therapeutic diet manual approved by the dietitian and medical staff must be
readily available to all medical, nursing, and food service
personnel.
(f) Education
programs, including orientation, on-the-job training, inservice education, and
continuing education programs shall be offered to dietetic services personnel
on a regular basis. Programs shall include instruction in personal hygiene,
proper inspection, handling, preparation and serving of food and
equipment.
(g) A minimum of three
(3) meals in each twenty-four (24) hour period shall be served. A supplemental
night meal shall be served if more than fourteen (14) hours lapse between
supper and breakfast. Additional nourishment shall be provided to patients with
special dietary needs.
(h) All food
shall be from sources approved or considered satisfactory by the department and
shall be clean, wholesome, free from spoilage, free from adulteration and
misbranding and safe for human consumption. No food which has been processed in
a place other than a commercial food processing establishment shall be
used.
(i) Food shall be protected
from sources of contamination whether in storage or while being prepared,
served and/or transported. Perishable foods shall be stored at such
temperatures as to prevent spoilage. Potentially hazardous foods shall be
maintained at safe temperatures as defined in the current "U.S. Public Health
Service Food Service Sanitation Manual."
(j) Written policies and procedures shall be
followed concerning the scope of food services in accordance with the current
edition of the "U.S. Public Health Service Recommended Ordinance and Code
Regulating Eating and Drinking Establishments" and the current "U.S. Public
Health Service Sanitation Manual" should be used as a guide to food
sanitation.
(10)
Critical Access Hospital.
(a) Every patient
shall be under the care of a physician or under the care of a mid-level
practitioner supervised by a physician.
(b) Whenever a patient is admitted to the
facility by a mid-level practitioner, the supervising physician shall be
notified of that fact, by phone or otherwise, and within 24 hours the
supervising physician shall examine the patient or before discharge if
discharged within 24 hours, and a plan of care shall be placed in the patient's
chart, unless the patient is transferred to a higher level of care within 24
hours.
(c) A physician, a mid-level
practitioner or a registered nurse shall be on duty and physically available in
the facility when there are inpatients.
(d) A physician on staff shall:
1. Provide medical direction to the
facility's health care activities and consultation for non-physician health
care providers.
2. In conjunction
with the mid-level practitioner staff members, participate in developing,
executing, and periodically reviewing the facility's written policies and the
services provided to patients.
3.
Review and sign the records of each patient admitted and treated by a
practitioner no later than fifteen (15) days after the patient's discharge from
the facility.
4. Provide health
care services to the patients in the facility, whenever needed and
requested.
5. Prepare guidelines
for the medical management of health problems, including conditions requiring
medical consultation and/or patient referral.
6. At intervals no more than two (2) weeks
apart, be physically present in the facility for a sufficient time to provide
medical direction, medical care services, and staff consultation as
required.
7. When not physically
present in the facility, either be available through direct telecommunication
for consultation and assistance with medical emergencies and patient referral,
or ensure that another physician is available for this purpose.
8. The physical site visit for a given two
week period is not required if, during that period, no inpatients have been
treated in the facility.
(e) A mid-level practitioner on staff shall:
1. Participate in the development, execution,
and periodic review of the guidelines and written policies governing treatment
in the facility.
2. Participate
with a physician in a review of each patient's health records.
3. Provide health care services to patients
according to the facility's policies.
4. Arrange for or refer patients to needed
services that are not provided at the facility.
5. Assure that adequate patient health
records are maintained and transferred as necessary when a patient is
referred.
(f) The
Critical Access Hospital, at a minimum, shall provide basic laboratory services
essential to the immediate diagnosis and treatment of patients, including:
1. Chemical examinations of urine stick or
tablet methods, or both (including urine ketoses);
2. Microscopic examinations of urine
sediment;
3. Hemoglobin or
hematocrit;
4. Blood
sugar;
5. Gram stain;
6. Examination of stool specimens for occult
blood;
7. Pregnancy test;
8. Primary culturing for transmittal to a
CLIA certified laboratory;
9.
Sediment rate; and,
10.
CBC.
(11)
Rural Emergency Hospital.
(a) A hospital shall
be eligible to apply for a Rural Emergency Health ("REH") designation as such
and conversion to a Rural Emergency Hospital, if the facility, as of December
27th, 2020, was a:
1. Critical Access Hospital
as defined under Tenn. Comp. R. & Regs.
0720-14-.01(19);
or
2. General hospital with no more
than 50 licensed beds located in an area designated by state or federal law as
a rural area; or
3. General
hospital with no more than 50 licensed beds located in an area designated as
rural under 42 U.S.C. §
1395ww(d)(8)(E), or any
successor statute.
(b) A
facility applying for designation as a Rural Emergency Hospital shall include
in its licensure application:
1. A detailed
transition plan that lists the services that the facility will retain, modify,
add, and discontinue.
2. A
description of services that the facility intends to furnish on an outpatient
basis pursuant to Tenn. Comp. R. & Regs.
0720-14-.01(83)(b).
3. A description of any additional services
the hospital would be supporting, such as furnishing telehealth services and
ambulance services, including operating the facility and maintaining the
emergency department to provide such services covered by these rules.
4. Any such other information as the rules
and regulations of the Health Facilities Commission may require.
(c) A Rural Emergency Hospital may
be allowed to own and operate an entity that provides ambulance
services.
(d) A licensed general
hospital or Critical Access Hospital that applies for and receives licensure as
a Rural Emergency Hospital and elects to operate as a Rural Emergency Hospital
shall retain its original license as a general hospital or Critical Access
Hospital. Such original license shall remain inactive while the Rural Emergency
Hospital license is in effect.
(e)
A licensed Rural Emergency Hospital may enter into any contracts required to be
eligible for federal reimbursement as a Rural Emergency Hospital.
Authority: T.C.A. §§
4-5-202,
4-5-204,
39-11-106,
68-3-511,
68-11-201,
68-11-202,
68-11-204,
68-11-206,
68-11-207,
68-11-209,
68-11-210,
68-11-211,
68-11-213,
68-11-216,
68-11-224,
68-11-255,
68-11-1802,
68-57-101,
68-57-102, and
68-57-105;
42 U.S.C. §
1395x(kkk); and
42 U.S.C. §
1395cc(j).