TENNESSEE. Tennessee Code.


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9-4-5116. Abortion funding.


No state funds shall be expended to perform abortions. The limitations established in this section shall not apply to an abortion if:


(1) The pregnancy is the result of an act of rape or incest; or


(2) In the case where a woman suffers from a physical disorder, physical injury, or physical illness, including a life-endangering physical condition caused by or arising from the pregnancy itself, that would, as certified by a physician, place the woman in danger of death unless the abortion is performed.

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37-10-301. Legislative intent and findings.


(a) It is the intent of the general assembly in enacting this parental consent provision to further the important and compelling state interests of:


(1) Protecting minors against their own immaturity;


(2) Fostering the family structure and preserving it as a viable social unit; and


(3) Protecting the rights of parents to rear children who are members of their household.


(b)The general assembly finds as fact that:


(1) Immature minors often lack the ability to make fully informed choices that take into account of both immediate and long-range consequences;


(2) The medical, emotional, and psychological consequences of abortion are serious and can be lasting, particularly when the patient is immature;


(3) The capacity to become pregnant and the capacity for mature judgment concerning the wisdom of an abortion are not necessarily related;


(4) Parents ordinarily possess information essential to a physician's exercise of the physician's best medical judgment concerning the child; and


(5) Parents who are aware that their minor daughter has had an abortion may better ensure that their daughter receives adequate medical attention after the abortion.


(c) The general assembly further finds that parental consultation is usually desirable and in the best interests of the minor.


37-10-302. Definitions.


As used in this part, unless the context otherwise requires:


(1) "Abortion" means the use of any instrument, medicine, drug, or any other substance or device with intent to terminate the pregnancy of a woman known to be pregnant with intent other than to increase the probability of a live birth, to preserve the life or health of the child after live birth, or to remove a dead fetus;


(2) "Emancipated minor" means any minor who is or has been married or has by court order or otherwise been freed from the care, custody and control of the minor's parents; and


(3) "Minor" means any person under eighteen (18) years of age.


37-10-303. Written consent required - Petition for waiver.


(a) No person shall perform an abortion on an unemancipated minor unless such person or such person's agent first obtains the written consent of one (1) parent or the legal guardian of the minor. The consent shall be signed.


(b) If neither a parent nor a legal guardian is available to the person performing the abortion or such person's agent, or the party from whom consent must be obtained pursuant to this section refuses to consent to the performance of an abortion, or the minor elects not to seek consent of the parent or legal guardian whose consent is required, then the minor may petition, on the minor's own behalf, or by next friend, the juvenile court of any county of this state for a waiver of the consent requirement of this section, pursuant to the procedures of Sec. 37-10-304.


(c)If a criminal charge of incest is pending against a parent of such minor pursuant to Sec. 39-15-302, the written consent of such parent, as provided for in subsection (a), is not required.


37-10-304. Applicability - Pseudonym - Counsel - Court proceedings - Appeals.


(a) The requirements and procedures under this part are available and apply to minors, whether or not they are residents of this state.


(b) The court shall ensure that the minor's identity is kept anonymous. The minor shall be allowed to proceed under a pseudonym and shall be allowed to sign all documents, including the petition, by that pseudonym. In any proceedings involving the use of a pseudonym by the minor, the court shall require one (1) copy of the petition to be filed, under seal, that contains the true name of the minor. This copy of the petition shall be kept in a separate file, under seal, and shall not be available for inspection by anyone, except as provided in subsection (h).


(c) (1) The minor may participate in proceedings in the court on the minor's own behalf or through a next friend. The court shall advise the minor that the minor has a right to court-appointed counsel and shall provide the minor with such counsel upon the minor's request. The state shall further provide a court-appointed advocate in each judicial district to give information regarding the legal process to the minor and to coordinate with the court-appointed counsel. Such court-appointed advocates shall be compensated from funds appropriated for the reimbursement of court-appointed counsel.


(2) The department of children's services shall assign from existing staff at least one (1) court advocate in each judicial district to provide minors with information regarding requirements and procedures established by the provisions of this part, to assist in coordination of the activities of court-appointed counsel, to attend legal proceedings with the minor or the minor's next friend, and to make available written material concerning the provisions and applications of this part. The advocate shall be trained in the juvenile court procedures, in the procedures established by this part, and in counseling minors. The department shall provide a toll-free telephone number for minors to use in order to obtain the telephone number and address of a court advocate. The department shall further provide and distribute a written brochure or information sheet which summarizes the provisions and applications of this part and which contains the toll-free telephone number as well as the names, addresses, and telephone numbers of the court advocates in each judicial district.


(d)Court proceedings under this section shall be given such precedence over other pending matters as is necessary to ensure that the court may reach a decision promptly, but in no case shall the court fail to rule within forty-eight (48) hours of the time of application; provided, that the forty-eight-hour limitation may be extended at the request of the minor. If, for any reason except the request of the minor, the court shall not have ruled within forty-eight (48) hours, the minor may deem the petition denied and immediately appeal the denial as provided in subsection (g). This provision is not deemed to restrict or forbid any other remedy now existing or hereafter enacted in such a situation.

(e)The consent requirement shall be waived if the court finds either that:


(1) The minor is mature and well-informed enough to make the abortion decision on the minor's own; or


(2) The performance of the abortion would be in the minor's best interests.


(f)A court that conducts proceedings under this section shall issue written and specific factual findings and legal conclusions supporting its decision and shall order that a confidential record of the evidence be maintained.


(g)An expedited, anonymous appeal shall be available to any minor. The appeal shall be de novo to the circuit court for the county in which the juvenile court is located. The appeal may be heard by the circuit court judge sitting in another county if necessary to meet the time limitations of this section. A notice of appeal shall be filed within twenty-four (24) hours of the decision by the juvenile court, but may be filed at any time, if the juvenile court has not ruled within forty-eight (48) hours of the filing of the petition. The record from the juvenile court must be received in the circuit court and the appeal docketed there within five (5) calendar days of the filing of the notice of appeal. The appeal shall be heard and a decision rendered by the circuit court within five (5) calendar days from when the case is docketed in the circuit court. For the purpose of expediting the appellate procedure under this section, the time requirements of this section may be reduced by the Tennessee supreme court pursuant to its rulemaking authority in order to ensure an expedited appeal. The decision of the circuit court shall be appealable to the Tennessee supreme court in an anonymous and expedited manner as provided by the rules of the Tennessee supreme court. Jurisdiction under this section will remain in the Tennessee supreme court, notwithstanding the provision of any other statute or rule to the contrary.


(h)All court files, documents, exhibits, and all other records lodged in or subject to the control of the court shall be kept confidential and under seal. Statistical summaries of these proceedings may be compiled for such reporting purposes as the supreme court may by rule require or allow. However, no information shall be released for these purposes that would tend to identify any minor who has made use of this procedure.


(i)The supreme court is respectfully requested to promulgate any rules necessary to ensure that proceedings under this part are handled in an expeditious and anonymous manner, including any amendments to the Tennessee Rules of Appellate Procedure, Tennessee Rules of Civil Procedure and Tennessee Rules of Juvenile Procedure.


(j)No fees shall be required of any minor who makes use of the procedures provided by this section.


37-10-305. Medical emergencies.


The requirements of Sec. 37-10-303 shall not apply when, in the best medical judgment of the physician based on the facts of the case before the physician, a medical emergency exists that so complicates the pregnancy as to require an immediate abortion.


37-10-306. Violations.


Any person who intentionally performs an abortion with knowledge that, or with reckless disregard as to whether the person upon whom the abortion is to be performed is an unemancipated minor, and who intentionally or knowingly fails to conform to any requirement of this part, commits a Class A misdemeanor.


37-10-307. Civil actions.


Failure to obtain consent pursuant to the requirements of this part is prima facie evidence of failure to obtain informed consent and of interference with family relations in appropriate civil actions. The law of this state shall not be construed to preclude the award of exemplary damages in any appropriate civil action relevant to violations of this part. Nothing in this part shall be construed to limit the common law rights of parents.


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39-15-201. Criminal abortion and attempt to procure criminal miscarriage - Penalties - Lawful abortions and attempts to procure miscarriage - Requirements.


(a) For the purpose of this section:


(1) "Abortion" means the administration to any woman pregnant with child, whether such child be quick or not, of any medicine, drug, or substance whatever, or the use or employment of any instrument, or other means whatever, with the intent to destroy such child, thereby destroying such child before the child's birth; and


(2) "Attempt to procure a miscarriage" means the administration of any substance with the intention to procure the miscarriage of a woman or the use or employment of any instrument or other means with such intent.


(b) (1) Every person who performs an abortion commits the crime of criminal abortion, unless such abortion is performed in compliance with the requirements of subsection (c). Criminal abortion is a Class C felony.


(2) Every person who attempts to procure a miscarriage commits the crime of attempt to procure criminal miscarriage, unless such attempt to procure a miscarriage is performed in compliance with the requirements of subsection (c). Attempt to procure a criminal miscarriage is a Class E felony.


(3) Every person who compels, coerces, or exercises duress in any form with regard to any other person in order to obtain or procure an abortion on any female commits a misdemeanor. A violation of this section is a Class A misdemeanor.


(c) No person is guilty of a criminal abortion or an attempt to procure criminal miscarriage when an abortion or an attempt to procure a miscarriage is performed under the following circumstances:


(1) During the first three (3) months of pregnancy, if the abortion or attempt to procure a miscarriage is performed with the pregnant woman's consent and pursuant to the medical judgment of the pregnant woman's attending physician who is licensed or certified under title 63, chapter 6 or 9;


(2) After three (3) months, but before viability of the fetus, if the abortion or attempt to procure a miscarriage is performed with the pregnant woman's consent and in a hospital as defined in Sec. 68-11-201, licensed by the state department of health, or a hospital operated by the state of Tennessee or a branch of the federal government, by the pregnant woman's attending physician, who is licensed or certified under title 63, chapter 6 or 9, pursuant to the attending physician's medical judgment; or [These provisions have been held to be unconstitutional and unenforceable.]


(3) During viability of the fetus, if the abortion or attempt to procure a miscarriage is performed with the pregnant woman's consent and by the pregnant woman's attending physician, who is licensed or certified under title 63, chapter 6 or 9; and, if all the circumstances and provisions required for a lawful abortion or lawful attempt to procure a miscarriage during the period set out in subdivision (c)(2) are adhered to; and if, prior to the abortion or attempt to procure a miscarriage the physician has certified in writing to the hospital in which the abortion or attempt to procure a miscarriage is to be performed, that in the physician's best medical judgment, after proper examination, review of history, and such consultation as may be required by either the rules and regulations of the board for licensing health care facilities promulgated pursuant to Sec. 68-11-209, or the administration of the hospital involved, or both, the abortion or attempt to procure a miscarriage is necessary to preserve the life or health of the mother, and shall have filed a copy of the certificate with the district attorney general of the judicial district wherein the abortion or attempt to procure a miscarriage is to be performed.


(d) No abortion shall be performed on any pregnant woman unless such woman first produces evidence satisfactory to the physician performing the abortion that she is a bona fide resident of Tennessee. Evidence to support such claim of residence shall be noted in the records kept by the physician and, if the abortion is performed in a hospital, in the records kept by the hospital. A violation of this subsection (d) is punished as provided by subdivision (b)(1).


39-15-202. Consent of pregnant woman required prior to abortion - Information provided by doctor - Waiting period - Penalty for violation - Requirements inapplicable in certain cases.[Except for (a) below, these provisions have been held to be unconstitutional and unenforceable.]


(a)An abortion otherwise permitted by law shall be performed or induced only with the informed written consent of the pregnant woman, given freely and without coercion. Such consent shall be treated as confidential.


(b)In order to ensure that a consent for an abortion is truly informed consent, an abortion shall be performed or induced upon a pregnant woman only after she has been orally informed by her attending physician of the following facts and has signed a consent form acknowledging that she has been informed as follows:


(1) That according to the best judgment of her attending physician she is pregnant;


(2) The number of weeks elapsed from the probable time of the conception of her unborn child, based upon the information provided by her as to the time of her last menstrual period or after a history, physical examination, and appropriate laboratory tests;


(3) That if more than twenty-four (24) weeks have elapsed from the time of conception, her child may be viable, that is, capable of surviving outside of the womb, and that if such child is prematurely born alive in the course of an abortion her attending physician has a legal obligation to take steps to preserve the life and health of the child;


(4) That abortion in a considerable number of cases constitutes a major surgical procedure;


(5) That numerous public and private agencies and services are available to assist her during her pregnancy and after the birth of her child, if she chooses not to have the abortion, whether she wishes to keep her child or place the child for adoption, and that her physician will provide her with a list of such agencies and the services available if she so requests; or


(6) Numerous benefits and risks are attendant either to continued pregnancy and childbirth or to abortion depending upon the circumstances in which the patient might find herself. The physician shall explain these benefits and risks to the best of such physician's ability and knowledge of the circumstances involved.


(c)At the same time the attending physician provides the information required by subsection (b), such physician shall inform the pregnant woman of the particular risks associated with her pregnancy and childbirth and the abortion or child delivery technique to be employed, including providing her with at least a general description of the medical instructions to be followed subsequent to the abortion or childbirth in order to ensure her safe recovery.


(d) (1)There shall be a two-day waiting period after the physician provides the required information, excluding the day on which such information was given. On the third day following the day such information was given, the patient may return to the physician and sign a consent form.


(2) A violation of this subsection (d) by a physician is a Class E felony.


(3) This subsection (d) shall not apply when the attending physician, utilizing experience, judgment or professional competence, determines that a two-day waiting period or any waiting period would endanger the life of the pregnant woman. Such determination made by the attending physician shall be in writing and shall state the physician's medical reasons upon which the physician bases the opinion that the waiting period would endanger the life of the pregnant woman. This provision shall not relieve the attending physician of the duty to the pregnant woman to inform her of the facts under subsection (b).


(e)The attending physician performing or inducing the abortion shall provide the pregnant woman with a duplicate copy of the consent form signed by her.


(f)"The physician" or "the attending physician," as used in this section, means any licensed physician on the service treating the pregnant woman.


(g)The provisions of this section shall not apply in those situations where an abortion is certified by a licensed physician as necessary to preserve the life of the pregnant woman.


39-15-203. Records and reports of abortions - Confidentiality.


A physician performing an abortion shall keep a record of each such operation and shall make a report to the commissioner of health with respect thereto at such time and in such form as the commissioner may reasonably prescribe. Each such record and report shall be confidential in nature and shall be inaccessible to the public.


39-15-204. Right to refuse to perform abortions.


No physician shall be required to perform an abortion and no person shall be required to participate in the performance of an abortion. No hospital shall be required to permit abortions to be performed therein.


39-15-205. Right of hospitals to refuse to accept abortion patients.


No section of this part shall be construed to force a hospital to accept a patient for an abortion.


39-15-206. Rights to medical treatment of infant prematurely born alive during abortion - Penalty for violation - Limitation on wrongful death action.


(a) The rights to medical treatment of an infant prematurely born alive in the course of an abortion are the same as the rights of an infant of similar medical status prematurely born spontaneously. Any person who performs or induces an abortion of such an infant shall exercise that degree of professional skill, care, and diligence in accordance with good medical practice necessary to preserve the life and health of such infant prematurely born alive in the course of an abortion, except that if it can be determined, through amniocentesis or medical observation, that the fetus is severely malformed, the use of extraneous life support measures need not be attempted.


(b)Any person who violates this section commits a Class E felony.


(c)No cause of action for wrongful death shall be brought which arises out of the death of a fetus or infant during the course of a lawful abortion, whether such fetus or infant is quick or not, so long as the abortion is performed in accordance with the provisions of this part; however, once an infant is born alive, any person in attendance thereto shall be civilly responsible for providing all reasonable and necessary care reasonable under the circumstances in the general vicinity in which the person in attendance practices.


39-15-207. Custody of infant prematurely born alive during abortion.


An infant prematurely born alive in the course of a voluntary abortion is hereby declared abandoned for purposes of custody only, and the department of children's services shall care for such infant as provided in Sec. 34-1-103.


39-15-208. Research, photography, sale, and experimentation upon aborted fetuses - Penalty for violation.


(a)It is unlawful for any person, agency, corporation, partnership or association to engage in medical experiments, research, or the taking of photographs upon an aborted fetus without the prior knowledge and consent of the mother.


(b)No person, agency, corporation, partnership or association shall offer money or anything of value for an aborted fetus; nor shall any person, agency, corporation, partnership or association accept any money or anything of value for an aborted fetus.


(c)It is the express intent of the general assembly that nothing in the provisions of this section shall be construed to grant to a fetus any legal right not possessed by such fetus prior to July 1, 1979.


(d)A violation of this section is punishable as a Class E felony.

39-15-209. Partial birth abortions. [These provisions are unconstitutional and unenforceable.]


(a)For purposes of this section, unless the context otherwise requires:


(1) "Partial-birth abortion" means an abortion in which the person performing the abortion partially vaginally delivers a living fetus before killing the fetus and completing the delivery; and


(2) "Vaginally delivers a living fetus before killing the fetus" means deliberately and intentionally delivers into the vagina a living fetus, or a substantial portion thereof, for the purpose of performing a procedure the physician knows will kill the fetus, and kills the fetus.


(b)No person shall knowingly perform a partial-birth abortion.


(c)Subsection (b) shall not apply to a partial-birth abortion that is necessary to save the life of the mother whose life is endangered by a physical disorder, illness or injury.


(d) (1)A defendant accused of an offense under this section may seek a hearing before the state medical board which licenses the physician, on whether the physician's conduct was necessary to save the life of the mother whose life was endangered by a physical disorder, illness or injury.


(2) The findings on that issue are admissible on that issue at the trial of the defendant. Upon a motion of the defendant, the court shall delay the beginning of the trial for not more than thirty (30) days to permit such a hearing to take place.


(e) (1) Performance of a partial-birth abortion in knowing or reckless violation of this section shall be a Class C felony.


(2) A woman upon whom a partial-birth abortion is performed may not be prosecuted under this section for violating this section or any of its provisions, or for conspiracy to violate this section or any of its provisions.


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53-10-104. Selling, bartering, giving away or obtaining legend drugs.


(a)It is unlawful for any person, firm or corporation to possess, sell, barter or give away any drug known as legend drugs, as defined in Sec. 53-10-101, except upon the written prescription of a duly licensed physician, certified physician assistant, nurse authorized pursuant to Sec. 63-6-204 or Sec. 63-9-113, who is rendering service under the supervision, control and responsibility of a licensed physician, and who meets the requirements pursuant to Sec. 63-7-123, a dentist, an optometrist authorized pursuant to Sec. 63-8-102(12), or a veterinarian, and compounded or dispensed by a duly registered pharmacist.


(b)It is unlawful for any person, firm or corporation to obtain or to attempt to obtain a legend drug, or to procure or to attempt to procure the administration of a legend drug, by fraud, deceit, misrepresentation, subterfuge, forgery, alteration of a prescription, by the concealment of a material fact, or by the use of a false name or address.


(c)Under no circumstances shall a nurse practitioner who has met the additional requirements of Sec. 63-7-207(14) to write and sign prescriptions and/or issue drugs nor a physician assistant working under a physician's supervision be delegated the authority to prescribe drugs which involve the following:


(1) The writing or signing a prescription for any drug or medication;


(2) The dispensing or administration of any prescribed or legend drug or medication; or


(3) The performing of any procedure which involves the use of a legend drug or medication;


whose sole purpose is to cause or perform an abortion.


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68-1-1205. Compliance with certain laws, etc., required of employees.


Each employee of the program, including each intern resident employed pursuant to Sec. 68-1-1203(c), shall at all times remain in compliance with, and shall fully abide by, all applicable federal, state and local statutes, rules, regulations, ordinances and policies pertaining to abortion. Furthermore, each employee of the program, including each intern or resident employed pursuant to Sec. 68-1-1203(c), shall at all times remain in compliance with and shall fully abide by all applicable federal, state and local statutes, rules, regulations, ordinances and policies pertaining to birth control devices and contraceptives. While present on the property or premises of any local education agency or while otherwise engaged in the activities of the program, no such employee shall at any time make abortion referrals or otherwise advocate or encourage abortion nor prescribe any form of birth control device or contraceptive. It shall be the policy of the program, and of each employee engaged in the activities of the program, including each intern or resident employed pursuant to Sec. 68-1-1203(c), to vigorously encourage and urge students to abstain from entering into any sexual relationship or activity.


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(A) Born children;


(B) Unborn children whose testing would result in treatment;


(C) Men;


(D) Nonpregnant women; and


(E) Those pregnant women whose testing would result in treatment for themselves or their unborn children.


(2) Induced abortion shall not be regarded as treatment. Therefore, procedures or services designed to search out disorders in unborn children which are not treatable shall not be provided for under this part and part 4 of this chapter, it being the finding of the general assembly that the use of this program to abort unborn children is against the public policy of the state of Tennessee.


(b)The department shall:


(1) Develop and administer statewide genetic and metabolic screening programs to prevent, detect and assure follow-up for birth defects and genetic disorders. Such screening programs shall include testing for phenylketonuria and hypothyroidism as provided by part 4 of this chapter, testing for sickle cell disease and other hemoglobinopathies and other testing programs as the department shall deem appropriate for the preventive treatment of mental retardation or physical dysfunction, as publicly noted through rules and regulations duly promulgated in accordance with the provisions of the Uniform Administrative Procedures Act, compiled in title 4, chapter 5;


(2) Prescribe effective tests and examinations designed to detect genetic disorders as determined by the department, prescribe the methods of obtaining samples or specimens for the required tests and examinations, and designate the person or persons required to conduct such tests and examinations;


(3) Develop standards for statewide genetic services;


(4) Assist in the development, expansion and maintenance of regional genetic centers and regional sickle cell centers, including purchase of equipment and employment of specialized personnel;


(5) Develop and implement state/regional programs of professional education and training for health care providers in the causes, prevention, detection and treatment of birth defects and genetic disorders;


(6) Support clinical diagnosis and counseling services regarding genetic disorders and birth defects;


(7) Implement public education programs to inform persons of genetic screening, genetic disorders, and birth defects and the various services available;


(8) Develop a system of consultation, communication and referral to regional genetics centers and regional sickle cell centers;


(9) Develop a reporting system to allow data to be collected and stored and to facilitate the compilation of statistical information on causes, methods of treatment and prevention of genetic disorders and birth defects. Such system shall be in accordance with laws and rules of the department governing confidentiality of information;


(10) Enter into contractual agreements with other agencies to provide services under the state program; and


(11) Promulgate and enforce all rules and regulations as may be necessary to effectuate the purposes of this part and part 4 of this chapter.


(c) It is the specific intent of the general assembly that neither abortion nor abortion research should be funded by this program.


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68-11-201. Definitions.


As used in this part, unless the context otherwise requires:


(1) "Alcohol and drug prevention and/or treatment facility" means an institution, treatment resource, group residence, (boarding home, sheltered workshop, activity center), rehabilitation center, hospital, community mental health center, DUI school, counseling center, clinic, halfway house, or other entity, by these or other names, providing alcohol and drug services; provided, that a DUI school operated by a state institution of higher education shall not be considered an "alcohol and drug treatment facility" for purposes of this chapter; further, "alcohol and drug prevention and/or treatment facility" does not include any facility otherwise licensed by the department of mental health and developmental disabilities or health or approved by the department of education;


(2) "Alcohol and drug services" includes evaluation, treatment, residential personal care, habilitation, rehabilitation, counseling, or supervision of persons who abuse or are dependent upon alcohol or drugs; or services to persons designed to prevent alcohol or drug abuse or dependence which either receive funds from the department of health or assess fees for services provided; provided, that a DUI school operated by a state institution of higher education shall not be considered "alcohol and drug services" for purposes of this chapter;


(3) "Ambulatory surgical treatment center" means any institution, place or building devoted primarily to the maintenance and operation of a facility for the performance of surgical procedures or any facility in which a medical or surgical procedure is utilized to terminate a pregnancy. Such facilities shall not provide beds or other accommodations for the stay of a patient to exceed twelve (12) hours duration; provided, that the length of stay may be extended for an additional twelve (12) hours in the event such stay is deemed necessary by the attending physician, the facility medical director, or the anesthesiologist for observation or recovery, but in no event shall the length of stay exceed twenty-four (24) hours. No patient for whom a medical or surgical procedure is utilized to terminate a pregnancy shall stay at such a facility for a period exceeding twelve (12) hours. Individual patients shall be discharged in an ambulatory condition without danger to the continued well-being of the patients or shall be transferred to a hospital. Excluded from this definition are the private physicians' and dentists' office practices, except those private physicians' and dentists' offices in which a substantial number of medical or surgical pregnancy terminations are performed;[This definition has been held to be unenforceable.]


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68-11-223. Ambulatory surgical treatment centers performing abortions.


(a)The general assembly finds and declares as fact, with regard to ambulatory surgical treatment centers that terminate pregnancies, that:


(1) Over twenty-one thousand (21,000) abortions are performed annually in Tennessee;


(2) The majority of these abortions are performed in ambulatory surgical treatment centers;


(3) Gross negligence, unethical conduct and unprofessional administration of some centers have been documented by the department, including conditions such as:


(A) The existence of unsterile and unsanitary conditions;


(B) Fire and safety violations, electrical code violations and inadequate ventilation;


(C) Improper disposal of infectious waste;


(D) Allowing patients to leave too soon after the abortion procedure;


(E) Lack of records on patients and complications;


(F) Doctors practicing without a license or without local hospital privileges; and


(G) Surgical procedures performed without a nurse in attendance;


(4) Such centers are the only medical facilities in the state that regularly perform surgery on minors without the knowledge or consent of the parents, guardian or custodian; and yet the parents, guardian or custodian are not relieved of their financial liability and familial responsibilities;


(5) Such centers should be held to similarly applicable standards as other health care related facilities;


(6) The state has a legitimate interest in protecting its citizens from exploitation, the spread of infectious diseases, and ensuring that its citizens utilizing such centers are provided with quality health care as is required in all health care facilities licensed and regulated by the state; and


(7) Many such centers do not carry or maintain adequate medical malpractice insurance, if any, and the state has an interest in ensuring that those persons utilizing such centers have an adequate recourse to recover financially if a malpractice suit arises from the use of such facilities.


(b) (1)In addition to complying with the rules and regulations promulgated by the board for licensing health care facilities for ambulatory surgical treatment centers, no ambulatory surgical treatment center that terminates pregnancies shall be granted a license, renewal of a license or be authorized to continue operation under this chapter, unless it complies in full with all of the following requirements:


(A) Maintenance of at least two million dollars ($2,000,000) of medical malpractice liability insurance in force, annually submitting to the department proof of such insurance coverage;


(B) Satisfaction of all applicable regulations and requirements of the board for compliance with state and local building codes, including electrical, plumbing, fire and other building and safety codes except where the board determines that a waiver is appropriate;


(C) Is not in violation of department regulations which directly impact the health care of multiple patients with such scope and magnitude as to clearly show consistent and willful neglect of the regulations, fundamental flaws in the facility's operation, or knowing failure to comply with departmental regulations;


(D) The administrator of such facility shall:


(i) be a licensed physician, licensed practical nurse, registered nurse, or have a college degree from a four-year accredited institution and experience in a health-related field; and


(ii) be of good moral character.


For purposes of this section, "administrator" means the person who is responsible for the operation of the medical facility where pregnancies are terminated;


(E) No employee providing direct patient care, officer, director, or owner of the facility, or if a corporation, a stockholder who owns fifty-one percent (51%) or more of the stock in such corporation, shall have been convicted of or pleaded nolo contendere to a felony or any crime involving moral turpitude within five (5) years immediately preceding the date of application; and


(F) No employee providing direct patient care, officer, director, or owner of the facility, or if a corporation, a stockholder who owns fifty-one percent (51%) or more of the stock in such corporation, shall have been convicted of or pleaded nolo contendere to any violation of this chapter.


(2) The board shall suspend or revoke a license of such center if a violation of this subsection occurs following the issuance or renewal of a license.


(3) In addition to any other lawful disciplinary action under this part, the board may assess a civil penalty not exceeding two thousand dollars ($2,000) for each violation of this subsection.


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CHAPTER 1200 8-10



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1200-8-10-.01 DEFINITIONS.


(1) Acceptable Plan of Correction. The Licensing Division approves an Ambulatory Surgical Treatment

Center's plan to correct deficiencies identified during an on-site survey conducted by the Survey

Division or its designated representative. The plan of correction shall be a written document and shall

provide, but not limited to, the following information:


(a) How the deficiency will be corrected.


(b) Who will be responsible for correcting the deficiency.


(c) The date the deficiency will be corrected.


(d) How the facility will prevent the same deficiency from re-occurring.


(2) Accredited Record Technician (ART). A person currently accredited as such by the American Medical

Records Association.


(3) Advance Directive. A written statement such as a living will, a durable power of attorney for health

care or a do not resuscitate order relating to the provision of health care when the individual is



(4) Ambulatory surgical treatment center (ASTC). Any institution, place or building devoted primarily to

the maintenance and operation of a facility for the performance of surgical procedures. Such facilities

shall not provide beds or other accommodations for the stay of a patient to exceed twelve (12) hours

duration, provided that the length of stay may be extended for an additional twelve (12) hours in the

event such stay is deemed necessary by the attending physician, the facility medical director, or the

anesthesiologist for observation or recovery, but in no event shall the length of stay exceed twenty-four


(24) hours. Individual patients shall be discharged in an ambulatory condition without danger to the

continued well-being of the patients or shall be transferred to a hospital. Excluded from this definition

are the private physicians' and dentists' office practices. For the purposes of this rule, those medical

and dental offices, facilities, and other settings at which surgical procedures exclusively are performed

are ASTCís and not private office practices.

ASTCís must comply with the following for purposes of these regulations:


(a) surgical procedures performed must be limited to those procedures which are commonly

performed on an inpatient basis in hospitals but may safely be performed in an ASTC;


(b) if anesthesia is required for a surgical procedure, it must be local, regional or general anesthesia

and routinely be four (4) hours or less in duration;


(c) surgical procedures that generally result in extensive blood loss, require major or prolonged

invasion of body cavities, or are considered emergency or life-threatening in nature may not be



(5) Board. The Tennessee Board for Licensing Health Care Facilities.


(6) Cancer Treatment and Radiation Clinic. A facility in which the only procedures performed are

diagnostic and therapeutic radiology, chemotherapy and related services.


(7) Cardiopulmonary Resuscitation (CPR). The administering of any means or device to support

cardiopulmonary functions in a patient, whether by mechanical devices, chest compressions,

mouth-to-mouth resuscitation, cardiac massage, tracheal intubation, manual or mechanical ventilators

or respirators, defibrillation, the administration of drugs and/or chemical agents intended to restore

cardiac and/or respiratory functions in a patient where cardiac or respiratory arrest has occurred or is

believed to be imminent.


(8) Certified Registered Nurse Anesthetist. A registered nurse currently licensed by the Tennessee Board

of Nursing who is currentlormal> 

(11) Collaborative Practice. The implementation of the collaborative plan that outlines procedures for

consultation and collaboration with other health care professionals, e.g., licensed physicians, mid-level

practitioners or nurse midwives.


(12) Commissioner. Commissioner of the Tennessee Department of Health or his or her authorized



(13) Competent. A patient who has decision-making capacity.


(14) Corrective Action Plan/Report. A report filed with the department by the facility after reporting an

unusual event. The report must consist of the following:


(a) the action(s) implemented to prevent the reoccurrence of the unusual incident,


(b) the time frames for the action(s) to be implemented,


(c) the person(s) designated to implement and monitor the action(s), and


(d) the strategies for the measurements of effectiveness to be established.


(15) Decision-making capacity. Decision-making capacity is shown by the fact that the person is able to

understand the proposed procedure, its risks and benefits, and the available alternative procedures.


(16) Dentist. A person currently licensed as such by the Tennessee Board of Dentistry.


(17) Department. The Tennessee Department of Health.


(18) Do Not Resuscitate (DNR) order. An order entered by the patient's treating physician in the patient's

medical records which states that in the event the patient suffers cardiac or respiratory arrest,

cardiopulmonary resuscitation should not be attempted. The order may contain limiting language to

allow only certain types of cardiopulmonary resuscitation.


(19) Electronic Signature. The authentication of a health record document or documentation in an

electronic form achieved through electronic entry of an exclusively assigned, unique identification

code entered by the author of the documentation.


(20) Gastrointestinal Endoscopy Clinic. A facility in which the only procedures performed are those related

to the gastrointestinal tract and other endoscopic procedures. This excludes laparoscopy and limits

entry to major body cavities by needle aspiration only.


(21) General Anesthesia. An induced state of unconsciousness accompanied by partial or complete loss of

protective reflexes inducing the inability to continually maintain an airway independently and respond

purposefully to physical stimulation or verbal command, and produced by a pharmacological or nonpharmacological

method or a combination thereof.


(22) Graduate Registered Nurse Anesthetist. A registered nurse currently licensed in Tennessee who is a

graduate of a nurse anesthesia educational program that is accredited by the American Association of

Nurse Anesthetist's Council on Accreditation of Nurse Anesthesia Educational Programs and awaiting

initial certification examination results, provided that initial certification is accomplished within

eighteen (18) months of completion of an accredited nurse anesthesia educational program.


(23) Hazardous Waste. Materials whose handling, use, storage and disposal are governed by local, state or

federal regulations.


(24) Health care decision. A decision made by an individual or the individualís health care decision-maker,

regarding the individualís health care including but not limited to:


(a) the selection and discharge of health-care providers and institutions;


(b) approval or disapproval of diagnostic tests, surgical procedures, programs of administration of

medication, and orders not to resuscitate;


(c) directions to provide, withhold or withdraw artificial nutrition and hydration and all other forms

of health care; and


(d) transfer to other health care facilities.


(25) Health Care Decision-maker. In the case of an incompetent patient, or a patient who lacks decisionmaking

capacity, the patientís health care decision-maker is one of the following: the patientís health

care agent as specified in an advance directive, the patientís court-appointed legal guardian or

conservator with health care decision-making authority, or the patientís surrogate as determined

pursuant to Rule 1200-8-10-.13 or T.C.A. ß33-3-220.


(26) Hospital. Any institution, place, building or agency represented and held out to the general public as

ready, willing and able to furnish care, accommodations, facilities and equipment for the use, in

connection with services of a physician or dentist, to one (1) or more non-related persons who may be

suffering from deformity, injury or disease or from any other condition for which nursing, medical or

surgical services would be appropriate for care, diagnosis or treatment.


(27) Incompetent. A patient who has been adjudicated incompetent by a court of competent jurisdiction

and has not been restored to legal capacity.


(28) Infectious Waste. Solid or liquid wastes which contain pathogens with sufficient virulence and

quantity such that exposure to the waste by a susceptible host could result in an infectious disease.


(29) Lacks Decision-Making Capacity. Lacks Decision-Making Capacity means the factual demonstration

by the attending physician and the medical director, or the attending physician and another physician

that an individual is unable to understand:


(a) A proposed health care procedure(s), treatment(s), intervention(s), or interaction(s);


(b) The risks and benefits of such procedure(s), treatment(s), intervention(s) or interaction(s); and


(c) The risks and benefits of any available alternative(s) to the proposed procedure(s), treatment(s),

intervention(s) or interaction(s).


(30) Legal Guardian. Any person authorized to act for the patient pursuant to any provision of T.C.A.

ßß34-5-102(4) or 34-11-101, or any successor statute thereto.


(31) Licensed Practical Nurse. A person currently licensed as such by the Tennessee Board of Nursing.


(32) Licensee. The person or entity to whom the license is issued. The licensee is held responsible for

compliance with all applicable rules and regulations.


(33) Life Threatening or Serious Injury. Injury requiring the patient to undergo significant additional

diagnostic or treatment measures.


(34) Medical emergency. A medical condition manifesting itself by acute symptoms of sufficient severity


(including severe pain) such that the absence of immediate medical attention could reasonably be

expected to result in placing the patient's health in serious jeopardy, serious impairment to bodily

functions or serious dysfunction of any bodily organ or part.


(35) Medical Record. Medical histories, records, reports, summaries, diagnoses, prognoses, records of

treatment and medication ordered and given, entries, x-rays, radiology interpretations and other written

electronics, or graphic data prepared, kept, made or maintained in a facility that pertains to

confinement or services rendered to patients admitted or receiving care.


(36) Medical Staff. An organized body composed of individuals appointed by the ambulatory surgical

treatment center governing board. All members of the medical staff shall be licensed to practice in

Tennessee, with the exception of interns and residents.


(37) Medically Futile Treatment. Resuscitation efforts that cannot be expected either to restore cardiac or

respiratory function to the patient or to achieve the expressed goals of the informed patient. In the case

of the incompetent patient, the patient's representative expresses the goals of the patient.


(38) Mid-Level Practitioner. A registered nurse licensed in Tennessee who holds a masterís degree in a

clinical nursing specialty, national certification through the ANCC or American Academy of Nurse

Practitioners and holds a certificate of fitness to prescribe from the Tennessee Board of Nursing.


(39) N.F.P.A. National Fire Protection Association.


(40) Nurse Midwife. A person currently licensed by the Tennessee Board of Nursing as a registered nurse


(R.N.) and qualified to deliver midwifery services or certified by the American College of Nurse-



(41) Patient. Includes but is not limited to any person who is suffering from an acute or chronic illness or

injury or who is crippled, convalescent or infirm, or who is in need of obstetrical, surgical, medical,

nursing or supervisory care.


(42) Patient Abuse. Patient neglect, intentional infliction of pain, injury, or mental anguish. Patient abuse

includes the deprivation of services by a caretaker which are necessary to maintain the health and

welfare of a patient or resident; however, the withholding of authorization for or provision of medical

care to any terminally ill person who has executed an irrevocable living will in accordance with the

Tennessee Right to Natural Death Law, or other applicable state law, if the provision of such medical

care would conflict with the terms of such living will shall not be deemed ďpatient abuseĒ for purposes

of these rules.


(43) PALS. Pediatric Advance Life Support.


(44) Physician. A person currently licensed as such by the Tennessee Board of Medical Examiners or

currently licensed to practice osteopathy by the Tennessee Board of Osteopathic Examination.


(45) Physician Assistant. A person who is licensed by the Tennessee Board of Medical Examiners and

Committee on Physician Assistants and has obtained prescription writing authority pursuant to T.C.A.



(46) Podiatrist. A person currently licensed as such by the Tennessee Board of Registration in Podiatry.


(47) Radiological Technologist. A person currently certified as such by the American Society of

Radiological Technologists.


(48) Registered Nurse (R.N.). A person currently licensed as such by the Tennessee Board of Nursing.


(49) Registered Record Administrator (RRA). A person currently registered as such by the American

Medical Records Association.


(50) Shall or Must. Compliance is mandatory.


(51) Surgical Procedure. A manual or operative method performed by a licensed medical practitioner to

treat diseases, injuries, conditions and/or deformities. ( As related to pregnancy termination, surgical

procedure excludes, but is not limited to, PAP smear or vaginal examinations, ultrasounds,

amniocentesis, intramuscular injections.)


(52) Transfer. The movement of a patient at the direction of a physician or other qualified medical

personnel when a physician is not readily available but does not include such movement of a patient

who leaves the facility against medical advice.


(53) Unusual Event. The abuse of a patient or an unexpected occurrence or accident that results in death,

life threatening or serious injury to a patient that is not related to a natural course of the patientís

illness or underlying condition.


(54) Unusual Event Report. A report form designated by the department to be used for reporting an unusual





(1) No person, partnership, association, corporation, or state, county, or local government unit, or any

division, department, board or agency thereof, shall establish, conduct, operate or maintain in the State

of Tennessee any ASTC as defined, without having a license. A license shall be issued only to the

applicant named and only for the premises listed in the application for licensure. Licenses are not

transferable or assignable and shall expire annually on June 30. The license shall be posted in a

conspicuous place in the ASTC.


(2) In order to make application for a license:


(a) The applicant shall submit an application on a form prepared by the department.


(b) Each applicant for a license shall pay an annual license fee in the amount of eight hundred

dollars ($800). The fee must be submitted with the application and is not refundable.


(c) The issuance of an application form is in no way a guarantee that the completed application will

be accepted or that a license will be issued by the department. Patients shall not be admitted to

the ASTC until a license has been issued. Applicants shall not hold themselves out to the public

as being an ASTC until the license has been issued. A license shall not be issued until the

facility is in substantial compliance with these rules and regulations including submission of all

information required by Tennessee Code Annotated ß 68-11-206(l), or as later amended, and all

information required by the Commissioner.


(d) The applicant must prove the ability to meet the financial needs of the facility.


(e) The applicant shall not use subterfuge or other evasive means to obtain a license, such as filing

for a license through a second party when an individual has been denied a license or has had a

license disciplined or has attempted to avoid inspection and review process.


(3) Each ASTC, when issued a license, shall be classified according to the type of services rendered or

category of patients served. The ASTC shall confine its services to those described in its license and

shall advertise only the services which it is licensed to perform. The classification shall be listed on

the license.


(4) A proposed change of ownership must be reported to the department a minimum of thirty (30) days

prior to the change. A new application and fee must be received by the department before the license

may be issued.


(a) For purposes of licensing, the licensee of an ASTC has the ultimate responsibility for the

operation of the facility, including the final authority to make or control operational decisions

and legal responsibility for the business management. A change of ownership occurs whenever

this ultimate legal authority for the responsibility of ASTC operations is transferred.


(b) Circumstances constituting a change of ownership may include, but are not limited to, the



1. Partnership. In the case of a partnership, the removal, addition, or substitution of a

partner constitutes a change of ownership. If the facility is owned by a limited

partnership, the removal of the general partner or general partners constitutes a change of


2. Corporation. The merger of a facility owner into another corporation, or the

consolidation of two or more corporations, resulting in the creation of a new corporation

constitutes a change of ownership. Transfer of corporate stock (even when a controlling

interest), or the merger of another corporation into the originally-licensed corporation

does not constitute a change of ownership.

3. Leasing. The lease of a facility's operations constitutes a change of ownership.

Sale/lease -back agreements shall not be treated as changes of ownership if the lease

involves the facility's entire real and personal property and if the identity of the lessee,

who shall continue the operation, retains the exact same legal form as the former owner.

4. Transfers. Transfer of a facility's legal title, or a transfer between levels of government

constitutes a change of ownership. A transfer between departments of the same level of

government does not constitute a change of ownership.

5. Management agreements are generally not changes of ownership if the owner continues

to retain ultimate authority for the operation of the facility. However, if the ultimate

authority is surrendered and transferred from the owner to a new manager, then a change

of ownership has occurred.


(5) To be eligible for a license or renewal of a license, each ASTC shall be periodically inspected for

compliance with these regulations. If deficiencies are identified, an acceptable plan of correction shall

be established and submitted to the department.




(1) The board may suspend or revoke a license for:


(a) Violation of federal or state statutes;


(b) Violation of the rules as set forth in this chapter;


(c) Permitting, aiding or abetting the commission of any illegal act in the ASTC;


(d) Conduct or practice found by the board to be detrimental to the health, safety, or welfare of the

patients of the ASTC; and


(e) Failure to renew license.


(2) The board may consider all factors which it deems relevant, including but not limited to the following

when determining sanctions:


* * *


(a) The degree of sanctions necessary to ensure immediate and continued compliance;


(b) The character and degree of impact of the violation on the health, safety and welfare of the

patients in the facility;


(c) The conduct of the facility in taking all feasible steps or procedures necessary or appropriate to

comply or correct the violation; and,


(d) Any prior violations by the facility of statutes, regulations or orders of the board.


(3) When an ambulatory surgical treatment center is found by the department to have committed a

violation of this chapter, the department will issue to the facility a statement of deficiencies. Within

ten (10) days of the receipt of the statement of deficiencies the facility must return a policy of

correction indicating the following:


(a) How the deficiency will be corrected;


(b) The date upon which each deficiency will be corrected;


(c) What measures or systemic changes will be put in place to ensure that the deficient practice

does not recur; and


(d) How the corrective action will be monitored to ensure that the deficient practice does not recur.


(4) Either failure to submit a plan of correction in a timely manner or a finding by the department that the

plan of correction is unacceptable shall subject the ambulatory surgical treatment center's license to

possible disciplinary action.


(5) Any licensee or applicant for a license, aggrieved by a decision or action of the department or board,

pursuant to this chapter, may request a hearing before the board. The proceedings and judicial review

of the boardís decision shall be in accordance with the Uniform Procedures Act, T.C.A. ß 4-5-101 et



1200-8-10-.04 ADMINISTRATION.


(1) The ASTC must have an effective governing body legally responsible for the conduct of the ASTC. If

an ASTC does not have an organized governing body, the persons legally responsible for the conduct

of the ASTC must carry out the functions specified in this chapter.


(2) The governing body shall appoint a chief executive officer or administrator who is responsible for

managing the ASTC. The chief executive officer or administrator shall designate an individual to act

for him or her in his or her absence, in order to provide the ASTC with administrative direction at all



(3) The governing body, whether it be that of the center alone or that of a parent organization, shall

establish effective mechanisms to ensure the accountability of the centerís medical staff and other

professional personnel.


(4) The governing body shall assure that the ASTC has the financial resources to provide the services

essential to the operation of the facility.


(5) Staffing shall be adequate to provide the services essential to the operation of the ASTC.


(6) The ambulatory surgical treatment center shall ensure a framework for addressing issues related to care

at the end of life.


(7) The ambulatory surgical treatment center shall provide a process that assesses pain in all patients.

There shall be an appropriate and effective pain management program.


(8) The ASTC shall perform only those surgical procedures which can be safely and effectively carried out

on an outpatient basis.


(9) Each ASTC shall have at all times a designated Medical Director who shall be a licensed physician or

dentist who shall be responsible for the direction and coordination of medical programs.


(10) Staff education programs and training sessions shall include life safety, medical equipment, utility

systems, infection control and hazardous waste practices. At least two (2) on duty members of the

facility shall be trained in emergency resuscitation.


(11) When licensure is applicable for a particular job, a copy of the current license must be included as a

part of the personnel file. Each personnel file shall contain accurate information as to the education,

training, experience and personnel background of the employee. Adequate medical screenings to

exclude communicable disease shall be required of each employee.


(12) Whenever the rules and regulations of this chapter require that a licensee develop a written policy,

plan, procedure, technique, or system concerning a subject, the licensee shall develop the required

policy, maintain it and adhere to its provisions. An ASTC which violates a required policy also

violates the rule and regulation establishing the requirement.


(13) Policies and procedures shall be consistent with professionally recognized standards of practice.


(14) No ASTC shall retaliate against or, in any manner, discriminate against any person because of a

complaint made in good faith and without malice to the board, the department, the Adult Protective

Services, or the Comptroller of the State Treasury. An ASTC shall neither retaliate, nor discriminate,

because of information lawfully provided to these authorities, because of a personís cooperation with

them, or because a person is subpoenaed to testify at a hearing involving one of these authorities.


(15) When services such as dietary, laundry or therapy services are purchased from others, the governing

body shall be responsible to assure the supplier(s) meet the same local and state standards the facility

would have to meet if it were providing those services itself using its own staff.


(16) The governing body shall provide for the appointment, reappointment or dismissal of members of the

medical, dental, and other health professions and provide for the granting of clinical privileges.


(17) The governing body shall ensure that there is a written facility agreement with one or more acute care

general hospitals licensed by the state, which will admit any patient referral who requires continuing



(18) Each ASTC shall specify the classification of services to be provided in the facility and list authorized

surgical procedures.


(19) Where the physician-owner-operator serves as the governing body, the articles of incorporation or

other written organizational plan shall describe the manner in which the owner-operator executes the

governing body responsibility.


(20) Infection Control.


(a) The ASTC 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 develops

guidelines and techniques for the prevention, surveillance, control and reporting of facility

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 facility;

3. Written procedures governing the use of aseptic techniques and procedures in all areas of

the facility;

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 facility personnel on the cause, effect,

transmission, prevention, and elimination of infections, as evidenced by front line

employees verbalizing understanding of basic techniques.


(c) The chief executive officer, the medical staff and the chief nursing officer must ensure that the

facility-wide 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.


(d) The facility shall develop policies and procedures for testing a patientís 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 patientís blood or other body fluid. The testing shall be performed at no charge to

the patient, and the test results shall be confidential.


(e) The facility and its employees shall adopt and utilize standard precautions (per CDC) for

preventing transmission of infections, HIV, and communicable diseases.


(f) All ASTC'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.


(21) Performance Improvement. The ASTC shall have a planned, systematic, organization-wide approach

to process design and redesign, performance measurement, assessment and improvement which is

approved by the designated medical staff committee of the facility, the owner and/or the governing

body. This plan shall address and/or include, but is not limited to:


(a) Infection control, including post-operative surveillance;


(b) Complications arising after the patient was admitted;


(c) Documentation of periodic review of the data collected and follow-up actions;


(d) A system which identifies appropriate plans of action to correct identified quality deficiencies;


(e) Documentation that the above policies are being followed and that appropriate action is taken

whenever indicated.


(22) The ASTC shall ensure a framework for addressing issues related to care at the end of life.


(23) The ASTC shall provide a process that assesses pain in all patients. There shall be an appropriate and

effective pain management program.




(1) Every person admitted for care or treatment to any ASTC shall be under the supervision of a physician

licensed to practice in Tennessee. The name, address and telephone number of the physician attending

the patient shall be recorded in the patientís medical record.


(2) The above does not preclude the admission of a patient to an ASTC by a dentist or podiatrist licensed

to practice in Tennessee with the concurrence of a physician member of the medical staff.


(3) This does not preclude qualified oral and maxillo-facial surgeons from admitting patients and

completing the admission history and physical examination and assessing the medical risk of the

procedure on their patients. A physician member of the medical staff is responsible for the

management of medical problems.


(4) The facility shall ensure that no person on the grounds of race, color, national origin, or handicap, will

be excluded from participation in, be denied benefits of, or otherwise subjected to discrimination in the

provision of any care or service of the facility. The facility shall protect the civil rights of residents

under the Civil Rights Act of 1964 and Section 504 of the Rehabilitation Act of 1973.


(5) For purposes of this chapter, the requirements for signature or countersignature by a physician, dentist,

podiatrist or other person responsible for signing, countersigning or authenticating an entry may be

satisfied by the electronic entry by such person of a unique code assigned exclusively to him or her, or

by entry of other unique electronic or mechanical symbols, provided that such person has adopted

same as his or her signature in accordance with established ASTC protocol or rules.


(6) Each ASTC must have a written transfer agreement with a local hospital.


(7) The ASTC shall develop a patient referral system both for referrals within the facility and other health

care providers.


(8) The ASTC shall have available a plan for emergency transportation to a licensed local hospital.


(9) The facility must ensure continuity of care and provide an effective discharge planning process that

applies to all patients. The facilityís discharge planning process, including discharge policies and

procedures, must be specified in writing and must:


(a) Be developed and/or supervised by a registered nurse, social worker or other appropriately

qualified personnel;


(b) Begin upon admission;


(c) Be provided when identified as a need by the patient, a person acting on the patientís behalf, or

by the physician; and


(d) Include the likelihood of a patientís capacity for self-care or the possibility of the patient

returning to his or her pre-ambulatory surgical treatment center environment.


(10) A discharge plan is required on every patient, even if the discharge is to home.


(11) The facility must arrange for the initial implementation of the patientís discharge plan and must

reassess the patientís discharge plan if there are factors that may affect continuing care needs or the

appropriateness of the discharge plan.


(12) As needed, the patient and family members or interested persons must be taught and/or counseled to

prepare them for post-operative care.


1200-8-10-.06 BASIC SERVICES.


(1) Surgical Services.


(a) Facilities restricted in services they provide, e.g. those that restrict services to radiation therapy

or use of local anesthetics only, may be exempted from all or part of the requirements of this

rule pertaining to laboratory services, food and dietetic services, surgical services, and

anesthesia services.


(b) If the facility provides surgical services, the services must be well organized and provided in

accordance with acceptable standards of practice. If outpatient surgical services are offered, the

services must be consistent in quality with inpatient care in accordance with the complexity of

services offered.


(c) A hospital may choose to separately license a portion of the facility as an Ambulatory Surgical

Treatment Center; the licensure fee for such is not required.


(d) The organization of the surgical services must be appropriate to the scope of the services



(e) The operating rooms must be supervised by an experienced registered nurse or a doctor of

medicine or osteopathy.


(f) Licensed practical nurses (LPNs) and surgical technologists (operating room technicians) may

serve as ďscrub nursesĒ under the supervision of a registered nurse.


(g) Qualified registered nurses may perform circulating duties in the operating room. In accordance

with applicable State laws and approved medical staff policies and procedures, LPNs and

surgical technologists may assist in circulatory duties under the supervision of a qualified

registered nurse who is immediately available to respond to emergencies.


(h) Surgical privileges must be delineated for all practitioners performing surgery in accordance

with the competencies of each practitioner. The surgical service must maintain a roster of

practitioners specifying the surgical privileges of each practitioner.


(i) Surgical services must be consistent with needs and resources. Policies covering surgical care

must be designed to assure the achievement and maintenance of high standards of medical

practice and patient care.


(j) There must be a complete history and physical work-up in the chart of every patient prior to

surgery, except in emergencies. If the history has been dictated, but not yet recorded in the

patientís chart, there must be a statement to that effect and an admission note in the chart by the

practitioner who admitted the patient.


(k) Properly executed informed consent, advance directive, and organ donation forms must be in

the patientís chart before surgery, except in emergencies.


(l) Adequate equipment and supplies must be available to the operating room suites and to the postoperative

care area;

1. Call-in system (OR)

2. Cardiac monitor

3. Pulse Oximeter

4. Resuscitator

5. Defibrillator

6. Aspirator

7. Tracheotomy set


(m) A crash cart must be available and include at a minimum the following medication and supplies:

1. adrenalin (epinephrine) 1: 10,000 dilution; 10 ml

2. adrenalin (epinephrine) 1:1000 dilution; 1 ml

3. atropine 0.1 mg/ml

4. benadryl (diphenhydramine)

5. calcium chloride 10%; 10ml amp

6. dextrose. 50%

7. dilantin (phentoin)

8. dopamine

9. heparin

10. inderal (proprandolol)

11. isuprel

12. lanoxin (digoxin)

13. lasix (furosemide)

14 xylocaine (lidocaine)

15. magnesium sulfate 50%

16. narcan (naloxone)

17. pronestyl (procainaimide)

18. sodium bicarbonate 50 mEq/50ml

19. solu-medrol (methylprednisolone)

20. verapamil hydrochloride

21. mazicon

22. Suction devices, endotracheal tubes, laryngoscopes, etc.,

23. Positive pressure ventilation device (e.g., Ambu) plus oxygen supply.

24. Double tourniquet for the Bier block procedure.

25. Emergency intubation equipment.

26. IV solution and IV equipment.


(n) At least one registered nurse shall be in the recovery area during the patient's recovery period.


(o) The operating room register must be complete and up-to-date.


(p) An operative report describing techniques, findings, and tissues removed or altered must be

written or dictated immediately following surgery and signed by the surgeon.


(q) The ASTC shall provide one or more surgical suites which shall be constructed, equipped, and

maintained to assure the safety of patients and personnel.


(r) Surgical suites are required to meet the same standards as hospital operating rooms, including

those using general anesthesia.


(s) The ASTC shall have separate areas for waiting rooms, recovery rooms, treatment and/or

examining rooms.


(2) Anesthesiology Services. Anesthesia shall be administered by:


(a) A qualified anesthesiologist;


(b) A doctor of medicine or osteopathy (other than an anesthesiologist);


(c) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law;


(d) A certified registered nurse anesthetist (CRNA); or


(e) A graduate registered nurse anesthetist under the supervision of an anesthesiologist who is

immediately available if needed.


(f) 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 dayís use of the anesthesia equipment. A record of all service and

maintenance performed on all anesthesia machines, vaporizers and ventilators shall also be on



(g) When general anesthesia and/or succinylcholine are administered, the facility shall maintain

thirty-six (36) ampules of dantrolene for injection on site. If dantrolene is administered,

appropriate monitoring must be provided post operatively.


(h) Written policies and procedures relative to the administration of anesthesia shall be developed

and approved by the Medical Staff and governing body.


(i) Any patient receiving conscious sedation shall receive:

1. continuous EKG monitoring;

2. continuous oxygen saturations;

3. serial BP monitoring at intervals no less than every 5 minutes; and

4. supplemental oxygen therapy and immediately available:


(i) ambubag;


(ii) suction;


(iii) endotracheal tube; and


(iv) crash cart.


(3) Medical Staff.


(a) The ASTC shall have a medical staff organized under written by-laws that are approved by the

governing body. The medical staff of the ASTC shall define a mechanism to:

1. Assure that an optimal level of professional performance is maintained;

2. Appoint independent practitioners through a defined credentialing process;

3. Apply credentialing criteria uniformly;

4. Utilize the current license, relevant training and experience, current competence and the

ability to perform requested privileges in the credentialing process; and

5. Provide for participation in required committees of the facility to ensure that quality

medical care is provided to the patients.


(b) Each licensed independent practitioner shall provide care under the auspices of the facility in

accordance with approved privileges.


(c) Clinical privileges shall be granted based on the practitionersí qualifications and the services

provided by the facility, and shall be reviewed and/or revised at least every two (2) years.


(4) Nursing Service. A licensed registered nurse (R.N.) shall be on duty at all times. Additional

appropriately trained staff shall be provided as needed to ensure that the medical needs of the patients

are fully met.


(a) The ASTC shall be organized under written policies and procedures relating to patient care,

establishment of standards for nursing care and mechanisms for evaluating such care and

nursing services.


(b) A qualified registered nurse designated by the administrator shall be responsible for

coordinating and supervising all nursing services.


(c) There shall be a sufficient staffing pattern of registered nurses to provide quality nursing care to

each surgical patient from admission through discharge. Additional staff shall be on duty and

available to assist the professional staff to adequately handle routine and emergency patient



(d) The ASTC shall establish written procedures for emergency services which will ensure that

professional staff members who have been trained in emergency resuscitation procedures shall

be on duty at all times when there is a patient in the ASTC and until the patient has been



(e) Nursing care policies and procedures shall be consistent with professionally recognized

standards of nursing practice and shall be in accordance with the Nurse Practice Act of the State

of Tennessee and the Association of Operating Room Nurses Standards of Practice.


(f) Staff development and training shall be provided to the nursing staff and other ancillary staff in

order to maintain and improve knowledge and skills. The educational/training program shall be

planned, documented and conducted on a continuing basis. There shall be at least appropriate

training on equipment, safety concerns, infection control and emergency care on an annual



(5) Pharmaceutical Services. The ASTC must provide drugs and biologicals in a safe and effective

manner in accordance with accepted standards of practice. Such drugs and biologicals must be stored

in a separate room or cabinet which shall be kept locked at all times.


(6) Ancillary Services. All ancillary or supportive health or medical services, including but not limited to,

radiological, pharmaceutical, or medical laboratory services shall be provided in accordance with all

applicable state and federal laws and regulations.


(7) Radiological Services. The ASTC shall provide within the facility, or through arrangement, diagnostic

radiological services commensurate with the needs of the ambulatory surgical treatment center.


(a) If radiological services are provided by facility staff, the services shall be maintained free of

hazards for patients and personnel.


(b) New installations of radiological equipment, and subsequent inspections for the identification of

radiation hazards shall be made as specified in state and federal requirements.


(c) 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 review.

1. Personnel - The ASTC shall have a radiologist either full-time or part-time on a

consulting basis, both to supervise the service and to discharge professional radiological


2. The use of all radiological apparatus shall be limited to personnel designated as qualified

by the radiologist; and use of fluoroscopes shall be limited to physicians.


(d) If provided under arrangement with an outside provider, the radiological services must be

directed by a qualified radiologist and meet state and federal requirements.


(8) Laboratory Services.


(a) The ASTC 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 ASTC.


(b) Any patient terminating pregnancy in an ASTC 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



(9) Food 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.


(10) Environmental Services.


(a) The facility shall provide a safe, accessible, effective and efficient environment of care

consistent with its mission, service, law and regulation.


(b) The facility shall develop policies and procedures that address:

1. Safety;

2. Security;

3. Control of hazardous materials and waste;

4. Emergency preparedness;

5. Life safety;

6. Medical equipment; and,

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 resolved.


(f) Appropriate staff shall participate in implementing safety recommendations and monitoring

their effectiveness.


(g) The building and grounds shall be suitable to services provided and patients served.


(11) Medical Records.


(a) The ASTC shall comply with the Medical Records Act of 1974, T.C.A. ß 68-11-301, et seq.


(b) A medical record shall be maintained for each person receiving medical care provided by the

ASTC and shall include:

1. Patient identification;

2. Name of nearest relative or other responsible agent;

3. Identification of primary source of medical care;

4. Dates and times of visits;

5. Signed informed consent;

6. Pertinent medical history;

7. Diagnosis;

8. Physician examination report;

9. Anesthesia records of pertinent preoperative and postoperative reports including

preanesthesia evaluation, type of anesthesia, technique and dosage used;

10. Operative report;

11. Discharge summary, including instructions for self care and instructions for obtaining

postoperative emergency care;

12. Reports of all laboratory and diagnostic procedures along with tests performed and the

results authenticated by the appropriate personnel; and,

13. X-ray reports.


(c) 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.


1200-8-10-.07 RESERVED.




(1) The ASTC must be constructed, arranged, and maintained to ensure the safety of the patient.


(2) The condition of the physical plant and the overall ASTC environment must be developed and

maintained in such a manner that the safety and well-being of patients are assured.


(3) After the application and licensure fees have been submitted, the building construction plans must be

submitted to the department. All new facilities shall conform to the 1999 edition of the Standard

Building Code (excluding Chapter I, Administration and Chapter 11, Handicapped Accessibility), the

handicap code as required by T.C.A. ß68-18-204(a), the most recent edition of the ASHRAE

Handbook of Fundamentals, the 2000 edition of the National Fire Protection Code (NFPA), NFPA 1

including Annex A, the 1999 National Electrical Code and the 2001 Edition of the Guidelines for

Design and Construction of Hospital and Health Care Facilities. When referring to height, area or

construction type, the Standard Building Code shall prevail. All new and existing facilities are subject

to the requirements of the Americans with Disabilities Act (A.D.A.). Where there are conflicts

between requirements in the above listed codes and regulations and provisions of this chapter, the most

restrictive shall apply.


(4) All new construction and renovations to ASTCís, other than minor alterations not affecting fire and life

safety or functional issues, shall be performed in accordance with the specific requirements of these

regulations governing new construction in facilities, including the submission of phased construction

plans and the final work drawings and the specifications to each. Phased construction plans, final

work drawings, and specifications shall also be submitted prior to any change in ASTC type.


(5) No new ASTC shall hereafter be constructed, nor shall major alterations be made to existing facilities,

or change in facility type be made without the prior written approval of the department, and unless in

accordance with plans and specifications approved in advance by the department. Before any new

ASTC is licensed or before any alteration or expansion of a licensed ASTC can be approved, the

applicant must furnish two (2) complete sets of plans and specifications to the department, together

with fees and other information as required. Plans and specifications for new construction and major

renovations, other than minor alterations not affecting fire and life safety or functional issues shall be

prepared by or under the direction of a licensed architect and/or qualified licensed engineer.


(6) In the event that submitted materials do not appear to satisfactorily comply with 1200-8-10-.08 (3) the

department shall furnish a letter to the party submitting the plans which shall list the particular items in

question and request further explanation and/or confirmation of necessary modifications.


(7) Notice of satisfactory review from the department constitutes compliance with this requirement if

construction begins within one hundred eighty (180) days of the date of such notice. This approval

shall in no way permit and/or authorize any omission or deviation from the requirements of any

restrictions, laws, regulations, ordinances, codes or rules of any responsible agency.


(8) Detailed plans shall be drawn to a scale of at least one-eighth inch equals one foot (1/8Ē=1í),

accurately dimensioned and identifying the general arrangement of the building, the intended purpose

and the fixed equipment in each room, with such additional information as the department may



(a) Phased construction plans shall be forwarded to the appropriate section of the department for

review. After receipt of approval of phased construction plans, the owner may proceed with site

grading and foundation work prior to receipt of approval of final plans and specifications with

the understanding that such work is at the ownerís risk and without assurance that final approval

of final plans and specifications shall be granted. Final plans and specifications shall be

submitted for review and approval. Final approval must be received before proceeding beyond

foundation work.


(b) Review of plans does not eliminate responsibility of owner and/or architect to comply with all

rules and regulations.


(9) Specifications shall supplement all drawings. They shall describe the characteristics of all materials,

products and devices, unless fully described and indicated on the drawings. Specification copies

should be bound in an 8Ĺ x 11 inch folder.


(10) Review of plans and specifications shall be acknowledged in writing by the department, with copies

sent to the architect and the owner, manager or other executive of the institution. The distribution of

such review may be modified at the discretion of the department.


(11) All construction shall be executed in accordance with the approved plans and specifications.


(12) Drawings and specifications shall be prepared for each of the following branches of work:

Architectural, Structural, Mechanical and Electrical.


(13) Architectural drawings shall include:


(a) Plot plan(s) showing property lines, finish grade, location of existing and proposed structures,

roadways, walks, utilities and parking areas;


(b) Floor plan(s) showing scale drawings of typical and special rooms, indicating all fixed and

movable equipment and major items of furniture;


(c) Separate life safety plans showing the compartment(s), all means of egress and exit markings,

exits and travel distances, dimensions of compartments and calculation and tabulation of exit

units. All fire and smoke walls must be identified;


(d) The elevation of each facade;


(e) The typical sections throughout the building;


(f) The schedule of finishes;


(g) The schedule of doors and windows;


(h) Roof plans;


(i) Details and dimensions of elevator shaft(s), car platform(s), doors, pit(s), equipment in the

machine room, and the rates of car travel; and,


(j) Code analysis.


(14) Structural drawings shall include:


(a) Plans of foundations, floors, roofs and intermediate levels which show a complete design with

sizes, sections and the relative location of the various members;


(b) Schedule of beams, girders and columns; and


(c) Design live load values for wind, roof, floor, stairs, guard, hand rails, and seismic.


(15) Mechanical drawings shall include:


(a) Specifications which show the complete heating, ventilating, fire protection, medical gas

systems and air conditioning systems;


(b) Water supply, sewerage and HVAC piping systems;


(c) Pressure relationships which shall be shown on all floor plans;


(d) Heating, ventilating, HVAC piping, medical gas systems and air conditioning systems with all

related piping and auxiliaries to provide a satisfactory installation;


(e) Water supply, sewage and drainage with all lines, risers, catch basins, manholes and cleanouts

clearly indicated as to location, size, capacities, etc., and location and dimensions of septic tank

and disposal field; and,


(f) Color coding to show clearly supply, return and exhaust systems.


(16) Electrical drawings shall include:


(a) A certification that all electrical work and equipment are in compliance with all applicable local

codes and laws, and that all materials are currently listed by recognized testing laboratories;


(b) All electrical wiring, outlets, riser diagrams, switches, special electrical connections, electrical

service entrance with service switches, service feeders and characteristics of the light and power

current, and transformers when located within the building;


(c) The electrical system, which shall comply with applicable codes, and shall include:

1. The nurses call system;

2. The paging system;

3. The fire alarm system; and,

4. The emergency power system including automatic services as defined by the codes.


(d) Color coding to show all items on emergency power.


(17) Final working drawings and specifications shall be accurately dimensioned and include all necessary

explanatory notes, schedules and legends. The working drawings and specifications shall be complete

and adequate for contract purposes. One (1) set of final plans shall be submitted to the department in

such a form as approved by the department.


(18) No system of water supply, plumbing, sewage, garbage or refuse disposal shall be installed nor shall

any existing system be materially altered or extended until complete plans and specifications for the

installation, alteration or extension have been submitted to the department and show that all applicable

codes have been met and necessary approval has been obtained.


(a) Before the facility is used, the water supply system shall be approved by the Tennessee

Department of Environment and Conservation.


(b) Sewage shall be discharged into a municipal system or approved package system where

available; otherwise, the sewage shall be treated and disposed of in a manner of operation

approved by the Department of Environment and Conservation and shall comply with existing

codes, ordinances and regulations which are enforced by cities, counties or other areas of local

political jurisdiction.


(19) Rooms and areas containing radiation producing machines or radioactive material must have primary

and/or secondary barriers to assure compliance with Regulations for Protection Against Radiation and

security of materials. Radiation material shall be required to be stored and security must be provided

in accordance with federal and state regulations to prevent exposure of the material to theft or



(20) Construction and renovation projects shall provide for the safety and protection of patients and



(21) When constructing new facilities or during major renovations to the operating suites, male and female

physicians and staff shall have equitable proportional locker facilities including equal equipment, and

similar amenities, with equal access to uniforms. In existing facilities the ASTC shall strive to have

equitable male and female facilities. If physical changes are required, the additional areas shall

maintain the flow and divisions in the sterile environments.


(22) Approved plans and specifications shall be kept at the job site.


(23) Prior to final inspection, a CD Rom disc, in TIF or DMG format, of the final approved plans including

all shop drawings, sprinkler, hood and duct, calculations, addenda, specifications, etc., shall be

submitted to the department.


1200-8-10-.09 LIFE SAFETY.


(1) Any facility which complies with the required applicable building and fire safety regulations at the

time the board adopts new codes or regulations will, so long as such compliance is maintained (either

with or without waivers of specific provisions), be considered to be in compliance with the

requirements of the new codes or regulations.


(2) The facility shall provide fire protection by the elimination of fire hazards, by the installation of

necessary fire fighting equipment and by the adoption of a written fire control plan. Fire drills shall be

held at least quarterly for each work shift for facility personnel in each separate patient-occupied

facility building. There shall be a written report documenting the evaluation of each drill and the

action recommended or taken for any deficiencies found. Records which document and evaluate these

drills must be maintained for at least three (3) years.


(3) All fires shall be reported to the department within seven (7) business days. The report shall contain

sufficient information to ascertain the nature and location of the fire, its probable cause and any

injuries incurred by any person or persons as a result of the fire. Initial reports by the facility may omit

the name(s) of patient(s) and parties involved; however, should the department find the identities of

such persons to be necessary to an investigation, the facility shall provide such information.




(1) Each ambulatory surgical treatment center must develop, maintain and implement written policies and

procedures for the definition and handling of its infectious and hazardous wastes, these policies and

procedures must comply with the standards of this section and all other applicable state and federal



(2) The following waste shall be considered to be infectious waste:


(a) Waste contaminated by patients who are isolated due to communicable disease, as provided in

the U.S. Centers for Disease Control ďGuidelines for Isolation Precautions in HospitalsĒ;


(b) Cultures and stocks of infectious agents including specimen cultures collected from medical and

pathological laboratories, cultures and stocks of infectious agents from research and industrial

laboratories, wastes from the production of biologicals, discarded live and attenuated vaccines,

and culture dishes and devices used to transfer, inoculate, and mix cultures;


(c) Waste human blood and blood products such as serum, plasma, and other blood components.;


(d) Pathological waste, such as tissues, organs, body parts, and body fluids that are removed during

surgery and autopsy;


(e) All discarded sharps (including but not limited to, hypodermic needles, syringes, pasteur

pipettes, broken glass, scalpel blades) used in patient care or which have come into contact with

infectious agents during use in medical, research, or industrial laboratories;


(f) Contaminated carcasses, body parts, and bedding of animals that were exposed to pathogens in

research, in the production of biologicals, or in the in vivo testing of pharmaceuticals;


(g) Other waste determined to be infectious by the facility in its written policy.


(3) Infectious and hazardous waste must be segregated from other waste at the point of generation (i.e., the

point at which the material becomes a waste) within the facility.


(4) Waste must be packaged in a manner that will protect waste handlers and the public from possible

injury and disease that may result from exposure to the waste. Such packaging must provide for

containment of the waste from the point of generation up to the point of proper treatment or disposal.

Packaging must be selected and utilized for the type of waste the package will contain, how the waste

will be treated and disposed, and how it will be handled and transported, prior to treatment and



(a) Contaminated sharps must be directly placed in leakproof, rigid, and puncture-resistant

containers which must then be tightly sealed;


(b) Whether disposable or reusable, all containers, bags, and boxes used for containment and

disposal of infectious waste must be conspicuously identified. Packages containing infectious

waste which pose additional hazards (e.g., chemical, radiological) must also be conspicuously

identified to clearly indicate those additional hazards;


(c) Reusable containers for infectious waste must be thoroughly sanitized each time they are

emptied, unless the surfaces of the containers have been completely protected from

contamination by disposable liners or other devices removed with the waste;


(d) Opaque packaging must be used for pathological waste.


(5) After packaging, waste must be handled and transported by methods ensuring containment and

preserving the integrity of the packaging, including the use of secondary containment where necessary.


(a) Waste must not be compacted or ground (i.e., in a mechanical grinder) prior to treatment, except

that pathological waste may be ground prior to disposal;


(b) Plastic bags of infectious waste must be transported by hand.


(6) Waste must be stored in a manner which preserves the integrity of the packaging, inhibits rapid

microbial growth and putrefaction, and minimizes the potential of exposure or access by unknowing



(a) Waste must be stored in a manner and location which affords protection from animals,

precipitation, wind, and direct sunlight, does not present a safety hazard, does not provide a

breeding place or food source for insects or rodents and does not create a nuisance.


(b) Pathological waste must be promptly treated, disposed of, or placed into refrigerated storage.


(7) In the event of spills, ruptured packaging, or other incidents where there is a loss of containment of

waste, the facility must ensure that proper actions are immediately taken to:


(a) Isolate the area from the public and all except essential personnel;


(b) To the extent practicable, repackage all spilled waste and contaminated debris in accordance

with the requirements of paragraph (6) of this section; and


(c) Sanitize all contaminated equipment and surfaces appropriately. Written policies and procedure

must specify how this will be done.


(d) Complete incident report and maintain copy on file.


(8) Except as provided otherwise in this section a facility must treat or dispose of infectious waste by one

or more of the methods specified in this part.


(a) A facility may treat infectious waste in an on-site sterilization or disinfection device, or in an

incinerator or a steam sterilizer, which has been designed, constructed, operated and maintained

so that infectious wastes treated in such a device are rendered non-infectious and is, if

applicable, authorized for that purpose pursuant to current rules of the Department of

Environment and Conservation. A valid permit or other written evidence of having complied

with the Tennessee Air Pollution Control Regulations shall be available for review, if required.

Each sterilizing or disinfection cycle must contain appropriate indicators to assure conditions

were met for proper sterilization or disinfection of materials included in the cycle, and records

kept. Proper operation of such devices must be verified at least monthly, and records of these

monthly checks shall be available for review. Waste that contains toxic chemicals that would be

volatilized by steam must not be treated in steam sterilizers. Infectious waste that has been

rendered to a carbonized or mineralized ash shall be deemed non-infectious. Unless otherwise

hazardous and subject to the hazardous waste management requirements of the current rules of

the Department of Environment and Conservation, such ash shall be disposable as a (nonhazardous)

solid waste under current rules of the Department of Environment and Conservation.


(b) The facility may discharge liquid or semi-liquid infectious waste to the collection sewerage

system of a wastewater treatment facility which is subject to a permit pursuant to T.C.A. ß 69-3-

101 et seq., provided that such discharge is in accordance with any applicable terms of that

permit and/or any applicable municipal sewer use requirements.


(c) Any health care facility accepting waste from another state must promptly notify the

Department of Environment and Conservation, county and city public health agencies, and must

strictly comply with all applicable local, state and federal regulations.


(9) The facility may have waste transported off-site for storage, treatment, or disposal. Such arrangements

must be detailed in a written contract, available for review. If such off-site location is located within

Tennessee, the facility must ensure that it has all necessary State and local approvals, and such

approvals shall be available for review. If the off-site location is within another state, the facility must

notify in writing all public health agencies with jurisdiction that the location is being used for

management of the facilityís waste. Waste shipped off-site must be packaged in accordance with

applicable Federal and State requirements. Waste transported to a sanitary landfill in this state must

meet the requirements of current rules of the Department of Environment and Conservation.


(10) Human anatomical remains which are transferred to a mortician for cremation or burial shall be

exempt from the requirements of this subparagraph. Any other human limbs and recognizable organs

must be incinerated or discharged (following grinding) to the sewer.


(11) All garbage, trash and other non-infectious wastes shall be stored and disposed of in a manner that

must not permit the transmission of disease, create a nuisance, provide a breeding place for insects and

rodents, or constitute a safety hazard. All containers for waste shall be water tight, be constructed of

easily cleanable material and be kept on elevated platforms.


(12) The physical environment of the facility shall be maintained in a safe, clean and sanitary manner.


(a) 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.


(b) Cats, dogs or other animals shall not be allowed in any part of the facility except for specially

trained animals for the handicapped. 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.


(c) 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.


(d) 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.


(e) Bath basin, emesis basin, bedpan and urinal shall be individually provided.


(f) 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.


1200-8-10-.11 RECORDS AND REPORTS.


(1) The Joint Annual Report of Ambulatory Surgical Treatment Centers shall be filed with the department.

The forms are furnished and mailed to each ASTC by the department each year and the forms must be

completed and returned to the department as required.


(2) The facility shall report information contained in the medical records of patients who have cancer or

pre-cancerous or tumorous diseases as provided by existing regulations. These reports shall be sent to

the Cancer Reporting System of the department on a quarterly schedule no later than six (6) months

after the date of the diagnosis or treatment.


(3) The ASTC shall report to the department each case of communicable disease detected in the center.

Repeated failure to report communicable diseases shall be cause for revocation of an ASTCís license.


(4) Unusual events shall be reported by the facility to the Department of Health in a format designed by

the Department within seven (7) business days of the date of the identification of the abuse of a patient

or an unexpected occurrence or accident that results in death, life threatening or serious injury to a



(a) The following represent circumstances that could result in an unusual event that is an

unexpected occurrence or accident resulting in death, life threatening or serious injury to a

patient, not related to a natural course of the patientís illness or underlying condition. The

circumstances that could result in an unusual event include, but are not limited to:

1. medication errors;

2. aspiration in a non-intubated patient related to conscious/moderate sedation;

3. intravascular catheter related events including necrosis or infection requiring repair or

intravascular catheter related pneumothorax;

4. volume overload leading to pulmonary edema;

5. blood transfusion reactions, use of wrong type of blood and/or delivery of blood to the

wrong patient;

6. perioperative/periprocedural related complication(s) that occur within 48 hours of the

operation or the procedure, including a procedure which results in any new central

neurological deficit or any new peripheral neurological deficit with motor weakness;

7. burns of a second or third degree;

8. falls resulting in radiologically proven fractures, subdural or epidural hematoma, cerebral

contusion, traumatic subarachnoid hemorrhage, and/or internal trauma, but does not

include fractures resulting from pathological conditions;

9. procedure related incidents, regardless of setting and within thirty (30) days of the

procedure and includes readmissions, which include:


(i) procedure related injury requiring repair or removal of an organ;


(ii) hemorrhage;


(iii) displacement, migration or breakage of an implant, device, graft or drain;


(iv) post operative wound infection following clean or clean/contaminated case;


(v) any unexpected operation or reoperation related to the primary procedure;


(vi) hysterectomy in a pregnant woman;


(vii) ruptured uterus;


(viii) circumcision;


(ix) incorrect procedure or incorrect treatment that is invasive;


(x) wrong patient/wrong site surgical procedure;


(xi) unintentionally retained foreign body;


(xii) loss of limb or organ, or impairment of limb if the impairment is present at

discharge or for at least two (2) weeks after occurrence;


(xiii) criminal acts;


(xiv) suicide or attempted suicide;


(xv) elopement from the facility;


(xvi) infant abduction, or infant discharged to the wrong family;


(xvii) adult abduction;


(xviii) rape;


(xix) patient altercation;


(xx) patient abuse, patient neglect, or misappropriation of resident/patient funds;


(xxi) restraint related incidents; or


(xxii) poisoning occurring within the facility.


(b) Specific incidents that might result in a disruption of the delivery of health care services at the

facility shall also be reported to the department, on the unusual event form, within seven (7)

days after the facility learns of the incident. These specific incidents include the following:

1. strike by the staff at the facility;

2. external disaster impacting the facility;

3. disruption of any service vital to the continued safe operation of the facility or to the

health and safety of its patients and personnel; and

4. fires at the facility which disrupt the provision of patient care services or cause harm to

patients or staff, or which are reported by the facility to any entity, including but not

limited to a fire department, charged with preventing fires.


(c) For health services provided in a ďhomeĒ setting, only those unusual events actually witnessed

or known by the person delivering health care services are required to be reported.


(d) Within forty (40) days of the identification of the event, the facility shall file with the

department a corrective action report for the unusual event reported to the department. The

departmentís approval of a Corrective Action Report will take into consideration whether the

facility utilized an analysis in identifying the most basic or causal factor(s) that underlie

variation in performance leading to the unusual event by (a) determining the proximate cause of

the unusual event, (b) analyzing the systems and processes involved in the unusual event, (c)

identifying possible common causes, (d) identifying potential improvements, and (e) identifying

measures of effectiveness. The corrective action report shall either: (1) explain why a corrective

action report is not necessary; or (2) detail the actions taken to correct any error identified that

contributed to the unusual event or incident, the date the corrections were implemented, how the

facility will prevent the error from recurring in the future and who will monitor the

implementation of the corrective action plan.


(e) The department shall approve in writing, the corrective action report if the department is

satisfied that the corrective action plan appropriately addresses errors that contributed to the

unusual event and takes the necessary steps to prevent the recurrence of the errors. If the

department fails to approve the corrective action report, then the department shall provide the

facility with a list of actions that the department believes are necessary to address the errors.

The facility shall be offered an informal meeting with the Commissioner or the Commissionerís

representative to attempt to resolve any disagreement over the corrective action report. If the

department and the facility fail to agree on an appropriate corrective action plan, then the final

determination on the adequacy of the corrective action report shall be made by the Board after a

contested case hearing.


(f) The event report reviewed or obtained by the department shall be confidential and not subject to

discovery, subpoena or legal compulsion for release to any person or entity, nor shall the report

be admissible in any civil or administrative proceeding other than a disciplinary proceeding by

the department or the appropriate regulatory board. The report is not discoverable or admissible

in any civil or administrative action except that information in any such report may be

transmitted to an appropriate regulatory agency having jurisdiction for disciplinary or license

sanctions against the impacted facility. The department must reveal upon request its awareness

that a specific event or incident has been reported.


(g) The department shall have access to facility records as allowed in Title 68, Chapter 11, Part 3.

The department may copy any portion of a facility medical record relating to the reported event

unless otherwise prohibited by rule or statute. This section does not change or affect the

privilege and confidentiality provided by T.C.A. ß63-6-219.


(h) The department, in developing the unusual event report form, shall establish an event

occurrence code that categorizes events or specific incidents by the examples set forth above in


(a) and (b). If an event or specific incident fails to come within these examples, it shall be

classified as ďotherĒ with the facility explaining the facts related to the event or incident.


(i) This does not preclude the department from using information obtained under these rules in a

disciplinary action commenced against a facility, or from taking a disciplinary action against a

facility. Nor does this preclude the department from sharing such information with any

appropriate governmental agency charged by federal or state law with regulatory oversight of

the facility. However, all such information must at all times be maintained as confidential and

not available to the public. Failure to report an unusual event, submit a corrective action report,

or comply with a plan of correction as required herein may be grounds for disciplinary action

pursuant to T.C.A. ß68-11-207.


(j) The affected patient and/or the patientís family, as may be appropriate, shall also be notified of

the event or incident by the facility.


(k) During the second quarter of each year, the Department shall provide the Board an aggregate

report summarizing by type the number of unusual events and incidents reported by facilities to

the Department for the preceding calendar year.


(l) The Department shall work with representatives of facilities subject to these rules, and other

interested parties, to develop recommendations to improve the collection and assimilation of

specific aggregate health care data that, if known, would track health care trends over time and

identify system-wide problems for broader quality improvement. The goal of such

recommendations should be to better coordinate the collection of such data, to analyze the data,

to identify potential problems and to work with facilities to develop best practices to remedy

identified problems. The Department shall prepare and issue a report regarding such



(5) The ASTC shall retain legible copies of the following records and reports which shall be retained in

the facility, shall be maintained in a single file, and shall be made available for inspection during

normal business hours to any patient who requests to view them for thirty-six (36) months following

their issuance:


(a) Local fire safety inspections;


(b) Local building code inspections, if any;


(c) Fire marshal reports;


(d) Department licensure and fire safety inspections and surveys;


(e) Department quality assurance surveys, including follow-up visits, and certification inspections,

if any;


(f) Federal Health Care Financing Administration surveys and inspections, if any;


(g) Orders of the Commissioner or Board, if any;


(h) Comptroller of the Treasuryís audit reports and finding, if any; and,


(i) Maintenance records of all safety equipment.


1200-8-10-.12 PATIENT RIGHTS.


(1) Each patient has at least the following rights:


(a) To privacy in treatment and personal care;


(b) To be free from mental and physical abuse. Should this right be violated, the facility must

notify the department within five (5) business days and the Tennessee Department of Human

Services, Adult Protective Services immediately as required by T.C.A. ß 71-6-101 et seq;


(c) To refuse treatment. The patient must be informed of the consequences of that decision, the

refusal and its reason must be reported to the physician and documented in the medical record;


(d) To refuse experimental treatment and drugs. The patientís written consent for participation in

research must be obtained and retained in his or her medical record;


(e) To have their records kept confidential and private. Written consent by the patient must be

obtained prior to release of information except to persons authorized by law. If the patient is

mentally incompetent, written consent is required from the patientís legal representative. The

ambulatory surgical center must have policies to govern access and duplication of the patientís



(f) To have appropriate assessment and management of pain; and


(g) To be involved in the decision making of all aspects of their care.


(2) Each patient has a right to self-determination, which encompasses the right to make choices regarding

life-sustaining treatment (including resuscitative services). This right of self-determination may be

effectuated by an advance directive.





(1) Pursuant to this Rule, each ambulatory surgical treatment center shall maintain and establish policies

and procedures governing the designation of a health care decision-maker for making health care

decisions for a patient who is incompetent or who lacks decision-making capacity, including but not

limited to allowing the withholding of CPR measures from individual patients. The policies and

procedures for determining when resuscitative services may be withheld must respect the patientís

rights of self-determination. The ambulatory surgical treatment center must inform the patient and/or

the patientís health care decision-maker of these policies and procedures upon admission or at such

time as may be appropriate.


(2) The ambulatory surgical treatment center should identify, after consultation with the family or

responsible party, the name of the health care decision-maker for a patient who is incompetent or who

lacks decision-making capacity, who will be responsible, along with the treating physician, for making

health care decisions, including but not limited to deciding on the issuance of a DNR order.


(3) Health care decisions made by a health care decision-maker must be made in accord with the patientís

individual health care instructions, if any, and other wishes to the extent known to the health care

decision-maker. If the patientís specific wishes are not known, decisions are to be made in accord

with the health care decision-makerís determination of the patientís desires or best interests in light of

the personal values and beliefs of the patient to the extent they are known.


(4) In the case of a patient who lacks decision-making capacity and who has not appointed an individual to

act on his or her behalf pursuant to an advance directive and who does not have a court-appointed

guardian or conservator with health care decision-making authority, documentation in the medical

record must identify the patientís surrogate to make health care decisions on the patientís behalf.


(a) The patientís surrogate shall be an adult who:

1. has exhibited special care and concern for the patient, who is familiar with the patientís

personal values, and who is reasonably available; and

2. consideration shall if possible be given in order of descending preference for service as a

surrogate to:


(i) the patientís spouse,


(ii) the patientís adult child,


(iii) the patientís parent,


(iv) the patientís adult sibling,


(v) any other adult relative of the patient, or


(vi) any other adult who satisfies the requirement under part 1 above.


(b) If none of the individuals eligible to act as a surrogate under subparagraph (a), is reasonably

available, the patientís treating physician may make health care decisions for the patient after

the treating physician either (i) consults with and obtains the recommendations of an

institutional ethics committee, or (ii) consults with a second physician who (A) is not directly

involved in the patientís health care; (B) either (i) does not serve in a capacity of decisionmaking

or influence or responsibility over the treating physician, or (ii) for whom the treating

physician does not exert decision-making, influence or responsibility; and (C) concurs with the

treating physicianís decision. For the purposes of this rule, ďinstitutional ethics committeeĒ

means a committee of a licensed health care institution which renders advice concerning ethical

issues involving health care.


(5) All patients shall be presumed as having consented to CPR unless there is documentation in the

medical record that the patient has specified that a DNR order be written. DNR orders may be written

to exclude any portion of the CPR measures deemed to be unacceptable.


(6) In the case of an incompetent patient who has appointed an attorney in fact to act on his or her behalf

pursuant to an advance directive or who has a court-appointed guardian or conservator with health care

decision-making authority, documentation in the medical record must reflect that the attorney in fact,

guardian or conservator has specified that a DNR order be written. In the case of a patient who lacks

decision-making capacity and who has not appointed an individual to act on his or her behalf pursuant

to an advance directive and who does not have a court-appointed guardian or conservator with health

care decision-making authority, documentation in the medical record must identify the patientís

surrogate to make health care decisions on the patientís behalf, and reflect that the patientís surrogate

and the patientís treating physician have mutually specified that a DNR order be written.


(7) CPR may be withheld from the patient if in the judgment of the treating physician an attempt to

resuscitate would be medically futile. Withholding and withdrawal of resuscitative services shall be

regarded as identical for the purposes of these regulations.


(8) Procedures for periodic review of DNR orders must be established and maintained. The ambulatory

surgical treatment center must have procedures for allowing revocation or amending DNR orders by

the patient, the patientís health care decision-maker, or treating physician. Such change shall be

documented in the medical record.


(9) Any treating physician who refuses to enter a DNR order in accordance with provisions set forth

above, or to comply with a DNR order, shall promptly advise the patient or the patientís health care

decision-maker of this decision. The treating physician shall then:


(a) Make a good faith attempt to transfer the patient to another physician who will honor the DNR

order; and,


(b) Permit the patient to obtain another physician.


(10) Each ambulatory surgical treatment center shall establish, and set forth in writing, a mediation process

to deal with any dispute regarding health care decisions, including DNR orders, or the determination of

the health care decision-maker.


(11) This rule does not alter any requirements imposed by state or federal law, where applicable, including

Title 33, the mental health and developmental disabilities law.




(1) The administration of every facility shall have in effect and available for all supervisory personnel and

staff, written copies of the following required disaster plans for the protection of all persons in the

event of fire and other emergencies for evacuation to areas of refuge and/or evacuation from the

building. A detailed log with staff signatures of training received shall be maintained. All employees

shall be trained annually as required in the following plans and shall be kept informed with respect to

their duties under the plans. A copy of the plans and the specific emergency numbers related to that

type of disaster shall be readily available at all times. Each of the following plans shall be exercised



(a) Fire Safety Procedures Plan shall include:

1. Minor fires;

2. Major fires;

3. Fighting the fire;

4. Evacuation procedures;

5. Staff functions.


(b) Tornado/Severe Weather Procedures Plan shall include:

1. Staff duties;

2. Evacuation procedures.


(c) Flood Procedure Plan, if applicable:

1. Staff duties;

2. Evacuation procedures;

3. Safety procedures following the flood.


(d) Earthquake Disaster Procedures Plan:

1. Staff duties;

2. Evacuation procedures;

3. Safety procedures;

4. Emergency services.


(2) All facilities shall participate in the Tennessee Emergency Management Agency local/county

emergency plan on an annual basis. Participation includes filling out and submitting a questionnaire




(3) The emergency power system shall:


(a) Use either propane, gasoline or diesel fuel. The generator shall be designed to meet the

facilityís HVAC and essential needs and shall have a minimum of twenty-four (24) hours of

fuel designed to operate at its rated load. The fuel quantity shall be based on its expected or

known connected load consumption during power interruptions.


(b) Automatically transfer within ten (10) seconds in ASTCís conducting invasive surgical



(c) Be inspected monthly and exercised at the actual load and operating temperature conditions and

not on dual power for at least thirty (30) minutes each month, including automatic and manual

transfer of equipment. A log shall be maintained for all inspections and tests and kept on file for

a minimum of three (3) years. The facility shall have trained staff familiar with the generatorís



(d) Emergency generators are not required if the facility does not utilize anesthesia that renders the

patient incapable of self preservation. However, the facility shall have an emergency power

source able to produce adequate power to run required equipment for a minimum of two (2)



(4) Emergency electrical power connections shall be through a switch which shall automatically transfer

the circuits to the emergency power source in case of power failure. (It is recognized that some

equipment may not sustain automatic transfer and provisions will have to be made to manually change

these items from a non-emergency powered outlet to an emergency powered outlet or other power



(5) In the event of natural disaster or electrical power failure, no new surgical procedures shall be begun,

and surgical procedures in progress shall be brought to conclusion as soon as possible.


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