services. If laboratory tests are performed in the nuclear medicine services,
they shall meet applicable requirements for laboratory services as specified in
(a) Radiological services provided shall be
maintained free of hazards for patients and personnel.
(b) Personnel monitoring shall be maintained
for each individual working in the area of radiation. Readings shall be on at
least a monthly basis and reports kept on file and available for
(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.
Periodic inspections of equipment must be made and hazards identified must be
personnel shall be qualified by education, training and experience for the type
of service rendered.
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. §
(g) Patient safety shall be ensured in all
areas of the facility.
Radioactive materials must be prepared, labeled, used, transported, stored, and
disposed of in accordance with acceptable standards of practice.
(i) In-house preparation of
radiopharmaceuticals shall be accomplished by, or under the direct supervision
of, an appropriately trained registered pharmacist or a doctor of medicine or
(j) The Outpatient
Diagnostic Center shall maintain records of the receipt and disposition of
(a) If the facility provides invasive
diagnostic procedures eg. cardiac catheterization, percutaneous transluminal
coronary angioplasty, vascular embolization or stereotactic procedures using
anesthesia, the services must be well organized and provided in accordance with
acceptable standards of practice.
(b) A qualified registered nurse shall be
present during invasive diagnostic procedures, as listed in subparagraph
(2)(a), where anything greater than local anesthesia is used during a
(c) Properly executed
informed consent forms shall be in the patient's chart before procedure is
performed, except in emergencies.
Adequate equipment and supplies shall be
available to the invasive diagnostic room and to the post procedure care area.
The following equipment and supplies shall be provided for cardiac
catheterization or angioplasty:
2. Cardiac monitor
3. Pulse Oximeter
7. Tracheotomy set
(e) A crash cart must be available with
qualified registered nurse shall be in the post procedure area during the
patient's recovery period during invasive diagnostic procedures, as listed in
subparagraph (2)(a), where anything greater than local anesthesia is used
during a procedure.
(g) A report
describing techniques, findings, and tissues removed or altered must be written
or dictated immediately following the procedure and signed by the
(h) The Outpatient
Diagnostic Center shall provide one or more procedure rooms which shall be
constructed, equipped, and maintained to assure the safety of patients and
Anesthesia. General anesthesia shall not be administered in Outpatient
(a) Written policies and
procedures relative to the administration of anesthesia shall be developed and
approved by the governing body, or responsible individual.
(b) After the completion of anesthesia,
patients shall be constantly attended by competent personnel until responsive
and able to summon aid. Each center shall maintain a log of the inspections
made prior to each day's use of the anesthesia equipment. A record of all
service and maintenance performed on all anesthesia machines shall also be on
Any patient receiving
conscious sedation shall receive:
continuous EKG monitoring;
continuous oxygen saturations;
serial BP monitoring at intervals no less than every 5 minutes; and
supplemental oxygen therapy and
(iii) endotracheal tube; and
(iv) crash cart.
Services. The Outpatient Diagnostic Center must provide drugs and biologicals
in a safe and effective manner in accordance with accepted federal and state
standards of practice. Such drugs and biologicals must be stored in a separate
room or cabinet which shall be kept locked at all times.
(a) The facility shall provide a safe,
accessible, effective and efficient environment of care consistent with its
mission, service, law and regulation.
The facility shall develop policies and
procedures that address:
3. Control of hazardous materials and
6. Medical equipment;
7. Utility systems.
(c) Staff shall have been oriented
to and educated about the environment of care and possess knowledge and skills
to perform responsibilities under the environment of care policies and
(d) Utility systems,
medical equipment, life safety elements, and safety elements of the environment
of care shall be maintained, tested and inspected.
(e) Safety issues shall be addressed and
(f) Appropriate staff
shall participate in implementing safety recommendations and monitoring their
(g) The building and
grounds shall be suitable to services provided and patients served.
(a) The Outpatient Diagnostic Center shall
comply with the Medical Records Act of 1974, T.C.A. §
A medical record
shall be maintained for each person receiving services provided by the
Outpatient Diagnostic Center and shall include:
1. Patient identification;
2. Name of nearest relative or other
Identification of primary source of medical care;
4. Dates and times of visits;
5. Signed informed consent;
6. Operative report;
7. Reports of all laboratory and diagnostic
procedures along with tests performed and the results authenticated by the
appropriate personnel; and,
Medical records shall be current and confidential. Medical records and copies
thereof shall be made available when requested by an authorized representative
of the board or the department.
(a) The Outpatient Diagnostic Center 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
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.
(c) The facility and its employees shall
adopt and utilize standard precautions (per CDC) for preventing transmission of
infections, HIV, and communicable diseases.
(d) All Outpatient Diagnostic Center's 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.
An Outpatient Diagnostic Center 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
Outpatient Diagnostic Center will encourage all staff and independent
practitioners to obtain an influenza vaccination;
Education of all employees about the
(i) Flu vaccination,
(ii) Non-vaccine control measures,
(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.
(f) The physical environment of the facility
shall be maintained in a safe, clean and sanitary manner.
(g) Any condition on the facility 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.
Performance Improvement. The Outpatient
Diagnostic Center shall have a planned, systematic, organization-wide approach
to process design and redesign, performance measurement, assessment and
improvement which is approved by the designated governing body or responsible
individual. This plan shall address and/or include, but is not limited to:
(a) Infection control, including
Complications of procedures;
Documentation of periodic review of the data collected and follow-up
(d) A system which
identifies appropriate plans of action to correct identified quality
that the above policies are being followed and that appropriate action is taken
Ancillary Services. All ancillary or supportive health or medical services,
including but not limited to, dietary, environmental, nursing, or medical
laboratory services shall be provided in accordance with all applicable state
and federal laws and regulations.
(a) The Outpatient Diagnostic Center shall
provide on the premises or by written agreement with a laboratory licensed
under T.C.A. §
68-29-105, a clinical laboratory
to provide those services commensurate with the needs and services of the
Outpatient Diagnostic Center.
Any patient terminating pregnancy in an Outpatient Diagnostic Center shall have
an Rh type, documented prior to the procedure, performed on her blood. In
addition, she shall be given the opportunity to receive Rh immune globulin
after an appropriate crossmatch procedure is performed within a licensed
and Dietetic Services. If a patient will be in the facility for more than four
(4) hours post-op, an appropriate diet shall be provided.