For further information, please call: (512) 458-7236

Subchapter A. PROGRAM ADMINISTRATION

25 TAC §14.1, §14.2

The new sections are adopted under Health and Safety Code, Chapter 61, and Human Resources Code, Chapters 22 and 32. The department has rule making authority for the County Indigent Health Care Program under Health and Safety Code, Chapter 61; and Health and Safety Code, §12.001, which provides the Board of Health (board) with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401840

For further information, please call: (512) 458-7236

Subchapter B. DETERMINING ELIGIBILITY

25 TAC §§14.101 - 14.109

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401841

For further information, please call: (512) 458-7236

25 TAC §§14.101 - 14.105

§14.103.Household.

(a) A county health care assistance household is a person living alone, or two or more persons living together, who are legally responsible for the support of the other person(s). Disqualified persons are not household members regardless of their legal responsibility for support.

(b) An inmate in a county jail qualifies as a household if the inmate meets all other eligibility criteria.

(c) A non-TANF foster care child qualifies as a household if the child meets all other eligibility criteria. A foster child in the managing conservatorship of a licensed, privately-funded 24-hour child care facility does not qualify for county health care assistance.

(d) A person appealing a social security disability denial qualifies as a household if the person meets all other eligibility criteria.

(e) Legal responsibility for support exists between persons who are legally married, a legal parent and a minor child, or a managing conservator and a minor child.

(f) A minor child is a person under 18 years of age who is not, or has not been, married and has not had the disabilities of minority removed for general purposes.

(g) An adult is a person at least 18 years of age, or a younger person, who is or has been married or had the disabilities of minority removed for general purposes.

(h) The following persons are disqualified from inclusion in the household:

(1) a person who receives or is categorically eligible to receive Medicaid;

(2) a person who receives TANF or SSI benefits; and

(3) a Medicaid recipient who has exhausted a part or all of that recipient's Medicaid benefit.

(i) The following persons are considered a one-person household:

(1) an adult living alone;

(2) an adult living with others who are not legally responsible for supporting each other;

(3) a minor child living alone or with others who are not legally responsible for his support; or

(4) a Medicaid-ineligible parent whose spouse and/or minor children are Medicaid-eligible.

(j) The following persons living together are considered a household group:

(1) two persons legally married to each other;

(2) one or both legal parents and their legal minor children;

(3) a managing conservator and a minor child and the conservator's spouse and other legal minor children, if any;

(4) minor children who are siblings; or

(5) both Medicaid-ineligible parents of Medicaid-eligible children.

(k) When one household lives with another household, eligibility for each household must be determined independently.

§14.104.Income.

(a) Definitions. The following words and terms when used within this chapter shall have the following meanings, unless the context clearly indicates otherwise.

(1) Income--Any type of payment that is of gain or benefit to the household. As established by the department, income is either countable or exempt under the department-established budgeting process.

(2) Earned income--Income related to employment and entitles the household to deductions not allowed for unearned income.

(3) Unearned income--Payments received without performing work-related activities. It includes benefits from other programs.

(b) A county must subtract the work-related and childcare expense deductions allowed under department guidelines.

(c) A household must pursue and accept all income to which the household is legally entitled. Reasonable time (at least three months) must be allowed for the household to pursue the income. The income is not considered available during this time.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401842

For further information, please call: (512) 458-7236

Subchapter C. PROVIDING SERVICES

25 TAC §§14.201 - 14.205

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401843

For further information, please call: (512) 458-7236

25 TAC §14.201

The new section is adopted under Health and Safety Code, Chapter 61, and Human Resources Code, Chapters 22 and 32. The department has rule making authority for the County Indigent Health Care Program under Health and Safety Code, Chapter 61; and Health and Safety Code, §12.001, which provides the Board of Health (board) with the authority to adopt rules to implement every duty imposed by law on the board, the department, and the commissioner of health.

§14.201.Basic and Optional Services.

(a) Except as specified in the department-established service exclusions and limitations, counties are required to provide the following basic health care services to eligible households by reimbursing providers of services who meet the requirements of this chapter and the responsible county.

(1) Inpatient hospital services. Services must be medically necessary and:

(A) provided in an acute care hospital;

(B) provided to hospital inpatients;

(D) provided for the care and treatment of patients.

(2) Outpatient hospital services. Services must be medically necessary and:

(A) provided in an acute care hospital or hospital-based ambulatory surgical center;

(B) provided to hospital outpatients;

(D) are diagnostic, therapeutic, or rehabilitative.

(3) Physician services. Services must be medically necessary and provided by a physician in the doctor's office, a hospital, a skilled nursing facility, or elsewhere.

(4) Up to three prescriptions for drugs per recipient per month. New and refilled prescriptions count equally toward this total prescription limit. Drugs must be prescribed by a physician or other practitioner within the scope of practice under law. The quantity of drugs prescribed depends on the prescribing practice of the physician and the needs of the patient.

(5) Skilled nursing facility services (SNF). Services must be medically necessary, ordered by a physician, and provided in a skilled nursing facility that provides daily services on an inpatient basis.

(6) Rural health clinic services. Rural health clinic services must be provided in a rural health clinic by a physician, a physician's assistant, a nurse practitioner, a nurse midwife, or other specialized nurse practitioner.

(7) Family planning services. These are preventive health and medical services that assist an individual in controlling fertility and achieving optimal reproductive and general health.

(8) Laboratory and x-ray services. These are technical laboratory and radiological services ordered and provided by, or under the direction of, a physician in an office or a similar facility other than a hospital outpatient department or clinic.

(9) Immunizations. These are given when appropriate.

(10) Medical screening services. These medical services include blood pressure, blood sugar, and cholesterol screening.

(11) Annual physical examinations. These are examinations provided once per calendar year by a physician or a physician's assistant (PA). Associated testing, such as mammograms, can be covered with a physician's referral. These services may also be provided by an Advanced Practice Nurse (APN) if they are within the scope of practice of the APN in accordance with the standards established by the Board of Nurse Examiners and published in 22 Texas Administrative Code, §221.13.

(b) The following services are optional health care services.

(1) Ambulatory surgical center (ASC) services. These services must be provided in a freestanding ASC, and are limited to items and services provided in reference to an ambulatory surgical procedure, including those services on the Center for Medicare and Medicaid Services (CMS)-approved list and selected Medicaid-only procedures.

(2) Federally Qualified Health Center (FQHC) services. These services must be provided in an FQHC by a physician, a physician's assistant, a nurse practitioner, a clinical psychologist, or a clinical social worker.

(3) Physician assistant (PA) services. These services must be medically necessary and provided by a PA under the direction of a physician and must be billed by and paid to the supervising physician.

(4) Advanced practice nurse (APN) services. An APN must be licensed as a registered nurse (RN) within the categories of practice, specifically, a nurse practitioner, a clinical nurse specialist, a certified nurse midwife (CNM), and a certified registered nurse anesthetist (CRNA), as determined by the Board of Nurse Examiners. APN services must be medically necessary, provided within the scope of practice of an APN, and covered in the Texas Medicaid Program.

(5) Counseling services. Psychotherapy services must be medically necessary based on a physician referral, and provided by a licensed professional counselor (LPC), a licensed master social worker-advanced clinical practitioner (LMSW-ACP), a licensed marriage family therapist (LMFT), or a Ph.D. psychologist. These services may also be provided based on an APN referral if the referral is within the scope of their practice in accordance with the standards established by the Board of Nurse Examiners and published in 22 Texas Administrative Code, §221.13.

(6) Diabetic medical supplies and equipment. These supplies and equipment must be medically necessary and prescribed by a physician. The county may require the supplier to receive prior authorization. Items covered are lancets, alcohol prep pads, syringes, test strips, humulin pens and glucometers. These supplies and equipment may also be prescribed by an APN if this is within the scope of their practice in accordance with the standards established by the Board of Nurse Examiners and published in 22 Texas Administrative Code, §221.13.

(7) Colostomy medical supplies and equipment. These supplies and equipment must be medically necessary and prescribed by a physician. The county may require the supplier to receive prior authorization. Items covered are colostomy bags/pouches; cleansing irrigation kits, paste, or powder; and skin barriers with flange (wafers). These supplies and equipment may also be prescribed by an APN if this is within the scope of their practice in accordance with the standards established by the Board of Nurse Examiners and published in 22 Texas Administrative Code, §221.13.

(8) Durable medical equipment. This equipment must be medically necessary; meet the Medicare/Medicaid requirements; and provided under a written, signed, and dated physician's prescription. The county may require the supplier to receive prior authorization. Items can be rented or purchased, whichever is the least costly. Items covered are crutches, canes, walkers, standard wheel chairs, hospital beds, home oxygen equipment (including masks, oxygen hose, and nebulizers), and reasonable and appropriate appliances for measuring blood pressure. These supplies and equipment may also be prescribed by an APN if this is within the scope of their practice in accordance with the standards established by the Board of Nurse Examiners and published in 22 Texas Administrative Code, §221.13.

(9) Home and community health care services. These services must be medically necessary; meet the Medicare/Medicaid requirements; and provided by a certified home health agency. A plan of care must be recommended, signed, and dated by the recipient's attending physician prior to care being given. The county may require prior authorization. Items covered are Registered Nurse (RN) visits for skilled nursing observation, assessment, evaluation, and treatment provided a physician specifically requests the RN visit for this purpose. A home health aide to assist with administering medication is also covered. Visits made for performing housekeeping services are not covered.

(10) Dental care. These services must be medically necessary and provided by a DDS, a DMD, or a DDM. The county may require prior authorization. Items covered are an annual routine dental exam and the least costly service for emergency dental conditions for the removal or filling of a tooth due to abscess, infection, or extreme pain.

(11) Vision care, including eyeglasses. The county may require prior authorization. Items covered are one examination of the eyes by refraction and one pair of prescribed glasses every 24 months.

(12) Emergency medical services. These services are ground ambulance transport services. When the client's condition is life-threatening and requires the use of special equipment, life support systems, and close monitoring by trained attendants while en route to the nearest appropriate facility, ground ambulance transport is an emergency service.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401844

For further information, please call: (512) 458-7236

Subchapter D. CASE MANAGEMENT

25 TAC §14.301, §14.302

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401845

For further information, please call: (512) 458-7236

Subchapter F. ADVISORY COMMITTEE

25 TAC §14.501

The Texas Department of Health (department) adopts the repeal of §14.501, concerning the Indigent Health Care Advisory Committee (committee). This repeal is adopted without changes as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10035), and will not be republished.

The committee has provided advice to the Texas Board of Health (board) and the department in the area of the Indigent Health Care Program.

In 1993, the Texas Legislature passed Senate Bill 383 (now codified in the Government Code, Chapter 2110) which requires that each state agency adopt rules on advisory committees. The rules must state the purpose of the committee, describe the tasks of the committee, and describe the manner in which the committee will report to the agency.

The Indigent Health Care Advisory Committee was established under the Health and Safety Code, §11.016, which allows the board to establish advisory committees. However, according to 78th Legislature, Chapter 198, §2.151 (House Bill 2292), all advisory committees were abolished, effective September 1, 2003, except those required by federal law or that advise the department with respect to certification or licensing programs, the regulation of entities providing health and human services, or the implementation of a duty prescribed under 78th Legislature, Chapter 198, Article 2 (House Bill 2292). The Commissioner of Health and Human Services announced in the August 29, 2003, issue of the Texas Register (28 TexReg 7493), that the department's Indigent Health Care Advisory Committee would not be certified as exempt from abolition on September 1, 2003. Therefore, the need for this rule no longer exists.

No public comments were received during the comment period for the repeal.

The repeal is adopted under the Health and Safety Code, §11.016, which allows the board to establish advisory committees; and the Health and Safety Code, §12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401855

For further information, please call: (512) 458-7236

Chapter 37. MATERNAL AND INFANT HEALTH SERVICES

The Texas Department of Health (department) adopts the repeal of §§37.33-37.46 and new §§37.561-37.573, concerning the provision of hearing aids and remedial services for eligible recipients with hearing loss through the Program for Amplification for Children of Texas (PACT). Sections 37.562-37.563, 37.565-37.566, 37.569-37.571, and §37.573 are adopted with changes to the proposed text as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10042). Sections 37.561, 37.564, 37.567-37.568, and 37.572, and the repealed §§37.33-37.46 are adopted without changes and, therefore, the sections will not be republished.

Specifically, the new sections concern purpose; definitions; program benefits; temporary loan of hearing aids; requirements for provider participation; application process; denial, modification, suspension, or termination of provider approval; recipient eligibility criteria; requirements for recipients to receive services; denial of application or modification, suspension, or termination of recipients' program participation; recipient rights; monitoring and record keeping concerning individuals with hearing loss; and confidentiality of information.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 37.33-37.46 have been reviewed and the department has determined that reasons for adopting the sections continue to exist because rules on this subject are needed. However, §§37.33-37.46 are repealed and new §§37.561-37.573 are located in a new, separate subchapter in the Texas Administrative Code. The new sections are both more accessible and more understandable.

The department published a Notice of Intention to Review for the sections in the Texas Register on April 28, 2000 (25 TexReg 3799). No comments were received as a result of the notice.

No comments were received concerning the proposal during the comment period; however, the department is making the following minor changes to clarify the intent and improve the accuracy of the sections.

Change: Concerning §37.562(7), the term "eligible provider" was redundant, since only providers approved by PACT are eligible to participate in the program. Section 37.562(7) was deleted and the appropriate definition of "provider" was added in alphabetical order at §37.562(13). Proposed §37.562(8)-(13) has been renumbered as §37.562(7)-(12). Amended references to PACT "providers" also have been added to §§37.563(c), 37.569(a), 37.569(c)(3), 37.571(a), and 37.573(a).

Change: Concerning §§37.562(2), 37.562(5), 37.562(12) as amended, and 37.570(c), the sections have been amended to reflect the fact that the Texas Department of Health and the Texas Board of Health will soon cease to exist as currently constituted.

Change: Concerning §37.563(a)-(d), references to "eligible recipients" have been deleted because only persons who are determined eligible by PACT to receive services are defined as "recipients" by §37.562(14), as those who are eligible.

Change: Concerning §37.565, subsection (b) has been omitted because the Special Senses and Communication Disorders Act, Health and Safety Code, Chapter 36, does not require that before the department modifies, suspends, or terminates a PACT provider's program participation, the department must afford the provider a fair hearing. However, Health and Safety Code, §36.08(d), directs that the department must give an applicant for or a recipient of program services a fair hearing before modification, suspension, or termination of access to program eligibility, indicating that the omission of a "right" to a hearing for a provider was a considered decision. Even without a fair hearing, a provider will be afforded a due process opportunity to respond to any findings by the department on which modification, suspension, or termination of participation is based. Since §37.565 no longer has two subdivisions, subsection (a) is superfluous and has also been deleted.

Change: Concerning §37.565(10), the paragraph has been amended to clarify that providers who are otologists and who also fit hearing aids are not required to have another otologist attest to the lack of contraindications.

Change: Concerning §37.566(h), the subsection was amended for clarity.

Change: Concerning §§37.570(a)(5) and 37.570(a)(6), addition of these eligibility criteria required by statute correct a prior omission in the rules. The proposed paragraph in §37.570(a)(5) has been renumbered as §37.570(a)(7).

Change: Concerning §37.571(a), the subsection has been amended to clarify that all providers are not approved to provide all PACT services.

Subchapter C. SPECIAL SENSES AND COMMUNICATION DISORDERS

25 TAC §§37.33 - 37.46

The repeals are adopted under Health and Safety Code, §36.007, which authorizes the Texas Board of Health (board) to adopt rules concerning the scope of remedial services, recipient and provider eligibility criteria, and procedures for provision of remedial services; and §12.001, which provides the board with the authority to adopt rules for its procedure and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of these sections implements Government Code, §2001.039.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401846

For further information, please call: (512) 458-7236

Subchapter U. PROGRAM FOR AMPLIFICATION FOR CHILDREN OF TEXAS

25 TAC §§37.561 - 37.573

The new sections are adopted under Health and Safety Code, §36.007, which authorizes the Texas Board of Health (board) to adopt rules concerning the scope of remedial services, recipient and provider eligibility criteria, and procedures for provision of remedial services; and §12.001, which provides the board with the authority to adopt rules for its procedure and for the performance of each duty imposed by law on the board, the department, or the commissioner of health. The review of these sections implements Government Code, §2001.039.

§37.562.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Audiologist--A person licensed to practice as an audiologist in Texas by the State Board of Examiners for Speech-Language Pathology and Audiology.

(2) Board--The Texas Board of Health, or its successor.

(3) Calibration--The process of comparing an instrument or device with a standard to determine its accuracy and to make the necessary repairs or adjustments to assure that the operating characteristics are within the allowable limits established by a national standard or manufacturer's specifications.

(4) Communication disorder--A functional abnormality related to a person's ability to express and/or receive ideas.

(5) Department--The Texas Department of Health, or its successor.

(6) Educator--An individual engaged in the formal educational development of the individual with hearing loss.

(7) Hearing aid--A small portable electronic device that amplifies sound and is worn by a person to compensate for auditory impairment.

(8) Hearing aid fitting--The physical attaching of the hearing aid(s) to the earmold(s), adjusting the hearing aid(s) to control parameters in order to meet the needs of the hearing-impaired individual, placing the resulting hearing aid arrangement on the individual's ear(s) and counseling regarding the appropriate usage of, care of, and maintenance of the hearing aid arrangement.

(9) Identification services--Professional examinations/evaluations to determine the type and degree of a recipient's hearing loss.

(10) Medicaid--The medical assistance program implemented by the State of Texas under the provisions of Title XIX of the Social Security Act, as amended, (42 USC §§1396-1396v).

(11) Otologist--A physician licensed to practice medicine by the Texas State Board of Medical Examiners, also referred to as an ear, nose, and throat specialist, an otolaryngologist, or an otorhinolaryngologist, who specializes in diseases of the ear and hearing mechanism.

(12) Program--The Program for Amplification for Children of Texas (PACT).

(13) Provider--A physician, audiologist, hospital, clinic, rehabilitation center, university, or medical school approved by the program to provide remedial services to individuals who have auditory impairment.

(14) Recipient--A person who is determined to be eligible for assistance through the program.

(15) Remediation services--Professional examinations/evaluations and prescribed remediation for auditory impairment, including hearing aids.

§37.563.Program Benefits.

(a) Recipients may receive only medically necessary identification and remediation services for hearing loss.

(b) Recipients may receive medically necessary services and hearing aid(s) only if a provider has requested and received prior authorization for the services and hearing aid(s).

(c) A provider must submit a written request to the program in order to receive prior authorization for services or hearing aid(s). The provider is responsible for fitting the hearing aid(s) on the recipient.

(d) Providers shall be reimbursed on a fee-for-service basis for professional hearing services provided to recipients according to the approved fee schedule.

§37.565.Requirements for Provider Participation.

All providers must be enrolled with the program and must meet the following criteria.

(1) Providers shall comply with the Health and Safety Code, Chapters 36 and 401; Occupations Code, Chapter 401; and other laws applicable to services provided through the program.

(2) A provider may not bill a recipient for services covered by Medicaid.

(3) A provider may bill a recipient for noncovered services for which Medicaid does not make any payment only if:

(A) a specific service is provided at the client's request; and

(B) the recipient, or the recipient's parent, guardian, or managing conservator, has acknowledged in writing that he or she is responsible for payment for services requested by or on behalf of the recipient that are determined not to be reasonable and necessary by Medicaid.

(4) A provider must demonstrate that each staff member has a current professional license or certification required for the provision of program services.

(5) A provider's testing equipment must be appropriately calibrated, be registered with the department, and must be suitable for and capable of evaluating the hearing loss of any recipient being tested.

(6) A provider must be capable of conducting all hearing evaluations in a sound-treated facility meeting current American National Standards Institute (ANSI) standards and any federal, state, or manufacturer's specifications in order to ensure the accuracy of all nonmedical evaluations including, but not limited to, pure-tone air and bone conduction testing and speech audiometry, both under earphones and in sound field, unaided and aided.

(7) A provider must supply its federal tax identification number to the program.

(8) A provider's equipment requiring calibration shall be calibrated annually by a calibration firm registered with the department.

(9) A provider's equipment and facilities shall be subject to monitoring and inspection visits by department staff in accordance with Health and Safety Code, Chapter 401.

(10) Providers who furnish services and/or hearing aids shall obtain a written statement from an otologist that the recipient has no medical contraindications to fitting and use of a hearing aid(s). Providers who are themselves otologists may attest to the lack of medical contraindications if they also fit the hearing aid(s).

(11) All providers, except those listed in §37.566(d)(2) of this title (relating to Application Process) shall have an audiologist on staff or on contract.

§37.566.Provider Application Process.

(a) An applicant must submit an application to the program.

(b) The application must be signed by the applicant's chief administrative officer.

(c) An applicant must provide written assurances that the applicant's facility and staff are capable of providing auditory services according to the standards established by the program. Program staff will confirm the status of the applicant's license with the appropriate licensing board.

(d) An applicant may seek approval to provide different levels of service, including the following:

(1) all program services to recipients from birth through 20 years of age;

(2) only otologic services for recipients from birth through 20 years of age, but no evaluation services; or

(3) a range of otologic and/or evaluation services for older children, but not for infants and very young children, according to the capabilities of the applicant's facility and personnel.

(e) All applications shall be reviewed by program staff. The review process shall be completed within 20 working days following receipt of an application.

(f) Incomplete applications shall be returned to the applicant without approval or denial by the program.

(g) Applications which do not meet program requirements shall be denied.

(h) After approval of a provider's application and enrollment by the program, the provider may participate as long as he or she continues to meet program criteria stated in §37.565 of this title (relating to Requirements for Provider Participation).

§37.569.Requirements for Recipients to Receive Services.

(a) The recipient must choose a provider, submit an application for PACT services through the provider, and be approved by the program.

(b) To receive identification services, the program must concur that the recipient has a potential hearing loss and give the recipient's provider prior authorization to perform identification services.

(c) To receive remediation services, the program must receive documentation of a recipient's permanent hearing loss and give the recipient's provider prior authorization to perform remediation services. Documentation includes information from:

(1) an otologist who has determined that the recipient's condition is treatable with the use of a hearing aid(s) and that use of a hearing aid(s) will pose no danger to the recipient;

(2) an otologist who has determined that the recipient has medically treatable hearing loss that should be treated with a hearing aid(s) on a temporary basis; or

(3) a provider, educator, and/or otologist who has determined that the hearing loss is an impediment to the recipient's educational advancement.

(d) The program shall refer individuals determined not to be eligible for Medicaid or the Children with Special Health Care Needs Services Program and who have medically and/or surgically treatable hearing losses to other programs and/or state agencies for medical treatment and management.

§37.570.Denial of Application or Modification, Suspension, or Termination of Recipients' Program Participation.

(a) The program shall notify any person applying for or receiving services through the program by mail, sent to the most recent address known to the program, of the program's intention to deny the person's application for participation, or to modify, suspend, or terminate the person's participation if:

(1) the person submits an application form or any document required in support of the application which contains an intentional misstatement of fact which is material to the program's consideration of the person's eligibility for program benefits;

(2) the person is not eligible for Medicaid;

(3) the person is not eligible for the Children With Special Health Care Needs Services Program;

(4) the person cannot provide documentation that services are medically necessary;

(5) the person has a permanent hearing loss but is eligible for special services that remediate the hearing loss that are administered by the Texas Education Agency through the public schools;

(6) the person, or the person's parent, managing conservator, or other person with a legal obligation to support the individual is eligible for some other benefit that would pay for all or part of the program services; or

(7) the person notifies the program in writing that he or she no longer seeks program benefits. Such a statement, however, does not free the recipient, or a person(s) with a legal obligation to support the recipient, of any outstanding obligation to reimburse the program at the time of withdrawal.

(b) The department shall notify any person applying for or receiving services through the program, by certified mail sent to the most recent address known to the program, of the program's intention to deny the person's application for participation, or to modify, suspend, or terminate the person's participation.

(c) Within 10 working days after receiving the notice described in subsection (b) of this section, the recipient or the recipient's representative must respond to, or question, the program's reason(s) for the proposed action by certified mail sent to the following address: Program for Amplification for Children of Texas, 1100 West 49th Street, Austin, Texas 78756-3190. Failure by the recipient to respond shall be deemed a waiver of the opportunity to respond to the program and of the opportunity for a hearing.

(d) Upon receipt of the recipient's response, the program shall affirm or modify the proposed action in writing, including the reason(s) for the decision, sent to the recipient's address of record.

(e) Any recipient aggrieved by a program decision to deny participation, or to modify, suspend, or terminate program participation, may request a fair hearing in writing, sent to the program at the address in subsection (c) of this section, within 10 working days of receipt of the program's decision. If the recipient fails to request a fair hearing within 10 working days of receipt of the program's decision, the recipient is presumed to have waived the opportunity for a fair hearing, and the program may take final action. A fair hearing requested by a recipient shall be conducted in accordance with §§1.51-1.55 of this title (relating to Fair Hearing Procedures).

(f) These procedures do not apply to adjustments made by the program in the type of program benefits or the amount of benefits available when such adjustments are necessary to conform to budgetary limitations.

§37.571.Recipient Rights.

(a) A recipient has the right to choose any provider approved by the program to provide the identification and/or remediation services required by the recipient.

(b) A recipient has the right to accept or refuse PACT services.

(c) No person eligible for benefits under the program shall be denied such benefits, or otherwise be subjected to discrimination because of race, color, national origin, sex, creed, handicap, or age.

§37.573.Confidentiality of Information.

(a) Federal law and Medicaid regulations prohibit the disclosure of information about Medicaid recipients without the recipient's consent, except for purposes directly connected with the administration of the program. Eligibility and other confidential information may be provided to providers only with the recipient's consent.

(b) Contracted agencies performing certain administrative functions, including outreach, informing, and transportation services, may receive confidential information without the Medicaid recipient's consent if disclosure is necessary for the administration of the program. Such administrative service contractors are bound by the same standards of confidentiality as the program and must implement effective safeguards to ensure confidentiality of information concerning recipients.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401847

For further information, please call: (512) 458-7236

Subchapter R. SCHOOL HEALTH ADVISORY COMMITTEE

25 TAC §37.350

The Texas Department of Health (department) adopts the repeal of §37.350, concerning the School Health Advisory Committee (committee). This repeal is adopted without changes as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10046), and will not be republished.

The committee has provided advice to the Texas Board of Health (board) and the department in establishing a leadership role in the support for and delivery of school health services.

The School Health Advisory Committee was established under the Health and Safety Code, §11.016, which allows the board to establish advisory committees. However, according to 78th Legislature, Chapter 198, §2.151 (House Bill 2292), all advisory committees were abolished, effective September 1, 2003, except those required by federal law or that advise the department with respect to certification or licensing programs, the regulation of entities providing health and human services, or the implementation of a duty prescribed under 78th Legislature, Chapter 198, Article 2 (House Bill 2292). The Commissioner of Health and Human Services announced in the August 29, 2003, issue of the Texas Register (28 TexReg 7493), that the department's School Health Advisory Committee would not be certified as exempt from abolition on September 1, 2003. Therefore, the need for this rule no longer exists.

No public comments were received during the comment period for the repeal.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401851

For further information, please call: (512) 458-7236

Chapter 38. CHILDREN WITH SPECIAL HEALTH CARE NEEDS SERVICES PROGRAM

25 TAC §38.15

The Texas Department of Health (department) adopts the repeal of §38.15, concerning the Children With Special Health Care Needs Advisory Committee (committee). This repeal is adopted without changes as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10047), and will not be republished.

The committee has provided advice to the Texas Board of Health (board) and the department in developing comprehensive systems of health care for children with special health care needs and their families.

The Children With Special Health Care Needs Advisory Committee was established under the Health and Safety Code, §11.016, which allows the board to establish advisory committees. However, according to 78th Legislature, Chapter 198, §2.151 (House Bill 2292), all advisory committees were abolished, effective September 1, 2003, except those required by federal law or that advise the department with respect to certification or licensing programs, the regulation of entities providing health and human services, or the implementation of a duty prescribed under 78th Legislature, Chapter 198, Article 2 (House Bill 2292). The Commissioner of Health and Human Services announced in the August 29, 2003, issue of the Texas Register (28 TexReg 7493), that the department's Children With Special Health Care Needs Advisory Committee would not be certified as exempt from abolition on September 1, 2003. Therefore, the need for this rule no longer exists.

No public comments were received during the comment period for the repeal.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401854

For further information, please call: (512) 458-7236

Chapter 49. ORAL HEALTH IMPROVEMENT SERVICES PROGRAM

25 TAC §49.16

The Texas Department of Health (department) adopts the repeal of §49.16, concerning the Oral Health Services Advisory Committee (committee). This repeal is adopted without changes as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10047), and will not be republished.

The committee has provided advice to the Texas Board of Health (board) and the department on matters relating to operation of the state dental program and Texas Health Steps dental services, and assists those programs and others in the department that require professional dental expertise.

The Oral Health Services Advisory Committee was established under the Health and Safety Code, §11.016, which allows the board to establish advisory committees. However, according to 78th Legislature, Chapter 198, §2.151 (House Bill 2292), all advisory committees were abolished, effective September 1, 2003, except those required by federal law or that advise the department with respect to certification or licensing programs, the regulation of entities providing health and human services, or the implementation of a duty prescribed under 78th Legislature, Chapter 198, Article 2 (House Bill 2292). The Commissioner of Health and Human Services announced in the August 29, 2003, issue of the Texas Register (28 TexReg 7493), that the department's Oral Health Services Advisory Committee would not be certified as exempt from abolition on September 1, 2003. Therefore, the need for this rule no longer exists.

No public comments were received during the comment period for the repeal.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401852

For further information, please call: (512) 458-7236

Chapter 61. CHRONIC DISEASES

Subchapter A. KIDNEY HEALTH CARE PROGRAM

25 TAC §61.12

The Texas Department of Health (department) adopts the repeal of §61.12, concerning the Kidney Health Care Advisory Committee (committee). This repeal is adopted without changes as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10048), and will not be republished.

The committee has provided advice to the Texas Board of Health (board) and the department in the area of end-stage renal disease (ESRD) and on current state-of-the-art treatment modalities, medication therapies, and prioritization of the needs of ESRD patients in Texas.

The Kidney Health Care Advisory Committee was established on September 1, 1973. However, according to 78th Legislature, Chapter 198, §2.151 (House Bill 2292), all advisory committees were abolished, effective September 1, 2003, except those required by federal law or that advise the department with respect to certification or licensing programs, the regulation of entities providing health and human services, or the implementation of a duty prescribed under 78th Legislature, Chapter 198, Article 2 (House Bill 2292). The Commissioner of Health and Human Services announced in the August 29, 2003, issue of the Texas Register (28 TexReg 7493), that the department's Kidney Health Care Advisory Committee would not be certified as exempt from abolition on September 1, 2003. Therefore, the need for this rule no longer exists.

No public comments were received during the comment period for the repeal.

The repeal is adopted under the Health and Safety Code, §11.016, which allows the Texas Board of Health (board) to establish advisory committees; and the Health and Safety Code, §12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law upon the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401850

For further information, please call: (512) 458-7236

Chapter 97. COMMUNICABLE DISEASES

Subchapter B. IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION

The Texas Department of Health (department) adopts the repeal of §§97.61-97.63, 97.65, 97.67, 97.71-97.77, and new §§97.61-97.72, concerning the immunization requirements for Texas child-care facilities, public or private primary and secondary schools, and students enrolled in health-related and veterinary courses in institutions of higher education. New §§97.62, 97.63, and 97.68 are adopted with changes to the proposed text as published in the December 5, 2003, Texas Register issue (28 TexReg 10870). The repeal of §§97.61-97.63, 97.65, 97.67, 97.71-97.77, and new §§97.61, 97.64-97.67, and 97.69-97.72 are adopted without changes, and the sections will not be republished.

The repeal and new sections will make the rules more accessible, understandable, and usable. The department's main goal is to enhance the effectiveness of the immunization requirements for Texas child-care facilities, public or private primary and secondary schools, and students enrolled in health-related and veterinary courses in institutions of higher education by making the requirements grade specific instead of age specific. Additional changes to the rules were mandated by the 78th Legislature, 2003, under House Bill 2292, which revised Health and Safety Code, §161.004(d) and added §161.0041, and revised Education Code, §§38.001 and 51.933, and Human Resources Code, §42.043 to allow exemptions from immunizations. These mandates were also included in the rules now considered for adoption.

Government Code, §2001.039, requires that each state agency conduct a review of its rules every four years and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed §§97.61-97.63, 97.65, 97.67, 97.71-97.77, and has determined that reasons for adopting the sections continue to exist; however, the repeal and the new sections are necessary to make the rules more accessible, understandable, and usable.

The department published a Notice of Intention to Review for §§97.61-97.63, 97.65, 97.67, 97.71-97.77, in the Texas Register on January 14, 2000 (25 TexReg 275). No comments were received due to publication of this notice.

In general, public comments made at the public hearing and sent to the department by mail, facsimile, and electronic mail were favorable. The commenters agreed that the rules as proposed here for adoption are easier to understand and implement. Many commenters supported the changes to the rules, adding that the change from grade level rather than by age will help simplify the process of verifying vaccination status of Texas school children. Following each comment is the department's response and any resulting changes.

Comment: Concerning §97.62, the majority of the commenters requested the elimination of the exemption for reasons of conscience.

Response: The department disagrees. The exemption was mandated by the 78th Legislature, 2003, under House Bill 2292. No change was made as a result of the comments.

Comment: Concerning §97.62, numerous commenters recommended the department limit the time period for the affidavit form for exemption for reasons of conscience to one-year period instead of the proposed five-year time period.

Response: The department agrees, in part, that five years is too long, but that one year is too short and recommends two years. The department determined that the two-year term assures the safety of children attending child-care facilities and public and private schools.

Comment: Concerning §97.62, three commenters recommended that the exemption for reasons of conscience be a lifelong exemption.

Response: The department disagrees. The department determined that the two-year term assures the safety of children attending child-care facilities and public and private schools. No change was made as a result of the comments.

Comment: Concerning §97.62, one commenter recommended that rules clarify that the conscientious exemption applies to students enrolled in health-related and veterinary courses in institutions of higher education.

Response: The department agrees. The department added a specific reference to Education Code, Chapter 51.

Comment: Concerning §97.62, two commenters suggested the removal of the requirement for obtaining identifying information on a child when a parent, or guardian, applies for the conscientious exemption affidavit form.

Response: The department disagrees. The department is requiring the name and date of birth of a child to prevent reproduction or unauthorized distribution of the affidavit form and to ensure security in accordance with House Bill 2292. The only information retained is the total number of affidavit forms sent out, total number of requests received, and the total number of children for whom requests were received. The department does not maintain any information that could identify persons requesting the affidavit forms or information that could identify the child. No change was made as a result of the comments.

Comment: Concerning §97.62, two commenters suggested the department expand the method for obtaining the conscientious exemption affidavit forms to include facsimile.

Response: The department agrees. The department added that the request for the conscientious exemption affidavit form by facsimile is acceptable.

Comment: Concerning §97.62, two commenters suggested the department expand the method for obtaining the conscientious exemption affidavit forms to include electronic mail.

Response: The department disagrees. The request for the conscientious exemption affidavit form by electronic mail is not acceptable. The department would be unable to ensure that identifiable information is not retained on the requestor and child. No change was made as a result of the comments.

Comment: Concerning §97.62, numerous commenters requested the department change the wording regarding the exclusion of unvaccinated students from attendance during times of an emergency or epidemic from an option to a requirement.

Response: The department disagrees. The language in House Bill 2292 states that a person "may be excluded from school in times of emergency or epidemic declared by the commissioner of public health." No change was made as a result of the comments.

Comment: Concerning §97.63, numerous commenters recommended the department make hepatitis A vaccination a requirement for all students in kindergarten through 12th grade in the Texas counties where it is required.

Response: The department disagrees. The department modified the rule in response to the comments and expanded the verification for Hepatitis A requirement for students to include kindergarten through third grade. This will achieve the public health benefits without significantly increasing the burden to schools.

Comment: Concerning §97.66, numerous commenters asked the department to limit the thirty-day provisional enrollment period for unvaccinated students to a one-time period only and to make the guidelines stricter.

Response: The department disagrees. Rules as proposed are clear. No change was made as a result of the comments.

Comment: Concerning §97.63, three commenters expressed a concern that the rules did not address the immunization requirements for pre-kindergarten students.

Response: The department agrees. The department added reference to pre-kindergarten and early childhood programs to §97.63(2)(A) regarding the requirements for children attending child-care facilities.

Comment: Concerning §97.63, three commenters suggested the department specify the intervals between doses for hepatitis A, hepatitis B, or measles vaccine.

Response: The department disagrees. Vaccine intervals are a medical decision under the auspices of medical license and are not a school compliance issue. No change was made as a result of the comments.

Comment: Concerning §97.63(2)(B)(vi) and (vii), numerous commenters requested that the department change the schedule for implementing the requirement for hepatitis B and varicella vaccines for grades kindergarten through twelfth grade because implementation of these changes would place a tremendous burden on local school districts.

Response: The department agrees. The department revised the requirement for students attending kindergarten through twelfth grades to enable schools to implement these rules without excessive burden and without delays.

Comment: Four commenters recommended the department delay implementation of the rules from August 1, 2004, to August 1, 2005.

Response: The department disagrees. The department revised the requirement for students attending kindergarten through twelfth grades to enable schools to implement these rules without excessive burden and without delays. No change was made as a result of the comments.

Comment: Concerning §97.63, two commenters suggested the department add pneumococcal vaccine to the required immunizations.

Response: The department disagrees. The department does not have adequate resources to ensure that parents would have access to this vaccine and to require this vaccine may cause an undue burden to parents and schools in order to enforce such a requirement. No change was made as a result of the comments.

Comment: Concerning §97.63, three commenters asked for clarification regarding the number of doses of DTaP and polio vaccine required for school entry.

Response: The department disagrees. The requirements for DTaP and polio vaccines are clearly stated in the proposed rules. No change was made as a result of the comments. Comment: Concerning §97.62, one commenter suggested that the medical exemption be renewed once a year.

Response: The department agrees. The department added the following sentence to §97.62(1) "Unless it is written in the statement that a lifelong condition exists, the exemption statement is valid for only one year from the date signed by the physician."

Comment: Concerning §97.68, one commenter requested that the department clarify that records from other school officials in Texas are acceptable.

Response: The department agrees. The department added clarification that records from school officials including a record from another state is acceptable.

Comment: Concerning §97.62, two commenters requested that the department remove the reference to the term medical contraindications because it was inconsistent with the statute stating only "the immunization required poses a significant risk to the health and well-being of the applicant or any member of the applicant's family or household."

Response: The department disagrees. The rules are consistent with the statutory language in House Bill 2292 as amended in §161.004(d)(2) of the Health and Safety Code that established the exemption if "the immunization is medically contraindicated based on the opinion of a physician licensed by any state in the United States who has examined the child."

The comments received were generally favorable of the rules as proposed; however, many of the commenters had questions or specific concerns, or offered suggestions for changes, including: comments requesting the conscientious exemption be eliminated, comments requesting the conscientious exemption affidavit form be limited to a one-year period; comments requesting gradual implementation of the varicella and hepatitis B requirements; comments requesting the provisional enrollment be restricted; comments requesting expansion of the Hepatitis A vaccine requirements to all students; and, comments requesting children be excluded from attendance in times of emergency or epidemic. The remaining comments were requesting specific language revisions and clarifications.

Commenters included Senator Craig Estes, Representative Frank J. Corte, Texas Medical Association, Texas Pediatric Society, Dallas County Medical Society, Texas Hospital Association, Children Hospital Association of Texas and two children's hospitals, March of Dimes, Houston Area Vaccination Outreach Coalition, Texas Public Health Association, representatives of thirty-four independent school districts, local health departments in Harris County, San Antonio, City of Garland, and Dallas County, VaccineWorks, Parents Requesting Open Vaccine Education (PROVE), and several individuals.

The department made the following changes due to staff comments for consistency.

Change: Concerning §97.62(2), revised from "parent" to "parent or guardian."

Change: Concerning §97.62(3), revised to delete heading "Armed Forces" and replace with "To claim an exclusion for armed forces."

In addition, a public hearing was held at the department during the public comment period on December 17, 2003, in order to listen to public comments and concerns. During the public hearing numerous groups and individuals made public comments.

25 TAC §§97.61 - 97.63, 97.65, 97.67, 97.71 - 97.77

The repeals are adopted under the authority of Health and Safety Code, §81.023, which requires the Texas Board of Health (board) to develop immunization requirements for children; Health and Safety Code, §§161.004(d) and 161.0041, which require the board to enact rules to implement exemptions to immunization requirements; Education Code, §38.001, which allows the board to develop immunization requirements for admission to any elementary or secondary school; Education Code, §51.933, which allows the board to develop immunization requirements for and students enrolled in health-related and veterinary courses in institutions of higher education; Human Resources Code, §42.043, which requires the department to make rules regarding the immunization of children admitted to child-care facilities; and Health and Safety Code, §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 12, 2004.

TRD-200401870

Proposal publication date: December 5, 2003

For further information, please call: (512) 458-7236

25 TAC §§97.61 - 97.72

The new sections are adopted under the authority of Health and Safety Code, §81.023, which requires the Texas Board of Health (board) to develop immunization requirements for children; Health and Safety Code, §§161.004(d) and 161.0041, which require the board to enact rules to implement exemptions to immunization requirements; Education Code, §38.001, which allows the board to develop immunization requirements for admission to any elementary or secondary school; Education Code, §51.933, which allows the board to develop immunization requirements for and students enrolled in health-related and veterinary courses in institutions of higher education; Human Resources Code, §42.043, which requires the department to make rules regarding the immunization of children admitted to child-care facilities; and Health and Safety Code, §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§97.62.Exclusions from Compliance.

Exclusions from compliance are allowable on an individual basis for medical contraindications, reasons of conscience, including a religious belief, and active duty with the armed forces of the United States. Children and students in these categories must submit evidence for exclusion from compliance as specified in the Health and Safety Code, §161.004(d), Health and Safety Code, §161.0041, Education Code, Chapter 38, Education Code, Chapter 51, and the Human Resources Code, Chapter 42.

(1) To claim an exclusion for medical reasons, the child or student must present a statement signed by the child's physician (M.D. or D.O.), duly registered and licensed to practice medicine in the United States who has examined the child, in which it is stated that, in the physician's opinion, the vaccine required is medically contraindicated or poses a significant risk to the health and well-being of the child or any member of the child's household. Unless it is written in the statement that a lifelong condition exists, the exemption statement is valid for only one year from the date signed by the physician.

(2) To claim an exclusion for reasons of conscience, including a religious belief, a signed affidavit must be presented by the child's parent or guardian, stating that the child's parent or guardian declines vaccinations for reasons of conscience, including because of the person's religious beliefs. The affidavit will be valid for a two-year period. The child, who has not received the required immunizations for reasons of conscience, including religious beliefs, may be excluded from school in times of emergency or epidemic declared by the commissioner of public health.

(A) A person claiming exclusion for reasons of conscience, including a religious belief, from a required immunization may only obtain the affidavit form by submitting a written request to the department. The request must include the following:

(i) full name of child;

(ii) child's date of birth (month/day/year);

(B) Written requests must be submitted through the United States Postal Service (or other commercial carrier), by facsimile, or by hand delivery to the department's Bureau of Immunization and Pharmacy Support, 1100 West 49th Street, Austin, Texas 78756.

(C) Upon request, one affidavit form for each child will be mailed unless otherwise specified (shall not exceed a maximum of five forms per child).

(D) The department shall not maintain a record of the names of individuals who request an affidavit and shall return the original request with the forms requested.

(3) To claim an exclusion for armed forces, persons who can prove that they are serving on active duty with the armed forces of the United States are exempted from the requirements in these sections.

§97.63.Required Immunizations.

Every child in the state shall be immunized against vaccine preventable diseases caused by infectious agents in accordance with the following immunization schedule.

(1) In accordance with the Texas Department of Health Immunization Schedule as informed by the Advisory Committee on Immunization Practices' (ACIP) recommendations and adopted by the Texas Board of Health and published in the Texas Register annually, for all vaccines herein, vaccine doses administered less than or equal to four days before the minimum interval or age shall be counted as valid.

(2) A child or student shall show acceptable evidence of vaccination prior to entry, attendance, or transfer to a child-care facility or public or private elementary or secondary school, or institution of higher education.

(A) Children enrolled in child-care facilities, pre-kindergarten, or early childhood programs shall have the following.

(i) Age-appropriate vaccination against diphtheria, pertussis, tetanus, poliomyelitis, Haemophilus influenzae type b, measles, mumps, rubella, hepatitis B, and varicella in accordance with the Texas Department of Health Immunization Schedule as informed by the Advisory Committee on Immunization Practices' (ACIP) recommendations and adopted by the Texas Board of Health and published in the Texas Register annually. A copy of the current schedule is available at www.ImmunizeTexas.com or by mail to the Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

(ii) Hepatitis A. Age-appropriate vaccination against hepatitis A for children attending a child-care facility, pre-kindergarten or early childhood programs located in a high incidence geographic area as designated by the department. A list of geographic areas for which hepatitis A is mandated shall be published in the Texas Register on an annual basis and is available at www.ImmunizeTexas.com or by mail to the Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

(B) Students in kindergarten through twelfth grade shall have the following vaccines.

(i) Poliomyelitis.

(I) Upon entry into kindergarten, students are required to have four doses of polio vaccine one of which must have been received on or after the fourth birthday. Or, if the third dose was administered on or after the fourth birthday only three doses are required. If any combination of four doses of OPV and IPV was received before four years of age no additional dose if required.

(II) Polio vaccine is not required for persons eighteen years of age or older.

(ii) Diphtheria/Tetanus/Pertussis.

(I) Upon entry into kindergarten, students are required to have five doses of a diphtheria-tetanus-pertussis containing vaccine in any combination unless the fourth dose was received on or after the fourth birthday in which case only four doses are required.

(II) Students who started their vaccinations after age seven are required to have at least three doses of a tetanus-diphtheria containing vaccine. Any combination of three doses of a tetanus-diphtheria containing vaccine will meet this requirement. One dose of a tetanus-diphtheria containing vaccine is required within the last ten years.

(iii) Measles. Two doses of measles-containing vaccine are required. The first dose shall be administered on or after the first birthday.

(iv) Rubella. One dose of rubella vaccine received on or after the first birthday is required.

(v) Mumps. One dose of mumps vaccine received on or after the first birthday is required.

(vi) Hepatitis B.

(I) Three doses of hepatitis B vaccine are required for the following grades for the following school years:

(-a-) 2004-2005 for kindergarten through fifth grade and seventh through tenth grade;

(-b-) 2005-2006 for kindergarten through eleventh grade; and

(-c-) thereafter, beginning in school year 2006-2007, for all students in grades kindergarten through twelfth grade.

(II) In some circumstances, the United States Food and Drug Administration may approve the use of an alternative dosage schedule for an existing vaccine. These alternative regimens may be used to meet this requirement only when alternative regimens are fully documented. Such documentation must include vaccine manufacturer and dosage received for each dose of that vaccine.

(vii) Varicella. One dose of varicella vaccine received on or after the first birthday is required for the following grades for the following school years:

(I) 2004-2005 for kindergarten through fourth grade and seventh through tenth grade;

(II) 2005-2006 for kindergarten through fifth grade and seventh through eleventh grade; and

(III) thereafter, beginning in school year 2006-2007, for all students in grades kindergarten through twelfth grade. Two doses are required if the child was thirteen years old or older at the time the first dose of varicella vaccine was received.

(viii) Hepatitis A. Upon entry into kindergarten through third grade, two doses of hepatitis A vaccine are required for students attending a school located in a high incidence geographic area as designated by the department. The first dose shall be administered on or after the second birthday. A list of geographic areas for which hepatitis A is mandated shall be published in the Texas Register on an annual basis and is available at www.ImmunizeTexas.com , or by mail request at Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

§97.68.Acceptable Evidence of Vaccination.

(a) Vaccines administered after September 1, 1991, shall include the month, day, and year each vaccine was administered.

(b) Documentation of vaccines administered that include the signature or stamp of the physician or his/her designee, or public health personnel is acceptable.

(d) A record received from school officials including a record from another state is acceptable.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 12, 2004.

TRD-200401871

Proposal publication date: December 5, 2003

For further information, please call: (512) 458-7236

Subchapter H. TUBERCULOSIS SCREENING FOR JAILS AND OTHER CORRECTIONAL FACILITIES

25 TAC §§97.171 - 97.180, 97.190, 97.191

The Texas Department of Health (department) adopts amendments to §§97.171-97.180, 97.190 and 97.191, concerning tuberculosis screening and treatment in jails and other correctional facilities. Sections 97.173-97.175, 97.178, 97.180 and 97.190 are adopted with changes to the proposed text as published in the October 3, 2003, issue of the Texas Register (28 TexReg 8555). Sections 97.171-97.172, 97.176-97.177, 97.179, and 97.191 are adopted without changes and will not be republished. The amended sections list the purpose, scope, screening, scope of professional examinations/evaluation, diagnostic evaluations, treatment, prevention of disease, reporting, tuberculosis record, resource allocation, approval of local jail screening standards, and continuity of care.

Government Code, §2001.039, requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). The department has reviewed the sections and has determined that reasons for adopting the sections continue to exist; however, revisions were needed in order to reflect the changes in national recommendations for tuberculosis screening and treatment of tuberculosis and latent tuberculosis infection.

The amendments clarify wording questioned by stakeholders and correct any discrepancies between the rules and recommendations from the Centers for Disease Control and Prevention, the American Thoracic Society, and the Infectious Diseases Society of America concerning screening and treatment of tuberculosis and latent tuberculosis infection as described in this preamble.

The department published a Notice of Intention to Review for the sections in the Texas Register on January 14, 2000 (25 TexReg 275). No comments were received due to the publication of this notice.

No public comments were received during the comment period for the rules. However, the department has made the following minor changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning §97.173(4)(C)(iii) the words "...or a certificate signed by a physician or registered nurse..." were deleted.

Change: Concerning §97.173(5)(A) the words "...to perform chest x-rays on inmates instead of a skin test screening program..." were changed to "...to perform chest x-rays on inmates on intake instead of a skin test screening program; however, use of the chest x-ray screening method on intake is to be followed by testing for latent TB infection within 14 days..."

Change: Concerning §97.174(b)(2) the words "If symptoms of TB shall develop..." were changed to "If symptoms of TB develop..."

Change: Concerning §97.174(b)(3) the deletion of the comma allows for clearer reading "...for asymptomatic persons..." in the first sentence of the paragraph.

Change: Concerning the chart in §97.175(a), the words "Retest all employees..." were changed to "Rescreen all employees..." in the information box describing actions to take when the reaction is not positive.

Change: Concerning §97.178(d) the words "shall be reported to the local health authority or a Texas Department of Health regional office" were added to the end of the section.

Change: Concerning §97.180(1) the words "...to jails and community corrections facilities..." were changed to "...to covered jails and community corrections facilities..."

Change: Concerning §97.190(d) the words "...department shall review jail TB screening plan..." were changed to "...department shall review the jail TB screening plans..."

The amendments are adopted under the authority of the Health and Safety Code, §89.072, which provides the department the right to recommend to the Commission on Jail Standards and the Texas Department of Criminal Justice rules to carry out Chapter 89 on screening and treatment for tuberculosis in jails and other correctional facilities; and Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner. The review of these rules implements Government Code, §2001.039.

§97.173.Screening.

Screening for tuberculosis (TB) in institutional settings usually involves testing for latent tuberculosis infection (LTBI) and additional evaluation of those who are infected. In some correctional facilities, it may be more practical to screen with chest x-rays to identify individuals with lung abnormalities suggestive of pulmonary tuberculosis. While the chest x-ray method is more expensive, it can be an acceptable technique to identify and segregate tuberculosis suspects; however, use of the chest x-ray screening method on intake is to be followed by testing for latent TB infection within 14 days.

(1) Tuberculin skin test.

(A) The tuberculin skin test utilizing purified protein derivative (PPD) is the standard method of identifying persons infected with Mycobacterium tuberculosis , the causative agent of TB. The intradermal Mantoux PPD test, not a multiple puncture test, shall be used to detect latent tuberculosis infection.

(B) The Mantoux PPD test is the only type of testing material that is supplied by the Texas Department of Health (department).

(2) Administration of tests.

(A) The Mantoux PPD test can be applied by anyone properly trained in tuberculin skin testing procedures including applying, reading, and interpretation.

(B) Unlicensed personnel should be supervised by licensed health care workers according to the requirements of the Board of Medical Examiners and Board of Nurse Examiners in conformity with the Texas Medical Practice Act and the Nurse Practice Act, §218.11, and other applicable laws.

(3) Interpretation of tests for latent tuberculosis infection.

(A) The Mantoux PPD test shall be read 48 to 72 hours after injection. However, if the person is not available for the scheduled reading, positive reactions may still be measurable up to one week after testing. The reading shall be based on measurement of induration (palpable swelling), not erythema (redness). The diameter of induration shall be measured transversely to the long axis of the forearm and recorded in millimeters.

(B) A reaction of 5 mm or greater shall be considered positive in persons who are human immunodeficiency virus (HIV) infected, who are recent contacts to TB cases, who have apical fibronodular infiltrates on chest x-rays consistent with prior tuberculosis, or persons with organ transplants and other immunosuppressed persons receiving the equivalent of 15 mg/d or greater of prednisone for 1 month or more. All other persons tested in a correctional facility will be considered positive if their skin test reaction is 10 mm or greater.

(C) Absence of a reaction to the tuberculin test does not exclude the diagnosis of TB or latent TB infection. Persons who have symptoms consistent with active tuberculosis shall be evaluated for disease even if they have a negative skin test.

(D) The PPD test can be read by anyone properly trained in tuberculin skin testing procedures including applying and reading.

(E) Positive tuberculin reactions in Bacillus Calmette-Guerin (BCG)-vaccinated persons usually indicate infection with TB. Such persons shall be evaluated for treatment of latent TB infection. Skin tests shall be interpreted without regard to a history of BCG vaccination.

(4) Scope. Skin test screening for tuberculosis shall be performed on employees and volunteers as well as inmates of county jails and correctional facilities as follows.

(A) Employees.

(i) Employees who share the same air with inmates shall be screened at time of employment and at least annually thereafter according to this section unless the employee or volunteer is exempt as described in clauses (ii), (iii), or (iv) of this subparagraph. A certificate or similar document may be used to record results. The recommended certificate is located in §97.179 of this title (relating to the Tuberculosis Record).

(ii) Employees with a history of a positive tuberculin skin test shall provide documentation of the test and any appropriate medical follow-up or a certificate signed by a physician or registered nurse. The documentation shall be included in the certificate or a similar document.

(iii) Employees are exempt from screening if the screening conflicts with the tenets of an organized religion to which they belong.

(iv) Employees may be exempt from screening if medically contraindicated based on an examination signed by a physician. The only valid contraindication is a documented history of severe reaction to a tuberculin skin test.

(v) Employees with a history of negative skin tests who are close contacts to a known or suspected case of TB shall be skin tested after exposure. If the test is still negative, they shall be retested 90 days after break in contact with the known or suspected case of TB occurs.

(B) Volunteers.

(i) All volunteers who share the same air space with inmates on a regular basis (more than 30 hours per month) shall be screened prior to becoming a volunteer and at least annually thereafter according to this section unless the volunteer is exempt as described in clauses (ii), (iii), or (iv) of this subparagraph. A certificate or similar document may be used to record results. The recommended certificate is located in §97.179 of this title.

(ii) Volunteers with a history of a positive tuberculin skin test shall provide documentation of the test and any appropriate medical follow-up or a certificate signed by a physician or registered nurse. The documentation shall be included in the certificate or a similar document.

(iii) Volunteers are exempt from screening if the screening conflicts with the tenets of an organized religion to which they belong.

(iv) Volunteers may be exempt from screening if medically contraindicated based on an examination signed by a physician. The only valid contraindication is a documented history of severe reaction to a tuberculin skin test.

(v) Volunteers with a history of negative skin tests who are close contacts to a known or suspected case of TB shall be skin tested after exposure. If the test is still negative, they shall be retested 90 days after break in contact with the known or suspected case of TB occurs.

(i) With the exception of those inmates who meet the criteria in clauses (iii), (iv) or (v) of this subparagraph, all inmates who reside (or are expected to reside) in the facility for seven days or longer shall be screened according to this section. A certificate or similar document may be used to document results. The recommended certificate is located in §97.179 of this title (relating to Tuberculosis Record).

(ii) Every inmate shall have a screening test on or before the seventh day of incarceration and at least annually thereafter if the inmate is not known to be a previous positive reactor.

(iii) Every inmate must have a screening test unless the inmate has documented results of at least one screening test during the previous 12-month period or documented history of a positive tuberculin skin test. An inmate with a history of a positive tuberculin skin test shall provide documentation of the test and any appropriate medical follow-up. The documentation shall be included in the certificate or a similar document.

(iv) Inmates are exempt from screening if the screening conflicts with the tenets of an organized religion to which they belong.

(v) Inmates may be exempt from screening if medically contraindicated based on an examination signed by a physician. The only valid contraindication is a documented history of severe reaction to a tuberculin skin test.

(vi) Inmates with a history of negative skin tests who are close contacts to a known or suspected case of TB shall be skin tested after exposure. If the test is still negative, they shall be retested 90 days after break in contact with the known or suspected case of TB occurs.

(5) X-ray screening programs.

(A) Correctional facilities may elect to perform chest x-rays on inmates on intake instead of a skin test screening program; however, use of the chest x-ray screening method on intake is to be followed by testing for latent TB infection within 14 days.

(B) If inmate chest x-rays screening is done on inmates, the requirement for skin test screening of staff and volunteers will remain in effect.

(6) Frequency of screening tests.

(A) Frequency. Annual (or more frequent) tuberculosis (TB) screening of employees, volunteers, or inmates is required. When a specific situation indicates an increased risk of transmission, more frequent TB screening is recommended.

(B) Repeat tests. Employees or volunteers who have a verified record of a previous positive test for TB do not have to have repeat tests.

§97.174.Scope of Professional Examinations/Evaluation.

(a) Examination for active tuberculosis (TB).

(1) Persons with positive tuberculin skin tests or with skin-test conversions on repeat testing or after exposure shall be clinically evaluated for active TB. Persons with symptoms suggestive of TB shall be evaluated regardless of skin-test results.

(2) If TB is diagnosed, appropriate therapy shall be instituted according to accepted medical practice.

(A) Persons diagnosed with active TB shall be offered counseling and human immunodeficiency virus (HIV)-antibody testing.

(B) The need for counseling and HIV testing should be stressed in persons diagnosed with active TB.

(b) Latent TB infection without disease.

(1) Persons who have latent TB infection but do not have symptoms or radiologic findings suggestive of TB disease shall be evaluated for treatment of latent TB infection. Persons with positive skin tests shall be evaluated for risk of HIV infection. If HIV infection is considered a possibility, counseling and HIV-antibody testing shall be strongly encouraged.

(2) All persons with a history of TB or latent TB infection are at risk for developing TB in the future. These persons shall be reminded at least annually and following their exposure to a known or suspected case of TB that they shall promptly report any pulmonary symptoms. If symptoms of TB develop, the person shall be evaluated immediately.

(3) Routine chest films are not required for asymptomatic persons who have negative tests for latent TB infection. After the initial chest radiograph is taken, persons with positive tuberculin skin-test reactions do not need repeat chest radiographs, unless symptoms develop that may be due to TB.

§97.175.Diagnostic Evaluations.

(a) The following flow chart shows the steps used in the diagnostic evaluation process.

Figure: 25 TAC §97.175(a) (.pdf)

(b) Bacteriologic examinations of specimens.

(1) Persons with TB symptoms and/or chest x-ray suggestive of active TB will need bacteriologic evaluation of sputum or another specimen for "acid fast bacilli" (AFB) smear and culture.

(2) Initially, a series of three sputum specimens shall be collected and examined by smear and culture. At least two of the sputum specimens shall be collected early in the morning of successive days. Supervision shall be used to ensure proper specimen collection.

(3) The Texas Department of Health will supply appropriate sputum collection materials and perform the smear and culture tests.

§97.178.Reporting.

(a) Cases.

(1) All suspected or diagnosed cases of tuberculosis (TB) shall be reported within one working day to the local health authority or a Texas Department of Health regional office.

(2) The following information shall be reported: complete name, date of birth, physical address and county of residence, information on which diagnosis was based or suspected. In addition, if known, radiographic or diagnostic imaging results and date(s); all information necessary to complete the most recent versions of forms TB 400 A & B (Report of Case and Patient Services), TB 340 (Report of Contacts) and TB 341 (Continuation of Report of Contacts); laboratory results used to guide prescribing, monitoring or modifying antibiotic treatment regimens for tuberculosis to include, but not limited to, liver function studies, renal function studies, and serum drug levels; pathology reports related to diagnostic evaluations of tuberculosis; reports of imaging or radiographic studies; records of hospital or outpatient care to include, but not limited to, histories and physical examinations, discharge summaries and progress notes; records of medication administration to include, but not limited to, directly observed therapy (DOT) records, and drug toxicity and monitoring records; a listing of other patient medications to evaluate the potential for drug-drug interactions; and copies of court documents related to court ordered management of tuberculosis. Reporting forms are available from local health departments, Texas Department of Health regional offices, or the TB Elimination Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756.

(b) Latent TB infection.

(1) All occurrences of latent TB infection shall be reported no later than one week after diagnosis to the local health authority or a Texas Department of Health regional office.

(2) The following information shall be reported: complete name; date of birth; physical address, county of residence, tuberculin skin test result, and chest x-ray result.

(3) For those with latent TB infection who are receiving treatment all information necessary to complete the most recent versions of forms TB 400 A & B (Report of Case and Patient Services) shall be reported.

(c) Tuberculin tests. Aggregate numbers of positive tests, total tests administered, and total tests read shall be reported monthly to the local health authority that shall forward the reports to the TB Elimination Division of the Texas Department of Health.

(d) Contacts. For contacts to a known case of tuberculosis -- complete name; date of birth; physical address; county of residence; and all information necessary to complete the most recent versions of forms TB 400 A & B (Report of Case and Patient Services), TB 340 (Report of Contacts), and TB 341 (Continuation of Report of Contacts) shall be reported to the local health authority or a Texas Department of Health regional office.

§97.180.Resource Allocation.

Under the terms of Chapter 786, §3, 73rd Legislature (Act), the costs of providing inmate screening, evaluation, and treatment is supported by a combination of individual counties and judicial districts, Texas Department of Health (department), and Texas Department of Criminal Justice (TDCJ) funds. The following terms govern this allocation.

(1) Texas Department of Health. The Texas Department of Health (department) shall supply the materials, pharmaceuticals, and laboratory services to covered jails and community corrections facilities that are necessary to accomplish the screening required by the Act, and provide other services requested by individual counties and judicial districts, where such services can be reasonably provided. These materials, drugs, and services may be requested from the Texas Department of Health, Tuberculosis Elimination Division, 1100 West 49th Street, Austin, Texas 78756.

(2) Texas Department of Criminal Justice.

(A) The Texas Department of Criminal Justice (TDCJ) shall provide funds for administering screenings, evaluating inmates, and administering drugs to two classes of inmates suspected of having an active case of tuberculosis. The two classes are:

(i) inmates whose paperwork and processing required under Code of Criminal Procedure, 8, Subsection (a), Article 42.09, has been completed; and

(ii) inmates in a community corrections facility.

(B) The TDCJ shall reimburse a county or judicial district in the same manner provided for reimbursements under Government Code, §499.123.

(3) Counties and judicial districts. Counties and judicial districts shall provide funds for administering screenings, evaluating inmates, and administering drugs to inmates suspected of having an active case of tuberculosis:

(A) for inmates who are pretrial, inmates whose paperwork and processing under Code of Criminal Procedure, §8, Subsection (a), Article 42.09, is not completed; and

(B) for inmates who are not to be transferred to a TDCJ facility.

§97.190.Approval of Local Jail Screening Standards.

(a) Counties, judicial districts, and private entities operating community corrections facilities shall adopt local standards for screening tests of employees, volunteers, and inmates.

(b) The standards required in subsection (a) of this section shall, at minimum, be compatible with, and at least as stringent as, the standards set out in these sections. In addition the standards shall incorporate the requirements set out in the Texas Health and Safety Code, §§89.001-89.072.

(c) Prior approval of the Texas Department of Health (department) shall be obtained before the adoption of local jail standards.

(d) Prior to final adoption of local jail standards, the jail TB screening plan shall be submitted to the Texas Department of Health, Tuberculosis Elimination Division, 1100 West 49th Street, Austin, Texas 78756-3199. The department shall review the jail TB screening plans to determine their compliance with subsection (b) of this section and the Texas Health and Safety Code, §89.073. This approval shall be from the director of the Tuberculosis Elimination Division. If the approval is denied by the director of the Tuberculosis Elimination Division, the county, judicial district, or private entity may appeal the denial to the Bureau Chief, Bureau of Communicable Disease Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 12, 2004.

TRD-200401864

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: April 1, 2004

Proposal publication date: October 3, 2003

For further information, please call: (512) 458-7236

Chapter 133. HOSPITAL LICENSING

The Texas Department of Health (department) adopts amendments to §§133.2, 133.22, 133.23, 133.26, 133.45, 133.101, 133.121, 133.141 - 133.143 and 133.161 - 133.167, and new §133.48, concerning the regulation of hospitals. Sections 133.2, 133.22, 133.23, 133.48 and 133.101 are adopted with changes to the proposed text as published in the November 21, 2003, issue of the Texas Register (28 TexReg 10381). Sections 133.26, 133.45, 133.121, 133.141 - 133.143 and 133.161 - 133.167 are adopted without changes and, therefore, the sections will not be republished.

The amendments and new section in Subchapters A - C, F, and G are required as a result of revisions and additions to sections of the Health and Safety Code. House Bill (HB) 2292, 78th legislature, 2003, revised Health and Safety Code, §§12.0111 and 12.0112, and requires two-year licenses effective January 1, 2005; HB 341, 78th legislature, 2003, added Health and Safety Code, §§161.451 and 161.452, and requires parenting and postpartum counseling information to be provided to patients; and Senate Bill 162, 78th legislature, 2003, which amended Health and Safety Code, §241.053, and added probation to the list of enforcement actions that can be taken against a facility; HB 15, 78th legislature, 2003, added Health and Safety Code, Chapter 171, and requires information and consent forms to be provided to abortion patients; HB 1614, 78th legislature, 2003, amended Health and Safety Code, Chapter 241, by adding Subchapter H, which establishes a patient safety program. The amendments to Subchapters H and I are necessary to make the rules compatible with the requirements of the federal Medicare Conditions of Participation, and will eliminate burdensome requirements concerning operable windows.

Specifically, the amendment to §133.2 includes additional definitions for action plan, adverse event, medical error, reportable event, and root cause analysis. Amendments to §§133.22 and 133.23 implement the process for converting to two-year licensing cycles beginning January 1, 2005. The amendment to §133.26 changes the description of fee assessment to accommodate the change to the two-year license cycle. The amendment to §133.45 requires a hospital which provides obstetrical services on a routine or emergency basis to adopt a policy concerning postpartum counseling and parental assistance, and requires a hospital that performs abortions to adopt a policy concerning informed consent for abortion. New §133.48 includes requirements related to development and implementation of a patient safety program, and establishes annual reporting requirements related to specific events occurring at the facility, and submission of best practice reports. The amendment to §133.101 clarifies limitations on the department's access related to a root analysis and action plan. The amendment to §133.121 reflects the addition of probation to the list of enforcement actions that can be taken against a facility. Amendments to §§133.141 - 133.143 and 133.161 - 133.167 change all references to compliance with National Fire Protection Association, Code for Safety to Life from Fire in Buildings and Structures, (NFPA 101), from the 1997 edition to the 2000 edition; update the editions of other codes referenced in NFPA 101 to those required by the 2000 edition; change chapter and section numbers referenced in the 1997 edition to the new chapter and section numbers in the 2000 edition; and eliminate the requirement for operable windows in patient sleeping rooms, a burdensome requirement which has resulted in numerous requests to the department for waiver of the requirement. Operable windows are not required in the 2000 edition of NFPA 101.

The following comments were received concerning the proposed sections. Following each comment is the department's response and any resulting change(s).

Comment: Concerning the rules in general, one commenter requested that the department add a definition for "legal custody", and recommended content for that definition. The commenter stated that questions had arisen regarding who has "legal custody" of a newborn, and whether proof of legal custody would be required through a court document before the newborn could be released. The commenter believed this would create an unworkable standard for the parent or legal guardian, and felt that including a definition in the rules would clarify what was required.

Response: The department disagrees. The legislature used the term "legal custody" in the legislation, and chose not to include any clarifying definition of that term. The term is legally defined as "lawfully in possession; guardianship by authority of a legal process." The department is not requiring that the parent or legal guardian obtain official court documentation in every instance before a newborn could be released to someone other than the parent or guardian. The language in the statute and the rule clearly states that the hospital is expected to exercise ordinary care in releasing a newborn to anyone other than the parent or legal guardian. The hospital must determine what documentation they will require and under what circumstances a newborn would be released to anyone other than the parent or legal guardian. No change was made as a result of this comment.

Comment: Concerning §133.2(4), one commenter was opposed to scope of the definition of "adverse event" in the proposed rule, and recommended that the department adopt the Institute of Medicine's definition of that term.

Response: The department agrees. Since the Institute of Medicine is a nationally recognized authority on health care quality and patient safety, it is appropriate to use their definition of the term "adverse event". The rule has been changed to include the definition found in the Institute of Medicine's 2004 publication entitled Patient Safety: Achieving a New Standard of Care.

Comment: Concerning §133.2(36), one commenter requested that the department consider changing the definition of "medical error" to be consistent with the definition used by the Institute of Medicine.

Response: The department agrees. Since the Institute of Medicine is a nationally recognized authority on health care quality and patient safety, it is appropriate to use their definition of the term "medical error". The rule has been changed to include the definition found in the Institute of Medicine's 2004 publication entitled Patient Safety: Achieving a New Standard of Care.

Comment: Concerning §133.48(a)(1)(B)(ii)-(iv), one commenter asked that the department clarify that these reporting requirements applied only to the hospitals internal reporting systems, and not to any external reporting requirements.

Response: Although §133.48(a)(1)(B)(ii)-(iv) as proposed did not place any external reporting requirements on the hospital, the department agreed to include the revised language in §133.48(a)(1)(B)(ii)-(iv) to provide the additional clarification requested by the commenter.

Comment: Concerning §133.48(a)(1)(B)(vi), one commenter stated that the requirement that hospitals have in place a support system for staff members who were involved in medical errors would be unduly burdensome for small and rural facilities.

Response: The rationale for including this requirement in the proposed rule was based on the recommendations of nationally recognized patient safety organizations who emphasize that a patient safety program can only be successful if it is presented in a non-punitive manner and with an organizational commitment to providing support to those who voluntary report medical errors. However, the department agrees that making this support system mandatory could be burdensome on some facilities, therefore, the requirement has been deleted in §133.48(a)(1)(B)(vi) and the subsequent clauses renumbered. Hospitals are encouraged to voluntarily provide a support system for staff who are involved in a medical error.

Comment: Concerning §133.48(a)(1)(B)(xi), two commenters requested that the proposed rule requiring that hospitals include a process for educating patients regarding their shared responsibility for patient safety be deleted, as the language was vague and it would be unduly burdensome to educate patients.

Response: The rationale for including this requirement in the proposed rule was based on the Institute of Medicine's recommendation that health care organizations implement polices designed to assist patients and their families in understanding their roles in assuring the safety of patients while they are in the hospital. However, the department understands that some hospitals may find compliance with this requirement excessively burdensome, therefore the requirement has been deleted from the final rule. Hospitals are strongly encouraged to voluntarily include patient safety issues in their patient education activities. Clause (xi) was deleted from subsection §133.48(a)(1)(B).

Comment: Concerning §133.48(a)(2), one commenter stated that, although training of certain personnel could be inferred to be a reasonable component of a hospital's patient safety program, the requirement to provide patient safety education and training to all clinical and administrative staff was excessive. The commenter believed it was not necessary to extend this requirement to administrative staff, and recommended that rule be revised to reflect that the training was required only for those staff directly involved with the patient safety program.

Response: The department agrees, and has revised §133.48(a)(2) to reflect this change.

Comment: Concerning §133.48(a)(3), one commenter stated that the proposed rule requiring that the hospital designate an individual to serve as the Patient Safety Program Coordinator could create an unworkable standard in many institutions. The commenter recommended that the rule be revised to allow more than one individual, or an interdisciplinary group, to be designated as responsible for the management of patient safety program.

Response: The department agrees, and has revised §133.48(a)(3) to reflect this change as well as grammatical changes to the subparagraphs of the paragraph.

Comment: Concerning §133.48(b), a commenter stated that the proposed rule which would require a hospital to report a best practice and safety measure for each type of reported event was not required by the legislation. It was the commenter's opinion that the legislation only required that hospitals submit one best practices report for a reported event, even if multiple types of reportable events were identified in the reporting year.

Response: Although the department believes that the legislation, as written, can be interpreted to mean that a best practice report should be submitted for each type of reported occurrence, the author of the legislation has clarified that the intent was only to require submission of one best practice report for each facility, not for each type of reported occurrence. The department believes this interpretation can also be considered consistent with the legislation, therefore the rule has been revised to reflect this change to paragraphs (1)(A) and (2)(A) of the subsection.

Comment: Concerning §133.48(b)(2)(A), a commenter requested that the rule be clarified to indicate the if a facility had no adverse events or occurrences to report, then no best practice reports would be required.

Response: The department disagrees. The rule clearly states that the required submission of a best practice and safety measure report is related to a reported occurrence. No change was made to the rule as a result of this comment.

The department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning §133.2(19), the definition of director was changed to reflect the correct title of the division, Health Facility Licensing and Compliance Division.

Change: Concerning §133.2(21), the definition of division was changed to reflect the correct name of the division, Health Facility Licensing and Compliance Division.

Change: Concerning §133.22(e)(2)(B), a comma was added after the date to be consistent with the punctuation following dates throughout the chapter.

Change: Concerning §133.23(b)(1)(E), the change from "and;" to "; and" in the subparagraph corrects the formatting in proposed.

Change: Concerning §133.48(a)(1)(B)(ix), the word "causeanalysis" was corrected to "cause analysis."

Change: Concerning §133.101(d)(1), the word "section" was deleted before "§133.48" to be consistent.

The commenters were the Texas Hospital Association and the Texas Scottish Rite Hospital for Children. The commenters were neither for nor against the rules in their entirety; however, they expressed concerns and made recommendations for change as discussed in the summary of comments.

Subchapter A. GENERAL PROVISIONS

25 TAC §133.2

The amendment is adopted under Health and Safety Code, §241.026, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the development, establishment, and enforcement of standards in the construction, maintenance, and operation of hospitals in Texas; and Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

§133.2.Definitions.

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Act--The Texas Hospital Licensing Law, Health and Safety Code, Chapter 241.

(2) Action plan--A written document that includes specific measures to correct identified problems or areas of concern; identifies strategies for implementing system improvements; and includes outcome measures to indicate the effectiveness of system improvements in reducing, controlling or eliminating identified problem areas.

(3) Advance directive--Written instructions recognized under state law relating to the provision of health care when individuals are unable to communicate their wishes regarding medical treatment. The advance directive may be a written document authorizing an agent or surrogate to make decisions on an individual's behalf (a durable power of attorney for health care), a written or oral statement (a living will), or some other form of instruction recognized under state law specifically addressing the provisions of health care.

(4) Adverse event--An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.

(5) Applicant--The person legally responsible for the operation of the hospital, whether by lease or ownership, who seeks a hospital license from the department.

(6) Attorney general--The attorney general of Texas or any assistant attorney general acting under the direction of the attorney general of Texas.

(7) Biological indicator--Commercially-available microorganisms (e.g., United States Food and Drug Administration (FDA) approved strips or vials of Bacillus species endospores) which can be used to verify the performance of waste treatment equipment and processes (or sterilization equipment and processes).

(8) Board--The Texas Board of Health.

(9) Chemical dependency services--A planned, structured, and organized program designed to initiate and promote a person's chemical-free status or to maintain the person free of illegal drugs. It includes, but is not limited to, the application of planned procedures to identify and change patterns of behavior related to or resulting from chemical dependency that are maladaptive, destructive, or injurious to health, or to restore appropriate levels of physical, psychological, or social functioning lost due to chemical dependency.

(10) Comprehensive medical rehabilitation--The provision of rehabilitation services that are designed to improve or minimize a person's physical or cognitive disabilities, maximize a person's functional ability, or restore a person's lost functional capacity through close coordination of services, communication, interaction, and integration among several professions that share responsibility to achieve team treatment goals for the person.

(11) Comprehensive medical rehabilitation hospital--A general hospital that specializes in providing comprehensive medical rehabilitation services, including surgery and related ancillary services.

(12) Comprehensive medical rehabilitation unit--An identifiable part of a hospital which provides comprehensive medical rehabilitation services to patients admitted to the unit.

(13) Contaminated linen--Linen which has been soiled with blood or other potentially infectious materials or may contain sharps. Other potentially infectious materials means:

(A) the following human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids;

(B) any unfixed tissue or organ (other than intact skin) from a human (living or dead); and

(C) Human Immunodeficiency Virus (HIV)-containing cell or tissue cultures, organ cultures, and HIV or Hepatitis B Virus (HBV) containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV.

(14) Cooperative agreement--An agreement among two or more hospitals for the allocation or sharing of health care equipment, facilities, personnel, or services.

(15) Dentist--A person licensed to practice dentistry by the State Board of Dental Examiners. This includes a doctor of dental surgery or a doctor of dental medicine.

(16) Department--The Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199.

(17) Designated provider--A provider of health care services, selected by a health maintenance organization, a self-insured business corporation, a beneficial society, the Veterans Administration, CHAMPUS, a business corporation, an employee organization, a county, a public hospital, a hospital district, or any other entity to provide health care services to a patient with whom the entity has a contractual, statutory, or regulatory relationship that creates an obligation for the entity to provide the services to the patient.

(18) Dietitian--A person who is currently licensed by the Texas State Board of Examiners of Dietitians as a licensed dietitian or provisional licensed dietitian, or who is a registered dietitian with the American Dietetic Association.

(19) Director--The hospital licensing director, Health Facility Licensing and Compliance Division, Texas Department of Health.

(20) Disciplinary action--Denial, suspension, or revocation of a license, issuance of an emergency order or imposition of an administrative penalty.

(21) Division--The Health Facility Licensing and Compliance Division, Texas Department of Health.

(22) Emergency medical condition--A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances or symptoms of substance abuse) such that the absence of immediate medical attention could reasonably be expected to result in one or all of the following:

(A) placing the health of the individual (or with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy;

(B) serious impairment to bodily functions;

(D) with respect to a pregnant woman who is having contractions:

(i) that there is inadequate time to effect a safe transfer to another hospital before delivery; or

(ii) that transfer may pose a threat to the health or safety of the woman or the unborn child.

(23) Fast-track projects--A construction project in which it is necessary to begin initial phases of construction before later phases of the construction documents are fully completed in order to establish other design conditions or because of time constraints such as mandated deadlines.

(24) General hospital--An establishment that:

(A) offers services, facilities, and beds for use for more than 24 hours for two or more unrelated individuals requiring diagnosis, treatment, or care for illness, injury, deformity, abnormality, or pregnancy; and

(B) regularly maintains, at a minimum, clinical laboratory services, diagnostic X-ray services, treatment facilities including surgery or obstetrical care or both, and other definitive medical or surgical treatment of similar extent.

(25) Governmental unit--A political subdivision of the state, including a hospital district, county, or municipality, and any department, division, board, or other agency of a political subdivision.

(26) Governing body--The governing authority of a hospital which is responsible for a hospital's organization, management, control, and operation, including appointment of the medical staff; includes the owner or partners for hospitals owned or operated by an individual or partners.

(27) Hospital--A general hospital or a special hospital.

(28) Hospital administration--Administrative body of a hospital headed by an individual who has the authority to represent the hospital and who is responsible for the operation of the hospital according to the policies and procedures of the hospital's governing body.

(29) Illegal conduct--A conduct prohibited by federal or state law.

(30) Inpatient--An individual admitted for an intended length of stay of 24 hours or greater.

(31) Inpatient services--Services provided to an individual admitted to a hospital for an intended length of stay of 24 hours or greater.

(32) Legally reproduced form--A medical record retained in hard copy, microform (microfilm or microfiche), or other electronic medium.

(33) Licensed vocational nurse--A person who is currently licensed under the Vocational Nurse Act by the Board of Vocational Nurse Examiners for the State of Texas as a licensed vocational nurse (LVN).

(34) Licensee--The person or governmental unit named in the application for issuance of a hospital license.

(35) Mandated provider--A person who provides health care services, is selected by a county, public hospital, or hospital district, and agrees to provide health care services to eligible residents.

(36) Medical error--The failure of a planned action to be completed as intended, the use of a wrong plan to achieve an aim, or the failure of an unplanned action that should have been completed, that results in an adverse event.

(37) Medical staff--A physician or group of physicians or a podiatrist or group of podiatrists who by action of the governing body of a hospital are privileged to work in and use the facilities of a hospital for, or in connection with, the observation, care, diagnosis, or treatment of an individual who is or may be suffering from mental or physical disease or disorder, or a physical deformity or injury.

(38) Mental health services--All services concerned with research, prevention, and detection of mental disorders and disabilities and all services necessary to treat, care for, supervise, and rehabilitate persons who have a mental disorder or disability, including persons whose mental disorders or disabilities result from alcoholism or drug addiction.

(39) Mental retardation--Significantly subaverage general intellectual functioning that is concurrent with deficits in adaptive behavior and originates during the developmental period.

(40) Mobile unit--Any pre-manufactured structure, trailer, or self-propelled unit equipped with a chassis on wheels and intended to provide shared medical services to the community on a temporary basis. Some of these units are equipped with expanding walls, and designed to be moved on a daily basis.

(41) Outpatient--An individual who presents for diagnostic or treatment services for an intended length of stay of less than 24 hours.

(42) Outpatient services--Services provided to patients whose medical needs can be met in less than 24 hours and are provided within the hospital.

(43) Owner--One of the following persons or governmental unit which will hold or does hold a license issued under the statute in the person's name or the person's assumed name:

(A) a corporation;

(B) a governmental unit;

(D) an individual;

(E) a partnership if a partnership name is stated in a written partnership agreement or an assumed name certificate;

(F) all partners in a partnership if a partnership name is not stated in a written partnership agreement or an assumed name certificate; or

(G) all co-owners under any other business arrangement.

(44) Patient--An individual who presents for diagnosis or treatment.

(45) Pediatric and adolescent hospital--A general hospital that specializes in providing services to children and adolescents, including surgery and related ancillary services.

(46) Person--An individual, firm, partnership, corporation, association, or joint stock company, and includes a receiver, trustee, assignee, or other similar representative of those entities.

(47) Physician--A physician licensed by the Texas State Board of Medical Examiners.

(48) Podiatrist--A podiatrist licensed by the Texas State Board of Podiatry Examiners.

(49) Practitioner--A health care professional licensed in the State of Texas, other than a physician, podiatrist, or dentist.

(50) Premises--A premises may be any of the following:

(A) a single building where inpatients receive hospital services; or

(B) multiple buildings where inpatients receive hospital services, provided that the following criteria are met:

(i) all inpatient buildings and inpatient services are subject to the control and direction of the governing body of the hospital;

(ii) all inpatient buildings are within a 30-mile radius of the main address of the licensee;

(iii) there is integration of the organized medical staff of the hospital;

(iv) there is a single chief executive officer who reports directly to the governing body and through whom all administrative authority flows and who exercises control and surveillance over all administrative activities of the hospital;

(v) there is a single chief medical officer who reports directly to the governing body and who is responsible for all medical staff activities of the hospital; and

(vi) each building that is geographically separate from other buildings contains at least one nursing unit for inpatients, unless providing only diagnostic or laboratory services, or a combination thereof, in the building for hospital inpatients.

(51) Presurvey conference--A conference held with department staff and the applicant or the applicant's representative to review licensure rules and survey documents and provide consultation prior to the on-site licensure inspection.

(52) Psychiatric disorder--A clinically significant behavioral or psychological syndrome or pattern that occurs in an individual and that is typically associated with either a painful syndrome (distress) or impairment in one or more important areas of behavioral, psychological, or biological function and is more than a disturbance in the relationship between the individual and society.

(53) Registered nurse--A person who is currently licensed by the Board of Nurse Examiners for the State of Texas as a registered nurse (RN).

(54) Relocatable unit--Any structure, not on wheels, built to be relocated at any time and provide medical services. These structures vary in size.

(55) Reportable event--A medical error or adverse event or occurrence which the hospital is required to report to the department, as set out in §133.48 of this title (relating to Patient Safety Program).

(56) Root cause analysis--An interdisciplinary review process for identifying the basic or contributing causal factors that underlie a variation in performance associated with an adverse event or reportable event. It focuses primarily on systems and processes, includes an analysis of underlying cause and effect, progresses from special causes in clinical processes to common causes in organizational processes, and identifies potential improvements in processes or systems.

(57) Special hospital--An establishment that:

(A) offers services, facilities, and beds for use for more than 24 hours for two or more unrelated individuals who are regularly admitted, treated, and discharged and who require services more intensive than room, board, personal services, and general nursing care;

(B) has clinical laboratory facilities, diagnostic X-ray facilities, treatment facilities, or other definitive medical treatment;

(D) maintains records of the clinical work performed for each patient.

(58) Stabilize--With respect to an emergency medical condition, to provide such medical treatment of the condition necessary to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a facility, or that the woman has delivered the child and the placenta.

(59) Transfer--The movement (including the discharge) of an individual outside a hospital's facilities at the direction of any person employed by (or affiliated or associated, directly or indirectly, with) the hospital, but does not include such a movement of an individual who has been declared dead, or leaves the facility without the permission of any such person.

(60) Transportable unit--Any pre-manufactured structure or trailer, equipped with a chassis on wheels, intended to provide shared medical services to the community on an extended temporary basis. These units are designed to be moved periodically, depending on need.

(61) Unethical conduct--Conduct prohibited by the ethical standards adopted by state or national professional organizations for their respective professions or by rules established by the state licensing agency for the respective profession.

(62) Universal precautions--Procedures for disinfection and sterilization of reusable medical devices and the appropriate use of infection control, including hand washing, the use of protective barriers, and the use and disposal of needles and other sharp instruments as those procedures are defined by the Centers for Disease Control (CDC) of the United States Public Health Service. This term includes standard precautions as defined by CDC which are designed to reduce the risk of transmission of blood borne and other pathogens in hospitals.

(63) Violation--Failure to comply with the licensing statute, a rule or standard, special license provision, or an order issued by the commissioner of health or the commissioner's designee, adopted or enforced under the licensing statute. Each day a violation continues or occurs is a separate violation for purposes of imposing a penalty.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401890

For further information, please call: (512) 458-7236

Subchapter B. HOSPITAL LICENSE

25 TAC §§133.22, 133.23, 133.26

The amendments are adopted under Health and Safety Code, §241.026, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the development, establishment, and enforcement of standards in the construction, maintenance, and operation of hospitals in Texas; and Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

§133.22.Application and Issuance of Initial License.

(a) Application submittal. The applicant shall submit the following documents to the Texas Department of Health (department) no earlier than 60 calendar days prior to the projected opening date of the hospital:

(1) an accurate and complete application form;

(2) a copy of the hospital's patient transfer policy which is developed in accordance with §133.44 of this title (relating to Hospital Patient Transfer Policy) and is signed by both the chairman and secretary of the governing body attesting to the date the policy was adopted by the governing body and the effective date of the policy;

(3) a copy of the hospital's memorandum of transfer form which contains at a minimum the information described in §133.44(b)(11)(B) of this title;

(4) if the application is for a special hospital license, a copy of a written agreement the special hospital has entered into with a general hospital which provides for the prompt transfer to and the admission by the general hospital of any patient when special services are needed but are unavailable at the special hospital. This agreement is required and is separate from any voluntary patient transfer agreements the hospital may enter into in accordance with §133.61 of this title (relating to Hospital Patient Transfer Agreements);

(5) copies of any patient transfer agreements entered into between the hospital and another hospital in accordance with §133.61 of this title;

(6) for existing facilities, a copy of a hospital fire safety survey indicating approval by the local fire authority in whose jurisdiction the hospital is based that is dated no earlier than one year prior to the hospital opening date. For new construction, addition, and renovation projects, written approval by the local building department and local fire authority shall be submitted during the final construction inspection by the department;

(7) the appropriate license fee as required in §133.26 of this title (relating to Fees); and

(8) if the applicant is a sole proprietor, partnership with individuals as a partner, or a corporation in which an individual has an ownership interest of at least 25% of the business entity, the names and social security numbers of the individuals.

(b) Verification of franchise tax status. Upon receipt of the application documents, the department shall verify the franchise tax status of an applicant who is a corporation prior to the issuance of a license. In accordance with Article 2.45, Part Two, Texas Business Corporation Act, the department will not issue a hospital license to an applicant who is a corporation if the corporation is delinquent in franchise tax owed to the state under the Tax Code, Texas Codes Annotated, Chapter 171.

(c) Additional documentation for new hospitals or conversions from nonhospital buildings. In addition to the document submittal requirements in subsection (a) of this section, and verification of the franchise tax information in subsection (b) of this section, the following shall be completed prior to the issuance of a hospital license to newly constructed hospitals or hospitals from conversions of nonhospital buildings.

(1) Preliminary and final architectural plans and specifications shall be reviewed and approved by the department in accordance with §133.167 of this title (relating to Preparation, Submittal, Review and Approval of Plans).

(2) For new construction, necessary preliminary inspections and final construction inspections shall be conducted by the department in accordance with §133.167(e)(4) of this title to determine that the hospital was constructed or remodeled in accordance with this chapter.

(3) When an applicant intends to reopen and relicense a building formerly licensed as a hospital, an on-site inspection shall be conducted by the department in accordance with §133.167(e)(4) of this title to determine compliance with applicable construction and fire safety requirements.

(4) All plan review and construction inspection fees shall be paid to the department.

(5) A certificate of occupancy approved by the local fire authority, and issued by the city building inspector, if applicable, shall be obtained and a copy submitted to the department.

(6) A complete, accurate, and notarized Affidavit for Final Construction Approval form shall be submitted to the department.

(7) The project architect shall submit a statement to the department that the hospital's project plans and specifications have been submitted to the Texas Department of Licensing and Regulation.

(d) Presurvey conference. The applicant or the applicant's representative shall attend a presurvey conference at the office designated by the department. The designated survey office may waive the presurvey conference requirement.

(e) Issuance of license. When it is determined that the hospital has complied with subsections (a)-(d) of this section, the department shall issue the license to the applicant.

(1) Effective date. The license shall be effective on the date the hospital is determined to be in compliance with subsections (a)-(d) of this section. The effective date shall not be prior to the date of the final construction inspection conducted by the department.

(2) Expiration date.

(A) For initial licenses issued prior to January 1, 2005.

(i) If the effective date of the license is the first day of a month, the license expires on the last day of the 11th month after issuance.

(ii) If the effective date of the license is the second or any subsequent day of a month, the license expires on the last day of the 12th month after issuance.

(B) For initial licenses issued January 1, 2005, or after.

(i) If the effective date of the license is the first day of a month, the license expires on the last day of the 23rd month after issuance.

(ii) If the effective date of the license is the second or any subsequent day of a month, the license expires on the last day of the 24th month after issuance.

(f) Withdrawal of application. If an applicant decides not to continue the application process for a license or renewal of a license, the application may be withdrawn. If a license has been issued, the applicant shall return the license to the department with its written request to withdraw. The department shall acknowledge receipt of the request to withdraw.

(g) Denial of a license. Denial of a license shall be governed by §133.121 of this title (relating to Enforcement Action).

(h) Inspection. During the licensing period, the department shall conduct an inspection of the hospital to ascertain compliance with the provisions of the Act and this chapter.

(1) If a hospital has applied to participate in the federal Medicare program, the inspection may be conducted in conjunction with the inspection to determine compliance with 42 Code of Federal Regulations, Part 482 (relating to Medicare Conditions of Participation for Hospitals).

(2) A hospital shall have admitted and be providing services to at least one inpatient in the hospital at the time of the inspection.

§133.23.Application and Issuance of Renewal License.

(a) Renewal notice. The Texas Department of Health (department) shall send a renewal notice to a hospital at least 60 calendar days before the expiration date of a license.

(1) If the hospital has not received the renewal notice from the department within 45 calendar days prior to the expiration date, it is the duty of the hospital to notify the department and request a renewal application for a license.

(2) If the hospital fails to submit the application and fee within 15 calendar days prior to the expiration date of the license, the department shall send by certified mail to the hospital a letter advising that unless the license is renewed, the hospital must cease operations upon the expiration of the hospital's license.

(b) Renewal license. The department shall issue a renewal license to a hospital which meets the minimum requirements for a license.

(1) The hospital shall submit the following to the department prior to the expiration date of the license:

(A) a complete and accurate application form;

(B) a copy of a hospital fire safety survey indicating approval by the local fire authority in whose jurisdiction the hospital is based that is dated no earlier than one year prior to the application date;

(D) if the applicant is accredited by the Joint Commission on Accreditation of Healthcare Organizations or the American Osteopathic Association, a copy of documentation from the accrediting body showing the current accreditation status of the hospital;

(E) an annual events report in accordance with §133.48(b)(1) of this title (relating to Patient Safety Program); and

(F) a best practices report in accordance with §133.48(b)(2) of this title.

(2) Upon receipt of the renewal documents, the department shall verify the franchise tax status of an applicant who is a corporation prior to the issuance of a license. In accordance with Article 2.45, Part Two, Texas Business Corporation Act, the department will not issue a hospital license to an applicant who is a corporation if the corporation is delinquent in franchise tax owed to the State under the Tax Code, Texas Codes Annotated, Chapter 171.

(3) The department may conduct an inspection prior to issuing a renewal license in accordance with §133.101 of this title (relating to Inspection and Investigation Procedures).

(4) Renewal licenses issued prior to January 1, 2005, will be valid for 12 months.

(5) Renewal licenses issued January 1, 2005, through December 31, 2005, will be valid for either 12 months or 24 months, to be determined by the department prior to the time of license renewal.

(6) Renewal licenses issued January 1, 2006, or after will be valid for 24 months.

(c) Notice to cease operation and return license. If a hospital fails to submit the application, documents, and fee by the expiration date of the hospital's license, the department shall notify the hospital by certified mail that it must cease operation and immediately return the license by certified mail to the department. If the hospital wishes to provide services after the expiration date of the license, it shall apply for a license under §133.22 of this title (relating to Application and Issuance of Initial License).

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401891

For further information, please call: (512) 458-7236

Subchapter C. OPERATIONAL REQUIREMENTS

25 TAC §133.45, §133.48

The amendment and new section are adopted under Health and Safety Code, §241.026, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the development, establishment, and enforcement of standards in the construction, maintenance, and operation of hospitals in Texas; and Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

§133.48.Patient Safety Program.

(a) General.

(1) The hospital must develop, implement and maintain an effective, ongoing, organization-wide, data driven Patient Safety Program (PSP).

(A) The governing body must ensure that the PSP reflects the complexity of the hospital's organization and services, including those services furnished under contract or arrangement, and focuses on the prevention and reduction of medical errors and adverse events.

(B) The PSP must be in writing, approved by the governing body and made available for review by the department. It must include the following components:

(i) the definition of medical errors, adverse events and reportable events;

(ii) the process for internal reporting of medical errors, adverse events and reportable events;

(iii) a list of events and occurrences which staff are required to report internally;

(iv) time frames for internal reporting of medical errors, adverse events and reportable events;

(v) consequences for failing to report events in accordance with hospital policy;

(vi) mechanisms for preservation and collection of event data;

(vii) the process for conducting root cause analysis;

(viii) the process for communicating action plans; and

(ix) the process for feedback to staff regarding the root cause analysis and action plan.

(2) The hospital must provide patient safety education and training to staff who have responsibilities related to the implementation, development, supervision or evaluation of the PSP. Training must include all PSP components as set out in paragraph (1)(B) of this subsection.

(3) The hospital must designate one or more individuals, or an interdisciplinary group, qualified by training or experience to be responsible for the management of the patient safety program. These responsibilities shall include:

(A) coordinating all patient safety activities;

(B) facilitating assessment and appropriate response to reported events;

(D) serving as liaison among hospital departments and committees to ensure hospital-wide integration of the PSP.

(4) Within 45 days of becoming aware of a reportable event specified under subsection (b)(1)(A) of this section, the hospital must:

(A) complete a root cause analysis to examine the cause and effect of the event through an impartial process; and

(B) develop an action plan identifying the strategies that the hospital intends to employ to reduce the risk of similar events occurring in the future. The action plan must:

(i) designate responsibility for implementation and oversight;

(ii) specify time frames for implementation; and

(iii) include a strategy for measuring the effectiveness of the actions taken.

(C) The hospital must make the root cause analysis and action plan available for on-site review by department representatives.

(b) Reporting requirements.

(1) Annual events report.

(A) On the renewal of the hospital's license, or annually based on the hospital's original licensing date, the hospital shall submit to the department a report that lists the number of occurrences at the hospital, including any outpatient facility owned or operated by the hospital, of each of the following events occurring during the preceding year:

(i) a medication error resulting in a patient's unanticipated death or major permanent loss of bodily function in circumstances unrelated to the natural course of the illness or underlying condition of the patient;

(ii) a perinatal death unrelated to a congenital condition in an infant with a birth weight greater that 2,500 grams;

(iii) the suicide of a patient in a setting in which the patient received care 24 hours a day;

(iv) the abduction of a newborn infant patient from the hospital or the discharge of a newborn infant patient from the hospital into the custody of an individual in circumstances in which the hospital knew, or in the exercise of ordinary care should have known, that the individual did not have legal custody of the infant;

(v) the sexual assault of a patient during treatment or while the patient was on the premises of the hospital or facility;

(vi) a hemolytic transfusion reaction in a patient resulting from the administration of blood or blood products with major blood group incompatibilities;

(vii) a surgical procedure on the wrong patient or on the wrong body part of a patient;

(viii) a foreign object accidentally left in a patient during a procedure; and

(ix) a patient death or serious disability associated with the use or function of a device designed for patient care that is used or functions other than as intended.

(B) The hospital is not required to include any information other than the total number of occurrences of each of the events listed under subparagraph (A) of this paragraph.

(2) Best practices report.

(A) On the renewal of the hospital's license, or annually based on the hospital's original licensing date, the hospital shall submit to the department at least one report of the best practices and safety measures related to a reported event.

(B) The best practice report may be submitted on a form to be prescribed by the department, or the hospital may submit a copy of a report submitted to a patient safety organization.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401892

For further information, please call: (512) 458-7236

Subchapter F. INSPECTION AND INVESTIGATION PROCEDURES

25 TAC §133.101

§133.101.Inspection and Investigation Procedures.

(a) Routine inspections. The Texas Department of Health (department) may conduct an inspection of each hospital prior to the issuance or renewal of a hospital license.

(1) A hospital is not subject to routine inspections subsequent to the issuance of the initial license while the hospital maintains:

(A) certification under Title XVIII of the Social Security Act, 42 United States Code (USC), §§1395 et seq; or

(B) accreditation by the Joint Commission on Accreditation of Healthcare Organizations or by the American Osteopathic Association.

(2) The department may conduct an inspection of a hospital exempt from an annual licensing inspection under paragraph (1) of this subsection before issuing a renewal license to the hospital if the certification or accreditation body has not conducted an on-site inspection of the hospital in the preceding three years and the department determines that an inspection of the hospital by the certification or accreditation body is not scheduled within 60 days.

(b) Complaint investigations.

(1) Complaint investigations are conducted if the department finds that reasonable cause exists to believe that the hospital has violated provisions of the Act, this chapter, special license conditions, or orders of the commissioner of health (commissioner).

(2) Complaints received by the department concerning abuse and neglect, or illegal, unprofessional, or unethical conduct will be conducted in accordance with §133.47(c) of this title (relating to Abuse and Neglect Issues).

(3) Complaint investigations are coordinated with the federal Health Care Financing Administration and its agents responsible for the inspection of hospitals to determine compliance with the conditions of participation under Title XVIII of the Social Security Act, (42 USC, §§1395 et seq), so as to avoid duplicate investigations.

(4) Complaint investigations are generally unannounced.

(1) Reinspections may be conducted by the department if a hospital applies for the reissuance of its license after the suspension or revocation of the hospital's license, the assessment of administrative or civil penalties, or the issuance of an injunction against the hospital for violations of the Act, this chapter, a special license condition, or an order of the commissioner.

(2) A reinspection may be conducted to ascertain compliance with either health or construction requirements or both.

(d) General.

(1) The department may make any inspection, survey, or investigation that it considers necessary. A representative of the department may enter the premises of a hospital at any reasonable time to make an inspection or an investigation to ensure compliance with or prevent a violation of the Act, the rules adopted under the Act, an order or special order of the commissioner, a special license provision, a court order granting injunctive relief, or other enforcement procedures. Ensuring compliance includes permitting photocopying of any records or other information by or on behalf of the department as necessary to determine or verify compliance with the statute or rules adopted under the statute, except that the department may not photocopy, reproduce, remove or dictate from any part of the root cause analysis or action plan required under §133.48 of this title (relating to Patient Safety Program).

(2) The department or a representative of the department is entitled to access to all books, records, or other documents maintained by or on behalf of the hospital to the extent necessary to enforce the Act, this chapter, an order or special order of the commissioner, a special license provision, a court order granting injunctive relief, or other enforcement procedures. The department shall maintain the confidentiality of hospital records as applicable under federal or state law.

(3) By applying for or holding a hospital license, the hospital consents to entry and inspection or investigation of the hospital by the department or a representative of the department in accordance with the Act and this chapter.

(e) Inspection and investigation protocol.

(1) The department surveyor(s) shall hold a conference with the hospital administrator or designee before beginning the on-site inspection or investigation to explain the nature, scope, and estimated time schedule of the inspection or investigation.

(2) Department surveyor(s) may conduct interviews with any person with knowledge of the facts.

(3) The department surveyor(s) shall inform the hospital administrator or designee of the preliminary findings of the inspection or investigation and shall give the person a reasonable opportunity to submit additional facts or other information to the department's authorized representative in response to those findings.

(4) Following an inspection or investigation of a hospital by the department, the department surveyor(s) shall hold an exit conference with the hospital administrator or designee and other invited staff and provide the following to the hospital administrator or designee:

(A) the specific nature of the inspection or investigation;

(B) any alleged violations of a specific statute or rule;

(D) the specific nature of any finding regarding an alleged violation or deficiency;

(E) if the deficiency is alleged, the severity of the deficiency; and

(F) if there are no deficiencies found, a statement indicating this fact.

(5) If deficiencies are cited, the department surveyor(s) shall obtain either at the time of the exit conference or within 10 days of the hospital's receipt of the statement of deficiencies a plan of correction which is provided by the hospital and indicates the date(s) by which correction(s) will be made and any other written comments, if any, by the hospital administrator or designee concerning the inspection or investigation. Additional facts, written comments, or other information provided by the hospital in response to the findings shall be made a part of the record of the inspection or investigation for all purposes.

(6) The department surveyor(s) shall obtain the signature of the hospital administrator or designee acknowledging the receipt of the statement of deficiencies and plan of correction form.

(7) The department surveyor(s) shall inform the administrator or designee of the hospital's right to an informal administrative review when there is disagreement with the surveyor's findings and recommendations or when additional information bearing on the findings is available.

(8) If deficiencies are cited and the plan of correction is not acceptable, the department shall notify the hospital in writing and request that the plan of correction be resubmitted within 10 calendar days of the hospital's receipt of the department's written notice. Upon resubmission of an acceptable plan of correction, written notice shall be sent by the department to the hospital acknowledging same.

(9) Responses to the department may be submitted by facsimile.

(10) The hospital shall come into compliance by the completion date provided on the statement of deficiencies and plan of correction form.

(11) The department shall verify the correction of deficiencies either by mail or by an on-site inspection or investigation.

(12) Acceptance of a plan of correction does not preclude the department from taking enforcement action under §133.121 of this title (relating to Enforcement Action) or under §133.122 of this title (relating to Administrative Penalty).

(f) Release of information by the department.

(1) Upon written request, the department shall provide information on the identity, including the signature, of each department representative conducting, reviewing, or approving the results of the inspection or investigation, and the date on which the department representative acted on the matter.

(2) Upon written request, the department shall release inspection documents in accordance with state and federal law.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401893

For further information, please call: (512) 458-7236

Subchapter G. ENFORCEMENT

25 TAC §133.121

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401894

For further information, please call: (512) 458-7236

Subchapter H. FIRE PREVENTION AND SAFETY REQUIREMENTS

25 TAC §§133.141 - 133.143

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401895

For further information, please call: (512) 458-7236

Subchapter I. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS

25 TAC §§133.161 - 133.167

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401896

For further information, please call: (512) 458-7236

Chapter 135. AMBULATORY SURGICAL CENTERS

The Texas Department of Health (department) adopts amendments to §§135.1-135.23, 135.41, 135.42, and 135.51-135.54, the repeal of §§135.24-135.29, and new §§135.24-135.28, concerning the regulation of ambulatory surgical centers. Sections 135.2, 135.20, 135.21, 135.22, 135.24, 135.27 and 135.52, are adopted with changes to the proposed text as published in the November 21, 2003, issue of the Texas Register (28 TexReg 10395). Sections 135.1, 135.3 - 135.19, 135.23, 135.25, 135.26, 135.28, 135.41, 135.42, 135.51, 135.53 and 135.54 and the repeals of §§135.24 - 135.29 are adopted without changes, and therefore the sections will not be republished.

The amendments and new sections are required as a result of revisions and additions to sections of the Health and Safety Code. House Bill (HB) 2292, 78th legislature, 2003, revised Health and Safety Code, §§12.0111 and 12.0112, and requires two-year licenses effective January 1, 2005; Senate Bill 162, 78th legislature, 2003, which amended Health and Safety Code, §243.011, and added probation to the list of enforcement actions that can be taken against a facility; HB 15, 78th legislature, 2003, added Health and Safety Code, Chapter 171, and requires information and consent forms to be provided to abortion patients; HB 1614, 78th legislature, 2003, amended Health and Safety Code, Chapter 243, by adding Subchapter B, which establishes a patient safety program. The amendments are also adopted based upon the department's review of Texas Administrative Code, Chapter 135, as required by Government Code §2001.039. The sections cover operating requirements, safety requirements, and physical plant and construction requirements for new and existing ambulatory surgical centers.

The sections for repeal cover denial, suspension or revocation of the license, emergency suspension, administrative penalties, complaints, reporting of incidents and confidentiality. The new sections cover enforcement, complaints, reporting of incidents, confidentiality and patient safety. The repeal of existing rules and new sections allows for the reorganization and renumbering of the sections for clarification. The amendments cover operating requirements, safety requirements and physical plant and construction requirements for new and existing ambulatory surgical centers.

Specifically, the amendments to §135.2 add definitions for action plan, adverse event, medical error, and root cause analysis; amend the definition of change of ownership; and renumber definitions as necessary to accommodate the added definitions. The amendments to §135.3 add the fee for relocation and change of ownership. The amendment to §135.4 adds a rule regarding informed consent for abortion. The amendments to §§135.5 - 135.10 are editorial. The amendments to §135.11 provide current references to national codes. The amendments to §§135.12 - 135.17 are editorial. The amendment to §135.18 requires a facility to respond to a request within 20 days instead of 10. The amendment to §135.19 requires the department to respond to a claim for exemption within 30 days instead of 90 days. The amendments to §135.20 add language related to the two-year renewal cycle as well as some editorial changes. The amendments to §135.21 change the inspection period from three to six years and add a statement that the department may enter a center at any reasonable time to survey and ensure compliance with the chapter. The amendments to §135.22 add language regarding the two-year renewal cycle as well as editorial changes. The amendments to §§135.23 are editorial. The new §135.24 covers enforcement activities. New §135.25 covers the department's complaint process. The new §135.26 covers facility responsibilities for reporting certain incidents. The new §135.27 covers information requests and access to records, includes requirements related to development and implementation of a patient safety program, and establishes annual reporting requirements related to specific events occurring at the facility, and submission of best practice reports. The new §135.28 covers requests for information under the Texas Public Information Act. The amendments to §135.41 and §135.42 provide current references to national codes, and update and delete obsolete language.

The amendments to §§135.51 - §135.54 relate to physical plant and construction requirements for new and existing ambulatory surgical centers provide current references to national codes and update and delete obsolete language.

Government Code, §2001.039, requires that each state agency review and consider for readoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). The sections have been reviewed and the department has determined that reasons for adopting the sections continue to exist, however, revisions to the sections are necessary as described in this preamble.

The department published a Notice of Intention to Review for §§135.1-135.29, 135.41, 135.42, and 135.51-135.54 in the Texas Register (28 TexReg 7423) on August 29, 2003. There were no comments received by the department on the sections following publication of the notice.

The following comments were received concerning the proposed sections. Following each comment is the department's response and any resulting change(s).

Comment: Concerning the rules in general, a commenter stated that the terms "ASC", "licensed ambulatory surgical center" and "facility" were used interchangeably throughout the proposed rules, and recommended that the department use only the terms "ASC" or "licensed ambulatory surgical center" in the proposed rules for the purposes of clarity.

Response: The department agrees, and has made the recommended changes in the final rules in §§135.20 - 135.22, 135.24, 135.27, and 135.52.

Comment: Concerning §135.2(5), one commenter was opposed to scope of the definition of "adverse event" in the proposed rule, and recommended that the department adopt the Institute of Medicine's definition of that term.

Comment: Concerning §135.2(19), one commenter requested that the department consider changing the definition of "medical error" to be consistent with the definition used by the Institute of Medicine.

Response: The department agrees. Since the Institute of Medicine is a nationally recognized authority on health care quality and patient safety, it is appropriate to use their definition of the term "medical error". The rule has been changed to include the definition found in the Institute of Medicine's 2004 publication entitled, Patient Safety: Achieving a New Standard of Care.

Comment: Concerning §135.27(a)(1)(B)(ii)-(iv), one commenter asked that the department clarify that these reporting requirements applied only to the ambulatory surgical center's internal reporting systems, and not to any external reporting requirements.

Response: Although §135.27(a)(1)(B)(ii)-(iv) as proposed did not place any external reporting requirements on the ambulatory surgical center, the department agreed to include the revised language in the final rule to provide the additional clarification requested by the commenter.

Comment: Concerning §135.27(a)(1)(B)(vi), one commenter stated that the requirement that ambulatory surgical centers have in place a support system for staff members who were involved in medical errors would be unduly burdensome for on small and rural facilities.

Response: The rationale for including this requirement in the proposed rule was based on the recommendations of nationally recognized patient safety organizations who emphasize that a patient safety program can only be successful if it is presented in a non-punitive manner and with an organizational commitment to providing support to those who voluntary report medical errors. However, the department agrees that making this support system mandatory could be burdensome on some facilities, so the requirement has been deleted in the final rule. Ambulatory surgical centers are encouraged to voluntarily provide a support system for staff who are involved in a medical error.

Comment: Concerning §135.27(a)(1)(C), a commenter requested that the proposed rule requiring that ambulatory surgical centers include a process for educating patients regarding their shared responsibility for patient safety be deleted, as the language was vague and it would be unduly burdensome to educate patients.

Response: The rationale for including this requirement in the proposed rule was based on the Institute of Medicine's recommendation that health care organizations implement policies designed to assist patients and their families in understanding their roles in assuring the safety of patients while they are in the facility. However, the department understands that some ambulatory surgical centers may find compliance with this requirement excessively burdensome, so it has been deleted from the final rule. ASCs are strongly encouraged to voluntarily include patient safety issues in their patient education activities.

Comment: Concerning §135.27(a)(1)(D), one commenter stated that, although training of certain personnel could be inferred to be a reasonable component of an ambulatory surgical center's patient safety program, the requirement to provide patient safety education and training to all clinical and administrative staff was excessive. The commenter believed it was not necessary to extend this requirement to administrative staff, and recommended that the rule be revised to reflect that the training was required only for those staff directly involved with the patient safety program.

Response: The department agrees and has deleted subparagraph (D) and added clarifying language to subparagraph (C).

Comment: Concerning §135.27(a)(2), one commenter stated that the proposed rule requiring that the ambulatory surgical center designate an individual to serve as the Patient Safety Program Coordinator could create an unworkable standard in many facilities. The commenter recommended that the rule be revised to allow more than one individual, or an interdisciplinary group, to be designated as responsible for the management of patient safety program.

Response: The department agrees, and has revised the final rule to reflect this change.

The department is making the following minor changes due to staff comments to clarify the intent and improve the accuracy of the sections.

Change: Concerning §135.27(b)(1), the department made editorial changes to clarify the timeframes for submitting the Annual Events Report.

Change: Concerning §135.27(b)(2)(A), the department made editorial changes to clarify the timeframes for submitting the Best Practices Report.

The commenter was the Texas Hospital Association. The commenter was neither for nor against the rules in their entirety; however, the commenter expressed concerns and made recommendations for change as discussed in the summary of comments.

Subchapter A. OPERATING REQUIREMENTS FOR AMBULATORY SURGICAL CENTERS

25 TAC §§135.1 - 135.28

The amendments and new rules are adopted under Health and Safety Code (HSC), Chapter 243, Texas Ambulatory Surgical Center Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ASCs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

§135.2.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise.

(1) Act--Texas Ambulatory Surgical Center Licensing Act, Health and Safety Code, Chapter 243.

(3) Administrator--A person who is a physician, registered nurse, has a baccalaureate or postgraduate degree in administration or a health-related field, or has one year of administrative experience in a health care setting.

(4) Advanced Practice Nurse (APN)--A professional nurse, currently licensed in Texas, who is prepared for advanced nursing practice by virtue of knowledge and skills obtained in an advanced educational program of study acceptable to the board, who meets requirements of Rule 221 and/or Rule 222 as defined by the Texas Board of Nurse Examiners, and has received authorization to practice as an APN in Texas.

(5) Adverse event--An event that results in unintended harm to the patient by an act of commission or omission rather than by the underlying disease or condition of the patient.

(6) Ambulatory Surgical Center (ASC)--A facility that operates primarily to provide surgical services to patients who do not require overnight hospital care.

(7) Autologous blood units--Units of blood or blood products derived from the recipient.

(8) Available--On the premises and sufficiently free from other duties to enable the individual to respond rapidly to emergency situations.

(9) Certified registered nurse anesthetist (CRNA)--A currently licensed registered nurse who has current certification from the Council on Certification of Nurse Anesthetists and who is currently authorized to practice as an Advanced Practice Nurse by the Board of Nurse Examiners.

(10) Change of ownership--

(A) A sole proprietor who transfers all or part of the ASC's ownership to another person or persons;

(B) The removal, addition, or substitution of a person or persons as a general, managing, or controlling partner in an ASC owned by a partnership and the tax identification number of that ownership changes; or

(C) A corporation that transfers all or part of the corporate stock which represents the ASC's ownership to another person or persons and the tax identification number of that ownership changes.

(11) Dentist--A person who is currently licensed under the laws of this state to practice dentistry.

(12) Department--The Texas Department of Health.

(13) Director--The director of the Health Facility Licensing and Compliance Division of the Texas Department of Health or his or her designee.

(14) Disposal--The discharge, deposit, injection, dumping, spilling, leaking, or placing of any solid waste or hazardous waste (whether containerized or uncontainerized) into or on any land or water so that such solid waste or hazardous waste or any constituent thereof may enter the environment or be emitted into the air or discharge into any waters, including ground waters.

(15) Electronic Signature--Signature produced or generated on a computer.

(16) FDA-approved blood bank--A facility that has been licensed in accordance with the Food and Drug Administration requirements in the preparation of blood and blood products.

(17) Health care practitioners (Qualified Medical Personnel)--Individuals currently licensed under the laws of this state who are authorized to provide services in an ASC.

(18) Licensed vocational nurse--A person who is currently licensed under the laws of this state to use the title, licensed vocational nurse.

(19) Medical error--The failure of a planned action to be completed as intended, the use of a wrong plan to achieve an aim, or the failure of an unplanned action that should have been completed, that results in an adverse event.

(20) Medicare-approved reference laboratory--A facility that has been certified and found eligible for Medicare reimbursement, and includes hospital laboratories which may be Joint Commission on Accreditation of Healthcare Facilities or American Osteopathic Association accredited or nonaccredited Medicare approved hospitals, Medicare certified independent laboratories.

(21) Physician--A person who is currently licensed under the laws of this state to practice medicine and who holds a doctor of medicine or a doctor of osteopathy degree.

(22) Person--Any individual, firm, partnership, corporation, or association.

(23) Prescriber--A person who is legally authorized to write an order or prescription for a health care service, medical device, or drug.

(24) Registered nurse--A person who is currently licensed under the laws of this state as a registered nurse.

(25) Root cause analysis--An interdisciplinary review process for identifying the basic or contributing causal factors that underlie a variation in performance associated with an adverse event or reportable event as listed under §135.27 of this title (relating to Patient Safety Program). It focuses primarily on systems and processes, includes an analysis of underlying cause and effect, progresses from special causes in clinical processes to common causes in organizational processes, and identifies potential improvements in processes or systems.

(26) Title XVIII--Title XVIII of the United States Social Security Act, 42 U.S.C. §1395 et seq.

§135.20.Initial Application and Issuance of License.

(a) All first-time applications for licensing, including those from unlicensed operating ASCs and licensed ASCs for which a change of ownership or relocation is anticipated, are applications for an initial license.

(b) Upon written or verbal request, the director shall furnish a person with an application form for an ASC license. The applicant shall submit to the director a completed original application and the nonrefundable license fee.

(1) The applicant shall provide:

(A) the name and address of the owner of the ASC or a list of names and addresses of persons who own an interest in the ASC;

(B) the name, Texas license number, and license expiration date of the medical chief of staff;

(D) the name, Texas license number, and license expiration date of the director of nursing of the ASC;

(E) whether the ASC has applied for certification under Title XVIII of the Social Security Act; and

(F) number of surgery suites.

(2) Upon receipt of the application, the director shall review the application to determine whether it is complete. All documents submitted to the department must be originals. The address provided on the application must be the address at which the ASC is operating.

(3) If the director determines that the application for an unlicensed ASC is complete and correct, a representative of the department shall schedule a presurvey conference with the applicant in order to inform the applicant of the standards for the operation of the ASC. A presurvey conference, may at the department's discretion, be waived for an applicant of a licensed ASC for which a change of ownership is anticipated.

(4) After a presurvey conference has been held or waived at the department's discretion and the facility has received an approved Life Safety Code inspection conducted by the department, the department may issue a license to an ASC to provide ambulatory surgical services in accordance with these sections.

(c) Issuance of license. When it is determined that the facility is in compliance with subsection (b) of this section, the department shall issue the license to the applicant.

(1) Effective date. The license shall be effective on the date the facility is determined to be in compliance with subsection (b) this section.

(2) Expiration date.

(A) For initial licenses issued prior to January 1, 2005.

(i) If the effective date of the license is the first day of a month, the license expires on the last day of the 11th month after issuance.

(ii) If the effective date of the license is the second or any subsequent day of a month, the license expires on the last day of the 12th month after issuance.

(B) For initial licenses issued January 1, 2005, or after.

(i) If the effective date of the license is the first day of a month, the license expires on the last day of the 23rd month after issuance.

(ii) If the effective date of the license is the second or any subsequent day of a month, the license expires on the last day of the 24th month after issuance.

(d) Withdrawal of application. If an applicant decides not to continue the application process for a license the application may be withdrawn. The applicant shall submit a written request to withdraw to the director. The director shall acknowledge receipt of the request to withdraw.

(e) During the initial licensing period, the department shall conduct a survey of the ASC to ascertain compliance with the provisions on the Health and Safety Code, Chapter 243, and this chapter.

(1) The ASC shall request that an on-site survey be conducted after the ASC has provided services to a minimum of one patient.

(2) The ASC shall be providing services at the time of the survey.

(3) If the ASC has applied to participate in the federal Medicare program, the Medicare survey may be conducted in conjunction with the licensing survey.

(4) The initial licensing survey may be waived if the ASC provides documented evidence of accreditation by the Joint Commission of Accreditation of Health Care Organization, the Accreditation Association for Ambulatory Health Care or the American Association for Accreditation of Ambulatory Surgery Facilities and Medicare deemed status.

§135.21.Inspections.

(a) The department shall conduct an on-site inspection to evaluate the ASC's compliance with the standards for licensing set forth in these sections.

(1) The department will evaluate the ASC on a standard-by-standard basis before the first renewal license is issued, unless waived in accordance with §135.20(e)(4) of this title (relating to Initial Application and Issuance of License).

(2) An on-site licensing inspection may be conducted once every three years.

(3) The department may make any survey or investigation that it considers necessary. A department representative(s) may enter the premises of a facility at any reasonable time to make a survey or an investigation to ensure compliance with or prevent a violation of HSC, Chapter 243 of this chapter, an order or special order of the commissioner, a special license provision, a court order granting injunctive relief, or other enforcement procedures. Ensuring compliance includes permitting photocopying of any records or other information by or on behalf of the department as necessary to determine or verify compliance with the statute or rules adopted under the statute, except that the department may not photocopy, reproduce, remove or dictate from any part of the root cause analysis or action plan required in §135.27 of this title (relating to Patient Safety Program).

(b) If an on-site inspection is conducted at an ASC and deficiencies are cited, the surveyor shall request the applicant or person in charge to sign the statement of deficiencies as an acknowledgment of receipt of a copy of the statement of deficiencies. Signing the statement of deficiencies does not indicate agreement with any deficiencies. If the applicant or person in charge declines to sign the form, the surveyor shall note the declination on the statement of deficiencies and the name of the person so declining. The surveyor shall leave a copy of the statement of deficiencies at the ASC and, if the person in charge is not the applicant, mail a copy of the statement of deficiencies to the applicant.

(1) a completed survey report form;

(2) a statement of which standards were evaluated;

(3) a statement of deficiencies, if any, and the signature of the applicant or person in charge;

(4) a plan of correction which has been provided by the ASC and the date(s) by which correction(s) will be made; and

(5) any comments by the applicant or person in charge concerning the survey.

(d) The survey report form shall be submitted as follows.

(1) The surveyor shall submit the survey report to the director for evaluation and decision.

(2) A license shall be issued to an ASC that is in compliance with minimum standards in accordance with these sections at the time of the on-site inspection.

(3) If deficiencies are cited and the plan of correction is acceptable, written notice will be sent to the applicant acknowledging same.

(4) If deficiencies are cited and the plan of correction is not acceptable, the director will notify the applicant in writing and request that the plan of correction be resubmitted. Upon resubmission of the acceptable plan of correction, written notice will be sent to the applicant acknowledging same.

(5) The ASC shall come into compliance at least 30 days prior to the expiration date of the temporary or annual license.

(6) The department shall verify the correction of deficiencies by mail or by an on-site inspection.

(7) If the ASC does not timely come into compliance, the department may take action in accordance with §135.24 of this title (relating to Enforcement).

§135.22.Renewal of Annual License.

(a) The department will send written notice of expiration of an annual license to an applicant at least 60 days before the expiration date. If the applicant has not received notice, it is the duty of the applicant to notify the department and request a renewal application.

(b) Renewal license. The department shall issue a renewal license to an ASC that meets the minimum standards for a license set forth in these sections.

(1) The ASC shall submit the following to the department no later than 30 days prior to the expiration date of the license:

(A) a completed renewal application form;

(B) a nonrefundable license fee;

(D) an annual events report in accordance with 135.28(b)(1) of this title (relating to Patient Safety Program); and

(E) a best practices report in accordance with 135.28(b)(2).

(2) Renewal licenses issued prior to January 1, 2005, will be valid for 12 months.

(3) Renewal licenses issued January 1, 2005, through December 31, 2005, will be valid for either 12 months or 24 months, to be determined by the department prior to the time of license renewal.

(4) Renewal licenses issued January 1, 2006, or after will be valid for 24 months.

(c) If the applicant fails to timely submit an application and fee in accordance with subsection (b) of this section, the department shall notify the applicant that the ASC must cease providing ambulatory surgical services. If the ASC can provide the department with sufficient evidence that the submission was completed in a timely manner and all dates were adhered to, the cease to perform will be dismissed. If the ASC cannot provide sufficient evidence, the ASC shall immediately thereafter return the license by certified mail. If the applicant wishes to provide ambulatory surgical services after the expiration date of the license, the applicant must reapply for an annual license under §135.20 of this title (relating to Initial Application and Issuance of License).

§135.24.Enforcement.

(a) Denial, Suspension or Revocation of a License. The department has jurisdiction to enforce the Acts or Rules adopted under this chapter.

(1) The department may refuse to issue or renew a license for an ASC that does not participate under Title XVIII if the center:

(A) fails to comply with any provisions of the Act or these sections; or

(B) is not in compliance with minimum standards for licensure at least 30 days prior to the expiration date of the temporary or annual license.

(2) The department may suspend the license of an ASC for one or more of the following reasons:

(A) misstatement or concealment of a material fact on any documents required to be submitted to the department or required to be maintained by the ASC pursuant to the Act; or

(B) materially altering any license issued by the department.

(3) The department may revoke the license of an ASC for one or more of the following reasons:

(A) an act has been committed by the ASC or its employees which affects the health and safety of a patient;

(B) if an ASC has been cited for deficiencies and fails to submit an acceptable plan of correction in accordance with these sections; or

(C) if an ASC has been cited for deficiencies and fails to timely comply with minimum standards for licensure within the dates designated in the plan of correction.

(4) The department shall refuse to issue or renew a license of an ASC that participates under Title XVIII, if the certifying body, Centers for Medicare and Medicaid Services, has terminated that ASC's provider agreement under Title XVIII.

(5) If the director proposes to deny, suspend, or revoke a license, the director shall give the applicant written notification of the reasons for the proposed action and offer the applicant an opportunity for a hearing. The applicant may request a hearing within 30 days after the date the applicant receives notice. The request must be in writing and submitted to the director, Health Facility Licensing and Compliance Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756. A hearing shall be conducted pursuant to the Government Code, Chapter 2001, Administrative Procedure Act, and §§1.21, 1.23, 1.25, and 1.27 of this title (relating to Formal Hearing Procedures). If a hearing is not requested in writing within 30 days after receiving notice of the proposed action, the applicant is deemed to have waived the opportunity for a hearing and the proposed action shall be taken.

(6) If the department finds that a violation of the standards or licensing requirements prescribed by the Act creates an immediate threat to the health and safety of patients of an ASC, the department may petition the district court for a temporary restraining order to restrain continuing violations.

(7) If the provisions of Occupations Code, Chapter 53, Consequences of Criminal Conviction, apply to an ASC, any procedures covering the denial, suspension, or revocation of a license shall be governed by the provisions in those statutes.

(8) If a person violates the licensing requirements or the standards prescribed by the Act, the department may petition the district court for an injunction to prohibit the person from continuing the violation or to restrain or prevent the establishment or operation of an ASC without a license issued under the Act.

(b) Emergency Suspension of a License. The department may issue an emergency order to suspend a license issued under this chapter if the department has reasonable cause to believe that the conduct of a license holder creates an immediate danger to the public health and safety.

(1) An emergency suspension is effective immediately without a hearing on notice to the license holder.

(2) On written request of the license holder, the department shall conduct a hearing not earlier than the 10th day or later than the 30th day after the date the hearing request is received to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and any appeal are governed by the department's rules for a contested case hearing and Government Code, Chapter 2001.

(c) Probation. In lieu of denying, suspending or revoking the license under subsection (a) of this section, the department may schedule the ASC for a probation period of not less than thirty days if the ASC's noncompliance does not endanger the health and safety of the public.

(1) The department shall provide notice of the probation to the ASC not later than the 10th day before the date the probation begins. The notice will include the items of noncompliance that resulted in placing the ASC on probation, and will designate the period of the probation.

(2) During the probationary period, the ASC must correct the items of noncompliance and provide a written report to the department that describes the corrective actions taken.

(3) The department may verify the corrective actions through an onsite inspection.

(d) Administrative penalty. The department may impose an administrative penalty on a person licensed under this chapter who violates the Act, this chapter, or order adopted under this chapter.

(1) A penalty collected under this section shall be deposited in the state treasury in the general revenue fund.

(2) A proceeding to impose the penalty is considered to be a contested case under Government Code, Chapter 2001.

(3) The amount of the penalty may not exceed $1,000 for each violation, and each day a violation continues or occurs is a separate violation for purposes of imposing a penalty. The total amount of the penalty assessed for a violation continuing or occurring on separate days under this paragraph may not exceed $5,000.

(4) In determining the amount of an administrative penalty assessed under this section, the department shall consider:

(A) the seriousness of the violation, including the nature, circumstances, extent, and gravity of the violation;

(B) the threat to health or safety caused by the violation;

(D) the amount necessary to deter a future violation;

(E) whether the violator demonstrated good faith, including when applicable whether the violator made good faith efforts to correct the violation; and

(F) any other matter that justice may require.

(5) Report and notice of violation and penalty. If the department initially determines that a violation occurred, the department shall give written notice of the report by certified mail to the person alleged to have committed the violation following the survey exit date. The notice must include:

(A) a brief summary of the alleged violation;

(B) a statement of the amount of the recommended penalty; and

(C) a statement of the person's right to a hearing on the occurrence of the violation, the amount of the penalty, or both.

(6) Penalty to be paid or hearing requested. Within 20 days after the date the person receives the notice under subsection (c) of this section, the person in writing may:

(A) accept the determination and recommended penalty of the department; or

(B) make a request for a hearing on the occurrence of the violation, the amount of the penalty, or both.

(7) If the person accepts the determination and recommended penalty or if the person fails to respond to the notice, the commissioner of public health (commissioner) or the commissioner's designee by order shall approve the determination and impose the recommended penalty.

(8) Hearing. If the person requests a hearing, the commissioner shall refer the matter to the State Office of Administrative Hearings (SOAH). The hearing shall be conducted in accordance with the Government Code, Chapter 2001, and all applicable SOAH and department rules.

(9) Decision by commissioner. Based on the proposal for decision made by the administrative law judge under paragraph (8) of this subsection, the commissioner by order may find that a violation occurred and impose a penalty, or may find that a violation did not occur. The commissioner or the commissioner's designee shall give notice of the commissioner's order under paragraph (1) of this subsection to the person alleged to have committed the violation in accordance with Government Code, Chapter 2001. The notice must include:

(A) a statement of the right of the person to judicial review of the order;

(B) separate statements of the findings of fact and conclusions of law; and

(10) Within 30 days after the date an order of the commissioner under subsection (f)(1) of this section that imposes an administrative penalty becomes final, the person shall:

(A) pay the penalty; or

(B) appeal the penalty by filing a petition for judicial review of the commissioner's order contesting the occurrence of the violation, the amount of the penalty, or both.

(11) Stay of enforcement of penalty. Within the 30-day period prescribed by paragraph (10) of this subsection, a person who files a petition for judicial review may:

(A) stay enforcement of the penalty by:

(i) paying the penalty to the court for placement in an escrow account; or

(ii) giving the court a supersedeas bond that is approved by the court for the amount of the penalty and that is effective until all judicial review of the commissioner's order is final; or

(B) request the court to stay enforcement of the penalty by:

(i) filing with the court a sworn affidavit of the person stating that the person is financially unable to pay the penalty and is financially unable to give the supersedeas bond; and

(ii) sending a copy of the affidavit to the commissioner by certified mail.

(C) If the commissioner receives a copy of an affidavit under paragraph (11)(B) of this subsection, the commissioner may file with the court, within five days after the date the copy is received, a contest to the affidavit. In accordance with Health and Safety Code, §243.016(c), the court shall hold a hearing on the facts alleged in the affidavit as soon as practicable and shall stay the enforcement of the penalty on finding that the alleged facts are true. The person who files an affidavit has the burden of proving that the person is financially unable to pay the penalty or to give a supersedeas bond.

(12) Collection of penalty. If the person does not pay the penalty and the enforcement of the penalty is not stayed, the department may refer the matter to the attorney general for collection of the penalty. As provided by the Health and Safety Code, §243.016(d), the attorney general may sue to collect the penalty.

(13) Decision by court. A decision by the court is governed by Health and Safety Code, §243.016(e) and (f), and provides the following.

(A) If the court sustains the finding that a violation occurred, the court may uphold or reduce the amount of the penalty and order the person to pay the full or reduced amount of the penalty.

(B) If the court does not sustain the finding that a violation occurred, the court shall order that a penalty is not owed.

(14) Remittance of penalty and interest and release of supersedeas bond. The remittance of penalty and interest is governed by Health and Safety Code, §243.016(g) and provides the following.

(A) If the person paid the penalty and if the amount of the penalty is reduced or the penalty is not upheld by the court, the court shall order, when the court's judgement becomes final, that the appropriate amount plus accrued interest be remitted to the person within 30 days after the date that the judgment of the court becomes final.

(B) The interest accrues at the rate charged on loans to depository institutions by the New York Federal Reserve Bank.

(C) The interest shall be paid for the period beginning on the date the penalty is paid and ending on the date the penalty is remitted.

(15) Release of bond. The release of supersedeas bond is governed by Health and Safety Code, §243.016(h), and provides the following.

(A) If the person gave a supersedeas bond and the court does not uphold the penalty, the court shall order, when the court's judgment becomes final, the release of the bond.

(B) If the person gave a supersedeas bond and the amount of the penalty is reduced, the court shall order the release of the bond after the person pays the reduced amount.

§135.27.Patient Safety Program

(a) General.

(1) The ASC must develop, implement and maintain an effective, ongoing, organization-wide, data driven Patient Safety Program (PSP).

(A) The governing body must ensure that the PSP reflects the complexity of the ASC's organization and services, including those services furnished under contract or arrangement, and focuses on the prevention and reduction of medical errors and adverse events.

(B) The PSP must be in writing, approved by the governing body and made available for review by the department. It must include the following components:

(i) the definition of medical errors, adverse events and reportable events;

(ii) the process for internal reporting of medical errors, adverse events and reportable events;

(iii) a list of events and occurrences which staff are required to report internally;

(iv) time frames for internal reporting of medical errors, adverse events and reportable events;

(v) consequences for failing to report events in accordance with ASC policy;

(vi) mechanisms for preservation and collection of event data;

(vii) the process for conducting root cause analysis;

(viii) the process for communicating action plans; and

(ix) the process for feedback to staff regarding the root cause analysis and action plan.

(C) The ASC must provide patient safety education and training to staff who have responsibilities related to the implementation, development, supervision or evaluation of the PSP. Training must include all PSP components as set out in subsection (a)(1)(B) of this section.

(2) The ASC must designate one or more individuals, or an interdisciplinary group, qualified by training or experience to be responsible for the management of the patient safety program. These responsibilities shall include:

(A) coordinating all patient safety activities;

(B) facilitating assessment and appropriate response to reported events;

(D) serving as liaison among ASC departments and committees to ensure facility-wide integration of the PSP.

(3) Within 45 days of becoming aware of a reportable event specified under subsection (b)(1) of this section, the ambulatory surgery center must:

(A) Complete a root cause analysis to examine the cause and effect of the event through an impartial process; and

(B) Develop an action plan identifying the strategies that the ASC intends to employ to reduce the risk of similar events occurring in the future. The action plan must:

(i) Designate responsibility for implementation and oversight;

(ii) Specify time frames for implementation; and

(iii) Include a strategy for measuring the effectiveness of the actions taken.

(C) The ASC must make the root cause analysis and action plan available for on-site review by department representatives.

(b) Reporting Requirements.

(1) Annual Events Report. On the renewal of the ASC's license, or annually based on the ASC's original licensing date, the ASC shall submit to the department a report that lists the number of occurrences at the ambulatory surgery center of each of the following events occurring during the preceding year. The ambulatory surgical center is not required to include any information other than the total number of occurrences of each of the events listed within this section.

(A) A medication error resulting in a patient's unanticipated death or major permanent loss of bodily function in circumstances unrelated to the natural course of the illness or underlying condition of the patient.

(B) The suicide of a patient in a setting in which the patient received care 24 hours a day.

(D) A hemolytic transfusion reaction in a patient resulting from the administration of blood or blood products with major blood group incompatibilities.

(E) A patient death or serious disability associated with the use or function of a device designed for patient care that is used or functions other than as intended.

(F) A surgical procedure on the wrong patient or on the wrong body part of a patient.

(G) A foreign object accidentally left in a patient during a procedure.

(2) Best Practices Report.

(A) On the renewal of the ASC's license, or annually based on the ASC's original licensing date, the ASC shall submit to the department at least one report of the best practices and safety measures related to a reported event.

(B) The best practice report may be submitted on a form to be prescribed by the department, or the ASC may submit a copy of a report submitted to a patient safety organization.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401917

For further information, please call: (512) 458-7236

25 TAC §§135.24 - 135.29

The repeals are adopted under Health and Safety Code (HSC), Chapter 243, Texas Ambulatory Surgical Center Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ASCs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401918

For further information, please call: (512) 458-7236

Subchapter B. SAFETY REQUIREMENTS FOR NEW AND EXISTING AMBULATORY SURGICAL CENTERS

25 TAC §135.41, §135.42

The amendments are adopted under Health and Safety Code (HSC), Chapter 243, Texas Ambulatory Surgical Center Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ASCs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401919

For further information, please call: (512) 458-7236

Subchapter C. PHYSICAL PLANT AND CONSTRUCTION REQUIREMENTS FOR NEW AND EXISTING AMBULATORY SURGICAL CENTERS

25 TAC §§135.51 - 135.54

§135.52.Construction Requirements for New Ambulatory Surgical Centers.

(a) Ambulatory surgical center (ASC) location. An ASC may be a distinct separate part of an existing hospital, it may occupy an entire separate independent structure, or it may be located within another building such as an office building or commercial building.

(1) Accessibility. The location of a proposed new ASC shall be easily accessible for service vehicles and fire protection apparatus.

(2) Means of egress. An ASC shall have at least two exits remotely located in accordance with National Fire Protection Association (NFPA) 101, Life Safety Code, 2000 edition (NFPA 101), §20.2.4.1. When a required means of egress from the ASC is through another portion of the building, that means of egress shall comply with the requirements of NFPA 101 which are applicable to the occupancy of that other building. Such means of egress shall be open, available, unlocked, unrestricted, and lighted at all times during the ASC hours of operation. All documents published by National Fire Protection Association (NFPA) as referenced in this section may be obtained by writing or calling the NFPA at the following address or telephone number: National Fire Protection Association, 1 Batterymarch Park, P.O. Box 9101, Quincy, MA 02269-9101 or (800) 344-3555.

(3) Hazardous location.

(A) Underground and above ground hazards. A new ASC or an addition(s) to an existing ASC may not be constructed near a hazardous location. Hazardous locations include underground liquid butane or propane, liquid petroleum or natural gas transmission lines, high pressure lines, or under high voltage electrical lines.

(B) Fire hazards. A new ASC may not be built within 300 feet of above ground or underground storage tanks containing liquid petroleum or other flammable liquids used in connection with a bulk plant, marine terminal, aircraft refueling, bottling plant of a liquefied petroleum gas installation, or near other hazardous or hazard producing areas.

(C) Health and safety hazards. A new ASC may not be located in a building(s) which, because of its location, physical condition, state of repair, or arrangement of facilities, would be hazardous to the health or safety of the patients.

(4) Undesirable locations.

(A) Nuisance producing sites. A new ASC may not be located near nuisance producing sites such as industrial sites, feed lots, sanitary landfills, or manufacturing plants which produce excessive noise or air pollution.

(B) Flood plains. Construction of new ASCs shall be avoided in designated flood plains. Where such is unavoidable, access and required ASC components shall be constructed above the designated flood plain. This requirement also applies to new additions to existing ASCs or portions of facilities which have been licensed previously as ASCs, but which have been vacated or used for other purposes. This requirement does not apply to remodeling of existing licensed ASCs.

(b) ASC site. The ASC site shall include paved roads, walkways, and parking in accordance with the requirements set out in this subsection.

(1) Paved roads and walkways.

(A) Paved roads shall be provided within lot lines for access from public roads to the main entrance and to service entrances.

(B) Finished surface walkways shall be provided for pedestrians. When public transportation or walkways serve the site, finished surface walkways or paved roads shall extend from the public conveyance to the building entrance.

(2) Parking.

(A) Off street parking shall be provided at the minimum ratio of two spaces for each operating room, one space for each staff member and one visitor's space for each operating room.

(B) Handicapped parking. Parking spaces for handicapped persons shall be provided in accordance with the Americans with Disabilities Act (ADA) of 1990, Public Law 101-336, 42 United States Code, Chapter 126, and Title 36 Code of Federal Regulations, Part 1191, Appendix A, Accessibility Guidelines for Buildings and Facilities.

(c) Building design and construction requirements. Every building and every portion thereof shall be designed and constructed to sustain all dead and live loads in accordance with accepted engineering practices and standards and local governing building codes. Where there is no local governing building code, one of the following codes shall govern: Uniform Building Code, 1999 edition, published by the International Conference of Building Officials, 5360 Workman Mill Road, Whittier, California 90601, telephone (562) 699-0541; or the Standard Building Code, 1997 edition, published by the Southern Building Code Congress International, Inc., 900 Montclair Road, Birmingham, Alabama 35213-1206, telephone (205) 591-1853.

(1) General architectural requirements. All new construction, including conversion of an existing building to an ASC or establishing a separately licensed ASC within another existing building, shall comply with NFPA 101, Chapter 20, "New Ambulatory Health Care Facilities," and this section.

(A) Construction types for multiple building occupancy.

(i) When an ASC is part of a larger building which complies with NFPA 101, §20.1.6, "Minimum Construction Requirements" for (fire resistance) construction type, the designated ASC shall be separated from the remainder of the building with a minimum of 1-hour fire rated construction.

(ii) Multistory buildings. When an ASC is located in a multistory building of two or more stories, the entire building shall meet the construction requirements of NFPA 101, §20.1.6.3. An ASC may not be located in a multistory building which does not comply with the minimum construction requirements of NFPA 101, §20.1.6.3.

(iii) Single story buildings. When an ASC is part of a one-story building that does not comply with the construction requirements of NFPA 101, §20.1.6.2, the ASC must be separated from the remainder of the building with a 2-hour fire rated construction. The designated ASC portion shall have the construction type upgraded to comply with NFPA 101, §20.1.6.2.

(B) Special design provisions. Special provisions shall be made in the design of a facility if located in a region where local experience shows loss of life or extensive damage to buildings resulting from hurricanes, tornadoes, or floods.

(2) Foundations. Foundations shall rest on natural solid bearing if satisfactory bearing is available. Proper soil-bearing values shall be established in accordance with nationally recognized requirements. If solid bearing is not encountered at practical depths, the structure shall be supported on driven piles or drilled piers designed to support the intended load without detrimental settlement, except that one-story buildings may rest on a fill designed by a soils engineer. When engineered fill is used, site preparation and placement of fill shall be done under the direct full-time supervision of the soils engineer. The soils engineer shall issue a final report on the compacted fill operation and certification of compliance with the job specifications.

(3) Physical environment. A physical environment that protects the health and safety of patients, personnel, and the public shall be provided in each facility. The physical premises of the facility and those areas of the facility's physical structure that are used by the patients (including all stairwells, corridors, and passageways) shall meet the local building and fire safety codes and the requirements of this chapter.

(4) State handicapped requirements. Special considerations benefiting handicapped staff, visitors, and patients shall be provided. Each ASC shall comply with the Americans with Disabilities Act (ADA) of 1990, Public Law 101-336, 42 United States Code, Chapter 126, and Title 36 Code of Federal Regulations, Part 1191, Appendix A, Accessibility Guidelines for Buildings and Facilities.

(5) Other regulations. Certain projects may be subject to other regulations, including those of federal, state, and local authorities. The more stringent standard or requirement shall apply when a difference in requirements exists.

(6) Exceeding minimum requirements. Nothing in these sections shall be construed to prohibit a better type of building construction, more exits, or otherwise safer conditions than the minimum requirements specified in these sections.

(7) Equivalency. Nothing in these sections is intended to prevent the use of systems, methods, or devices of equivalent or superior quality, strength, fire resistance, effectiveness, durability, and safety to those prescribed by these sections, provided technical documentation which demonstrates equivalency is submitted to the department for approval.

(8) Separate freestanding buildings (not for patient use). Separate freestanding buildings for nonpatient use which are located at least 20 feet from the ASC building such as the heating plant, boiler plant, repair workshops, or general storage may be designed and constructed in accordance with other applicable occupancy classification requirements listed in NFPA 101.

(d) Spatial requirements.

(1) Administration and public areas.

(A) Entrance. Entrances shall be located at grade level, be accessible to individuals with disabilities, and protected against inclement weather from the point of passenger loading/unloading to the building entrance. When an ASC is located on a floor above grade level, elevators shall be accessible and shall meet the requirements of subsection (g) of this section.

(B) Waiting area. A waiting area or lobby shall be provided which includes having access to the following rooms and items:

(i) public toilet facilities;

(ii) telephone(s) for public use; and

(iii) access to potable drinking water.

(D) Interview space(s). Space shall be provided for private interviews relating to social services, credit, or admission.

(E) General or individual office(s). An office(s) shall be provided for business transactions, records, and administrative and professional staff.

(F) Medical records area. Medical record storage space shall be located within a secure designated area under direct visual supervision of administrative staff.

(G) General storage room.

(i) A minimum of 50 square feet per operating room shall be provided exclusive of soiled holding, sterile supplies, clean storage, drug storage, locker rooms, and surgical equipment storage. General storage may be located in one or more rooms or closets and shall be located outside of the patient treatment areas.

(ii) General storage room(s) shall be separated from adjacent areas by fire-rated construction in accordance with the NFPA 101, §§38.3.2.1 and 38.3.2.2.

(H) Wheelchair storage space or alcove. Storage space for wheelchairs shall be provided and shall be out of the direct line of traffic.

(2) Engineering services and equipment areas. Equipment rooms with adequate space shall be provided for mechanical and electrical equipment. These areas shall be separate from public, patient, and staff areas.

(3) Janitor's closet. In addition to the janitor's closet exclusive to the surgery suite, a sufficient number of janitor's closets shall be provided throughout the facility to maintain a clean and sanitary environment. The closet shall contain a floor receptor or service sink and storage space for housekeeping supplies and equipment.

(4) Laboratory.

(A) General. Laboratory services shall be provided within the ASC or through a contract or other arrangement with a hospital or accredited laboratory.

(B) Special requirements. When the laboratory is located on-site the following minimum items shall be provided:

(i) a room with work counter, utility sink, and storage cabinets or closet(s); and

(ii) specimen collection facilities. For dip stick urinalysis, urine collection rooms shall be equipped with a water closet and lavatory. Blood collection facilities shall have space for a chair, work counter and hand washing facilities.

(i) Construction for fire protection in laboratories employing quantities of flammable, combustible, or other hazardous material shall be in accordance with the National Fire Protection Association 99, Health Care Facilities, 1999 edition, (NFPA 99).

(ii) Laboratories shall comply with the requirements of NFPA 99, "Health Care Facilities," 1999 edition, Chapter 10, as applicable and the requirements of NFPA 45, "Standards on Fire Protection for Laboratories Using Chemicals," 1996 edition, as applicable.

(5) Laundry and linen processing area(s). Laundry and linen processing may be done within the center or off-site at a commercial laundry.

(A) On-site linen processing. When on-site linen processing is provided, soiled and clean processing operations shall be separated and arranged to provide a one-way traffic pattern from soiled to clean areas. The following rooms and items shall be provided:

(i) a soiled linen processing room which includes areas for receiving, holding, sorting, and washing;

(ii) a clean linen processing room which includes areas for drying, sorting, folding, and holding prior to distribution;

(iii) supply storage cabinets in the soiled and clean linen processing rooms;

(iv) hand washing facilities within the soiled linen processing room; and

(v) a storage room for clean linen located within the surgical suite. Clean linen storage may be combined with the clean work room.

(B) Off-site linen processing. When linen is processed off-site, the following rooms or items shall be provided:

(i) a storage room for clean linen located within the surgical suite. Clean linen storage may be combined with the clean work room; and

(ii) a soiled linen holding room or area located within the surgical suite. Soiled linen holding may be combined with the soiled workroom.

(6) Pharmacy. A pharmacy work room or alcove shall be provided and located separate from patient and public areas and under the direct supervision of staff. A work counter, refrigerator, medication storage and locked storage for biologicals and drugs shall be provided. Hand washing facilities shall be located in or convenient to the pharmacy room or alcove.

(7) Preoperative patient holding room.

(A) General. A preoperative holding area shall be provided and arranged in a one-way traffic pattern so that patients entering from outside the surgical suite can change, gown, and move directly into the restricted corridor of the surgical suite. The holding area shall be separate from recovery and the restricted corridor.

(B) Patient station. A minimum of one patient station per operating room shall be provided.

(i) A minimum area of 60 square feet shall be provided for each patient station.

(ii) When a gurney or bed is used, the minimum clearance from the gurney or bed to a sidewall may not be less than three feet. A space of four feet shall be provided at the foot of the gurney or bed and the minimum clearance between gurneys or beds may not be less than four feet six inches.

(iii) Space shall be made available for storing and securing patient's personal effects.

(C) Patient toilet. A toilet room with handicapped accessible water closet and hand washing facilities shall be provided. The toilet room may be shared with the recovery room, if conveniently located to both.

(D) Special requirements. Hand washing facilities and a counter or shelf space for writing shall be provided for staff use within or convenient to the preop area. Staff hand washing facilities shall be separate from and in addition to patient toilet accommodations.

(8) Radiology.

(A) Special requirements. When radiology services are provided on-site, the following minimum facilities shall be provided:

(i) film processing facilities, if used;

(ii) viewing capabilities;

(iii) storage facilities for exposed film, if used, located in rooms or areas constructed in accordance with the NFPA 101, §38.3.2.1 and §38.3.2.2; and

(iv) dressing area(s) shall be required, depending on services provided, with convenient access to toilets and may be shared with patient changing/preop rooms.

(B) Fluoroscopy room. When fluoroscopy services are provided on site in a dedicated fluoroscopy room, a toilet room with handicapped accessible water closet and hand washing facilities shall be directly accessible to the room.

(9) Recovery room.

(A) General. A recovery room shall be distinct and separate from preoperative areas. The recovery room shall be arranged to provide a one way traffic pattern from the restricted surgical corridor to recovery and then to second stage recovery or discharge.

(B) Patient station(s). A minimum of one patient station per operating room, plus one additional station, shall be provided.

(i) When a gurney or bed is used, the minimum clearance from the gurney or bed to a sidewall may not be less than three feet. A space of not less than four feet shall be provided at the foot of each gurney or bed.

(ii) The minimum clearance between gurneys and beds may not be less than four feet six inches.

(C) Patient toilet. A toilet room with handicapped accessible water closet and hand washing facilities shall be provided. The toilet room may be shared with the preoperative patient holding area, if conveniently located to both.

(D) Second stage recovery. A separate supervised room or area may be provided for patients who are able to leave the recovery/post-anesthesia room, but need additional time for all vital signs to be stabilized to the point where the patient may leave the facility.

(i) When individual rooms are provided for second stage recovery, the rooms shall have an area of at least 60 square feet. When such rooms include a bed or recliner, a minimum clearance of three feet at the foot and on each side of the bed or recliner shall be provided.

(ii) When an open or ward area is provided for second stage recovery, the minimum clearance from the bed or recliner to the side wall may not be less than three feet; and a space of four feet shall be provided at the foot of each bed or recliner. The minimum clearance between beds or recliners may not be less than three feet.

(10) Staff clothing change area.

(A) General. The change area shall be designed to provide a one-way traffic pattern so that personnel entering from outside the surgical suite can change into scrub attire and move directly into the restricted corridor of the surgical suite.

(B) Staff changing area. A staff changing area shall include the following rooms and accommodations:

(i) dressing room with lockers;

(ii) toilet room(s) with water closet and hand washing facilities (may be shared if accessible to both male and female dressing rooms); and

(iii) a shower located somewhere within the facility.

(C) Surgical lounge. When provided, a lounge for surgical staff shall be located to permit use without leaving the surgical suite. These facilities may be integrated with the staff changing areas.

(11) Soiled workroom. In addition to the soiled workroom provided in the surgical suite, a separate soiled workroom(s) shall be required when a treatment room is provided, except as allowed in subparagraph (B) of this paragraph.

(A) Special requirements. The workroom(s) shall contain a clinical sink or equivalent flushing type fixture, work counter, designated space for waste and linen receptacles, and hand washing facilities.

(B) Shared functions. The soiled workroom required in support of a treatment room may be combined with a surgical suite soiled work room with two means of entry. A separate door into the soiled workroom shall serve a treatment room located outside the surgical suite.

(12) Sterilizing facilities. A system for sterilizing equipment and supplies shall be provided. Sterilizing procedures may be done on-site or off-site, or disposables may be used to satisfy functional needs.

(A) Off-site sterilizing. When sterilizing is provided off-site and disposables and prepackage surgical supplies are used, the following rooms shall be provided near the operating room.

(i) Soiled holding room. A room for receiving contaminated/soiled material and equipment from the operating room shall be provided. The room shall be physically separate from all other areas of the suite. The room shall include a work counter(s) or a table(s), clinical sink or equivalent flushing type fixture, equipment for initial disinfection and preparation for transport to off-site sterilizing, and hand washing facilities. The soiled holding room may be combined with the surgical suite soiled workroom.

(ii) Clean workroom. A clean workroom shall be provided for the exclusive use of the surgical suite. The workroom shall contain a work counter, with space for receiving, disassembling and organizing clean supplies, storage cabinets or shelving, and hand washing facilities.

(iii) Sterilizer equipment. Sterilizer equipment shall be located in a separate room convenient to the operating room(s), in an alcove adjacent to the restricted corridor, or in the clean workroom.

(B) On-site sterilizing facilities. When sterilizing facilities are provided on-site they shall be located near the operating room and provide the following rooms.

(i) Receiving/decontamination room. The receiving/decontamination room shall be physically separate from all other areas of the surgical suite. The room shall include a work counter(s) or table(s), clinical sink or equivalent flushing type fixture, equipment for initial washing/disinfection, and hand washing facilities. Pass-through doors, windows, and washer/sterilizer decontaminators shall serve in delivering material to the clean workroom. The receiving/decontamination room may be combined with the surgical suite soiled workroom.

(ii) Clean/assembly workroom. The clean/assembly workroom shall include a counter(s) or table(s) with space for organizing, assembling, and packaging of medical/surgical supplies and equipment, equipment for terminal sterilizing, and hand washing facilities. Clean and soiled work areas shall be physically separated.

(iii) Sterile storage. A storage room for clean and sterile supplies shall be provided. The storage room shall have adequate areas and counters for breakdown of manufacturers' clean/sterile medical/surgical supplies. This room may be combined with the clean assembly/workroom.

(iv) Cart storage room or alcove. The storage space for distribution carts shall be adjacent to clean and sterile storage area(s) and close to main distribution points.

(13) Surgical suite. The surgical suite shall be arranged to preclude unrelated traffic through the suite. The surgical suite shall contain at least one operating room and all surgical service areas required under subparagraph (B) of this paragraph.

(A) Operating room. The operating room(s) shall have a clear floor area of at least 240 square feet exclusive of fixed or moveable cabinets, counters, or shelves. The minimum clear dimension between built-in cabinets, counters, and shelves shall be 14 feet.

(B) Surgical service areas.

(i) Restricted corridor. The restricted corridor shall serve as the primary passageway for staff and patients within the surgical suite. The following rooms and areas when provided or required by NFPA 101 shall have direct access to the restricted corridor:

(I) preoperative patient holding area;

(II) operating room(s);

(III) recovery room;

(IV) soiled workroom;

(V) clean workroom;

(VI) janitor's closet;

(VII) equipment storage;

(VIII) sterilizing facilities;

(IX) anesthesia workroom;

(X) area for emergency crash cart; and

(XI) emergency eyewash.

(ii) Soiled workroom. A soiled workroom shall be provided for the exclusive use of the surgical suite staff. The workroom shall contain a clinical sink or equivalent flushing type fixture, work counter, designated space for waste and linen receptacles, and hand washing facilities. The soiled workroom may not have direct connection with operating room(s) or other sterile activity room(s).

(iii) Clean linen storage. A storage room or alcove shall be provided for storing clean linen.

(iv) Scrub facilities. A scrub sink shall be provided near the entrance to each operating room. Scrub facilities shall be arranged to minimize incidental splatter on nearby personnel or carts. One scrub station with dual faucets and separate controls may serve two adjacent operating rooms.

(v) Janitor's closet. A janitor's closet shall be provided for the exclusive use of the surgical suite. The closet shall contain a floor receptor or service sink and storage space for housekeeping supplies and equipment.

(vi) Equipment storage. A room, alcove, or designated area shall be provided for storing equipment and supplies used in the surgical suite. The storage room or area shall be a minimum of 50 square feet per operating room.

(vii) Medical gas storage room. When provided or required by NFPA 101, a medical gas storage room shall comply with the requirements of NFPA 99, 1999, Chapter 4 "Gas and Vacuum Systems".

(viii) Area for emergency crash cart. An area or alcove located out of traffic and convenient to the operating room(s) shall be provided for an emergency crash cart.

(ix) Stretcher storage area. An area or alcove shall be located convenient for use and out of the direct line of traffic for the storage of stretchers as required. Stored stretchers shall not encroach on corridor widths.

(14) Treatment room.

(A) A treatment room is not required, but when provided, it may be used for minor procedures that use only local anesthetics.

(B) The treatment room shall have a clear floor area of at least 100 square feet exclusive of fixed or moveable cabinets, counters, or shelves.

(15) Examination room. An examination room is not required, but when provided, the room shall have:

(A) a minimum clear floor area of at least 80 square feet exclusive of fixed or moveable cabinets, counters, or shelves; and

(B) a work counter with space for writing and hand washing facilities.

(16) Medical waste processing. Space and facilities shall be provided for the safe storage and disposal of waste as appropriate for the material being handled and in compliance with all applicable rules and regulations.

(e) Details.

(1) Corridors.

(A) Public corridor. The minimum clear and unobstructed width of a public corridor shall be at least four feet.

(B) Communicating corridor. The communicating corridor shall be used to convey patients by stretcher, gurney, or bed.

(i) The communicating corridor shall link the preoperative holding area, operating rooms(s), and recovery room(s), and shall be continuous to at least one exit.

(ii) The minimum clear and unobstructed width of the communicating corridor shall be eight feet.

(2) Doors and windows.

(A) Door types. Doors at all openings between corridors and rooms or spaces subject to occupancy shall be swing type. Elevator doors are excluded from this requirement.

(B) Door swing. Doors, except doors to spaces such as small closets which are not subject to occupancy, shall not swing into corridors in a manner that might obstruct traffic flow or reduce the required corridor width. Large walk-in type closets are considered as occupiable spaces.

(C) Patient access doors. The minimum width of doors for patient access to examination and consultation rooms shall be three feet. The minimum width of doors requiring access for beds and gurneys (preoperative holding area, operating room, recovery room) shall be three feet eight inches.

(D) Emergency access. At least one door into a patient use toilet room shall swing outward or have hardware to permit access from the outside in an emergency.

(E) Labeled doors. Labeled fire doors shall be listed by an independent testing laboratory and shall meet the construction requirement for fire doors in NFPA 80, "Standard for Fire Doors and Fire Windows," 1999 edition. Reference to a labeled door shall be construed to include labeled frame and hardware.

(F) Glazing. Glass doors, sidelights, borrowed lights, and windows located within 12 inches of a door jamb or with a bottom-frame height of less than 18 inches above the finished floor shall be glazed with safety glass or plastic glazing material that will resist breaking and will not create dangerous cutting edges when broken. Similar materials shall be used for wall openings unless otherwise required for fire safety. Safety glass, tempered glass, or plastic glazing materials shall be used for shower doors, bath enclosures, interior windows, and doors (which have glazing).

(3) Ceiling heights. The minimum ceiling height shall be eight feet with the following exceptions.

(A) Rooms containing ceiling-mounted light fixtures or equipment. Operating rooms or other rooms containing ceiling-mounted light fixtures or equipment shall have ceiling heights of not less than nine feet. Additional ceiling height may be required to accommodate special fixtures or equipment.

(B) Minor rooms. Ceilings in storage rooms, toilet rooms, and other minor rooms shall be not less than seven feet six inches.

(C) Special requirements. Suspended tracks, rails, pipes, signs, lights, door closures, exit signs, and other fixtures that protrude into the path of normal traffic shall be not less than six feet eight inches above the finished floor.

(4) Toilet room accessories. Grab bars shall be provided at water closets and showers in accordance with the ADA.

(5) Hand washing facilities. Location and arrangement of fittings for hand washing facilities shall permit their proper use and operation. Hand washing fixtures with hands free controls shall be provided in each examination room, preoperative area, recovery room, soiled utility room, fluoroscopy room, clean work room, and toilet room. Particular care shall be given to the clearances required for blade-type operating handles. Lavatories and hand washing facilities shall be securely anchored to withstand an applied vertical load of not less than 250 pounds on the front of the fixture. In addition to the specific areas noted, hand washing facilities shall be conveniently located for staff use in rooms and areas noted under spacial requirements in subsection (d) of this section and throughout the center where patient care services are provided.

(6) Hand drying. Provisions for hand drying shall be included at all hand washing facilities except scrub sinks. Hot air dryers or individual paper units shall be provided and must be enclosed in such a way as to provide protection against dust or soil. Paper dispensing units shall provide for single unit dispensing.

(7) Radiation protection. Shielding shall be designed, tested, and approved by a medical physicist licensed under the Medical Physics Act, Occupations Code, Chapter 602. The ASC must obtain a certificate of registration issued by the Bureau of Radiation Control to use radiation machines.

(8) Rooms with heat producing equipment. Rooms containing heat producing equipment such as mechanical and electrical equipment and laundry rooms shall be insulated and ventilated to prevent floors of any occupied room located above it from exceeding a temperature differential of 10 degrees Fahrenheit above the ambient room temperature.

(f) Finishes.

(1) Floor finishes.

(A) General. Floor materials shall be easily cleanable, wear resistant, and appropriate for the location involved. In areas subject to frequent wet cleaning methods, floor materials shall not be physically affected by germicidal and cleaning solutions. Floors that are subject to traffic while wet, such as shower areas and certain work areas, shall have nonslip surfaces.

(B) Operating rooms and sterilizing facility(ies).

(i) Floor finishes shall be seamless, be tightly sealed to the wall without voids, and be impervious to water.

(ii) Base materials shall be coved and integral with the floor.

(iii) Welded joint flooring is acceptable.

(C) Threshold and expansion joint covers. Thresholds at doorways may not exceed 3/4 inch in height for exterior sliding doors or 1/2 inch for other type doors. Raised thresholds and floor level changes at accessible doorways shall be beveled with a slope no greater than 1:2. Expansion joint covers may not exceed 1/2 inch in height and shall have beveled edges with a slope no greater than 1:2.

(2) Wall finishes. Wall finishes shall be smooth, washable, moisture resistant, and cleanable by standard housekeeping practices. Wall finishes shall be in compliance with the requirements of NFPA 101, §38.3.3, relating to flame spread.

(A) Finishes at plumbing fixtures. Wall finishes shall be water resistant in the immediate area of plumbing fixtures.

(B) Wet cleaning methods. Wall finishes in areas subject to frequent wet cleaning methods shall be impervious to water, tightly sealed; and without voids.

(3) Ceiling finishes.

(A) General. All occupied rooms and spaces shall be provided with finished ceilings, unless otherwise noted. Ceilings which are a part of a rated roof and ceiling assembly or a floor-ceiling assembly shall be constructed of listed components (by a nationally recognized testing laboratory) and installed in accordance with the listing.

(B) Monolithic ceilings. Ceilings in operating rooms and sterilizing facilities shall be monolithic from wall to wall, smooth and without fissures, open joints, or crevices and with a washable and moisture impervious finish.

(C) Special requirements. Finished ceilings may be omitted in mechanical and equipment spaces, shops, and similar spaces unless required for fire-resistive purposes.

(4) Floor, wall, and ceiling penetrations. Floor, wall, and ceiling penetrations by pipes, ducts, and conduits shall be tightly sealed to minimize entry of dirt particles, rodents, and insects. Joints of structural elements shall be similarly sealed.

(5) Cubicle curtains, draperies, and other hanging fabrics. Cubicle curtains, draperies, and other hanging fabrics shall be noncombustible or flame retardant and shall pass both the small scale and large scale test of NFPA 701, "Standard Methods of Fire Tests for Flame-Resistant Textiles and Films," 1999 edition. Copies of laboratory test reports for installed materials shall be submitted to the department at the time of the final construction inspection.

(g) Elevators. All buildings that have patient services located on other than the main entrance floor shall have electric or electrohydraulic elevators. The elevators shall be installed in sufficient quantity, capacity, and speed to ensure that the average interval of dispatch time will not exceed one minute, and average peak loading can be accommodated.

(1) Requirements for new elevators. New elevators shall be installed in accordance with the requirements of Health and Safety Code, Chapter 754, Elevators, Escalators, and Related Equipment, and ASME A17.1, "Safety Code for Elevators and Escalators," 1996 latest edition, published by the American Society of Mechanical Engineers and the American National Standards Institute (ASME/ANSI A17.1). All new elevators shall conform to the Fire Fighters' Service Requirements of ASME/ANSI A17.1 requirements of NFPA 101, §9.4.3.1. All documents published by the ASME/ANSI as referenced in this section may be obtained by writing the ANSI, United Engineering Center, 345 East 47th Street, New York, N.Y. 10017.

(2) Requirements for existing elevators. Existing elevators shall comply with the ASME/ANSI A17.1, Safety Code for Elevators and Escalators, current edition, Part XII "Alterations, Repair, Replacements, and Maintenance" and ASME A17.3, 1995, "Safety Code for Existing Elevators and Escalators," current edition. All existing elevators having a travel distance of 25 feet or more above or below the level that best serves the needs of emergency personnel for fire fighting or rescue purposes shall conform to Fire Fighters' Service Requirements of ASME/ANSI A17.3 as required by NFPA 101, §9.4.3.2.

(3) Elevator machine rooms. Elevator machine rooms that contain solid-state equipment for elevators having a travel distance of more than 50 feet above the level of exit discharge or more than 30 feet below the level of exit discharge shall be provided with independent ventilation or air-conditioning systems with the capability to maintain an operating temperature during fire fighter service operations. The operating temperature shall be established by the elevator equipment manufacturer's specifications and shall be posted in each such elevator machine room. When standby power is connected to the elevator, the machine room ventilation or air conditioning shall be connected to standby power. These requirements are not applicable to existing elevators.

(4) Elevator car size.

(A) Minimum elevator car size shall be five feet wide and five feet deep.

(B) When an operating room(s) is located on a floor other than the preoperative and recovery floors a hospital-type elevator shall be provided. Cars of hospital-type elevators shall be at least five feet eight inches wide by eight feet five inches deep.

(5) Elevator and elevator shaft doors. When light beams are used for operating door opening devices, the beams shall be used in combination with door edge devices and shall be interconnected with a system of smoke detectors. The light control feature shall be disengaged when smoke is detected in any elevator lobby.

(A) The smallest elevator car door opening shall be at least three feet wide and seven feet high.

(B) The elevator car door opening for a hospital-type elevator shall be at least 44 inches wide and seven feet high.

(6) Type of controls and alarms. Elevator call buttons, controls, and door safety stops shall be of a type that will not be activated by heat or smoke.

(7) Leveling. All elevators shall be equipped with an automatic leveling device of the two-way automatic maintaining type with an accuracy of one-half inch.

(8) Operation. All elevators, except freight elevators, shall be equipped with a two-way key operated service switch permitting cars to bypass all landing button calls and be dispatched directly to any floor.

(9) Accessibility of controls and alarms. Elevator controls, alarm buttons, and telephones shall be accessible to wheelchair occupants in accordance with the Americans with Disabilities Act.

(10) Location. Elevators shall not open to an exit.

(11) Testing. An ASC shall have all elevators and escalators routinely and periodically inspected and tested in accordance with ASME/ANSI A17.1. All elevators equipped with fire fighter service shall be subject to a monthly operation with a written record of the findings made and kept on the premises as required by NFPA 101, §7-4.8, "Elevator Testing".

(12) Certification. An ASC shall obtain a certificate of inspection evidencing that the elevators and related equipment were inspected in accordance with the requirements in Health and Safety Code (HSC), Chapter 754, Subchapter B, and determined to be in compliance with the safety standards adopted under HSC, §754.014, administered by the Texas Department of Licensing and Regulation. The certificate of inspection shall be on record in each center.

(h) Mechanical requirements. This subsection contains requirements for mechanical systems; air-conditioning, heating and ventilating systems; steam and hot and cold water systems; plumbing fixtures; piping systems; and thermal and acoustical insulation.

(1) Cost. All mechanical systems shall be designed for overall efficiency and life cycle costing, including operational costs. Recognized engineering practices shall be followed to achieve the most economical and effective results except that in no case shall patient care or safety be sacrificed for conservation.

(2) Equipment location. Mechanical equipment may be located indoors or outdoors (when in a weatherproof enclosure), or in a separate building(s).

(3) Vibration isolation. Mechanical equipment shall be mounted on vibration isolators as required to prevent unacceptable structure-borne vibration. Ducts, pipes, etc. connected to mechanical equipment which is a source of vibration shall be isolated from the equipment with vibration isolators.

(4) Performance and acceptance. Prior to completion and acceptance of the facility, all mechanical systems shall be tested, balanced, and operated to demonstrate to the design engineer or his representative that the installation and performance of these systems conform to the requirements of the plans and specifications.

(A) Material lists. Upon completion of the contract, the owner shall obtain from the construction contractor parts lists and procurement information with numbers and description for each piece of equipment.

(B) Instructions. Upon completion of the contract, the owner shall obtain from the construction contractor instructions in the operational use and maintenance of systems and equipment as required.

(5) Heating, ventilating, and air conditioning (HVAC) systems.

(A) All central HVAC systems shall comply with and shall be installed in accordance with the requirements of NFPA 90A, "Standard for the Installation of Air Conditioning and Ventilating Systems," 1999 edition, or NFPA 90B, "Standard for the Installation of Warm Air Heating and Air-Conditioning Systems," 1999 edition, as applicable and the requirements contained in this subparagraph. Air handling units serving two or more rooms are considered to be central units.

(B) Non-central air handling systems, i.e., individual room units that are used for heating and cooling purposes (e.g., fan-coil units, heat pump units, and packaged terminal air conditioning units) shall be equipped with permanent (cleanable) or replaceable filters. The filters shall have an average efficiency of 25-30% and an average arrestance of 85% based on ASHRAE Test Standard 52.1-92. These units may be used as air recirculating units only. All outdoor air requirements shall be met by a separate central air handling system with the proper filtration, as required in Table 1 in §135.54(a) of this title (relating to Tables).

(C) Ventilation system requirements. All rooms and areas in the center shall have provision for positive ventilation. Fans serving exhaust systems shall be located at the discharge end and shall be conveniently accessible for service. Exhaust systems may be combined, unless otherwise noted, for efficient use of recovery devices required for energy conservation. The ventilation rates shown in Table 1 of §135.54(a) of this title shall be used only as minimum requirements since they do not preclude the use of higher rates that may be appropriate.

(i) Temperatures and humidities. The designed capacity of the systems shall be capable of providing the following ranges of temperatures and humidities.

(I) Operating room. The systems serving the operating room shall be capable of maintaining a temperature range between 68 and 75 degrees Fahrenheit and a relative humidity range between 45% and 60%.

(II) Recovery room. The system serving the recovery room shall be capable of maintaining a temperature of 75 degrees Fahrenheit and a relative humidity range between 45% and 60%.

(III) Other areas. The indoor design temperature in all other patient care areas shall be 75 degrees Fahrenheit with relative humidity of not less than 30%.

(ii) Thermometers and humidity gauges. Each operating room and recovery room shall have temperature and humidity indicating devices mounted at eye level.

(iii) Air handling duct requirements. Fully ducted supply, return and exhaust air systems shall be provided for all patient care areas. Combination systems, utilizing both ducts and plenums for movement of air in these areas shall not be permitted. Ductwork access panels shall be labeled.

(I) X-ray protection. Ducts which penetrate construction intended for X-ray or other ray protection shall not impair the effectiveness of the protection.

(II) Protection of ducts penetrating fire and smoke partitions. Combination fire and smoke leakage limiting dampers (Class II) shall be installed in accordance with manufacturer's instructions for all ducts penetrating 1 and 2-hour rated fire and smoke partitions required by NFPA 101, §20.3.7 "Subdivision of Building Space" (not required in ASCs meeting the provisions of NFPA 101, §20.3.7.2, Exception No. 1).

(-a-) Fail-safe installation. Combination smoke and fire dampers shall close on activation of the fire alarm system by smoke detectors installed and located as required by NFPA 72, Chapter 5, "National Fire Alarm Code," 1999 edition; NFPA 90A, Chapter 4; and NFPA 101, §20.3.7; the fire sprinkler system; and upon loss of power. Smoke dampers shall not close by fan shut-down alone. This requirement applies to all existing and new installations.

(-b-) Interconnection of air handling fans and smoke dampers. Air handling fans and smoke damper controls shall be interlocked so that closing of smoke dampers will not damage the ducts.

(-c-) Frangible devices. The use of frangible (nonresetting) devices for shutting smoke dampers shall not be permitted.

(iv) Outside air intake locations.

(I) Outside air intakes shall be located at least 25 feet from exhaust outlets of ventilating systems, combustion equipment stacks, medical-surgical vacuum system outlets, plumbing vents, or areas which may collect vehicular exhaust or other noxious fumes. (Prevailing winds and proximity to other structures may require other arrangements).

(II) Plumbing and vacuum vents that terminate five feet above the level of the top of the air intake may be located as close as 10 feet to the air intake.

(III) The bottom of outside air intakes shall be located not less than six feet above ground level. The bottom of outside air intakes located on a roof shall be not less than three feet above the adjacent roof level.

(v) Air exhaust outlets. Exhaust outlets from areas containing ethylene oxide sterilizers and other contaminants, e.g. glutaraldehyde, shall terminate not less than eight feet above the roof level (or be appropriately labeled as "hazardous exhaust") and arranged to exhaust upward.

(vi) Pressure relationship. Ventilation systems shall be designed and balanced to provide pressure relationships contained in Table 1 of §135.54(a) of this title. For reductions and shut down of ventilation systems when a room is unoccupied, the provisions in Note 4 of Table 1 of §135.54(a) of this title shall be followed.

(vii) Air Distribution Devices. Supply diffusers grilles located in operating rooms and other anesthetizing locations shall be located on the ceiling or on a wall near the ceiling and bottoms of return air grilles in operating rooms and other anesthetizing locations shall be located not more than 12 inches above the finished floor nor less than six inches above the finished floor. At least two return air outlets shall be provided in each operating room on opposing walls or opposite corners.

(viii) Ventilation start-up requirements. Air handling systems shall not be operated without the proper installation of the filter in accordance with the manufacturer recommendation or instruction. This includes the 90% efficiency filters where required. Ducts shall be cleaned thoroughly by a National Air Duct Cleaner Association (NADCA) certified air duct cleaning contractor when the air handling systems have been operated without the required filters in place. This includes construction operations.

(ix) Humidifier location. When duct humidifiers are located upstream of the final filters, they shall be located at least 15 feet from the filters. Duct work with duct-mounted humidifiers shall be provided with a means of removing water accumulation. An adjustable high-limit humidistat shall be located downstream of the humidifier to reduce the potential of condensation inside the duct. All duct takeoffs should be sufficiently downstream of the humidifier to ensure complete moisture absorption. Reservoir-type water spray or evaporative pan humidifiers shall not be used.

(x) Filtration requirements. All air handling units shall be equipped with filters having efficiencies equal to, or greater than, those specified in Table 2 of §135.54(b) of this title. Filter efficiencies shall be average dust spot efficiencies tested in accordance with American Society of Heating, Refrigerating, and Air-conditioning Engineers (ASHRAE), Inc., Standard 52, "Gravimetric and Dust Spot Procedures for Testing Air Cleaning Devices Used in General Ventilation for Removing Particulate Matter," 1992 edition. All joints between filter segments, and between filter segments and the enclosing ductwork, shall have gaskets and seals to provide a positive seal against air leakage. All documents published by ASHRAE as referenced in this section may be obtained by writing or calling the ASHRAE, Inc. at the following address or telephone number: ASHRAE, Inc., 1791 Tullie Circle, N. E., Atlanta, GA 30329; telephone (404) 636-8400.

(I) Location of multiple filters. When two filter beds are required by Table 2 of §135.54(b) of this title, filter bed No. 1 shall be located upstream of the air-conditioning equipment, and filter bed No. 2 shall be located downstream of the supply fan or blowers.

(II) Location of single filters. Where only one filter bed is required by Table 2 of §135.54(b) of this title, it shall be located upstream of the cooling and heating coils.

(III) Duct linings. Friable internal linings shall not be used in ducts, air terminal units, or other air system components supplying operating rooms and post anesthesia recovery rooms unless terminal filters of at least 90% efficiency are installed downstream of linings. This requirement shall not apply to air terminal units and sound attenuators that have approved nonfriable coverings, e.g., foil facing, over such linings.

(xi) Pressure monitoring devices. A manometer or draft gauge shall be installed across each filter bed having a required efficiency of 75% or more, including laboratory hoods requiring high efficiency particulate air (HEPA) filters.

(xii) Ventilation for anesthetizing locations. Ventilation for anesthetizing locations (defined in NFPA 99, §2-2) shall comply with NFPA 99, §5.4.1 and the requirements of subclauses (I) and (II) of this clause.

(I) Smoke removal systems for anesthetizing locations (surgical suites). Supply and exhaust systems for windowless anesthetizing locations shall be arranged to automatically exhaust smoke and products of combustion, prevent recirculation of smoke originating within the surgical suite, and prevent the circulation of smoke entering the system intakes, without in either case interfering with the exhaust function of the system as required by NFPA 99, §5-4.1.3.

(II) Smoke exhaust grilles. Exhaust grilles for smoke evacuation systems shall be ceiling-mounted or on the wall near the ceiling.

(D) Thermal and acoustical insulation for air handling systems. Asbestos containing insulation materials shall not be used.

(i) Thermal duct insulation. Air ducts and casings with outside surface temperature below the ambient dew point or temperature above 80 degrees Fahrenheit shall be provided with thermal insulation.

(ii) Insulation in air plenums and ducts. When installed, linings in air ducts and equipment shall meet the Erosion Test Method described in Underwriters' Laboratories, Inc., Standard 181, "Factory-Made Duct Materials and Air Duct Connectors." This document may be obtained from the Underwriters' Laboratories, Inc., 333 Pfingsten Road, Northbrook, IL 60062-2096.

(iii) Insulation flame spread and smoke developed ratings. Interior and exterior insulation, including finishes and adhesives on the exterior surfaces of ducts and equipment, shall have a flame spread rating of 25 or less and a smoke developed rating of 50 or less as required by NFPA 90A, Chapters 2 and 3 and as determined by an independent testing laboratory in accordance with NFPA 255, A Standard Method of Test of Surface Burning Characteristics of Building Materials, 2000 edition.

(iv) Friable insulation. Insulation of soft and spray-on types shall not be used where it is subject to air currents or mechanical erosion or where loose particles may create a maintenance problem or occupant discomfort.

(6) Piping systems and plumbing fixture requirements. All piping systems and plumbing fixtures shall be designed and installed in accordance with the requirements of the Uniform Plumbing Code, 1997 Edition, published by the International Conference of Building Officials, 5360 Workman Mill Road, Whittier, California 90601, telephone (562) 699-0541; or the Standard Plumbing Code, 1997 edition, published by the Southern Building Code Congress International, Inc., 900 Montclair Road, Birmingham, Alabama 35213-1206, telephone (205) 591-1853.

(A) Water supply piping systems. Water supply piping systems shall be designed to supply water at sufficient pressure to operate all fixtures and equipment during maximum demand.

(i) Valves. Each water service main, branch main, riser, and branch to a group of fixtures shall be valved. Stop valves shall be provided at each fixture.

(ii) Backflow preventers. Backflow preventers (vacuum breakers) shall be installed on hose bibs, laboratory sinks, janitor sinks, bedpan flushing attachments, and on all other fixtures to which hoses or tubing can be attached. Connections to high hazard sources, e.g., x-ray film processors, shall be from a cold water hose bibb through a reduced pressure principle type backflow preventer (RPBFP).

(iii) Flushing valves. Flush valves installed on plumbing fixtures shall be of a quiet operating type, equipped with silencers.

(iv) Water storage tanks. Water storage tanks shall be fabricated of corrosion-resistant metal or lined with noncorrosive material.

(B) Fire sprinkler systems. When provided, fire sprinkler systems shall comply with the requirements of NFPA 101, §9.7 "Automatic Sprinklers and Other Extinguishing Equipment" and the requirements of this clause. All fire sprinkler systems shall be designed, installed, and maintained in accordance with the requirements of NFPA 13, "Standard for the Installation of Sprinkler Systems," 1999 edition, and shall be certified as required by §135.53(e)(4) of this title (relating to Preparation, Submittal, Review, and Approval of Plans).

(C) Piped nonflammable medical gas and clinical vacuum systems. When provided, piped nonflammable medical gas and clinical vacuum system installations shall be designed, installed and certified in accordance with the requirements of NFPA 99, §4-3 for "Level 1 Piped Systems" and the requirements of this subparagraph.

(i) Outlets. Nonflammable medical gas and clinical vacuum outlets shall be provided in accordance with Table 3 of §135.54(c) of this title.

(ii) Installer qualifications. All installations of the medical gas piping systems shall be done only by, or under the direct supervision of a holder of a master plumber license or a journeyman plumber license with a medical gas piping installation endorsement issued by the Texas State Board of Plumbing Examiners.

(iii) Installer tests. Prior to closing of walls, the installer shall perform an initial pressure test, a blowdown test, a secondary pressure test, a cross-connection test, and a purge of the piping system as required by NFPA 99.

(iv) Qualifications for conducting verification tests and inspections. Verification tests and inspections by a party, other than the installer, shall be conducted by individuals who are technically competent and experienced in the field of piped medical gas systems.

(v) Verification tests. Upon completion of the installer inspections and tests and after closing of walls, verification tests of the medical gas piping systems, the warning system, and the gas supply source shall be conducted. The verification tests shall include a cross-connection test, valve test, flow test, piping purge test, piping purity test, final tie-in test, operational pressure tests, and medical gas concentration test.

(vi) Verification test requirements. Verification tests of the medical gas piping system and the warning system, shall be performed on all new piped medical gas systems, additions, renovations, or repaired portions of an existing system. All systems that are breached and components that are added, renovated, or replaced shall be inspected and appropriately tested. The breached portions of a system shall be repaired with all new components in the immediate zone or area located upstream of the point or area of intrusion and downstream to the end of the system or at a properly installed isolation valve.

(vii) Warning system verification tests. Verification tests of piped medical gas systems shall include tests of the source alarms and monitoring safeguards, master alarm systems, and the area alarm systems.

(viii) Source equipment verification tests. Source equipment verification tests shall include medical gas supply sources (bulk and manifold) and the compressed air source systems (compressors, dryers, filters, and regulators).

(ix) Written certification. Written certification for piped medical gas and vacuum systems including the supply sources and warning systems shall be provided by a party technically competent and experienced in the field of medical gas pipeline testing. The certification shall document compliance with NFPA 99 and the integrity of the completed system. The written certification shall be submitted directly to the ASC and the installer. A copy shall be available at final department construction inspection.

(x) Facility responsibility. Before new piped medical gas systems, additions, renovations, or repaired portions of an existing system are put into use, ASC medical personnel shall verify that the gas delivered at the outlet corresponds with labeling required at each outlet.

(xi) Documentation of medical gas and clinical vacuum outlets. Documentation of the installed, modified, extended or repaired medical gas piping system shall be submitted to the department by the same party certifying the piped medical gas systems. The number and type of medical gas outlets (e.g., oxygen, vacuum, medical air, nitrogen, nitrous oxide) shall be documented and arranged tabularly by room numbers and room types.

(D) Waste anesthetic gas disposal (WAGD) systems. Each space routinely used for administering inhalation anesthesia shall be provided with a WAGD system as required by NFPA 99, §4-3.3.

(7) Steam and hot water systems.

(A) Boilers. When provided, boilers shall have the capacity, based upon the net ratings published by the Hydronics Institute or another acceptable national standard, to supply the normal heating, hot water, and steam requirements of all systems and equipment.

(i) Valves. Supply and return mains and risers of cooling, heating, and process steam systems shall be valved to isolate the various sections of each system. Each piece of equipment shall be valved at the supply and return ends except that vacuum condensate returns need not be valved at each piece of equipment.

(ii) Boiler certification. When required, the ASC shall ensure compliance with Texas Department of Licensing and Regulation, Boiler Section, Texas Boiler Law, 1995 (Health and Safety Code, Chapter 755, Boilers), which requires certification documentation for boilers to be posted on site at each boiler installation.

(B) Domestic hot water system. Hot water distribution system serving all patient care areas shall be under constant recirculation to provide continuous hot water at each hot water outlet.

(i) Capacity of water heating equipment. Water heating equipment shall have sufficient capacity to supply water for all clinical needs based on accepted engineering practices using actual number and type of fixtures and for heating, when applicable.

(ii) Water temperature measurements. Water temperatures shall be measured at hot water point of use or at the inlet to processing equipment. Hot water temperature at point of use for patients, staff and visitors shall not exceed 110 degrees Fahrenheit.

(8) Drainage systems. Building sewers shall discharge into a community sewage system. Where such a system is not available, a facility providing sewage treatment must conform to applicable local and state regulations.

(A) Above ground piping. Soil stacks and roof drains installed above ground within buildings shall be drain-waste-vent (DWV) weight or heavier and shall be: copper pipe, copper tube, cast iron pipe, or Schedule 40 polyvinyl chloride (PVC) pipe. Buildings or portions of buildings remodeled to an ASC need not comply with this requirement.

(B) Underground piping. All underground building drains shall be cast iron soil pipe, hard temper copper tube (DWV or heavier), acrylonitrile-butodiene-styrene (ABS) plastic pipe (DWV Schedule 40 or heavier), or PVC pipe (DWV Schedule 40 or heavier. Underground piping shall have at least 12 inches of earth cover or comply with local codes. Existing building or portions of buildings that are being remodeled need not comply with this subparagraph.

(C) Drains for chemical wastes. Separate drainage systems for chemical wastes (acids and other corrosive materials) shall be provided. Materials acceptable for chemical waste drainage systems shall include chemically resistant borosilicate glass pipe, high silicone content cast iron pipe, polypropylene plastic pipe, or plastic lined pipe.

(9) Thermal insulation for piping systems and equipment. Asbestos containing insulation materials shall not be used.

(A) Insulation. Insulation shall be provided for the following:

(i) boilers, smoke breeching, and stacks;

(ii) steam supply and condensate return piping;

(iii) hot water piping and all hot water heaters, generators, converters, and storage tanks;

(iv) chilled water, refrigerant, other process piping, equipment operating with fluid temperatures below ambient dew point, and water supply and drainage piping on which condensation may occur. Insulation on cold surfaces shall include an exterior vapor barrier; and

(v) other piping, ducts, and equipment as necessary to maintain the efficiency of the system.

(B) Flame spread. Flame spread shall not exceed 25 and smoke development rating shall not exceed 50 for pipe insulation as determined by an independent testing laboratory in accordance with NFPA 255, "Standard Method of Test of Surface Burning Characteristics of Building Materials," 2000 edition.

(10) Plumbing fixtures. Plumbing fixtures shall be made of nonabsorptive, acid resistant materials and shall comply with the requirements of the Uniform Plumbing Code, 1997 edition, and this paragraph.

(A) Sink and lavatory controls. All lavatories used by medical and nursing staff and by patients shall be trimmed with valves or electronic controls which can be operated without the use of hands. Blade handles used for this purpose shall not be less than four inches in length. Single lever or wrist blade devices may also be used.

(B) Clinical sink traps. Clinical sinks shall have an integral trap in which the upper portion of a visible trap seal provides a water surface.

(C) Sinks for disposal of plaster of paris. Sinks that are used for the disposal of plaster of paris shall have a plaster trap.

(D) Back flow or siphoning. All plumbing fixtures and equipment shall be designed and installed to prevent the back-flow or back-siphonage of any material into the water supply. The over-the-rim type water inlet shall be used wherever possible. Vacuum-breaking devices shall be properly installed when an over-the-rim type water inlet cannot be utilized.

(E) Drinking fountain. Each drinking fountain shall be designed so that the water issues at an angle from the vertical, the end of the water orifice is above the rim of the bowl, and a guard is located over the orifice to protect it from lip contamination and in compliance with the American Disabilities Act.

(F) Sterilizing equipment. All sterilizing equipment shall be designed and installed to prevent not only the contamination of the water supply but also the entrance of contaminating materials into the sterilizing units.

(G) Hose attachment. No hose shall be affixed to any faucet if the end of the hose can become submerged in contaminated liquid unless the faucet is equipped with an approved, properly installed vacuum-breaker.

(H) Bedpan washers and sterilizers. When provided, bedpan washers and sterilizers shall be designed and installed so that both hot and cold water inlets shall be protected against back-siphonage at maximum water level.

(I) Flood level rim clearance. The water supply spouts for lavatories and sinks required in patient care areas shall be mounted so that its discharge point is a minimum of five inches above the rim of the fixture.

(J) Scrub sink controls. Freestanding scrub sinks and lavatories used for scrubbing in procedure rooms shall be trimmed with foot, knee, or electronic hands-free controls. Single lever wrist blades are not acceptable at scrub sinks.

(K) Floor drains or floor sinks. Where floor drains or floor sinks are installed, they shall be of a type that can be easily cleaned by removal of the cover. Removable stainless steel mesh shall be provided in addition to a grilled drain cover to prevent entry of large particles of waste which might cause stoppages.

(L) Under counter piping. Under counter piping and above floor drains shall be arranged (raised) so as not to interfere with cleaning of the floor below the equipment.

(11) Moisture sensor. A moisture sensor with remote indicator light or drainage system shall be provided for the drain pans located beneath the plumbing lines above operating rooms.

(i) Electrical requirements. All electrical material and equipment, including conductors, controls, and signaling devices, shall be installed in compliance with applicable sections of the NFPA 70, "National Electrical Code," 1999 edition, §517-50; NFPA 99, Chapter 13; the requirements of this subsection; and as necessary to provide a complete electrical system. Electrical systems and components shall be listed by nationally recognized listing agencies as complying with available standards and shall be installed in accordance with the listings and manufacturer's instructions.

(1) All fixtures, switches, sockets, and other pieces of apparatus shall be maintained in a safe and working condition.

(2) Extension cords and cables shall not be used for permanent wiring.

(3) All electrical heating devices shall be equipped with a pilot light to indicate when the device is in service, unless equipped with a temperature limiting device integral with the heater.

(4) All equipment, fixtures, and appliances shall be properly grounded in accordance with NFPA 70.

(5) Under-counter electrical installations shall be arranged (raised) to not interfere with cleaning of the floor below the equipment.

(6) Installation testing and certification.

(A) Installation testing. The electrical installations, including grounding continuity, fire alarm, nurses calling system and communication systems, shall be tested to demonstrate that equipment installation and operation is appropriate and functional. A written record of performance tests on special electrical systems and equipment must show compliance with applicable codes and standards and shall be available to the department upon request.

(B) Installation certification. Certifications, in affidavit form, signed by a registered electrical engineer attesting that the electrical service, electrical equipment, and electrical appliances have been installed in compliance with the approved plans and applicable standards, shall be submitted to the department upon request.

(7) Electrical safeguards. Shielded isolation transformers, voltage regulators, filters, surge suppressors, and other safeguards shall be provided as required where power line disturbances are likely to affect fire alarm components, data processing, equipment used for treatment, and automated laboratory diagnostic equipment.

(8) Services and switchboards. Main switchboards shall be located in an area separate from plumbing and mechanical equipment and shall be accessible to authorized persons only. Switchboards shall be convenient for use, readily accessible for maintenance, away from traffic lanes, and located in dry, ventilated spaces free of corrosive or explosive fumes, gases, or any flammable material. Overload protective devices must operate properly in ambient temperatures.

(9) Panelboard. Distribution panels containing circuit breakers which control lighting and power to essential and normal electrical circuits shall be located within the ASC.

(10) Wiring. All conductors for controls, equipment, lighting and power operating at 100 volts or higher shall be installed in metal or metallic raceways in accordance with the requirements of NFPA 70, Article 517. All surface mounted wiring operating at less than 100 volts shall be protected from mechanical injury with metal raceways to a height of seven feet above the floor. Conduits and cables shall be supported in accordance with NFPA 70, Article 300.

(11) Lighting.

(A) Lighting intensity for staff and patient needs shall comply with guidelines for health care facilities set forth in the Illuminating Engineering Society of North America (IES) Handbook published by the Illuminating Engineering Society of North America, 120 Wall Street, New York, NY 10005.

(i) Consideration should be given to controlling light intensity and wavelength to prevent harm to the patient's eyes.

(ii) Approaches to buildings and parking lots, and all spaces within buildings shall have fixtures that can be illuminated as necessary. All rooms including storerooms, electrical and mechanical equipment rooms, and all attics shall have sufficient artificial lighting so that all spaces shall be clearly visible.

(iii) Consideration should be given to the special needs of the elderly. Excessive contrast in lighting levels that makes effective sight adaptation difficult shall be minimized.

(B) Means of egress and exit sign lighting intensity shall comply with NFPA 101, §§7.8, 7.9, and 7.10.

(C) Electric lamps which may be subject to breakage or which are installed in fixtures in confined locations when near woodwork, paper, clothing, or other combustible materials, shall be protected by wire guards, or plastic shields.

(D) Ceiling mounted surgical and examination light fixtures shall be suspended from rigid support structures mounted above the ceiling.

(E) Operating rooms shall have general lighting in addition to local lighting provided by special lighting units at the surgical tables. Each fixed special lighting unit at the tables, except for portable units, shall be connected to an independent circuit.

(F) X-ray film illuminators for handling at least two films simultaneously shall be provided in each operating room and special procedure room.

(12) Receptacles. Only listed hospital grade grounding receptacles shall be used in the operating rooms and post anesthesia recovery area. This does not apply to special purpose receptacles.

(A) Installations of multiple ganged receptacles shall not be permitted in patient care areas.

(B) All receptacles powered from the critical branch shall be colored red.

(C) Replacement of malfunctioning receptacles and installation of new receptacles powered from the critical branch in existing facilities shall be accomplished with receptacles of the same distinct color as the existing receptacles.

(D) In locations where mobile X-ray or other equipment requiring special electrical configuration is used, the additional receptacles shall be distinctively marked for the special use.

(E) Each receptacle shall be grounded to the reference grounding point by means of a green insulated copper equipment grounding conductor in accordance with NFPA 70, §517-13.

(F) Each operating room and special procedure room shall have at least four duplex receptacles located convenient to the head of the procedure table and one receptacle on the other walls.

(G) Appliances shall be grounded in accordance with NFPA 99, Chapter 9.

(H) A minimum of one duplex receptacle in each wall shall be installed in each work area or room other than storage or lockers. Each examination and work table shall have access to a minimum of two duplex receptacles.

(13) Equipment.

(A) The following shall be powered from the Type I essential electrical system in accordance with the requirements of NFPA 99, §3-4.2.2.3 when such a system is required for safe operation of the ASC referenced in paragraph (17) of this subsection.

(i) Boiler accessories including feed pumps, heat-circulating pumps, condensate return pumps, fuel oil pumps, and waste heat boilers shall be connected to the equipment system.

(ii) Ventilating system serving preoperative areas, operating rooms, and post anesthesia recovery rooms shall be connected to the equipment system in accordance with the requirements of NFPA 99, Chapter 3.

(B) Laser equipment shall be installed according to manufacturer recommendations and shall be registered with the Bureau of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756.

(14) Wet patient care location. Wet patient care locations shall be protected against shock in accordance with the requirements of NFPA 99, §3-3.2.1.2(f).

(15) Grounding requirements. Fixed electrical equipment shall be grounded in accordance with the requirements of NFPA 99, §3.3.2.1.2 and NFPA 70, Article 517-13.

(16) Nurses calling systems.

(A) A nurse emergency calling system shall be installed in all toilets used by patients to summon nursing staff in an emergency. Activation of the system shall sound an audible signal which repeats every five seconds at a staffed location and shall activate a distinct visible signal outside of toilet room where the call originated. The visible and audible signals shall be cancelable only at the patient calling station. Activation of the system shall also activate distinct visible signals in the clean workroom, in the soiled workroom, and if provided, in the nourishment station.

(B) A staff emergency assistance calling system station shall be located in each operating room, treatment room, examination room, recovery and preoperative holding area to be used by staff to summon additional help in an emergency. Activation of the system shall sound an audible signal at a staffed location, indicate type and location of call on the system monitor and activate a distinct visible signal in the corridor at the door. Additional visible signals shall be installed at corridor intersections in multi-corridor facilities. Distinct visible and audible signals shall be activated in the clean workroom, in soiled workroom, and if provided, in the nourishment station.

(17) Essential electrical system. The essential electrical system shall comply with the requirements of NFPA 99, §13-3.3.2.

(A) A Type 1 essential electrical system shall be installed, maintained and tested in each ASC in accordance with requirements of NFPA 99, §3-4; NFPA 101, §20.2.9; and National Fire Protection Association 110, Standard for Emergency and Standby Power Systems, 1999 edition.

(i) All autoclaving/sterilizing equipment shall be connected to the emergency power system.

(ii) One electrical outlet connected to the life safety branch of the electrical system shall be provided adjacent to (or on) the emergency generator.

(iii) The battery charger for emergency lighting at the emergency generator shall be connected to the life safety branch of the electrical system.

(B) Fuel storage capacity for an on-site generator for a Type 1 essential electrical system shall allow continuous operation, under full load for eight hours and six months of testing as required by NFPA 99, §3-4.4.1.1(b).

(18) Fire alarm system. A fire alarm system which complies with the requirements of NFPA 101, §20.3.4; NFPA 70, Article 760; and NFPA 72, Chapter 3 requirements, shall be provided in each ASC.

(A) Fire alarm system shall be installed by or under direct supervision of a fire alarm installer licensed by the State Fire Marshal.

(B) The ASC shall submit a copy of the Fire Alarm Installation Certificate (State Fire Marshal's form FML 009 040392) to the department for all new installations and for any material changes to the existing systems.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 15, 2004.

TRD-200401920

For further information, please call: (512) 458-7236

Chapter 137. BIRTHING CENTERS

The Texas Department of Health (department) adopts amendments to §137.11 and §137.22, and new §137.44, concerning the regulation of birthing centers without changes to the proposed text as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10049), and therefore the sections will not be republished.

The amendments and new section are required as a result of revisions and additions to sections of the Health and Safety Code. House Bill 2292, 78th legislature, 2003, revised Health and Safety Code, §§12.0111 and 12.0112, and requires two-year licenses effective January 1, 2005; House Bill 341, 78th legislature, 2003, added Health and Safety Code, §161.451 and §161.452 and requires parenting and postpartum counseling information to be provided to patients; and Senate Bill 162, 78th legislature, 2003, which amended Health and Safety Code, §244.011, and added probation to the list of enforcement actions that can be taken against a facility.

Specifically, the amendment to §137.11 implements the process for converting to two-year licensing cycles beginning January 1, 2005. The amendment to §137.22 reflects the addition of probation to the list of enforcement actions that can be taken against a facility. New §137.44 requires birthing centers that provide prenatal care to a pregnant woman during gestation or at delivery of an infant to provide the woman with parenting and postpartum counseling information.

No comments were received on the proposal during the comment period.

Subchapter B. LICENSING PROCEDURES

25 TAC §137.11

The amendment is adopted under Health and Safety Code, §244.009, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the issuance, renewal, denial, suspension, and revocation of each level of license; and Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401858

For further information, please call: (512) 458-7236

Subchapter C. ENFORCEMENT

25 TAC §137.22

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401859

For further information, please call: (512) 458-7236

Subchapter D. OPERATIONAL AND CLINICAL STANDARDS FOR THE PROVISION AND COORDINATION OF TREATMENT AND SERVICES

25 TAC §137.44

The new section is adopted under Health and Safety Code, §244.009, concerning rules and minimum standards to protect and promote the public health and welfare by providing for the issuance, renewal, denial, suspension, and revocation of each level of license; and Health and Safety Code, §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401860

For further information, please call: (512) 458-7236

Chapter 169. ZOONOSIS CONTROL

Subchapter E. DOG AND CAT STERILIZATION

The Texas Department of Health (department) adopts the repeal of §169.101, concerning the Animal Friendly Advisory Committee (committee) and an amendment to §169.102, concerning the Texas Department of Health Animal Friendly Grants. The repeal and amended section are adopted without changes to the proposal as published in the November 14, 2003, issue of the Texas Register (28 TexReg 10078), and will not be republished.

The committee has provided advice to the Texas Board of Health (board) and the department on the dispensing of grant money in the animal friendly account.

The Animal Friendly Advisory Committee was created because of Health and Safety Code, §828.015. However, according to 78th Legislature, Chapter 198, §2.151 (House Bill 2292), all advisory committees were abolished, effective September 1, 2003, except those required by federal law or that advise the department with respect to certification or licensing programs, the regulation of entities providing health and human services, or the implementation of a duty prescribed under 78th Legislature, Chapter 198, Article 2 (House Bill 2292). The Commissioner of Health and Human Services announced in the August 29, 2003, issue of the Texas Register (28 TexReg 7493), that the department's Animal Friendly Advisory Committee would not be certified as exempt from abolition on September 1, 2003. Therefore, the need for this rule no longer exists.

The amendment to §169.102 is necessary to eliminate language referencing the committee.

No public comments were received during the comment period for the proposal.

25 TAC §169.101

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on March 11, 2004.

TRD-200401848