TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 37. MATERNAL AND INFANT HEALTH SERVICES

The Texas Department of Health (department) adopts amendments to §§37.141-37.152 concerning the minimum standards and requirements for detection of abnormal spinal curvature in certain school-age children attending public and private schools. Sections 37.142, 37.147, and 37.148 are adopted with changes to the proposed text as published in the October 5, 2001 issue of the Texas Register (26 TexReg 7758). Sections 37.141, 37.143-37.146, and 37.149-37.152 are adopted without changes, and therefore the sections will not be republished.

The amendments improve the clarity and consistency of the rules; increase the program's capacity to detect abnormal spinal curvature in children by offering additional opportunities for children to obtain a spinal screening exam under the current law; reduce the chance that school transfers or school administrative oversights will prevent children from receiving spinal screenings; and clarify that only adult non-students may serve as screeners.

In accordance with the requirements of Government Code, §2001.039, the sections 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, the sections required revision as described in this preamble.

The department published a Notice of Intention to Review for §§37.141-37.152 in the Texas Register on January 21, 2000 (25 TexReg 398). No comments were received.

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

Change: The definition of "health practitioner" at §37.142(6) has been amended to specify that such individuals are licensed professionals who have completed a course of study in physical assessment. The change has been made to ensure that health practitioners who choose not to attend a spinal screener certification workshop nevertheless have adequate educational background and training to perform spinal screenings.

Change: The definition of "non-health practitioner" at §37.142(7) has been amended to clarify that other individuals such as licensed vocational nurses and health assistants who have a health background but may lack training in physical assessment may also attain certification by attending a spinal screener workshop.

Change: The definition of "screener" at §37.142(10) has been clarified to specify that screeners must be adults and may not themselves be students. The department has determined that potential utilization by schools of students to conduct state-mandated spinal screening on their peers would be inappropriate.

Change: The spelling of "conducting" in §37.142(15) has been corrected.

Change: The language of proposed §37.148(c) has been moved to §37.148(b) to improve the clarity and the logical order of the sections. The language of §37.148(b) as proposed has been deleted.

Change: Section 37.148(c) as proposed has been amended to clarify that new students who have no record of a spinal screening enrolling in grades six and nine (or five and eight) shall nevertheless be screened before the end of the year they enroll. The department has also amended §37.148(c) to clarify that schools shall consider, but are not required, to offer spinal screening to newly enrolled students in grades ten, 11, or 12 who have no record of having received spinal screening.

Change: The language in §37.148(d) has been clarified by deleting the specific references to grades six and nine, or five and eight, because only one of the pairs of grades will be applicable in any one school.

Change: The reference in §37.148(e) to professional examinations obtained in lieu of receiving spinal screening in school has been clarified by requiring that professional examinations must include a forward-bend test, thereby assuring that they are equivalent to spinal screenings performed in schools. In addition, the time within which parents must obtain professional exams has been clarified by authorizing parents to obtain the exam at any time during the school year that the child is scheduled for screening, or during the summer break but before the beginning of the following school year. This change enables parents to incorporate a spinal screening into a regularly scheduled physician visit, and lessens any additional burden on the parent and missed school time for the student.

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 as a whole, one commenter suggested reviewing the necessity for schools to send home letters to parents to announce upcoming spinal screenings, adding that schools can reduce costs of conducting screening by not sending out this letter.

Response: The department recommends the use of announcement letters by schools to new screeners during spinal screener certification, but the Spinal Screening Program rules do not require notification letters. The department strongly urges schools to notify parents before a spinal screening takes place so they may exercise their right to obtain spinal screening from their physician or to claim exemption from screening based on their religious beliefs. Prior notification also helps parents prepare students for the screening and ensures that they come to screening dressed appropriately. Several schools provide parental notification by including the spinal screening information among other communications sent to parents such as report cards, newsletters, websites, or orientation packets sent at the beginning of school year. No changes were made as a result of this comment.

Comment: Concerning the rules as a whole, one commenter stated that the department should address students' use of backpacks, resulting muscle strain, and other related issues.

Response: Although students' use of backpacks, resulting muscle strain, and related issues may affect the health of many students, they are outside the scope of the spinal screening rules. No changes were made as a result of this comment.

Comment: Concerning §37.142(6), one commenter stated that spinal screening is not always included in the course of study of registered nurses (RNs), and therefore the department should place more emphasis on training registered nurses to conduct spinal screening.

Response: Staff of the Texas Board of Nurse Examiners has stated that registered nursing programs in Texas do include training in physical assessment techniques. Additionally, registered nurses in Texas practice according to the Nursing Practice Act, which obligates licensees to "accept only those nursing assignments that take into consideration patient safety and that are commensurate with one's own educational preparation, experience, knowledge, and physical and emotional ability". Hence RNs must seek screener certification if he/she does not have sufficient educational preparation or experience, or feels unable to perform the assignment for any other reason. RN's will continue to be exempt from required screener certification, but are free to attend voluntarily. No changes were made as a result of this comment.

Comment: Concerning §137.142(6), one commenter stated that registered nurses should not be required to attend a certification workshop, nor be re-certified every five years.

Response: The department agrees, but adds that a registered nurse must be confident that she or he is adequately trained and prepared to conduct spinal screenings. If not, the RN should participate in a certification workshop. No changes were made as a result of this comment.

Comment: Concerning §37.142(6) and §37.142(7), one commenter asked whether a licensed vocational nurse (LVN) is classified as a health practitioner or a non-health practitioner. The commenter stated that although they are licensed health practitioners, the department nevertheless requires LVNs to obtain non-health practitioner certification before conducting spinal screening.

Response: According to the Board of Vocational Nurse Examiners, vocational nursing education programs in Texas are not required to include training in spinal screening, scoliosis, and/or the forward-bend test. For this reason, the department requires LVNs to obtain screener certification before conducting spinal screening. The department has amended the proposed definitions of "health practitioner" at §37.142(6) and "non-health practitioner" at §37.142(7) to explain why such professionals as registered nurses who have an educational background in physical assessment techniques may conduct spinal screening without taking a department certification course, but licensed vocational nurses may not do so without department certification.

Comment: Concerning §37.142(9), one commenter suggested changing the phrase "five - 21" to either "five and twenty-one" or "5 and 21".

Response: The published text complies with Texas Register style guidelines. No changes were made as a result of this comment.

Comment: Concerning §37.147(1), one commenter suggests adding a comma after the first occurrence of the word "test" in the sentence "The basic spinal screening test known as the forward-bend test..."

Response: The department agrees, and has amended the section accordingly.

Comment: Concerning §37.148, two commenters stated that they are in full agreement with the mandated grades to screen and support the proposed amendments to the rules.

Response: The department acknowledges the commenters' support for the rules. No changes were made as a result of the comments.

Comment: Concerning §37.148(a), one commenter stated that school districts should be able to set their own grade levels for conducting spinal screening, since student populations in each grade level vary among campuses in districts across the state. The commenter added that such variation influences the number of students to be screened per campus, and that permitting each district to determine the grade levels at which screening will be conducted would facilitate use of the best ratio of screening staff to students.

Response: Health and Safety Code, §37.001(b) requires the Texas Board of Health to adopt rules for the mandatory spinal screening of children in grades six and nine attending public or private schools. The department cannot by rule authorize individual school districts to schedule spinal screening in other grades. No changes were made as a result of this comment.

Comment: Concerning §37.148(b), one commenter stated that screening in grades 10, 11, and 12 does not fall into the recommended ages for spinal screening.

Response: The department believes that in order to safeguard the health of all students in public and private schools most effectively, each student should receive at least one spinal screening before graduation if he or she has missed the regularly scheduled screening(s) for any reason. However, the department is aware of no research supporting the screening of students for spinal abnormalities in grades 10, 11, or 12, and the department acknowledges that it lacks the authority to change the grades for screening mandated by the Texas Legislature. The department has therefore amended §37.148(b) as proposed to require only that schools must consider offering students in grades 10, 11 and 12 the opportunity for spinal screening if the student has no record of having been screened previously.

Comment: Concerning §37.148(b), one commenter stated that by the time they reach grade 10, most students with a spinal abnormality should already be under treatment, and if not under treatment, many students may be unwilling to undergo screening and/or treatment.

Response: The department has no empirical basis upon which to either agree or disagree with the commenter's opinions. The department is aware of no research supporting the screening of students for spinal abnormalities in grades 10, 11, or 12, and affirms that in any case, it lacks the authority to change the grades for screening mandated by the Texas Legislature. However, the department has amended §37.148(b) as proposed to require only that schools must consider offering students in grades 10, 11 and 12 the opportunity for spinal screening if the student has no record of having been screened previously.

Comment: Concerning §37.148(b), one commenter stated that the rules do not address screening in grades seven and eight, which could result in a student not previously screened entering grade seven but not actually being screened until two years later in grade nine. The commenter added that it is more important to screen these new students in grade seven and eight than it is to screen students with no record of prior screening entering in grades 10, 11, or 12.

Response: The department agrees that students enrolling in a new school during grades seven and eight may not receive a timely screening under the present rules, and has amended §37.148(b) to require that schools screen any student entering a grade scheduled for screening (i.e., grades six and nine or five and eight) during that year if the student has no record of having been screened previously. Although the department has no statutory authority to require by rule that screening take place in grade seven, schools may elect to offer screening at other grade levels in addition to those required. In regards to screening new students without a record of a previous spinal screening in grades 10, 11, or 12, the department has amended §37.148(b) as proposed to require only that schools must consider offering students in grades 10, 11 and 12 the opportunity for spinal screening if the student has no record of having been screened previously.

Comment: Concerning §37.148(b), one commenter stated that it is difficult to schedule screenings in the grades 10, 11, and 12 because of varying and sporadic class schedules at those grade levels, and added that screening in grades 10, 11, and 12 would cause too many record-keeping hardships for schools.

Response: Since the proposed rule would have required screening of only those new students in grades 10, 11, or 12 who have no record of having received prior spinal screening, the department believes the resulting scheduling and record-keeping requirements would have been easily manageable. However, the department has amended §37.148(b) as proposed to require only that schools must consider offering students in grades 10, 11 and 12 the opportunity for spinal screening if the student has no record of having been screened previously.

Comment: Concerning §37.148(b), one commenter stated that spinal screening in grades 10, 11, and 12 would require schools to incur additional costs for the training of screeners and the additional time needed to perform the screens.

Response: The department believes that the additional staff time and/or expenses necessary to offer screening to newly enrolled students in grades 10, 11, or 12 who lack a record of having received a previous spinal screening would be negligible, and that the relatively small cost of additional screening and record-keeping would be more than balanced by the value of providing each student in Texas the opportunity to undergo at least one spinal screening. Nevertheless, the department has amended §37.148(b) as proposed to require only that schools must consider offering students in grades 10, 11 and 12 the opportunity for spinal screening if the student has no record of having been screened previously.

Comment: Concerning §37.148(b), one commenter stated that screening new students enrolling in grades 10, 11, or 12 who have no record of having previously undergone spinal screening would take additional time, but would result in very few referrals.

Response: The department believes that the additional time required to screen new enrollees in grades 10, 11, or 12 who have no record of prior screening would vary from school to school. The department is aware of no data concerning either the number of students who enroll in grades 10, 11, or 12 each year who lack records of previous spinal screening. Although the referral rate among all students following spinal screening is statistically small, state law nevertheless requires that spinal screening be conducted on all students in public and private schools. The department has amended §37.148(b) as proposed to require only that schools must consider offering students in grades 10, 11 and 12 the opportunity for spinal screening if the student has no record of having been screened previously.

Comment: Concerning §37.148(c), one commenter stated that screening students in the fifth grade for spinal abnormalities is inconsistent with the position of the American Academy of Orthopaedic Surgeons, which states that a reasonable approach would be screening girls in grades five and seven and boys in grades six or nine. The commenter added that she has seen few positive findings from screenings of students in grade five.

Response: Section 37.148(c) authorizes schools to screen students in grades five and eight, but only in lieu of screening which otherwise must be conducted the next year, in grades six and nine, at the option of the school. Although the department cannot authorize individual school districts to conduct mandatory spinal screening in other grades, schools may elect to offer voluntary screening opportunities in additional grade levels. No changes were made as a result of this comment.

Comment: Concerning §37.148(c), one commenter suggested that since schools are screening for vision and hearing in grades five and nine, it would be better to conduct spinal screening in grades six and eight so that nurses would have contact with each student each year from grades five through nine.

Response: The department does not have the authority to adopt rules varying the grades for spinal screening mandated by the Texas Legislature. Under current rules, schools may elect to offer voluntary screening in other grades in addition to grades five and eight or six and nine. No changes were made as a result of this comment.

Comment: Concerning §37.148(c), one commenter stated that it is better to screen children in grades six and eight because they are screening boys at an older age more consistent with the position statement of the American Academy of Orthopaedic Surgeons. The commenter added that screening in grade nine is conducted in a high school setting where there is usually a significantly higher population of students and conducting screening is therefore more difficult and time-consuming.

Response: The department does not have authority to change the grades for screening mandated by the Texas Legislature. Under current rules, districts that prefer not to screen high school students may choose to screen in grades five and eight. No changes were made as a result of this comment.

Comment: Concerning §37.148(c), one commenter stated that the department should review the statistics concerning age, grade, and outcome to help districts decide if screening should be conducted in grades five and nine if school districts are not already screening those grades.

Response: The department agrees that the Spinal Screening Program could benefit from conducting statistical research into the effectiveness of screening of students in various grades, and that such research could form the basis for recommendations to the Texas Legislature in the future. Nevertheless, the department does not currently have authority to change the grades for screening mandated by the Texas Legislature. No changes were made as a result of this comment.

Comment: Concerning §37.148(e), one commenter states that the phrase "may submit to the school's chief administrator documentation..." should read "must submit to the school's chief administrator documentation...", in order to ensure that screening is conducted and proper records are obtained by school.

Response: The department agrees and has amended the section accordingly.

Comments on the proposed rules received by the department during the comment period were submitted by Shriners Hospitals for Children--Houston, by the Texas Board of Nurse Examiners, and by the Texas Board of Vocational Nurse Examiners.

The sections are adopted under Health and Safety Code, §37.001(b), which requires the Texas Board of Health (board) to adopt rules for the mandatory spinal screening of children in grades six and nine attending public or private schools; §37.001(c), which requires the board to adopt rules necessary to administer screening activities; and §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.

§37.142.Definitions.

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

(1) Abnormal spinal curvature--An anatomic, structural deviation from the normal spinal curve, such as scoliosis or kyphosis.

(2) Child's health record--The official individual student health record(s) maintained by a school for a child.

(3) Conflict of interest--The use of the screening process for solicitation of follow-up services which enable the individual, his/her immediate family members or professional associates to benefit financially, or earn favors or free publicity as a result of the screening process.

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

(5) Forward-bend test--A screening procedure approved by the department to determine whether a child may have an abnormal spinal curvature.

(6) Health practitioner--A licensed professional who has completed a course of study in physical assessment and who is appropriately licensed under state law, including physicians, chiropractors, physical therapists, and registered nurses.

(7) Non-health practitioner--A person who may or may not have a health background, or whose training has not included physical assessment skills and techniques, which generally includes teachers, coaches, athletic trainers, licensed vocational nurses, health assistants, parents, and volunteers.

(8) Professional examination--An evaluation performed by a health practitioner licensed under state law and whose expertise addresses the diagnostic needs of the individual identified as having a possible spinal deformity.

(9) School--An educational institution that admits children who are between five-21 years of age, which includes an individual school campus.

(10) Screener--An adult, non-student who performs the spinal screening test in a school setting. Screeners may be health practitioners who are licensed under state law or non-health practitioners who have successfully completed a department-approved course in spinal screening.

(11) Screener certification--Department-approved training which qualifies the individual to receive a certificate stating that the person may perform spinal screening.

(12) Screener recertification--A department-approved review course for screeners to extend their certification for an additional five years.

(13) Screening--The forward-bend test, which is used for the determination of the need for a professional examination to diagnose a spinal deformity.

(14) Trainer certification--A department-approved course which qualifies the individual to receive a certificate stating the person may teach the screener certification course.

(15) Trainer--Individuals, including department staff and those health practitioners appropriately licensed under state law, who have successfully completed the department approved trainer certification course, and have at least two years of experience conducting spinal screening in a school-setting.

§37.147.Standards for Spinal Screening Testing.

The department and school districts, private schools, state agencies, volunteer organizations, and other entities performing spinal screening shall adhere to the following standards.

(1) The basic spinal screening test, known as the forward-bend test, shall be used to screen children for abnormal spinal curvature. A description of the test is available from the Texas Department of Health, Bureau of Children's Health, Child Wellness Division, 1100 West 49th Street, Austin, Texas 78756.

(2) In order to avoid over-referrals, children failing the initial screening shall be rescreened using the forward-bend test prior to parental notification of the possible presence of an abnormal spinal curvature.

§37.148.Responsibilities of Public and Private Schools.

(a) All children in grades six and nine attending public and private schools shall be screened for abnormal spinal curvature before the end of the school year. The screening requirements may also be met by a professional examination as defined in §37.142 of this title (relating to Definitions).

(b) The screening requirement for children entering grade six or nine may be met if the child has been screened for spinal deformities during the previous year. Schools may implement a program that includes screening in grades five and eight in lieu of grades six and nine.

(c) New students enrolling in grades scheduled for screening (i.e., grades six and nine or five and eight) who have no record of having received their scheduled screening(s) shall be screened the year they enroll. Schools shall consider offering a student enrolling in grades 10, 11, or 12 the opportunity for spinal screening if the student has no record of having been screened previously.

(d) The chief administrator of each school shall ensure that every child complies with the state-mandated spinal screening requirements or submits an affidavit of exemption. An affidavit shall be signed by the child's parent, managing conservator, or guardian that spinal screening conflicts with the tenets and practices of a recognized church or religious denomination of which the child is an adherent or a member. This affidavit shall be submitted to the school's chief administrator on or before the day of the screening procedure each year the screening is performed, to meet the requirements of the Act. A copy of this affidavit shall be filed in the child's health record.

(e) A parent, managing conservator, or guardian who declines participation in the spinal screening provided by the school must submit to the school's chief administrator documentation of a professional examination which includes the results of a forward-bend test. This documentation must be submitted to the school during the school year the student is scheduled for screening, or, if the professional exam is obtained during the following summer, at the beginning of the following school year.

(f) If the spinal screening test indicates that a child may have an abnormal spinal curvature, the individual performing the test shall fill out a report on a form prescribed by the department. The chief administrator of the school shall retain one copy of such report and send the original to the parent(s), managing conservator, or guardian of the child screened. The form shall contain information regarding the results of the screening and shall be accompanied by a letter advising the parent, managing conservator or guardian of his/her responsibility to select an appropriate health practitioner for the examination.

(g) A copy of the previously mentioned report shall be filed at the child's school and an entry shall be made in the child's health record. The original is returned with the final diagnosis and the plans for treatment, as indicated.

(h) The chief administrator of each school shall monitor the referral process and encourage a professional exam, and may provide information about services to families without insurance or unable to afford private care. These services may include but are not limited to Medicaid, Children's Health Insurance Plan, Children with Special Health Care Needs, or local resources.

(i) A list of children who failed the spinal screening test may be kept to assist in determining whether a professional examination has occurred.

(j) Proof of screening shall be provided by an entry in the child's health record stating that the child has undergone screening tests that meet the standards outlined in these sections. Such an entry shall also include the results of screening.

(k) Personnel performing screening may maintain a list of children screened for spinal deformities as proof of screening.

(l) In cases when a professional examination was performed in lieu of the required screening test, the date, results, name, and title of the professional performing the exam shall be entered in the child's health record.

(m) The chief administrator of each school shall ensure that each individual complies with the screening requirements in these sections.

(n) Each school shall submit to the department an annual report of spinal screening performed during the school year no later than June 30 of the reporting year. The report shall be submitted by the chief administrator of each school district as specified on a form issued by the department.

(o) The child's health record shall be acceptable as proof of screening if such record contains entries of screening results. In such a case, the original or a true and correct copy of that record may be transferred between schools and shall be honored by the governing body of the school upon transfer of a student from another school in Texas or another school within the United States.

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 25, 2002.

TRD-200201898

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: August 1, 2002

Proposal publication date: October 5, 2001

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

Chapter 133. HOSPITAL LICENSING

Subchapter C. OPERATIONAL REQUIREMENTS

25 TAC §§133.41, 133.43, 133.45

The Texas Department of Health (department) adopts amendments to §§133.41, 133.43 and 133.45 concerning the regulation of hospitals. Sections 133.41 and 133.43 are adopted with changes to the proposed text as published in the December 14, 2001, issue of the Texas Register (26 TexReg 10207). Section 133.45 is adopted without changes, and therefore the section will not be republished.

The amendments are based upon a joint recommendation by the Texas Nurses Association and the Texas Hospital Association. The associations recommended the adoption of rules to address concerns about the nursing workplace environment, specifically, the adequacy of nursing staffing in hospitals. The amendment to §133.41 establishes educational and administrative qualifications for the chief nursing officer; requires the consideration of certain critical factors which are set out in the rules in determining staffing levels; requires hospitals to adopt, implement and enforce a process for setting staffing levels; establishes an advisory committee to solicit and receive input from nurses on the development, monitoring and evaluation of the staffing plan; requires the hospital to adopt, implement and enforce a written staffing plan which addresses patient care and operational outcomes, patient concerns, and staffing issues; and requires policies and procedures to address nursing staff orientation and competency as well as the use of mandatory overtime. Section 133.43 precludes a hospital from suspending or terminating the employment of, discipline, or otherwise discriminate against an employee for reporting a violation of law, the Health and Safety Code, Chapter 241, or 25 Texas Administrative Code, Chapter 133. The amendment to §133.43 adds a federal agency and a national accrediting organization to the persons and entities listed in the rule to which an employee may report. The amendment to §133.45 requires hospitals to have a written policy for identifying and addressing instances of alleged verbal or physical abuse or harassment of hospital employees or contracted personnel.

The following comments were received concerning the proposed rules. Following each comment is the department's response and any resulting changes.

Comment: Concerning the rule preamble and the rules in general, one commenter disagreed with the department's fiscal note which stated there is no anticipated cost because all hospitals are currently required to ensure that there are adequate number of registered nurses, licensed vocational nurses and other personnel to provide nursing care to all patients as needed. The commenter stated that the obvious purpose is to create a mechanism to force hospitals to hire more staff, and suggested that the department eliminate the proposed rules because they will accomplish nothing without the funds to back them up. Another commenter stated that the rule will create an additional administrative and financial burden on the part of the hospital.

Response: The department disagrees with the commenters. It is not the department's purpose to create a mechanism to force hospitals to hire more staff. These rules are designed to assist hospitals in developing a viable nurse staffing plan in order to promote staff satisfaction and patient safety. The department believes that those hospitals which comply with current rules and regulations will not experience increased costs. No changes were made as a result of these comments.

Comment: Concerning the rules in general, one commenter stated that we have a group of people at all levels of government writing regulations to correct problems and to increase quality, but without regard or knowledge of the financial implications of such regulations. The commenter further stated that we badly need some type of law that requires new programs and new regulations to estimate the cost of said programs and to identify the resources for those programs.

Response: The department disagrees with the commenter. The department provided a fiscal note in accordance with Government Code §2001.024, which requires state agencies to provide a fiscal note when proposing rules. The department stated in the fiscal note that hospitals that comply with current rules and regulations will not experience increased costs. The rules are based upon recommendations from the associations who represent Texas hospitals and nurses. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter stated that the rule appears to be very vague when it comes to direct patient care and very specific with administrative requirements, which appears to be role reversal to support the additional layer of bureaucracy.

Response: The department disagrees and refers the commenter to the specific direct care issues contained in §133.41(o)(2)(I)(i)(II) which requires the utilization of outcomes and nursing-sensitive indicators as an integral role in setting and evaluating the adequacy of the staffing plan. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter stated that because of understaffing, nurses have left the hospitals because of stress and liability issues, and that the problem cannot be solved by passing these regulations. The commenter stated that the department is laying the basis for more lawsuits against hospitals for understaffing. Two other commenters stated if the department really wanted to solve the nursing shortage, it should address the problem of abusive doctors and lawyers who believe they have the right to talk down to anyone.

Response: The department disagrees with the first commenter. Both state rules and federal regulations presently require hospitals to have adequate staffing. These rules establish a process which allow hospitals to evaluate and establish their own individual staffing plan and do not set forth specific staffing requirements. The department agrees with the commenters' concerns about abuse in the workplace, and refers the commenters to §133.45(f) which requires hospitals to have a written policy for identifying and addressing instances of alleged verbal or physical abuse or harassment of hospital employees or contracted personnel. No changes were made as a result of these comments.

Comment: Concerning the rules in general, one commenter stated these regulations will not solve the underlying problem of lack of money and supply of professional staff, and will make administrators' management lives more difficult and take up valuable time that is needed to campaign for more money and the promote the nursing field.

Response: The department disagrees. The department is aware that reimbursement and staffing issues present challenges in today's health care environment. However, the department believes that the rules establish mechanisms, which will create a safer patient care environment, promote staff satisfaction in the workplace, and create efficiencies in the staffing process. No change was made as a result of this comment.

Comment: Concerning the rules in general, one commenter stated that agency nurses are rarely oriented to the particular hospital, unless they happen to be on a permanent assignment on the same nursing unit. The commenter suggested the department include a regulation that prohibits the use of agency nurses unless they have received two weeks of orientation. The commenter believes the suggested regulation would eliminate the use of agencies, bring many of the agency nurses back into the hospital arena, and solve many of the staffing problems.

Response: The department disagrees with the commenter. Both state rules and federal regulations presently require adequate orientation and supervision of non-employee licensed nurses; the existing state rule has been brought forward in the new rule at §133.41(o)(2)(J). In addition, the policy and procedures required by §133.41(o)(2)(I)(i)(IV) include a requirement that nursing assignments be congruent with documented competency. The department believes the period of orientation suggested by the commenter would not provide hospitals the flexibility of providing orientation particular to the individual's competency level. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(1)(A), one commenter requested a more specific definition of the master's degree requirements, and questioned the time frame for starting and completing the master's degree.

Response: The department disagrees that the rule needs further clarification. The department believes that clauses §133.41(o)(1)(A)(i)-(iii) clearly describe the requirements for a master's degree. As provided in §133.41(o)(1)(A)(iv), there is no specific time frame for starting and completing the degree; it is up to the hospital to provide a time-line for accomplishing skills. This provides the individual and the hospital greater flexibility in establishing a time-line for accomplishing the needed skills. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(1)(A), one commenter stated there should be exceptions for proven management experience and track record for chief nursing officers who do not have a master's degree, and that there should be exceptions for small towns and rural areas where qualified staff are not available. Two other commenters stated that having to hire an MSN chief nursing officer for a critical access hospital would just increase personnel costs needlessly.

Response: The department agrees in part with the commenters. Some degree granting programs do recognize and give credit for work experience. In addition, the department believes that the provision in §133.41(o)(1)(A)(iv) that allows a CNO to progress under a written plan to obtain the nursing administration qualifications associated with a master's degree in nursing, and the exception for hospitals under 100 beds and counties with less than 50,000 population provided for in §133.41(o)(1)(B) are adequate to address the first commenter's concerns. The department's response to the two other commenters is that these rules do not require a hospital to hire a MSN chief nursing officer. However, the department has added language in §133.41(o)(1)(B) which also exempts a hospital that is federally certified as a critical access hospital under Title 42, Public Health, Chapter IV, Part 485, §485.606 from the requirement.

Comment: Concerning §133.41(o)(1)(A)(iv), one commenter stated that some concrete assistance should be supplied to the individual while the plan is being carried out, and suggested the assistance be in the form of a consultant.

Response: The department disagrees. The department believes the flexibility of the requirement is such that the CNO would be able to continue with assigned responsibilities with little disruption. There is nothing to prevent the use of a consultant should the hospital choose to do so, however, the department does not believe there should be a regulatory requirement. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(2)(B), one commenter stated the problem with the rule is that hospitals look at the number of staff not their skill level and years of experience. What is adequate with one group of staff is not with another. The commenter suggested that the department consider a hotline for nursing to report flagrant violations of inadequate staffing.

Response: The department agrees in part with the commenter. The department believes that the requirements of §133.41(o)(2)(F)(v) adequately address the commenter's concern that skill level and experience be considered to ensure adequate staffing. In regard to the hotline suggestion, the department already has a toll-free line for complaint reporting and does not see a need for establishing a separate hotline. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(2)(H), one commenter did not support the advisory committee as described, and stated that staffing should be one of the primary responsibilities of the CNO with accountability to the organization's CEO and board.

Response: The department disagrees with the commenter. The advisory committee does not eliminate the responsibility of the CNO as required by §133.41(o)(1)(C). The advisory committee is responsible for soliciting and receiving input from nurses involved in direct patient care on the development, on-going monitoring, and evaluation of the staffing plan. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(2)(H), one commenter stated the proposal adds another layer of bureaucracy in every hospital system in the form of an advisory committee, and that the ones serving on the required committees could help solve the real problem by attending patients instead of setting in committee meetings. Two other commenters stated that another committee would not be looked on in a positive light by nurses, physicians, or the risk manager of their hospital, and questioned who would work the floor while the nurses are in the new additional committee meetings.

Response: The department disagrees with the commenters. The rule does not require that a separate committee be established. The functions described may be carried out as part of an existing committee. No changes were made as a result of these comments.

Comment: Concerning §133.41(o)(2)(H), one commenter stated the advisory group process seems very prescriptive and suggested that requiring such a group to exist and to include staff nurses should be adequate direction.

Response: The department disagrees with the commenter. The department believes the wording as contained in §133.41(o)(2)(H)(i)-(iii) assists the hospital in obtaining valuable feedback from a broad perspective of staff members. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(2)(H), one commenter expressed concern that since the advisory committee and variance reports are not subject to disclosure, discovery or subpoena, there is no way to validate that the appropriate process is in place.

Response: The department disagrees. Internal oversight over all hospital functions is already a responsibility of the hospital governing body. In addition, the department has statutory authority for access to all books, records, or other documents maintained by or on behalf of the hospital to the extent necessary to enforce the statute, the rules, an order or special order of the commissioner of health, a special license provision, a court order granting injunctive relief, or other enforcement procedure. Therefore, the department will also be able to validate the hospital's process. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(2)(I)(i)(I), one commenter expressed incredulity that the department would make itself subservient to the Texas Nurses Association (TNA) by allowing the TNA to set standards based on a review of the code of ethics developed by national nursing organizations.

Response: The department disagrees with the commenter. The second part of the rule only requires that the staffing plan should be based upon a review of the code of ethics. This process is a recommendation only, not a mandatory requirement. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(2)(I)(i)(IV), one commenter stated that assigned unit staff get the training, but there is no will on the part of administration to pay for staff who float to the unit periodically to receive adequate training. The commenter suggested substitute language which requires assignments must be congruent with documented competency and regulatory requirements.

Response: The department disagrees with the commenter. Section 133.41(o)(2)(I)(i)(IV)(-c-) requires staffing to be congruent with documented competency and with standards established by the Texas nurse licensing boards. The department refers the commenter to the requirement which appears at §133.41(o)(2)(I)(i)(I). No change was made as a result of this comment.

Comment: Concerning §133.41(o)(2)(I)(i)(V), one commenter did not support having any regulations regarding overtime, and stated that hospitals should monitor themselves regarding this important issue and have processes in place. Another commenter stated it is not feasible for a hospital to require mandatory overtime with the current shortage of registered nurses. A third commenter stated that hospitals do not want mandatory overtime since there is no provision to cover the cost.

Response: The department believes that the commenters may have misunderstood the rule; the rule does not require mandatory overtime. However, the department has rearranged the rule text in §133.41(o)(2)(I)(i)(V) for clarification. In regard to the comment that there should not be any regulations regarding overtime, the department disagrees. The department believes that hospitals should have a mechanism in place to evaluate mandatory overtime when it is utilized as a means for meeting staffing needs.

Comment: Concerning §133.41(o)(2)(I)(i), one commenter stated she would like to see more definition of the staffing policy, and does not support having any sort of staffing ratios in the regulation since each entity/service line is unique.

Response: The department disagrees that the staffing plan needs more definition. The information contained in §133.41(o)(2)(I)(i) is sufficient to provide guidance for developing a staffing plan. The department has not included staffing ratios in the rule. No change was made as a result of this comment.

Comment: Concerning §133.41(o)(2)(I), one commenter stated there is an administrative burden associated with the creation and implementation of the staffing plan in many rural areas. The commenter also expressed concern in the department's ability to ensure that the survey process remains unbiased, given the potential for inconsistency that might potentially arise.

Response: The department disagrees that the creation and implementation of the staffing plan will be an added administrative burden as current rules require the director of nurses to determine the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital. However, the department has extended the effective date for §133.41(o)(2)(I)(i) to April 1, 2003, for hospitals with 100 or fewer licensed beds and located in counties with a population of less than 50,000, and for hospitals that have been certified by the Centers for Medicare and Medicaid Services as critical access hospitals in accordance with the Code of Federal Regulations, Title 42, Volume 3, Part 485, Subpart F, §485.606(b), to assist the hospitals in the overall implementation process. The annual evaluation required by §133.41(o)(2)(I)(ii) for the hospitals previously identified in this response will be due April 1, 2004. In regard to the survey process, the department continually strives to ensure consistency in the application of rules

Comment: Concerning §133.41(o)(2)(I), one commenter questioned why an MD should be included in the staffing plan.

Response: The department recognizes the commenter's concern about the rule and has added the word "nursing" for clarification to §133.41(o)(2)(H)(iii). The clause now reads, "to the extent feasible, represent multiple areas of nursing practice." The rule, however, does not preclude other individuals from being members of the committee or participating in the process.

Comment: Concerning §133.41(o)(2)(I)(i)(III)(-d-), one commenter recommended that feedback be provided during the proceedings of the advisory committee to maintain the confidentiality of the process. The commenter recommended the words "during the advisory committee meeting" be added to the rule.

Response: The department agrees with the commenter and has added the suggested language to §133.41(o)(2)(I)(i)(III)(-d-).

Comment: Concerning §133.43(b), one commenter recommended that the department review the adequacy of the definition of "good faith." The commenter believes the intent of the definition is to clarify that the protections of the section not be available to an individual who makes groundless reports or who continues to raise factual or legal issues to ones addressed in response to a prior report by that individual. The commenter noted that the definition, as written, might be interpreted to mean that a report is not in good faith if it raises the same issues even if the report is made to another entity. The commenter suggested alternate language.

Response: The department agrees with the commenter as to the intent of the definition and that the definition needs to be revised because it could be misinterpreted to preclude legitimate reporting. The department has deleted the last phrase of the definition §133.43(b).

Comment: Concerning §133.43(b), two commenters stated the discrimination issue for reporting a violation is already considered in other rules and regulations and questioned why it has to be repeated.

Response: The department is unable to address the commenters' concern because the commenter did not provide specific instances of the redundant rules and regulations. No changes were made as a result of these comments.

Comment: Concerning §133.45(f), one commenter stated that harassment and abuse are really in the eyes of the beholder and some definition of what it is should be in order.

Response: The department disagrees. As stated in the proposed rule, the required hospital policy is to be set up to identify and address abuse and harassment and to deal with such matters on a case specific basis. The common definition of the terms is implied by this rule. No change was made as a result of this comment.

The commenters were Baptist St. Anthony's Health System, Baylor Specialty Health Centers, East Texas Medical Center Regional Healthcare System, Faith Community Hospital, Frio Regional Hospital, Hendrick Medical Center, Hillcrest Baptist Medical Center, Las Palmas Medical Center, Lyon Associates, Mercy Health Center, Northwest Texas Healthcare System, Presbyterian Hospital of Winnsboro, Sweeny Community Hospital, Texas Health Resources, Texas Hospital Association, Texas Nurses Association, Texas Organization of Rural and Community Hospitals, Texas Woman's University College of Nursing-Houston Center, and several individuals. The majority of commenters were generally in favor of the rules, however, some had questions and suggestions for change. Only one commenter was against the amendments in their entirety.

The amendments are adopted under Health and Safety Code, §241.026, concerning rules and minimum standards for staffing by physicians and nurses; 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.

§133.41.Hospital Functions and Services.

(a) Anesthesia services. If the hospital furnishes anesthesia services, these services shall be provided in a well-organized manner under the direction of a qualified physician. The anesthesia service is responsible for all anesthesia administered in the hospital.

(1) Organization and staffing. The organization of anesthesia services shall be appropriate to the scope of the services offered. Anesthesia shall be administered only by:

(A) a qualified anesthesiologist;

(B) a physician (other than an anesthesiologist);

(D) a certified registered nurse anesthetist who is under the supervision, as defined by the Medical Practice Act, Texas Civil Statutes, Article 4495b, and the Nurse Practice Act, Texas Civil Statutes, Article 4513-4528, of the operating physician or of an anesthesiologist who is immediately available if needed.

(2) Delivery of services. Anesthesia services shall be consistent with needs and resources. Policies on anesthesia procedures shall include the delineation of pre-anesthesia and post-anesthesia responsibilities. The policies shall ensure that the following are provided for each patient.

(A) A pre-anesthesia evaluation by an individual qualified to administer anesthesia under paragraph (1) of this subsection shall be performed within 48 hours prior to surgery.

(B) An intraoperative anesthesia record shall be provided. The record shall include any complications or problems occurring during the anesthesia including time, description of symptoms, review of affected systems, and treatments rendered. The record shall correlate with the controlled substance administration record.

(C) A post-anesthesia follow-up report shall be written by the person administering the anesthesia before transferring the patient from the recovery room and shall include evaluation for recovery from anesthesia, level of activity, respiration, blood pressure, level of consciousness, and patient color.

(i) With respect to inpatients, a post-anesthesia evaluation for proper anesthesia recovery shall be performed after transfer from recovery and within 48 hours after surgery by the person administering the anesthesia, registered nurse (RN), or physician in accordance with policies and procedures approved by the medical staff and using criteria written in the medical staff bylaws for post-operative monitoring of anesthesia.

(ii) With respect to outpatients, immediately prior to discharge, a post-anesthesia evaluation for proper anesthesia recovery shall be performed by the person administering the anesthesia, RN, or physician in accordance with policies and procedures approved by the medical staff and using criteria written in the medical staff bylaws for post-operative monitoring of anesthesia.

(b) Chemical dependency services.

(1) Chemical dependency unit. A hospital may not admit patients to a chemical dependency services unit unless the unit is approved by the Texas Department of Health (department) as meeting the requirements of §133.163(p) of this title (relating to Hospital Spatial Requirements).

(2) Admission criteria. A hospital providing chemical dependency services shall have written admission criteria that are applied uniformly to all patients who are admitted to the chemical dependency unit.

(A) The hospital's admission criteria shall include procedures to prevent the admission of minors for a condition which is not generally recognized as responsive to treatment in an inpatient setting for chemical dependency services.

(i) The following conditions are not generally recognized as responsive to treatment in a treatment facility for chemical dependency unless the minor to be admitted is qualified because of other disabilities, such as:

(I) cognitive disabilities due to mental retardation;

(II) learning disabilities; or

(III) psychiatric disorders.

(ii) A minor may be qualified for admission based on other disabilities which would be responsive to chemical dependency services.

(iii) A minor patient shall be separated from adult patients.

(B) The hospital shall have a preadmission examination procedure under which each patient's condition and medical history are reviewed by a member of the medical staff to determine whether the patient is likely to benefit significantly from an intensive inpatient program or assessment.

(C) A voluntarily admitted patient shall sign an admission consent form prior to admission to a chemical dependency unit which includes verification that the patient has been informed of the services to be provided and the estimated charges.

(3) Compliance. A hospital providing chemical dependency services in an identifiable unit within the hospital shall comply with 40 Texas Administrative Code (TAC), Chapter 148 (Chemical Dependency Treatment Facility Licensure Standards) administered by the Texas Commission on Alcohol and Drug Abuse.

(1) Rehabilitation units. A hospital may not admit patients to a comprehensive medical rehabilitation services unit unless the unit is approved by the department as meeting the requirements of §133.163(y) of this title.

(2) Equipment and space. The hospital shall have the necessary equipment and sufficient space to implement the treatment plan described in paragraph (7)(C) of this subsection and allow for adequate care. Necessary equipment is all equipment necessary to comply with all parts of the written treatment plan. The equipment shall be on-site or available through an arrangement with another provider. Sufficient space is the physical area of a hospital which in the aggregate, constitutes the total amount of the space necessary to comply with the written treatment plan.

(3) Emergency requirements. Emergency personnel, equipment, supplies and medications for hospitals providing comprehensive medical rehabilitation services shall be as follows.

(A) A hospital which provides comprehensive medical rehabilitation services shall have emergency equipment, supplies, medications, and designated personnel assigned for providing emergency care to patients and visitors.

(B) The emergency equipment, supplies, and medications shall be properly maintained and immediately accessible to all areas of the hospital. The emergency equipment shall be periodically tested according to the policy established by the hospital.

(C) At a minimum, the emergency equipment and supplies shall include those specified in subsection (e)(1)(D)(i)-(viii) of this section.

(D) The personnel providing emergency care in accordance with this subsection shall be staffed for 24-hour coverage and accessible to all patients receiving comprehensive medical rehabilitation services. At least one person who is qualified by training to perform advanced cardiac life support and administer emergency drugs shall be on duty each shift.

(E) All direct patient care licensed personnel shall maintain current certification in cardiopulmonary resuscitation (CPR).

(4) Medications. A rehabilitation hospital's governing body shall adopt and enforce policies and procedures that require all medications to be administered by licensed nurses, physicians, or other licensed professionals authorized by law to administer medications.

(5) Organization and Staffing.

(A) A hospital providing comprehensive medical rehabilitation services shall be organized and staffed to ensure the health and safety of the patients.

(i) All provided services shall be consistent with accepted professional standards and practice.

(ii) The organization of the services shall be appropriate to the scope of the services offered.

(iii) The hospital shall have written patient care policies that govern the services it furnishes.

(B) The provision of comprehensive medical rehabilitation services in a hospital shall be under the medical supervision of a physician who is on duty and available, or who is on call 24 hours each day.

(C) A hospital providing comprehensive medical rehabilitation services shall have a director who supervises and administers the provision of comprehensive medical rehabilitation services.

(i) The director shall be a physician who is board certified or eligible for board certification in physical medicine and rehabilitation, orthopedics, neurology, neurosurgery, internal medicine, or rheumatology as appropriate for the rehabilitation program.

(ii) The director shall be qualified by training or at least two years training and experience to serve as medical director. A person is qualified under this subsection if the person has training and experience in the treatment of rehabilitation patients in a rehabilitation setting.

(6) Admission criteria. A hospital providing comprehensive medical rehabilitation services shall have written admission criteria that are applied uniformly to all patients who are admitted to the comprehensive medical rehabilitation unit.

(A) The hospital's admission criteria shall include procedures to prevent the admission of a minor for a condition which is not generally recognized as responsive to treatment in an inpatient setting for comprehensive medical rehabilitation services.

(i) The following conditions are not generally recognized as responsive to treatment in an inpatient setting for comprehensive medical rehabilitation services unless the minor to be admitted is qualified because of other disabilities, such as:

(I) cognitive disabilities due to mental retardation;

(II) learning disabilities; or

(III) psychiatric disorders.

(ii) A minor may be qualified for admission based on other disabilities which would be responsive to comprehensive medical rehabilitation services.

(7) Care and services.

(A) A hospital providing comprehensive medical rehabilitation services shall use a coordinated interdisciplinary team which is directed by a physician and which works in collaboration to develop and implement the patient's treatment plan.

(i) The interdisciplinary team for comprehensive medical rehabilitation services shall have available to it, at the hospital at which the services are provided or by contract, members of the following professions as necessary to meet the treatment needs of the patient:

(I) physical therapy;

(II) occupational therapy;

(III) speech-language pathology;

(IV) therapeutic recreation;

(V) social services and case management;

(VI) dietetics;

(VII) psychology;

(VIII) respiratory therapy;

(IX) rehabilitative nursing;

(X) certified orthotics;

(XI) certified prosthetics;

(XII) pharmaceutical care; and

(XIII) in the case of a minor patient, persons who have specialized education and training in emotional, mental health, or chemical dependency problems, as well as the treatment of minors.

(ii) The coordinated interdisciplinary team approach used in the rehabilitation of each patient shall be documented by periodic entries made in the patient's medical record to denote:

(I) the patient's status in relationship to goal attainment; and

(II) that team conferences are held at least every two weeks to determine the appropriateness of treatment.

(B) An initial assessment and preliminary treatment plan shall be performed or established by the physician within 24 hours of admission.

(C) The physician in coordination with the interdisciplinary team shall establish a written treatment plan for the patient within seven working days of the date of admission.

(i) Comprehensive medical rehabilitation services shall be provided in accordance with the written treatment plan.

(ii) The treatment provided under the written treatment plan shall be provided by staff who are qualified to provide services under state law. The hospital shall establish written qualifications for services provided by each discipline for which there is no applicable state statute for professional licensure or certification.

(iii) Services provided under the written treatment plan shall be given in accordance with the orders of practitioners who are authorized by the governing body, hospital administration, and medical staff to order the services, and the orders shall be incorporated in the patient's record.

(iv) The written treatment plan shall delineate anticipated goals and specify the type, amount, frequency, and anticipated duration of service to be provided.

(v) Within 10 working days after the date of admission, the written treatment plan shall be provided. It shall be in the person's primary language, if practicable. What is or would have been practicable shall be determined by the facts and circumstances of each case. The written treatment plan shall be provided to:

(I) the patient;

(II) a person designated by the patient; and

(III) upon request, a family member, guardian, or individual who has demonstrated on a routine basis responsibility and participation in the patient's care or treatment, but only with the patient's consent unless such consent is not required by law.

(vi) The written treatment plan shall be reviewed by the interdisciplinary team at least every two weeks.

(vii) The written treatment plan shall be revised by the interdisciplinary team if a comprehensive reassessment of the patient's status or the results of a patient case review conference indicates the need for revision.

(viii) The revision shall be incorporated into the patient's record within seven working days after the revision.

(ix) The revised treatment plan shall be reduced to writing in the person's primary language, if practicable, and provided to:

(I) the patient;

(II) a person designated by the patient; and

(8) Discharge and continuing care plan. The patient's interdisciplinary team shall prepare a written continuing care plan that addresses the patient's needs for care after discharge.

(A) The continuing care plan for the patient shall include recommendations for treatment and care and information about the availability of resources for treatment or care.

(B) If the patient's interdisciplinary team deems it impracticable to provide a written continuing care plan prior to discharge, the patient's interdisciplinary team shall provide the written continuing care plan to the patient within two working days after the date of discharge.

(C) Prior to discharge or within two working days after the date of discharge, the written continuing care plan shall be provided in the person's primary language, if practicable, to:

(i) the patient;

(ii) a person designated by the patient; and

(iii) upon request, to a family member, guardian, or individual who has demonstrated on a routine basis responsibility and participation in the patient's care or treatment, but only with the patient's consent unless such consent is not required by law.

(d) Dietary services. The hospital shall have organized dietary services that are directed and staffed by adequate qualified personnel. However, a hospital that has a contract with an outside food management company or an arrangement with another hospital may meet this requirement if the company or other hospital has a dietitian who serves the hospital on a full-time, part-time, or consultant basis, and if the company or other hospital maintains at least the minimum requirements specified in this section, and provides for the frequent and systematic liaison with the hospital medical staff for recommendations of dietetic policies affecting patient treatment. The hospital shall ensure that there are sufficient personnel to respond to the dietary needs of the patient population being served.

(1) Organization.

(A) The hospital shall have a full-time employee who:

(i) serves as director of the food and dietetic service;

(ii) is responsible for the daily management of the dietary services; and

(iii) is qualified by experience or training.

(B) There shall be a qualified dietitian who works full-time, part-time, or on a consultant basis. If by consultation, such services shall occur at least once per month for not less than eight hours. The dietitian shall:

(i) be currently licensed under the laws of this state to use the titles of licensed dietitian or provisional licensed dietitian, or be a registered dietitian;

(ii) maintain standards for professional practice;

(iii) supervise the nutritional aspects of patient care;

(iv) make an assessment of the nutritional status and adequacy of nutritional regimen;

(v) provide diet counseling and teaching;

(vi) document nutritional status and pertinent information in patient medical records;

(vii) approve menus; and

(viii) approve menu substitutions.

(C) There shall be administrative and technical personnel competent in their respective duties. The administrative and technical personnel shall:

(i) participate in established departmental or hospital training pertinent to assigned duties;

(ii) conform to food handling techniques in accordance with paragraph (2)(E)(vii) and (viii) of this subsection;

(iii) adhere to clearly defined work schedules and assignment sheets; and

(iv) comply with position descriptions which are job specific.

(2) Director. The director shall:

(A) comply with a position description which is job specific;

(B) clearly delineate responsibility and authority;

(D) establish, implement, and enforce policies and procedures for the overall operational components of the department to include, but not be limited to:

(i) quality assurance;

(ii) frequency of meals served;

(iii) non-routine occurrences; and

(iv) identification of patient trays;

(E) maintain authority and responsibility for the following, but not be limited to:

(i) orientation and training;

(ii) performance evaluations;

(iii) work assignments;

(iv) supervision of work and food handling techniques;

(v) procurement of food, paper, chemical, and other supplies, to include implementation of first-in first-out rotation system for all food items;

(vi) menu planning;

(vii) ensuring compliance with §§229.161-229.171 of this title (relating to Food Service Sanitation); and

(viii) ensuring compliance with United States Department of Health and Human Services, Public Health Service, Food and Drug Administration, Food Service Sanitation Manual, Department of Health, Education, and Welfare Publication Number (FDA) 78-2081, 1976 edition, which is available from the United States Department of Health and Human Services, Public Health Service, Division of Retail Food Protection, Food and Drug Administration, Washington, D.C. 20204.

(3) Diets. Menus shall meet the needs of the patients.

(A) Therapeutic diets shall be prescribed by the physician(s) responsible for the care of the patients. The dietary department of the hospital shall:

(i) establish procedures for the processing of therapeutic diets to include, but not be limited to:

(I) accurate patient identification;

(II) transcription from nursing to dietary services;

(III) diet planning by a dietitian;

(IV) regular review and updating of diet when necessary; and

(V) written and verbal instruction to patient and family. It shall be in the patient's primary language, if practicable, prior to discharge. What is or would have been practicable shall be determined by the facts and circumstances of each case;

(ii) ensure that therapeutic diets are planned in writing by a qualified dietitian;

(iii) ensure that menu substitutions are approved by a qualified dietitian;

(iv) document pertinent information about the patient's response to a therapeutic diet in the medical record; and

(v) evaluate therapeutic diets for nutritional adequacy.

(B) Nutritional needs shall be met in accordance with recognized dietary practices and in accordance with orders of the physician(s) responsible for the care of the patients. The following requirements shall be met.

(i) Menus shall provide a sufficient variety of foods served in adequate amounts at each meal according to the guidance provided in the following publications:

(I) Recommended Dietary Allowances, as published by the Food and Nutrition Board, National Academy of Sciences, National Research Council, Tenth edition, 1989, which may be obtained by writing the National Academy Press, 2101 Constitution Avenue, Box 285, Washington, D.C. 20055, telephone (800) 624-6242; and

(II) Nutrition and Your Health: Dietary Guidelines for Americans, Fourth edition, 1995, published by the United States Department of Agriculture and the United States Department of Health and Human Services. The document is available from the Food and Nutrition Information Center, USDA/National Agricultural Library, 10301 Baltimore Boulevard, Beltsville, MD 20705-2351.

(ii) A different written menu shall be followed each day of the week with at least three meals per day, seven days per week. The menu shall be posted in the food preparation area.

(iii) A maximum of 15 hours shall not be exceeded between the last meal of the day (i.e. supper) and the breakfast meal, unless a substantial snack is provided. The hospital shall adopt, implement, and enforce a policy on the definition of "substantial" to meet each patient's varied nutritional needs.

(iv) Current and previous menus shall meet the recommended allowances that include:

(I) fats, oils, and sweets used sparingly;

(II) 2-3 servings of the milk, yogurt, and cheese group;

(III) 2-3 servings of the meat, poultry, fish, dry beans, eggs, and nuts group;

(IV) 3-5 servings of the vegetable group;

(V) 2-4 servings of the fruit group; and

(VI) 6-11 servings of the bread, cereal, rice, and pasta group.

(C) A current therapeutic diet manual approved by the dietitian and medical staff shall be readily available to all medical, nursing, and food service personnel. The therapeutic manual shall:

(i) be revised as needed, not to exceed 5 years;

(ii) be appropriate for the diets routinely ordered in the hospital;

(iii) have standards in compliance with the RDA;

(iv) contain specific diets which are not in compliance with RDA; and

(v) be used as a guide for ordering and serving diets.

(e) Emergency services.

(1) Emergency department. A general hospital shall have an emergency department that complies with §133.163(f) of this title and the following.

(A) Organization. The organization of the emergency services shall be appropriate to the scope of the services offered.

(i) The services shall be organized under the direction of a qualified member of the medical staff.

(ii) The services shall be integrated with other departments of the hospital.

(iii) The policies and procedures governing medical care provided in the emergency service or department shall be established by and shall be a continuing responsibility of the medical staff.

(iv) Medical records indicating patient identification, complaint, physician, nurse, time admitted to the emergency room, treatment, time discharged, and disposition shall be maintained for all emergency patients.

(B) Personnel.

(i) There shall be adequate medical and nursing personnel qualified in emergency care to meet the written emergency procedures and needs anticipated by the hospital.

(ii) There shall be on duty at all times at least one person qualified as determined by the medical staff to initiate immediate appropriate lifesaving measures.

(iii) The hospital shall provide that one or more physicians shall be available at all times for emergencies.

(iv) Schedules, names, and telephone numbers of all physicians and others on emergency call duty, including alternates, shall be maintained. Schedules shall be retained for no less than one year.

(C) Supplies and equipment. Adequate supplies and equipment shall be available and in readiness for use. Facilities shall be available for the administration of intravenous medications as well as facilities for the control of bleeding and emergency splinting of fractures. Provision shall be made for the storage of blood and blood products as needed. The emergency equipment shall be periodically tested according to the policy established by the hospital.

(D) Required emergency equipment. At a minimum, the emergency equipment and supplies shall include the following:

(i) emergency call system;

(ii) oxygen;

(iii) mechanical ventilatory assistance equipment, including airways, manual breathing bag, and mask;

(iv) cardiac defibrillator;

(v) cardiac monitoring equipment;

(vi) laryngoscopes and endotracheal tubes;

(vii) suction equipment; and

(viii) emergency drugs and supplies specified by the medical staff.

(E) Exceptions.

(i) A comprehensive medical rehabilitation hospital shall comply with subparagraphs (A)-(D) of this paragraph but need not comply with the requirement for an emergency department. At a minimum, an emergency treatment room shall be provided in accordance with §133.163(f)(1)(B)(v) of this title. The emergency treatment room may be located anywhere in the hospital.

(ii) A pediatric and adolescent hospital shall comply with subparagraphs (A)-(D) of this paragraph but need not comply with the requirement for an emergency department. At a minimum, an emergency treatment room shall be provided in accordance with §133.163(f)(1)(B)(v) of this title. The emergency treatment room may be located anywhere in the hospital.

(2) Emergency treatment room. A special hospital shall comply with paragraph (1)(A)-(D) of this subsection except for the requirement in paragraph (1) concerning the emergency department. Each special hospital shall have at least an emergency treatment room that complies with §133.163(f)(1)(B)(v) of this title. The emergency treatment room may be located anywhere in the hospital.

(f) Governing body.

(1) Legal responsibility. There shall be a governing body responsible for the organization, management, control, and operation of the hospital, including appointment of the medical staff. For hospitals owned and operated by an individual or by partners, the individual or partners shall be considered the governing body.

(2) Organization. The governing body shall be formally organized in accordance with a written constitution and bylaws which clearly set forth the organizational structure and responsibilities.

(3) Meeting records. Records of governing body meetings shall be maintained.

(4) Responsibilities relating to the medical staff. The governing body shall:

(A) ensure that the medical staff has current bylaws, rules, and regulations which are implemented and enforced;

(B) approve medical staff bylaws and other medical staff rules and regulations;

(C) determine, in accordance with state law and with the advice of the medical staff, which categories of practitioners are eligible candidates for appointment to the medical staff;

(D) ensure that criteria for selection include individual character, competence, training, experience, and judgment;

(E) ensure that under no circumstances is the accordance of staff membership or professional privileges in the hospital dependent solely upon certification, fellowship or membership in a specialty body or society;

(F) ensure the process for considering applications for medical staff membership and privileges affords each physician, podiatrist, and dentist procedural due process;

(G) ensure in granting or refusing medical staff membership or privileges, the hospital does not differentiate on the basis of the academic medical degree;

(H) ensure that equal recognition is given to training programs accredited by the Accreditation Council on Graduate Medical Education and by the American Osteopathic Association if graduate medical education is used as a standard or qualification for medical staff membership or privileges for a physician;

(I) ensure that equal recognition is given to certification programs approved by the American Board of Medical Specialties and the Bureau of Osteopathic Specialists if board certification is used as a standard or qualification for medical staff membership or privileges for a physician;

(J) ensure that the medical staff is accountable to the governing body for the quality of care provided to patients;

(K) ensure that a hospital's credentials committee acts expeditiously and without unnecessary delay when a licensed physician, podiatrist, or dentist submits a completed application, as defined by each hospital, for medical staff membership or privileges, in accordance with the following:

(i) The hospital's credentials committee shall take action on the completed application not later than the 90th day after the date on which the application is received;

(ii) The governing body of the hospital shall take final action on the application for medical staff membership or privileges not later than the 60th day after the date on which the recommendation of the credentials committee is received; and

(iii) The hospital must notify the applicant in writing of the hospital's final action, including a reason for denial or restriction of privileges, not later than the 20th day after the date on which final action is taken;

(L) ensure that the hospital complies with the requirements concerning physician communication and contracts entered into or renewed on or after September 1, 1997, as set out in Health and Safety Code (HSC) §241.1015 (Physician Communication and Contracts); and

(M) ensure the hospital complies with the requirements for reporting to the Texas Board of Medical Examiners the results and circumstances of any professional review action in accordance with the Medical Practice Act, Texas Civil Statutes, Article 4495b, §5.06(b) and (d).

(5) Hospital administration. The governing body shall appoint a chief executive officer or administrator who is responsible for managing the hospital.

(6) Patient care. In accordance with hospital policy, the governing body shall ensure that:

(A) every patient is under the care of:

(i) a physician. This provision is not to be construed to limit the authority of a physician to delegate tasks to other qualified health care personnel to the extent recognized under state law or the state's regulatory mechanism;

(ii) a dentist who is legally authorized to practice dentistry by the state and who is acting within the scope of his or her license; or

(iii) a podiatrist, but only with respect to functions which he or she is legally authorized by the state to perform.

(B) patients are admitted to the hospital only by members of the medical staff who have been granted admitting privileges; and

(7) Contracted services. The governing body shall be responsible for services furnished in the hospital whether or not they are furnished directly or under contracts. The governing body shall ensure that a contractor of services (including one for shared services and joint ventures) furnishes services in a safe and effective manner that permits the hospital to comply with all applicable rules and standards for contracted services.

(g) Infection control. The hospital shall provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. There shall be an active program for the prevention, control, and investigation of infections and communicable diseases.

(1) Organization and policies. A person shall be designated as infection control coordinator. The hospital shall ensure that policies governing prevention, control and surveillance of infections and communicable diseases are developed, implemented and enforced.

(A) There shall be a system for identifying, reporting, investigating, and controlling nosocomial infections and communicable diseases between patients and personnel.

(B) The infection control coordinator shall maintain a log of all reportable diseases and nosocomial infections designated as epidemiologically significant according to the hospital's infection control policies.

(C) There shall be a written policy for reporting all reportable diseases to the local health authority or the Infectious Disease Epidemiology and Surveillance Division, Texas Department of Health, 1100 West 49th Street, Austin, TX 78756-3199, in accordance with Chapter 97 of this title (relating to Communicable Diseases).

(2) Responsibilities of the chief executive officer (CEO), medical staff, and director of nursing (DON). The CEO, the medical staff, and the DON shall be responsible for the following.

(A) The hospital-wide quality assurance program and training programs shall address problems identified by the infection control coordinator.

(B) Successful corrective action plans in affected problem areas shall be implemented.

(3) Universal precautions. The hospital shall adopt, implement, and enforce a written policy to monitor compliance of the hospital and its personnel and medical staff with universal precautions in accordance with the HSC, Chapter 85, Subchapter I (Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus).

(h) Laboratory services. The hospital shall maintain directly, or have available adequate laboratory services to meet the needs of its patients.

(1) Hospital laboratory services. A hospital that provides laboratory services shall comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988), in accordance with the requirements specified in 42 Code of Federal Regulations (CFR), §§493.1-493.1780. CLIA 1988 applies to all hospitals with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings.

(2) Contracted laboratory services. The hospital shall ensure that all laboratory services provided to its patients through a contractual agreement are performed in a facility certified in the appropriate specialties and subspecialties of service in accordance with the requirements specified in 42 CFR Part 493 to comply with CLIA 1988.

(3) Adequacy of laboratory services. The hospital shall ensure the following.

(A) Emergency laboratory services shall be available 24 hours a day.

(B) A written description of services provided shall be available to the medical staff.

(D) The medical staff and a pathologist shall determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examination.

(E) When blood and blood components are stored, there shall be written procedures readily available containing directions on how to maintain them within permissible temperatures and including instructions to be followed in the event of a power failure or other disruption of refrigeration. A label or tray with the recipient's first and last names and identification number, donor unit number and interpretation of compatibility, if performed, shall be attached securely to the blood container.

(4) Chemical hygiene. A hospital that provides laboratory services shall adopt, implement, and enforce written policies and procedures to manage, minimize, or eliminate the risks to laboratory personnel of exposure to potentially hazardous chemicals in the laboratory which may occur during the normal course of job performance.

(i) Linen and laundry services. The hospital shall provide sufficient clean linen to ensure the comfort of the patient. The hospital, whether it operates its own laundry or uses commercial service, shall ensure the following.

(1) Employees of a hospital involved in transporting, processing, or otherwise handling clean or soiled linen shall be given initial and follow-up inservice training to ensure a safe product for patients and to safeguard employees in their work.

(2) Clean linen shall be handled, transported, and stored by methods that will ensure its cleanliness.

(3) All contaminated linen shall be placed and transported in bags or containers labeled or color-coded.

(4) Employees who have contact with contaminated linen shall wear gloves and other appropriate personal protective equipment.

(5) Contaminated linen shall be handled as little as possible and with a minimum agitation. Contaminated linen shall not be sorted or rinsed in patient care areas.

(6) All contaminated linen shall be bagged or put into carts at the location where it was used.

(A) Bags containing contaminated linen shall be closed prior to transport to the laundry.

(B) Whenever contaminated linen is wet and presents a reasonable likelihood of soak-through of or leakage from the bag or container, the linen shall be deposited and transported in bags that prevent leakage of fluids to the exterior.

(D) If chutes are not used to convey linen to a central receiving or sorting room, then adequate space shall be allocated on the various nursing units for holding the bagged contaminated linen.

(7) Linen shall be processed as follows:

(A) If hot water is used, linen shall be washed with detergent in water with a temperature of at least 71 degrees Centigrade (160 degrees Fahrenheit) for 25 minutes. Hot water requirements specified in Table 5 of §133.169(e) of this title (relating to Tables) shall be met.

(B) If low temperature (less than or equal to 70 degrees Centigrade) (158 degrees Fahrenheit) laundry cycles are used, chemicals suitable for low-temperature washing at proper use concentration shall be used.

(C) Commercial dry cleaning of fabrics soiled with blood also renders these items free of the risk of pathogen transmission.

(8) Flammable liquids shall not be used in the laundry.

(j) Medical record services. The hospital shall have a medical record service that has administrative responsibility for medical records. A medical record shall be maintained for every individual who presents to the hospital for evaluation or treatment.

(1) The organization of the medical record service shall be appropriate to the scope and complexity of the services performed. The hospital shall employ adequate personnel to ensure prompt completion, filing, and retrieval of records.

(2) The hospital shall have a system of coding and indexing medical records. The system shall allow for timely retrieval by diagnosis and procedure, in order to support medical care evaluation studies.

(3) The hospital shall adopt, implement, and enforce a policy to ensure that the hospital complies with HSC, Chapter 241, Subchapter G (Disclosure of Health Care Information).

(4) The medical record shall contain information to justify admission and continued hospitalization, support the diagnosis, and describe the patient's progress and response to medications and services. Medical records shall be accurately written, promptly completed, properly filed and retained, and accessible.

(5) The hospital shall use a system of author identification and record maintenance that ensures the integrity of the authentication and protects the security of all entries to the records.

(A) The author of each entry shall be identified and shall authenticate his or her entry.

(B) Authentication shall include signatures, written initials, or computer entry.

(C) Use of signature stamps by physicians may be allowed in hospitals when the signature stamp is authorized by the individual whose signature the stamp represents. The administrative offices of the hospital shall have on file a signed statement to the effect that he or she is the only one who has the stamp and uses it. Delegation of use to another individual shall not be acceptable.

(D) A list of computer codes and written signatures shall be readily available and shall be maintained under adequate safeguards.

(E) Signatures by facsimile shall be acceptable. If received on a thermal machine, the facsimile document shall be copied onto regular paper.

(6) Medical records (reports and printouts) shall be retained by the hospital in their original or legally reproduced form for a period of at least ten years. Films, scans, and other image records shall be retained for a period of at least five years. For retention purposes, medical records that shall be preserved for ten years include:

(A) identification data;

(B) the medical history of the patient;

(C) evidence of a physical examination, including a health history, performed no more than seven days prior to admission or within 48 hours after admission;

(D) admitting diagnosis;

(E) diagnostic and therapeutic orders;

(F) properly executed informed consent forms for procedures and treatments specified by the medical staff, or by federal or state laws if applicable, to require written patient consent;

(G) clinical observations, including the results of therapy and treatment, all orders, nursing notes, medication records, vital signs, and other information necessary to monitor the patient's condition;

(H) reports of procedures, tests, and their results, including laboratory, pathology, and radiology reports;

(I) results of all consultative evaluations of the patient and appropriate findings by clinical and other staff involved in the care of the patient;

(J) discharge summary with outcome of hospitalization, disposition of care, and provisions for follow-up care; and

(K) final diagnosis with completion of medical records within 30 calendar days following discharge.

(7) If a patient was less than 18 years of age at the time he was last treated, the hospital may authorize the disposal of those medical records relating to the patient on or after the date of his 20th birthday or on or after the 10th anniversary of the date on which he was last treated, whichever date is later.

(8) The hospital shall not destroy medical records that relate to any matter that is involved in litigation if the hospital knows the litigation has not been finally resolved.

(9) If a licensed hospital should close, the hospital shall notify the department at the time of closure the disposition of the medical records, including the location of where the medical records will be stored and the identity and telephone number of the custodian of the records.

(k) Medical staff.

(1) The medical staff shall be composed of physicians and may also be composed of podiatrists, dentists and other practitioners appointed by the governing body.

(A) The medical staff shall periodically conduct appraisals of its members according to medical staff bylaws.

(B) The medical staff shall examine credentials of candidates for medical staff membership and make recommendations to the governing body on the appointment of the candidate.

(2) The medical staff shall be well-organized and accountable to the governing body for the quality of the medical care provided to patients.

(A) The medical staff shall be organized in a manner approved by the governing body.

(B) If the medical staff has an executive committee, a majority of the members of the committee shall be doctors of medicine or osteopathy.

(D) The responsibility for organization and conduct of the medical staff shall be assigned only to an individual physician.

(E) Each medical staff member shall sign a statement signifying they will abide by medical staff and hospital policies.

(3) The medical staff shall adopt, implement, and enforce bylaws, rules, and regulations to carry out its responsibilities. The bylaws shall:

(A) be approved by the governing body;

(B) include a statement of the duties and privileges of each category of medical staff (e.g., active, courtesy, consultant);

(D) describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body;

(E) include criteria for determining the privileges to be granted and a procedure for applying the criteria to individuals requesting privileges; and

(F) include a requirement that a physical examination and medical history be done no more than seven days before or 48 hours after an admission for each patient by a physician, or, for patients admitted only for oromaxillofacial surgery, by a dentist who has been granted such privileges by the medical staff.

(l) Mental health services.

(1) Mental health services unit. A hospital may not admit patients to a mental health services unit unless the unit is approved by the department as meeting the requirements of §133.163(p) of this title.

(2) Admission criteria. A hospital providing mental health services in a mental health services unit shall have written admission criteria that are applied uniformly to all patients who are admitted to the unit.

(i) The following conditions are not generally recognized as responsive to treatment in a hospital unless the minor to be admitted is qualified because of other disabilities, such as:

(I) cognitive disabilities due to mental retardation; or

(II) learning disabilities.

(ii) A minor may be qualified for admission based on other disabilities which would be responsive to mental health services.

(B) The medical record shall contain evidence that admission consent was given by the patient, the patient's legal guardian, or the managing conservator, if applicable.

(C) The hospital shall have a preadmission examination procedure under which each patient's condition and medical history are reviewed by a member of the medical staff to determine whether the patient is likely to benefit significantly from an intensive inpatient program or assessment.

(D) A voluntarily admitted patient shall sign an admission consent form prior to admission to a mental health unit which includes verification that the patient has been informed of the services to be provided and the estimated charges.

(3) Compliance. A hospital providing mental health services in an identifiable part of the hospital shall comply with the following rules administered by the Texas Board of Mental Health and Mental Retardation (TXMHMR). The TXMHMR rules are:

(A) Chapter 401, Subchapter J of this title (relating to Standards of Care and Treatment in Psychiatric Hospitals);

(B) Chapter 404, Subchapter E of this title (relating to Rights of Persons Receiving Mental Health Services);

(D) Chapter 405, Subchapter FF of this title (relating to Consent to Treatment with Psychoactive Medication); and

(E) Chapter 405, Subchapter F of this title (relating to Voluntary and Involuntary Behavioral Interventions in Mental Health Programs).

(m) Mobile, transportable, and relocatable units. The hospital shall adopt, implement and enforce procedures which address the potential emergency needs for those inpatients who are taken to mobile units on the hospital's premises for diagnostic procedures or treatment.

(n) Nuclear medicine services. If the hospital provides nuclear medicine services, these services shall meet the needs of the patients in accordance with acceptable standards of practice.

(1) Policies and procedures. Policies and procedures shall be adopted, implemented, and enforced which will describe the services nuclear medicine provides in the hospital and how employee and patient safety will be maintained.

(2) Organization and staffing. The organization of the nuclear medicine services shall be appropriate to the scope and complexity of the services offered.

(A) There shall be a director who is a physician qualified in nuclear medicine.

(B) The qualifications, training, functions, and responsibilities of nuclear medicine personnel shall be specified by the services director and approved by the medical staff.

(3) Delivery of services. Radioactive materials shall be prepared, labeled, used, transported, stored, and disposed of in accordance with acceptable standards of practice and in accordance with state laws concerning radiation control.

(A) In-house preparation of radiopharmaceuticals shall be by, or under, the direct supervision of an appropriately trained registered pharmacist or physician.

(B) There shall be proper storage and disposal of radioactive materials.

(C) If clinical laboratory tests are performed by the nuclear medicine services staff, the nuclear medicine staff shall comply with CLIA 1988 in accordance with the requirements specified in 42 CFR Part 493.

(D) Nuclear medicine workers shall be checked periodically, by the use of exposure meters or badge tests, for amount of radiation exposure. Exposure reports and documentation shall be available for review.

(4) Equipment and supplies. Equipment and supplies shall be appropriate for the types of nuclear medicine services offered and shall be maintained for safe and efficient performance. The equipment shall be inspected, tested, and calibrated at least annually by qualified personnel.

(5) Records. The hospital shall maintain signed and dated reports of nuclear medicine interpretations, consultations, and procedures.

(A) The physician approved by the medical staff to interpret diagnostic procedures shall sign and date the interpretations of these tests.

(B) The hospital shall maintain records of the receipt and disposition of radiopharmaceuticals for a period of two years.

(C) Nuclear medicine services shall be ordered only by an individual whose scope of state licensure and whose defined staff privileges allow such referrals.

(o) Nursing services. The hospital shall have an organized nursing service that provides 24-hour nursing services as needed.

(1) Organization. The hospital shall have a well-organized service with a plan of administrative authority and delineation of responsibilities for patient care.

(A) Nursing services shall be under the administrative authority of a chief nursing officer (CNO) who shall be an RN and comply with one of the following:

(i) possess a master's degree in nursing;

(ii) possess a master's degree in health care administration or business administration;

(iii) possess a master's degree in a health-related field obtained through a curriculum that included courses in administration and management; or

(iv) be progressing under a written plan to obtain the nursing administration qualifications associated with a master's degree in nursing. The plan shall:

(I) describe efforts to obtain the knowledge associated with graduate education and to increase administrative and management skills and experience;

(II) include courses related to leadership, administration, management, performance-improvement and theoretical approaches to delivering nursing care; and

(III) provide a time-line for accomplishing skills.

(B) The CNO in hospitals with 100 or fewer licensed beds and located in counties with a population of less than 50,000, or in hospitals that have been certified by the Centers for Medicare and Medicaid Services as critical access hospitals in accordance with the Code of Federal Regulations, Title 42, Volume 3, Part 485, Subpart F, §485.606(b), shall be exempted from the requirements in subparagraph (A)(i)-(iv) of this paragraph effective September 1, 2002.

(i) The staffing plan referenced in paragraph (2)(I)(i) of this subsection will apply to hospitals listed in this subparagraph beginning April 1, 2003.

(ii) The annual evaluation required by paragraph (2)(I)(ii) of this subsection will apply to hospitals listed in this subparagraph beginning April 1, 2004.

(C) The CNO shall be responsible for the operation of the services, including determining the types and numbers of nursing personnel and staff necessary to provide nursing care for all areas of the hospital.

(D) The CNO shall report directly to the individual who has 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 board.

(E) The CNO shall participate with leadership from the governing body, medical staff, and clinical areas, in planning, promoting and conducting performance-improvement activities.

(2) Staffing and delivery of care.

(A) The nursing services shall adopt, implement and enforce a procedure to verify that hospital nursing personnel for whom licensure is required have valid and current licensure.

(B) There shall be adequate numbers of RNs, licensed vocational nurses (LVNs), and other personnel to provide nursing care to all patients as needed.

(C) There shall be supervisory and staff personnel for each department or nursing unit to provide, when needed, the immediate availability of an RN for bedside care of any patient.

(D) An RN shall supervise and evaluate the nursing care for each patient and assign the nursing care to other nursing personnel in accordance with the patient's needs and the specialized qualifications and competence of the nursing staff available.

(E) The nursing staff shall develop and keep current a nursing plan of care for each patient which addresses the patient's needs.

(F) At a minimum, the following critical factors shall be considered in the determination of staffing levels:

(i) patient characteristics and number of patients for whom care is being provided, including number of admissions, discharges and transfers on a unit;

(ii) intensity of patient care being provided and variability of patient care across a nursing unit;

(iii) scope of services provided;

(iv) context within which care is provided, including architecture and geography of the environment, and the availability of technology; and

(v) nursing staff characteristics, including staff consistency and tenure, preparation and experience, and the number and competencies of clinical and non-clinical support staff the nurse must collaborate with or supervise.

(G) The hospital shall adopt, implement and enforce a written process for setting staffing levels that takes into account the critical factors specified in subparagraph (F) of this paragraph. The process shall include:

(i) establishing presumptive or initial staffing levels that are recalculated at least annually or as necessary;

(ii) setting staffing levels on a unit by unit basis or other bases appropriate to the hospital;

(iii) adjusting of staffing levels from shift to shift based on factors, such as, the intensity of patient care; and

(iv) reporting to the advisory committee, as referenced in subparagraph (H) of this paragraph, showing variance between desired and actual staffing levels, and an explanation for the variance. The reports shall be confidential and not subject to disclosure under Government Code, Chapter 552 and not subject to disclosure, discovery, subpoena or other means of legal compulsion for their release.

(H) The hospital shall designate an advisory committee established in accordance with Health and Safety Code (HSC) §§161.031-161.033 to be responsible for soliciting and receiving input from nurses on the development, on-going monitoring, and evaluation of the staffing plan. As provided by HSC §161.032, the hospital's records and review relating to evaluation of these outcomes and indicators are confidential and not subject to disclosure under Government Code, Chapter 552 and not subject to disclosure, discovery, subpoena or other means of legal compulsion for their release. The committee shall:

(i) have, as one-third of its members, registered nurses who are involved in direct patient care at least 50% of their work time;

(ii) include at least one RN from either infection control, quality assurance or risk management; and

(iii) to the extent feasible, represent multiple areas of nursing practice.

(I) The hospital shall adopt, implement and enforce a written staffing plan.

(i) The staffing plan shall:

(I) be consistent with standards established by the Texas nurse licensing boards and should be developed based upon a review of the codes of ethics developed by the nursing profession through national nursing organizations;

(II) utilize outcomes and nursing-sensitive indicators as an integral role in setting and evaluating the adequacy of the staffing plan. At least one from each of the following three types of outcomes shall be correlated to the adequacy of staffing:

(-a-) patient outcomes that are nursing-sensitive, such as, patient falls, adverse drug events, injuries to patients, skin breakdown, pneumonia, infection rates, upper gastrointestinal bleeding, shock, cardiac arrest, length of stay, or patient readmissions;

(-b-) operational outcomes, such as, work-related injury or illness, vacancy and turnover rates, nursing care hours per patient day, on-call use, or overtime rates; and

(-c-) validated patient complaints related to staffing levels;

(III) incorporate a process that facilitates the timely and effective identification of concerns about the adequacy of the staffing plan by the advisory committee established pursuant to subparagraph (H) of this paragraph. This process shall include:

(-a-) a prohibition on retaliation for reporting concerns;

(-b-) a requirement that nurses report concerns timely through appropriate channels within the hospital;

(-c-) orientation of nurses on how to report concerns and to whom;

(-d-) a process for providing feedback during the advisory committee meeting on how concerns are addressed by the advisory committee established under subparagraph (H) of this paragraph; and

(-e-) use of the nurse safe harbor peer review process pursuant to Occupations Code, §303.005;

(IV) include policies and procedures that require:

(-a-) orientation of nurses and other personnel who provide nursing care to all units to which they are assigned on either a temporary or permanent basis;

(-b-) that the orientation of nurses and other personnel and the competency to perform nursing services is documented in accordance with hospital policy;

(-c-) that nursing assignments be congruent with documented competency; and

(V) when utilized as a means for meeting staffing needs, include policy and procedures for mandatory overtime. The policy and procedures shall include:

(-a-) documentation of the basis and justification for mandatory overtime;

(-b-) an action plan for the reduction or elimination of the use of mandatory overtime to meet staffing needs;

(-c-) a process for monitoring and evaluating the use of mandatory overtime; and

(-d-) procedures for notifying nurses and other personnel who provide nursing care of the mandatory overtime policy. As used in this subsection, "mandatory overtime" means being required to work, other than on call time, when not scheduled including beyond hours or days scheduled. Neither the length of the shift (whether 4, 8, 12, or 16 hours) nor the number of shifts scheduled to work (whether 4, 5, or 6 a week) is the determinative factor in defining mandatory overtime.

(ii) There shall be an annual evaluation of the nurse staffing plan, including an evaluation of the outcomes and nursing-sensitive indicators as set out in clause (i)(II) of this subparagraph. This evaluation shall be documented in the minutes of the advisory committee established under subparagraph (H) of this paragraph. Hospitals may determine whether this evaluation is done on a unit or facility level basis.

(iii) The staffing plan shall be retained for a period of two years.

(J) Non-employee licensed nurses who are working in the hospital shall adhere to the policies and procedures of the hospital. The CNO shall provide for the adequate orientation, supervision, and evaluation of the clinical activities of non-employee nursing personnel which occur within the responsibility of the nursing services.

(3) Drugs and biologicals. Drugs and biologicals shall be prepared and administered in accordance with federal and state laws, the orders of the individuals granted privileges by the medical staff, and accepted standards of practice.

(A) All drugs and biologicals shall be administered by, or under supervision of, nursing or other personnel in accordance with federal and state laws and regulations, including applicable licensing rules, and in accordance with the approved medical staff policies and procedures.

(B) All orders for drugs and biologicals shall be in writing and signed by the individual responsible for the care of the patient as specified under subsection (f)(6)(A) of this section. When telephone or oral orders must be used, they shall be:

(i) accepted only by personnel who are authorized to do so by the medical staff policies and procedures, consistent with federal and state laws;

(ii) signed or initialed by the individual who ordered the medication on their next visit; and

(iii) used infrequently.

(C) There shall be a hospital procedure for immediately reporting transfusion reactions, adverse drug reactions, and errors in administration of drugs to the attending physician and, if appropriate, to the hospital-wide quality assurance program.

(4) Blood transfusions.

(A) There shall be a written protocol for the administration of blood and blood components and the use of infusion devices and ancillary equipment.

(B) Personnel administering blood transfusions and intravenous medications shall have special training for this duty according to written hospital policy.

(C) Blood and blood components shall be transfused through a sterile, pyrogen-free transfusion set that has a filter designed to retain particles potentially harmful to the recipient.

(D) Transfusions shall be prescribed and administered under medical direction. The patient must be observed during the transfusion and for an appropriate time thereafter for suspected adverse reactions.

(E) Pretransfusion and posttransfusion vital signs shall be recorded.

(F) When warming of blood is indicated, this shall be accomplished during its passage through the transfusion set. The warming system shall be equipped with a visible thermometer and may have an audible warning system. Blood shall not be warmed above 42 degrees Celsius.

(G) Drugs or medications, including those intended for intravenous use, shall not be added to blood or blood components. A 0.9% sodium chloride injection, United States Pharmacopeia, may be added to blood or blood components. Other solutions intended for intravenous use may be used in an administration set or added to blood or blood components under either of the following conditions:

(i) they have been approved for this use by the Federal Drug Administration; or

(ii) there is documentation available to show that addition to the component involved is safe and efficacious.

(H) There shall be a system for detection, reporting and evaluation of suspected complications of transfusion. Any adverse event experienced by a patient in association with a transfusion is to be regarded as a suspected transfusion complication. In the event of a suspected transfusion complication, the personnel attending the patient shall notify immediately a responsible physician and the transfusion service and document the complication in the patient's medical record. All suspected transfusion complications shall be evaluated promptly according to an established procedure.

(I) Following the transfusion, the blood transfusion record or a copy shall be made a part of the patient's medical record.

(5) Professional nurse reporting and peer review. A hospital shall adopt, implement, and enforce a policy to ensure that the hospital complies with the Occupations Code §§301.401-301.403, 301.405 and Chapter 303 (respectively Professional Nurse Reporting and Peer Review), and with the rules adopted by the Board of Nurse Examiners at 22 TAC, §217.17 (relating to Minimal Procedural Standards During Peer Review) and 22 TAC, §217.16 (relating to Minor Incidents).

(p) Outpatient services. If the hospital provides outpatient services, the services shall meet the needs of the patients in accordance with acceptable standards of practice.

(1) Organization. Outpatient services shall be appropriately organized and integrated with inpatient services.

(2) Personnel.

(A) The hospital shall assign an individual to be responsible for outpatient services.

(B) The hospital shall have appropriate physicians on staff and other professional and nonprofessional personnel available.

(q) Pharmacy services. The hospital shall provide pharmaceutical services that meet the needs of the patients.

(1) Compliance. Pharmacy services shall comply with the following Acts and rules:

(A) Texas Pharmacy Act, Texas Civil Statutes (TCS), Article 4542a-1, and 22 TAC Part XV (Texas State Board of Pharmacy);

(B) Texas Dangerous Drug Act, HSC, Chapter 483; and

(2) Organization. The hospital shall have a pharmacy directed by a licensed pharmacist.

(3) Medical staff. The medical staff shall be responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital's organized pharmaceutical services.

(4) Pharmacy management and administration. The pharmacy or drug storage area shall be administered in accordance with accepted professional principles.

(A) Standards of practice as defined by state law shall be followed regarding the provision of pharmacy services.

(B) The pharmaceutical services shall have an adequate number of personnel to ensure quality pharmaceutical services including emergency services.

(i) The staff shall be sufficient in number and training to respond to the pharmaceutical needs of the patient population being served. There shall be an arrangement for emergency services.

(ii) Employees shall provide pharmaceutical services within the scope of their license and education.

(D) Records shall have sufficient detail to follow the flow of drugs from entry through dispensation.

(E) There shall be adequate controls over all drugs and medications including the floor stock. Drug storage areas shall be approved by the pharmacist, and floor stock lists shall be established.

(F) Inspections of drug storage areas shall be conducted throughout the hospital under pharmacist supervision.

(G) There shall be a drug recall procedure.

(H) A full-time, part-time, or consulting pharmacist shall be responsible for developing, supervising, and coordinating all the activities of the pharmacy services.

(i) Direction of pharmaceutical services may not require on premises supervision but may be accomplished through regularly scheduled visits in accordance with state law.

(ii) A job description or other written agreement shall clearly define the responsibilities of the pharmacist.

(I) Current and accurate records shall be kept of the receipt and disposition of all scheduled drugs.

(i) There shall be a record system in place that provides the information on controlled substances in a readily retrievable manner which is separate from the patient record.

(ii) Records shall trace the movement of scheduled drugs throughout the services, documenting utilization or wastage.

(iii) The pharmacist shall be responsible for determining that all drug records are in order and that an account of all scheduled drugs is maintained and reconciled with written orders.

(5) Delivery of services. In order to provide patient safety, drugs and biologicals shall be controlled and distributed in accordance with applicable standards of practice, consistent with federal and state laws.

(A) All compounding, packaging, and dispensing of drugs and biologicals shall be under the supervision of a pharmacist and performed consistent with federal and state laws.

(B) Drugs and biologicals shall be kept in a locked storage area.

(i) A policy shall be adopted, implemented, and enforced to ensure the safeguarding, transferring, and availability of keys to the locked storage area.

(ii) Dangerous drugs as well as controlled substances shall be secure from unauthorized use.

(D) When a pharmacist is not available, drugs and biologicals shall be removed from the pharmacy or storage area only by personnel designated in the policies of the medical staff and pharmaceutical service, in accordance with federal and state laws.

(i) There shall be a current list of individuals identified by name and qualifications who are designated to remove drugs from the pharmacy.

(ii) Only amounts sufficient for immediate therapeutic needs shall be removed.

(E) Drugs and biologicals not specifically prescribed as to time or number of doses shall automatically be stopped after a reasonable time that is predetermined by the medical staff.

(i) Stop order policies and procedures shall be consistent with those of the nursing staff and the medical staff rules and regulations.

(ii) A protocol shall be established by the medical staff for the implementation of the stop order policy, in order that drugs shall be reviewed and renewed, or automatically stopped.

(iii) A system shall be in place to determine compliance with the stop order policy.

(F) Drug administration errors, adverse drug reactions, and incompatibilities shall be immediately reported to the attending physician and, if appropriate, to the hospital-wide quality assurance program. There shall be a mechanism in place for capturing, reviewing, and tracking medication errors and adverse drug reactions.

(G) Abuses and losses of controlled substances shall be reported, in accordance with applicable federal and state laws, to the individual responsible for the pharmaceutical services, and to the chief executive officer, as appropriate.

(H) Information relating to drug interactions and information on drug therapy, side effects, toxicology, dosage, indications for use, and routes of administration shall be immediately available to the professional staff.

(i) A pharmacist shall be readily available by telephone or other means to discuss drug therapy, interactions, side effects, dosage, assist in drug selection, and assist in the identification of drug induced problems.

(ii) There shall be staff development programs on drug therapy available to facility staff to cover such topics as new drugs added to the formulary, how to resolve drug therapy problems, and other general information as the need arises.

(I) A formulary system shall be established by the medical staff to ensure quality pharmaceuticals at reasonable costs.

(r) Quality assurance. The governing body shall ensure that there is an effective, hospital-wide quality assurance (QA) program to evaluate the provision of patient care.

(1) Implementation plan. The hospital-wide QA program shall be on-going and have a written plan of implementation.

(A) All organized services related to patient care, including services furnished by contract, shall be evaluated.

(B) Nosocomial infections and medication therapy shall be evaluated.

(C) All medical and surgical services performed in the hospital shall be evaluated as they relate to appropriateness of diagnosis and treatment.

(2) Medically-related patient care services. The hospital shall have an on-going plan, consistent with available community and hospital resources, to provide or make available social work, psychological, and educational services to meet the medically-related needs of its patients. The hospital also shall have an effective, on-going discharge planning program that facilitates the provision of follow-up care.

(A) Discharge planning shall be initiated in a timely manner.

(B) Patients, along with necessary medical information, shall be transferred or referred to appropriate facilities, agencies, or outpatient services, as needed for follow-up or ancillary care.

(3) Implementation. The hospital shall take and document appropriate remedial action to address deficiencies found through the QA program. The hospital shall document the outcome of the remedial action.

(s) Radiology services. The hospital shall maintain, or have available, diagnostic radiologic services according to needs of the patients. If therapeutic services are also provided, the services, as well as the diagnostic services, shall meet professionally approved standards for safety and personnel qualifications. In a special hospital, portable X-ray equipment may be acceptable as a minimum requirement.

(1) Policies and procedures. Policies and procedures shall be adopted, implemented and enforced which will describe the radiology services provided in the hospital and how employee and patient safety will be maintained.

(2) Safety for patients and personnel. The radiology services, particularly ionizing radiology procedures, shall be free from hazards for patients and personnel.

(A) Proper safety precautions shall be maintained against radiation hazards. This includes adequate shielding for patients, personnel, and facilities.

(B) Inspection of equipment shall be made periodically. Defective equipment shall be promptly repaired or replaced.

(C) Radiation workers shall be checked, by the use of exposure meters or badge tests, for amount of radiation exposure. Exposure reports and documentation shall be available for review.

(D) Radiology services shall be provided only on the order of individuals granted privileges by the medical staff.

(3) Personnel.

(A) A qualified full-time, part-time, or consulting radiologist shall supervise the ionizing radiology services and shall interpret only those radiology tests that are determined by the medical staff to require a radiologist's specialized knowledge. For purposes of this section a radiologist is a physician who is qualified by education and experience in radiology in accordance with medical staff bylaws.

(B) Only personnel designated as qualified by the medical staff shall use the radiology equipment and administer procedures.

(4) Records. Records of radiology services shall be maintained. The radiologist or other individuals who have been granted privileges to perform radiology services shall sign reports of his or her interpretations.

(t) Respiratory care services. The hospital shall meet the needs of the patients in accordance with acceptable standards of practice.

(1) Policies and procedures shall be adopted, implemented, and enforced which describe the provision of respiratory care services in the hospital.

(2) The organization of the respiratory care services shall be appropriate to the scope and complexity of the services offered.

(3) There shall be a director of respiratory care services who is a physician with the knowledge, experience, and capabilities to supervise and administer the services properly. The director may serve on either a full-time or part-time basis.

(4) There shall be adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with the state law.

(5) Personnel qualified to perform specific procedures and the amount of supervision required for personnel to carry out specific procedures shall be designated in writing.

(6) If blood gases or other clinical laboratory tests are performed by the respiratory care services staff, the respiratory care staff shall comply with CLIA 1988 in accordance with the requirements specified in 42 CFR, Part 493.

(7) Services shall be provided only on, and in accordance with, the orders of a physician.

(u) Sterilization and sterile supplies.

(1) Supervision. The sterilization of all supplies and equipment shall be under the supervision of a person qualified by education, training and experience. Staff responsible for the sterilization of supplies and equipment shall participate in a documented continuing education program; new employees shall receive initial orientation and on-the-job training.

(2) Equipment and procedures.

(A) Sterilization. Every hospital shall provide equipment adequate for sterilization of supplies and equipment as needed. Equipment shall be maintained and operated to perform, with accuracy, the sterilization of the various materials required.

(B) Written policy. Written policies and procedures for the decontamination and sterilization activities performed shall be adopted, implemented and enforced. Policies shall include the receiving, cleaning, decontaminating, disinfecting, preparing and sterilization of reusable items, as well as those for the assembly, wrapping, storage, distribution and quality control of sterile items and equipment. These written policies shall be reviewed at least every other year and approved by the infection control practitioner or committee.

(C) Separation. Where cleaning, preparation, and sterilization functions are performed in the same room or unit, the physical facilities, equipment, and the policies and procedures for their use, shall be such as to effectively separate soiled or contaminated supplies and equipment from the clean or sterilized supplies and equipment. Hand washing facilities shall be provided and a separate sink shall be provided for safe disposal of liquid waste.

(D) Labeling. All containers for solutions, drugs, flammable solvents, ether, alcohol, and medicated supplies shall be clearly labeled to indicate contents. Those which are sterilized by the hospital shall be labeled so as to be identifiable both before and after sterilization. Sterilized items shall have a load control identification that indicates the sterilizer used, the cycle or load number, and the date of sterilization.

(E) Preparation for sterilization.

(i) All items to be sterilized shall be prepared to reduce the bioburden. All items shall be thoroughly cleaned, decontaminated and prepared in a clean, controlled environment.

(ii) All articles to be sterilized shall be arranged so all surfaces will be directly exposed to the sterilizing agent for the prescribed time and temperature.

(F) Packaging. All wrapped articles to be sterilized shall be packaged in materials recommended for the specific type of sterilizer and material to be sterilized.

(G) External chemical indicators.

(i) External chemical indicators, also known as sterilization process indicators, shall be used on each package to be sterilized, including items being flash sterilized to indicate that items have been exposed to the sterilization process.

(ii) The indicator results shall be interpreted according to manufacturer's written instructions and indicator reaction specifications.

(iii) A log shall be maintained with the load identification, indicator results, and identification of the contents of the load.

(H) Biological indicators.

(i) The efficacy of the sterilizing process shall be monitored with reliable biological indicators appropriate for the type of sterilizer used (e.g., Bacillus stearothermophilus for steam sterilizers, and Bacillus subtilis variant (var.) niger or var. globigii for ethylene oxide (EO) and low temperature hydrogen peroxide plasma sterilizers).

(ii) Biological indicators shall be included in at least one run each week of use for steam sterilizers, at least one run each day of use for low temperature hydrogen peroxide gas sterilizers, and every load for ethylene oxide sterilizers.

(iii) Biological indicators shall be included in every load that contains implantable objects.

(iv) A log shall be maintained with the load identification, biological indicator results, and identification of the contents of the load.

(v) If a test is positive, the sterilizer shall immediately be taken out of service.

(I) Implantable items shall be recalled and reprocessed if a biological indicator test (spore test) is positive.

(II) All available items shall be recalled and reprocessed if a sterilizer malfunction is found and a list of those items not retrieved in the recall shall be submitted to infection control.

(III) A malfunctioning sterilizer shall not be put back into use until it has been serviced and successfully tested according to the manufacturer's recommendations.

(I) Sterilizers.

(i) Steam sterilizers (saturated steam under pressure) shall be utilized for sterilization of heat and moisture stable items. Steam sterilizers shall be used according to manufacturer's written instructions.

(ii) EO sterilizers shall be used for processing heat and moisture sensitive items. EO sterilizers and aerators shall be used and vented according to the manufacturer's written instructions.

(iii) Flash sterilizers shall be used for emergency sterilization of clean, unwrapped instruments and porous items only.

(J) Disinfection.

(i) Written policies, approved by the infection control committee, shall be adopted and implemented for the use of chemical disinfectants.

(ii) The manufacturer's written instructions for the use of disinfectants shall be followed.

(iii) An expiration date, determined according to manufacturer's written recommendations, shall be marked on the container of disinfection solution currently in use.

(iv) Disinfectant solutions shall be kept covered and used in well ventilated areas.

(v) Chemical germicides that are registered with the United States Environmental Protection Agency as "sterilants" may be used either for sterilization or high-level disinfection.

(vi) All staff personnel using chemical disinfectants shall have received training on their use.

(K) Performance records.

(i) Performance records for all sterilizers shall be maintained for each cycle. These records shall be retained and available for review for a minimum of five years.

(ii) Each sterilizer shall be monitored continuously during operation for pressure, temperature, and time at desired temperature and pressure. A record shall be maintained and shall include:

(I) the sterilizer identification;

(II) sterilization date;

(III) cycle number;

(IV) contents of each load;

(V) duration and temperature of exposure phase (if not provided on sterilizer recording charts);

(VI) identification of operator(s);

(VII) results of biological tests and dates performed;

(VIII) time-temperature recording charts from each sterilizer;

(IX) gas concentration and relative humidity (if applicable); and

(X) any other test results.

(L) Storage of sterilized items.

(i) Sterilized items shall be transported so as to maintain cleanliness and sterility and to prevent physical damage.

(ii) Sterilized items shall be stored in well-ventilated, limited access areas with controlled temperature and humidity.

(iii) The hospital shall adopt and implement a policy which describes the mechanism used to determine the shelf life of sterilized packages.

(M) Preventive maintenance. Preventive maintenance of all sterilizers shall be performed according to individual policy on a scheduled basis by qualified personnel, using the sterilizer manufacturer's service manual as a reference. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least two years and shall be available for review.

(v) Surgical services. If a hospital provides surgical services, the services shall be well-organized and provided in accordance with acceptable standards of practice. If outpatient surgical services are offered, the services shall be consistent in quality with inpatient care in accordance with the complexity of services offered. A special hospital may not offer surgical services.

(1) Organization and staffing. The organization of the surgical services shall be appropriate for the scope of the services offered.

(A) The operating rooms shall be supervised by an experienced RN or physician.

(B) Licensed vocational nurses (LVNs) and surgical technologists (operating room technicians) may serve as scrub nurses or technologists under the supervision of an RN.

(C) Qualified RNs may perform circulating duties in the operating room. In accordance with approved medical staff polices and procedures, LVNs and surgical technologists may assist in circulatory duties under the supervision of a qualified RN who is immediately available to respond to emergencies.

(D) Surgical privileges shall be delineated for all physicians, podiatrists, and dentists performing surgery in accordance with the competencies of each. The surgical services shall maintain a roster specifying the surgical privileges of each.

(2) Delivery of service. Surgical services shall be consistent with needs and resources. Written policies governing surgical care which are designed to ensure the achievement and maintenance of high standards of medical practice and patient care shall be adopted, implemented and enforced.

(A) There shall be a complete medical history and physical examination in the medical record of every patient prior to surgery, except in emergencies. If this has been dictated, but not yet recorded in the patient's medical record, there shall be a statement to that effect and an admission note in the record by the individual who admitted the patient.

(B) A properly executed informed consent form for the operation shall be in the patient's medical record before surgery, except in emergencies.

(i) communication system;

(ii) cardiac monitor;

(iii) resuscitator;

(iv) defibrillator;

(v) aspirator; and

(vi) tracheotomy set.

(D) There shall be adequate provisions for immediate post-operative care.

(E) The operating room register shall be complete and up-to-date. The register shall contain, but not be limited to, the following:

(i) patient's name and hospital identification number;

(ii) date of operation;

(iii) operation performed;

(iv) operating surgeon and assistant(s);

(v) type of anesthesia used and name of person administering it;

(vi) time operation began and ended;

(vii) time anesthesia began and ended;

(viii) disposition of specimens;

(ix) names of scrub and circulating personnel;

(x) unusual occurrences; and

(xi) disposition of the patient.

(F) An operative report describing techniques, findings, and tissue removed or altered shall be written or dictated immediately following surgery and signed by the surgeon.

(w) Therapy services. If the hospital provides physical therapy, occupational therapy, audiology, or speech pathology services, the services shall be organized and staffed to ensure the health and safety of patients.

(1) Organization and staffing. The organization of the services shall be appropriate to the scope of the services offered.

(A) The director of the services shall have the necessary knowledge, experience, and capabilities to properly supervise and administer the services.

(B) Physical therapy, occupational therapy, speech therapy, or audiology services, if provided, shall be provided by staff who meet the qualifications specified by the medical staff, consistent with state law.

(2) Delivery of services. Services shall be furnished in accordance with a written plan of treatment. Services shall be given in accordance with orders of the physician, podiatrist or dentist who is authorized by the medical staff to order the services, and the orders shall be incorporated in the patient's medical record.

(x) Waste and waste disposal.

(1) Special waste and liquid/sewage waste management.

(A) The hospital shall comply with the requirements set forth by the department in §§1.131-1.137 of this title (relating to Definition, Treatment and Disposition of Special Waste from Health Care Related Facilities) and the Texas Natural Resource Conservation Commission (TNRCC) requirements in Title 30, Texas Administrative Code, §330.1004 (Generators of Medical Waste).

(B) All sewage and liquid wastes shall be disposed of in a municipal sewerage system or a septic tank system permitted by the TNRCC in accordance with Title 30, Texas Administrative Code, Chapter 285 (On-Site Sewage Facilities).

(2) Waste receptacles.

(A) Waste receptacles shall be conveniently available in all toilet rooms, patient areas, staff work areas, and waiting rooms. Receptacles shall be routinely emptied of their contents at a central location(s) into closed containers.

(B) Waste receptacles shall be properly cleaned with soap and hot water, followed by treatment of inside surfaces of the receptacles with a germicidal agent.

(C) All containers for other municipal solid waste shall be leak-resistant, have tight-fitting covers, and be rodent-proof.

(D) Non-reusable containers shall be of suitable strength to minimize animal scavenging or rupture during collection operations.

§133.43.Discrimination or Retaliation Standards.

(a) Posting requirements for reporting a violation of law. In accordance with §161.135(h) of the Health and Safety Code (HSC), each hospital shall prominently and conspicuously post for display in a public area of the hospital that is readily visible to patients, residents, employees, and visitors a statement that non-employees, employees and staff are protected from discrimination or retaliation for reporting a violation of law. The statement shall be in English and in a second language appropriate to the demographic makeup of the community served.

(b) Discrimination relating to employee reporting a violation of law. In accordance with §161.134(a) of the HSC, and 25 TAC, §133.41(o)(2)(I)(i)(III), a hospital may not suspend or terminate the employment of, discipline, or otherwise discriminate against an employee for reporting in good faith to the employee's supervisor, an administrator of the hospital, a state or federal regulatory agency, a national accrediting organization or a law enforcement agency a violation of law, including a violation of the Act or this chapter. For purposes of this subsection, a report is not made in good faith if there is not a reasonable factual or legal basis for making the report.

(c) Retaliation relating to non-employee reporting a violation of law. In accordance with §161.135(a) of the HSC, a hospital may not retaliate against a person who is not an employee for reporting a violation of law, including a violation of the Act or this chapter.

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 28, 2002.

TRD-200201949

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: September 1, 2002

Proposal publication date: December 14, 2001

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

Chapter 289. RADIATION CONTROL

Subchapter D. GENERAL

25 TAC §289.204

The Texas Department of Health (department) adopts an amendment to §289.204, concerning fees for certificates of registration, radioactive material licenses, emergency planning and implementation, and other regulatory services with changes to the proposed text as published in the December 14, 2001, issue of the Texas Register (26 TexReg 10219).

The department deleted the proposed additional nonrefundable fee equal to 5.0% of the annual fee to be paid annually by each holder of a specific license, excluding the diagnostic nuclear medicine licensees, as authorized by House Bill 1099 (77th Legislature 2001). The intent was that the additional fee be deposited to the Radiation and Perpetual Care Fund. However, the department has determined that the department's appropriation from the Radiation and Pepetual Care Fund is limited to financial security only; therefore, additional fees are not allowed to be used from that Fund. Fees for in situ and disposal only uranium recovery and byproduct material disposal facility licenses that were inadvertently omitted in the 2000 submission of the fee rule revision to the Texas Register are incorporated in this rule revision. Language is added to §289.204(e)(1) to clarify fees required by this section. A rule citation is corrected in §289.204(k)(3). In Figure 25 TAC §289.204(f), category (17)(A), "/Portable" is added after "Pipe-Thickness;" category (17)(B), "Fixed" replaces "Other;" category (40), the words "(Includes Low Dose-Rate and High Dose-Rate Remote Afterloaders and Intravenous Brachytherapy)" are added after "Device" to clarify the category of license; category (44) "Storage Only," is deleted after category (43) "Special Nuclear Material" since this category is no longer necessary; and subsequent categories are renumbered to reflect the deletion; new category (45), the words "(Used in Other Than Oil and Gas Industry Wellbores)" replace "(Non-Oil Well) to clarify the category of license; new category (46), the words "(Used in Oil and Gas Industry Wellbores)" replace "(Oil Well)" to clarify the category of license. In Figure: 25 TAC §289.204(i), category (8)(C), the words "(includes computerized tomography scanner)" are added after "Sources;" category (11)(C)(ii), the words "Calibration and Repair of X-Ray Equipment" replace the words "Calibration of X-Ray Equipment and Nonionizing Devices;" category (11)(C)(v), "of X-Ray Equipment" is added after "Demonstration/Sales;" category (11)(C)(vii), "X-Ray" is added after "of;" category (11)(C)(viii) is added to read "X-Ray Equipment Performance Evaluation" to be consistent with a requirement that was added to another section in the 2000 submission to the Texas Register ; category (14)(A), "of Lasers" is added after "Demonstration/Sales;" category (14)(B), "Provider of Lasers" replaces "Provision of Lasers;" and category (14)(C), "of Lasers" is added after "Calibration/Alignment/Repair" to clarify the categories of services. In Figure 25 TAC §289.204(l), a heading titled "License Category" is added to the second column for consistency within the table and for "In Situ" and "Disposal Only," "$47,601" is incorporated under the "Operational Year' heading to state the number that was inadvertently omitted in the 2000 submission of the fee rule revision to the Texas Register . This amendment is part of the department's ongoing evaluation of program fees to comply with the provisions of Health and Safety Code §401.301.

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). Section 289.204 has been reviewed and the department has determined that the reasons for adopting the section continue to exist; however, revisions to the rule are necessary.

The department published a Notice of Intention to Review for §289.204 as required by Government Code §2001.039 in the Texas Register (26 TexReg 5449) on July 20, 2001. No comments were received by the department on this section.

The department received no public comments during the comment period for this amendment. However, the department is making the following changes due to a comment from a member of the Texas Radiation Advisory Board and a staff comment to clarify the intent and improve the accuracy of the section.

Change: Concerning §289.204(e)(1), in the last sentence, the department deleted the word "annual" after the word "appropriate" to clarify the intent of the paragraph.

Change: Concerning new proposed §289.204(e)(5), the department deleted the language of this paragraph because the department has determined that the department's appropriation from the Radiation and Pepetual Care Fund is limited to financial security only; therefore, additional fees are not allowed to be used from that Fund. Subsequent paragraphs are renumbered.

Change: Concerning Figure: 25 TAC §289.204(f), new category (45), the words "(Used in Other Than Oil and Gas Industry Wellbores)" replace "(Non-Oil Well) and in new category (46), the words "(Used in Oil and Gas Industry Wellbores)" replace "(Oil Well)" to clarify the categories of licenses.

Change: Concerning Figure: 25 TAC §289.204(l), the department added a heading titled "License Category" to the second column for consistency within the table.

The amendment is adopted under the Health and Safety Code, §401.301, which provides the Texas Board of Health (board) with authority to adopt rules and guidelines relating to the control of radiation; 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.

§289.204.Fees for Certificates of Registration, Radioactive Material Licenses, Emergency Planning and Implementation, and Other Regulatory Services.

(a) Purpose. The requirements in this section establish fees for licensing, registration, emergency planning and implementation, and other regulatory services, and provide for their payment.

(b) Scope. Except as otherwise specifically provided, the requirements in this section apply to any person who is the following:

(1) an applicant for, or holder of:

(A) a radioactive material license issued in accordance with §289.252 of this title (relating to Licensing of Radioactive Material), §289.254 of this title (relating to Licensing of Radioactive Waste Processing and Storage Facilities), §289.259 of this title (relating to Licensing of Naturally Occurring Radioactive Material (NORM)), or §289.260 of this title (relating to Licensing of Uranium Recovery and Byproduct Material Disposal Facilities); or

(B) a general license acknowledgment issued in accordance with §289.251 of this title (relating to Exemptions, General Licenses, and General License Acknowledgments); or

(C) a certificate of registration for radiation machines and/or services, or sources of laser radiation, issued in accordance with §289.226 of this title (relating to Registration of Radiation Machine Use and Services), §289.230 of this title (relating to Certification of Mammography Systems and Accreditation of Mammography Facilities), or §289.301 of this title (relating to Registration and Radiation Safety Requirements for Lasers); or

(2) the holder of a fixed nuclear facility construction permit or operating license issued by the United States Nuclear Regulatory Commission (NRC) in accordance with 10 Code of Federal Regulations Part 50; or

(3) the operator of any other fixed nuclear facility.

(c) Definitions. The following words and terms when used in this section shall have the following meaning, unless the context clearly indicates otherwise.

(1) Contiguous properties -- Those locations adjacent to an existing licensed or permitted area.

(2) Decontamination services -- Providing deliberate operations to reduce or remove residual radioactivity from equipment, facilities, and land owned, possessed, or controlled by other persons to a level that permits release of equipment, facilities, and land for unrestricted use and/or termination of a license.

(3) Emergency planning and implementation -- The development and application of those capabilities necessary for the protection of the public and the environment from the effects of an accidental or uncontrolled release of radioactive materials, including the equipping, training and periodic retraining of response personnel.

(4) Fixed nuclear facility -- The following are considered fixed nuclear facilities:

(A) any nuclear reactor(s) at a single site;

(B) any facility designed or used for the assembly or disassembly of nuclear weapons; or

(C) any other facility using special nuclear material for which the agency conducts off-site environmental surveillance and/or emergency planning and implementation to protect the public health and safety or the environment.

(5) Limited manufacturer -- A manufacturer/distributor of radioactive material that is not required to submit a decommissioning funding plan or an emergency plan in accordance with §289.252 of this title.

(6) Post-closure -- The time period after which closure activities have been completed by the conventional mill licensee and prior to transfer of land ownership of tailings disposal sites to the State of Texas or the United States of America and termination of the license or after which confirmatory surveys have been conducted by the agency of an in-situ facility and before termination of the license or site.

(d) Exemptions. No application or annual fee shall be required for a general license issued in accordance with §289.251 of this title that does not require a general license acknowledgment.

(e) Payment of fees.

(1) Each application for a license, general license acknowledgement, or certificate of registration for which a fee is prescribed in subsections (f), (h), or (i) of this section shall be accompanied by a nonrefundable fee equal to the appropriate annual fee. Each request for evaluation of a sealed source and/or device shall be accompanied by a nonrefundable fee equal to the appropriate fee as prescribed in subsection (g) of this section.

(A) An application for a license covering more than one license or general license category shall be accompanied by the prescribed fee for the highest category and 25% of the applicable prescribed fee for each additional requested category.

(B) An application for a certificate of registration shall be accompanied by the prescribed base fee for the highest category of use plus the prescribed machine or service fee for each category of use.

(2) A nonrefundable fee, in accordance with subsection (f) of this section shall be paid annually for each radioactive material license and/or for each general license acknowledgement. The fee shall be paid in full each year on or before the last day of the expiration month of the license or general license acknowledgement. For example, if the license or general license acknowledgement expires May 31, 2010, annual fees are due on or before May 31 of each calendar year. In the case of a single license that authorizes more than one category of use, the annual fee shall be the prescribed fee for the highest license category plus 25% of the applicable prescribed fee for each additional license category authorized.

(3) A nonrefundable fee, in accordance with subsections (f) or (i) of this section, shall be paid annually for each certificate of registration for radiation machines and/or services, or sources of laser radiation. The fee consists of a base fee for all registrants plus a fee where specified for each machine possessed or registrable service offered.

(4) In the case of a single certificate of registration that authorizes more than one category of use, the category listed in subsection (i) of this section and assigned the higher of the fee or base fee plus corresponding machine/service fee, as applicable, will be used.

(5) Each application for reciprocal recognition of an out-of-state license in accordance with §289.252(s) of this title, an out-of-state registration in accordance with §289.226 of this title, or an out-of-state laser registration in accordance with §289.301 of this title shall be accompanied by the applicable annual fee, provided that no such fee has been submitted within 12 months of the date of commencement of the proposed activity.

(6) Each holder of a fixed nuclear facility construction permit or operating license or an operator of any other fixed nuclear facility shall submit an annual fee for services received. This fee shall recover for the State of Texas the actual expenses arising from environmental surveillance and emergency planning and implementation activities. Payment shall be made within 90 days following the date of invoice.

(7) Fee payments shall be in cash or by check or money order made payable to the Texas Department of Health. The payments may be made by personal delivery to the central office, Bureau of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas, or mailed to the Bureau of Radiation Control, Texas Department of Health, 1100 West 49th Street, Austin, Texas, 78756-3189.

(8) Any applicant requesting authorization for any of the categories in subsection (f) of this section for veterinary use will be assessed the annual fee for the corresponding category.

(f) Schedule of annual fees for radioactive material licenses. The following schedule contains the annual fees for radioactive material licenses:

Figure: 25 TAC §289.204(f)

(g) Fee for Evaluation of a Sealed Source and/or Device.

(1) Each time a manufacturer submits a request for evaluation of a unique sealed source, one of the following fees shall be paid:

(A) for an initial evaluation, a fee of $3,614; or

(B) for an amendment requiring re-evaluation, a fee of $1,804.

(2) Each time a manufacturer submits a request for evaluation of a unique device, one of the following fees shall be paid:

(A) for an initial evaluation, a fee of $7,233; or

(B) for an amendment requiring re-evaluation, a fee of $3,619.

(3) No request for evaluation will be processed prior to payment of the full amount specified.

(h) Fees for certification of mammography systems.

(1) An application for certification of mammography systems shall be accompanied by a fee of $422 for each unit.

(2) The annual fee for mammography systems is $422 for each unit.

(i) Schedule of annual fees for certificates of registration for radiation machines, lasers, and services. The following schedule contains the annual fees for certificates of registration for radiation machines, lasers, and services:

Figure: 25 TAC §289.204(i)

(j) Annual fees for environmental surveillance and emergency planning and implementation. Fees shall be set annually by the agency for each facility. Fees for fixed nuclear facilities shall be the actual expenses for environmental surveillance and emergency planning and implementation activities. Costs of activities benefiting more than one facility shall be prorated.

(k) Failure to pay prescribed fees.

(1) In any case where the agency finds that an applicant for a license or certificate of registration has failed to pay the fee prescribed in this section, the agency will not process that application until such fee is paid.

(2) In any case where the agency finds that a licensee or registrant has failed to pay a fee prescribed by this section by the due date, the licensee or registrant shall pay an annual late payment fee of 20% of the annual fee prescribed in subsections (f), (h), (i) and (l) of this section, in addition to the annual license and registration fee. The annual late payment fee shall not exceed $10,000 for each licensee or registrant who fails to pay the fees prescribed by this section.

(3) In any case where the agency finds that a licensee or registrant has failed to pay a fee prescribed by this section by the due date, the agency may implement compliance procedures as provided in §289.205 of this title (relating to Hearing and Enforcement Procedures).

(4) In any case where the agency finds that a fixed nuclear facility has failed to pay fees for environmental surveillance or emergency planning and implementation within 90 days following date of invoice, the agency may issue an order to show cause why those services should not be terminated.

(l) Schedule of fees for uranium recovery and byproduct material disposal facility licenses. The following schedule contains the fees for uranium recovery and byproduct material disposal facility licenses:

Figure: 25 TAC §289.204(l)

(m) Adjustments to annual fees for uranium recovery and byproduct material disposal facility licenses.

(1) If additional noncontiguous uranium recovery facility sites are authorized under the same license, the appropriate annual fee shall be increased by 25% for each additional site for an operational year and 50% for closure only.

(2) If an authorization for disposal of byproduct material is added to a license, the appropriate annual fee shall be increased by 25%.

(n) One-time fee adjustments for uranium recovery and byproduct material disposal facility licenses. For the addition of the following items after an environmental assessment has been completed on a facility, a one-time fee corresponding to the item shall be paid:

(1) $22,389 for in situ wellfield on noncontiguous property;

(2) $55,977 for in situ satellite;

(3) $8,777 for wellfield on contiguous property;

(4) $39,653 for non-vacuum dryer; or

(5) $55,977 for disposal (including processing, if applicable) of byproduct material.

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 25, 2002.

TRD-200201897

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: May 1, 2002

Proposal publication date: December 14, 2001

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

Part 16. TEXAS HEALTH CARE INFORMATION COUNCIL

Chapter 1301. HEALTH CARE INFORMATION

Subchapter A. HOSPITAL DISCHARGE DATA RULES

25 TAC §§1301.11, 1301.16 - 1301.18, 1301.20

The Texas Health Care Information Council adopts amendments to §§1301.11, 1301.16 - 1301.18 and 1301.20, relating to Hospital Discharge Data Rules. Amended §1301.11 is adopted with changes to the proposed text as published in the December 28, 2001 issue of the Texas Register (26 TexReg 10772). Sections 1301.16 - 1301.18 and §1301.20 are adopted without changes and will not be republished.

The amended sections are adopted, in part, to implement Chapter 108, Health and Safety Code, to clarify existing language, and to implement a practical resolution for the submission of late or missing claim data from a provider. Changes in the adopted amendments respond to public comments or otherwise reflect non-substantive variations from the proposed amendments. The Council's representative from the Office of the Attorney General has advised that the changes affect no new persons, entities, or subjects other than those given notice and that compliance with the adopted sections will be less burdensome than under the proposed sections.

Amended §1301.11 amends the definitions of "Attending Physician", and "Operating or Other Physician" with changes from the proposed text and repeals the definition of "Treating Physician" and withdraws the proposed definition of "Public Information Report". Amended §1301.16 adds a new process for submitting late or missing claims data. Amended §1301.17 amends the time parameters for acceptance of late or missing claims data and the types of "Physicians" or "Other Health Professionals" who may appear in the "attending", or "operating or other" physician fields. Amended §1301.20 amends the list of research data elements that may be released to a requestor after being approved by the Scientific Review Panel.

The following entities furnished written comments on the proposed amendment: Methodist Hospitals of Dallas, Dallas-Fort Worth Hospital Council, Texas Hospital Association, Texas Health Resources, University Medical Center, Inc. and the Texas Medical Association.

Comments by Section

Preamble

Three commenters stated that they thought the estimated costs that the Council proposed were too high. The Council has reviewed the late claims process estimate submitted by Commonwealth Clinical Systems and is reducing the cost estimate from $30,000 to $17, 900 for the first five year per period that the adopted sections are in effect. Approximately $8,000 is for development and programming changes and $2,260 each for the first and second quarter of 2001, then $1,762.75 per fiscal year with an increase of five percent each year thereafter.

Four commenters recommended that the Council strike the term "qualitative measures" because it does not collect qualitative data and replace the terms "quality measures" and "quality data" with the terms "quantitative measures" and "quantitative data". The Council agrees that it does not currently collect qualitative data/measures other than the comments submitted by the hospitals and has removed those terms from this version to be adopted. The terms qualitative measures do not appear in the proposed amendments, and the Council withdrew the terms from the adopted version of Subchapter C, Rules Relating to Reports Created by the Council.

§1301.11(2) Attending Physician

Five commenters recommended that the Council retain the phrase "during the hospital episode". One commenter recommended the deletion of the last sentence regarding which physician should be reported as attending physician in a Skilled Nursing Unit of a hospital. The Council agrees with the commenters on retaining the phrase "during the hospital episode" and has withdrawn the proposed deletion of that phrase. The Council disagrees with the commenter that the last sentence be deleted for the following reason. The Council believes this is a clear and specific instruction to hospitals with skilled nursing units, as to who the Council expects to be reported in the "attending physician" field.

§1301.11(25) Operating or other Physician

One commenter recommended that additional language be included that clearly states the physicians that appear in this field are licensed by the Texas State Board of Medial Examiners or the "Other Health Professionals" that may appear, must be licensed by the State of Texas. The Council agrees with the recommended language and has amended the proposed text.

§1301.11(31) Provider Quality Data

All six commenters opposed the proposed definition of "Provider Quality Data". All six commenters recommended removing the phrase "public information" from the definition. Five of the commenters recommended adding the phrase "after severity adjustment" between "prognoses," and "prepared by the Council" and recommended the withdrawal of the phrase "and, upon approval of the scientific review panel, the research file". The Council disagrees with the commenters recommended language. The Council has withdrawn the definition from the text to be adopted and will consider proposing a new definition of "Provider Quality Data" in the future.

§1301.11(32) Public Information Report

All Six commenters recommended language be added to the end of the definition that stated that a "Public Information Report" does not identify individual providers and presents data in an aggregate form that protects provider, physician and patient confidentiality. The Council has chosen to withdraw this definition, because it is not used in Subchapter A: Relating to the Hospital Discharge Data Rules.

§1301.20(f)(6)

Five commenters supported the proposed amendments to the paragraph.

The amendments are adopted under the Health and Safety Code, §108.006 and §108.009. The Council interprets §108.006 as authorizing it to adopt rules necessary to carry out Chapter 108, including rules concerning data dissemination requirements. The Council interprets §108.009 as authorizing the Council to adopt rules regarding the collection of data from hospitals in uniform submission formats in order for the incoming data to be substantially valid, consistent, compatible and manageable.

The Health and Safety Code, §§108.002, 108.006, 108.009, 108.010, 108.011, 108.012 and 108.013 are affected by these amendments.

§1301.11.Definitions.

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

(1) Accurate and Consistent data--Data that has been edited by the Council and subjected to provider validation and certification.

(2) Attending Physician--The individual licensed under the Medical Practice Act (Occupations Code, Chapter 151) who would normally be expected to certify and recertify the medical necessity of the services rendered or the licensed health professional primarily responsible for the care of the patient during the hospital episode. For Skilled Nursing Facility (SNF) services, the attending physician is the individual who certifies the SNF plan of care.

(3) Batch file--A set of computer records as specified in §1301.19 of this title (relating to Discharge Reports--Records, Data Fields and Codes) which contains one or more discharge files and other required header and trailer records. A batch contains discharge files for only one hospital.

(4) Certification Process--The process by which a provider confirms the accuracy and completeness of the encounter data set required to produce the public use data file as specified in §1301.17 of this title (relating to Certification of Discharge Reports).

(5) Charge--The amount billed by a provider for specific procedures or services provided to a patient before any adjustment for contractual allowances, government mandated fee schedules or write-offs for charity care, bad debt or administrative courtesy. The term does not include co-payments charged to health maintenance organization enrollees by providers paid by capitation or salary in a health maintenance organization.

(6) Comments--The notes or explanations submitted by the hospitals, physicians or other health professionals concerning the provider quality reports or the encounter data for public use as described in the Texas Health and Safety Code, §108.010(c) and (e) and §108.011(g) respectively.

(7) Council--The Texas Health Care Information Council.

(8) Data format--The sequence or location of data elements on a paper form or electronic record according to prescribed specifications.

(9) Discharge--The formal release of a patient by a hospital; that is, the termination of a period of hospitalization by death or by disposition to a residence or another health care provider.

(10) Discharge file --A set of computer records as specified in §1301.19 of this title relating to a specific patient.

(11) Discharge report--A computer file as defined in §1301.19 of this title periodically submitted on or on behalf of a Hospital in compliance with the provisions of this chapter.

(12) DRG--Diagnosis Related Group

(13) EDI--Electronic Data Interchange--A method of sending data electronically from one computer to another. EDI helps providers and payers maintain a flow of vital information by enabling the transmission of claims and managed care transactions.

(14) Edit--An electronic standardized process developed and implemented by the Council to identify potential errors and mistakes in data elements by reviewing data fields for the presence or absence of data and the accuracy and appropriateness of data.

(15) Electronic filing--The submission of computer records in machine readable form by modem transfer from one computer to another (EDI) or by recording the records on a nine track magnetic tape, computer diskette or other magnetic media acceptable to the executive director.

(16) Error--Data submitted on a discharge report which are not consistent with the format and data standards contained in this section or with editing criteria established by the executive director, or the failure to submit required data.

(17) Ethnicity--The status of patients relative to Hispanic background. Hospitals shall report this data element according to the following ethnic types: Hispanic or Non-Hispanic.

(18) Executive director--The chief administrative officer of the Council, or, in the event the Council is without an executive director, the person designated by the chairperson of the Council to perform the functions and exercise the authority of the executive director.

(19) Facility Type Indicators--An indicator that provides information to the data user as to the type of facility or the primary health services delivered at that facility (e.g. Teaching, Acute Care, Rehabilitation, Psychiatric, Pediatric, Cancer, Skilled Nursing or other Long Term Care Facility). A facility may have more than one indicator. Hospitals may request updates to this field.

(20) Geographic identifiers--A set of codes indicating the public health region and county in which the patient resides.

(21) Health care facility--A hospital, an ambulatory surgery center licensed under Chapter 243 of the Health and Safety Code, a chemical dependency treatment facility licensed under Chapter 464 of the Health and Safety Code, a renal dialysis center, a birthing center, a rural health clinic or a federally qualified health center as defined by 42 United States Code, §1396(1)(2)(B).

(22) Hospital--A public, for-profit, or nonprofit institution licensed or owned by this state that is a general or special hospital, private mental hospital, chronic disease hospital or other type of hospital.

(23) ICD--International Classification of Disease.

(24) Inpatient--A patient, including a newborn infant, who is formally admitted to the inpatient service of a hospital and who is subsequently discharged, regardless of status or disposition. Inpatients include patients admitted to medical/surgical, intensive care, nursery, subacute, skilled nursing, long-term, psychiatric, substance abuse, physical rehabilitation and all other types of hospital units.

(25) Operating or Other Physician--The "physician" licensed by the Texas State Board of Medical Examiners, or "other health professional" licensed by the State of Texas who performed the principal procedure or performed the surgical procedure most closely related to the principal diagnosis.

(26) Other exempted provider--A hospital exempt from state franchise, sales, ad valorem, or other state and local taxes that does not seek or receive reimbursement for providing health care services to patients from any source, including the patient or any person legally obligated to support the patient; a third party payer; or Medicaid, Medicare, or any other federal, state or local program for indigent health care.

(27) Other health professional--A person licensed to provide health care services other than a physician. An individual other than a physician who admits patients to hospitals or who provides diagnostic or therapeutic procedures to inpatients. The term encompasses persons licensed under various Texas practice statutes, such as psychologists, chiropractors, dentists, nurse practitioners, nurse midwives, and podiatrists who are authorized by the hospital to admit or treat patients.

(28) Patient control number--A number assigned to each patient by the hospital, which appears on each computer record in a patient discharge file. This number is not consistent for a given patient from one hospital to the next, or from one admission to the next in the same hospital. The Council deletes or encrypts this number to protect patient confidentiality prior to release of data.

(29) Physician--An individual licensed under the laws of this state to practice medicine under the Medical Practice Act, Occupations Code, Chapter 151.

(30) Provider--A physician or health care facility.

(31) Provider quality data--A report or reports authored by the Council on provider quality or outcomes of care, as defined in Chapter 108 of Health and Safety Code, created from data collected by the Council or obtained from other sources.

(32) Public use data file--A data file composed of discharge files with risk and severity adjustment scores which have been altered by the deletion, encryption or other modification of data fields to protect patient and physician confidentiality and to satisfy other restrictions on the release of hospital discharge data imposed by statute.

(33) Race--A division of patients according to traits that are transmissible by descent and sufficient to characterize them as distinctly human types. Hospitals shall report this data element according to the following racial types: American Indian, Eskimo, or Aleut; Asian or Pacific Islander; Black; White; or Other.

(34) Required minimum data set--The list of data elements which hospitals are required to submit in a discharge file for each inpatient stay in the hospital. The required minimum data set is specified in §1301.19(d) of this title.

(35) Research data file--A customized data file, which includes the data elements in the public use file and may include data elements other than the required minimum data set submitted to the Council, except those data elements that could reasonably identify a patient or physician. The data elements maybe released to a requestor when the requirements specified in §1301.18(f) of this title (relating to Hospital Discharge Data Release) are completed.

(36) Risk adjustment--A statistical method to account for a patient's severity of illness at the time of admission and the likelihood of development of a disease or outcome, prior to any medical intervention.

(37) Rural provider-A health care facility located in a county with a population of not more than 35,000 as of July 1 of the most recent year according to the most recent United States Bureau of the Census estimate; or located in a county with a population of more than 35,000 but with 100 or fewer licensed hospital beds and not located in an area that is delineated as an urbanized area by the United States Bureau of the Census; and is not state owned, or not managed or directly or indirectly owned by an individual, association, partnership, corporation, or other legal entity that owns or manages one or more other hospitals. A health care facility is not a rural provider if an individual or legal entity that manages or owns one or more other hospitals owns or controls more than 50% of the voting rights with respect to the governance of the facility.

(38) Scientific Review Panel--The Council's appointees or agent who have experience and expertise in ethics, patient confidentiality, and health care data who review and approve or disapprove requests for data or information other than the public use data. Described in §1301.20 of this title (relating to Scientific Review Panel).

(39) Service Unit Indicator--An indicator derived from submitted data (based on Bill type or Revenue Codes) and represents the type of service unit or units (e.g., Coronary Care Unit, Detoxification Unit, Intensive Care Unit, Hospice Unit, Nursery, Obstetric Unit, Oncology Unit, Pediatric Unit, Psychiatric Unit, Rehabilitation Unit, Sub acute Care Unit or Skilled Nursing Unit) where the patient received treatment.

(40) Severity adjustment--A method to stratify patient groups by degrees of illness and mortality.

(41) Submission--A set of computer records as specified in §1301.19 of this title that constitutes the discharge report for one or more hospitals.

(42) Submitter--The person or organization, which physically prepares discharge reports for one or more hospitals and submits them to the Council. A submitter may be a hospital or an agent designated by a hospital or its owner.

(43) THCIC Identification Number--A string of six characters assigned by the Council to identify health care facilities for reporting and tracking purposes.

(44) Uniform facility identifier--A unique number assigned by the Council to each health care facility licensed in the state. For hospitals, this will include the hospital's state license number. For hospitals operating multiple facilities under one license number and duplicating services, the Council will assign a distinguishable uniform facility identifier for each separate facility. The relationship between facility identifier and the name and license number of the facility is public information.

(45) Uniform patient identifier--A unique identifier assigned by the Council to an individual patient and composed of numeric, alpha, or alphanumeric characters, which remains constant across hospitals and inpatient admissions. The relationship of the identifier to the patient-specific data elements used to assign it is confidential.

(46) Uniform physician identifier--A unique identifier assigned by the Council to a physician or other health professional who is reported as attending or treating a hospital inpatient and which remains constant across hospitals. The relationship of the identifier to the physician-specific data elements used to assign it is confidential. The uniform physician identifier shall consist of alphanumeric characters.

(47) Validation--The process by which a provider verifies the accuracy and completeness of data and corrects any errors identified before certification.

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 April 1, 2002.

TRD-200202059

Jim Loyd

Executive Director

Texas Health Care Information Council

Effective date: April 21, 2002

Proposal publication date: December 28, 2001

For further information, please call: (512) 482-3320

Subchapter C. RULES RELATING TO REPORTS CREATED BY THE COUNCIL

25 TAC §§1301.41 - 1301.44

The Texas Health Care Information Council adopts new §§1301.41 - 1301.44, relating to provider level reports created by the Council with changes to the proposed text as published in the December 28, 2001, issue of the Texas Register (26 TexReg 10777). Sections 1301.45 - 1301.47 are being withdrawn elsewhere in this issue of the Texas Register .

The new sections are adopted, in part, to establish guidelines and timelines regarding the creation of provider level reports generated by the Council. The new rules include the reasonable review and comment period for providers as required by §108.011(f). Changes in the adopted amendments respond to public comments or otherwise reflect non-substantive variations from the proposed amendments. The Council's representative from the Office of the Attorney General has advised that the changes affect no new persons, entities, or subjects other than those given notice and that compliance with the adopted sections will be less burdensome than under the proposed sections.

The new sections are adopted under the Health and Safety Code, §§108.006, 108.010 and §108.011. The Council interprets §108.006 as authorizing it to adopt rules necessary to carry out Chapter 108, including rules concerning data dissemination requirements. The Council interprets §108.011 as requiring the Council to produce reports for the Governor, Legislature and the public. The Council interprets §108.010 and §108.011 as requiring the Council to identify the individual providers in the reports created by the Council using either "provider quality data" or "public use data".

The order entered by the Council today accomplishes the following: (1) An amendment of the subchapter's title to "Rules Relating to Reports Created by the Council"; (2) withdrawal of the definition of "Qualitative Comparative Measures"; (3) withdrawal of the title of §1301.42 and §1301.42(a) and (b); renumbering of §1301.43 and changing its title to "Procedures for Council Generated Public Information Provider Reports"; an amendment of §1301.43(a) by adding the word "provider" between "produce a" and "report"; renumbering §1301.44, changing the title to "Technical Documentation Regarding Public Information Provider Reports", and replacing the phrase "public information" with the word "provider" in §1301.44(c); renumbering and changing the title of §1301.45 to "Timeline Requirements for Release of Technical Documentation and Public Information Provider Reports"; amendment of §1301.45(a) by replacing the phrase "public information" with the word "provider"; withdrawal of §1301.45(b) and the title of §1301.46; merger of §1301.46(a) with the prior section and replacement of the phrase "public information" with the word "provider", renumbering §1301.46(b)(4) and withdrawal of the phrase "level public information"; and withdrawal of §1301.46(c) and §1301.47.

In the fiscal impact statement for the state, the Council proposed language that may require the Council to make an exceptional item request to the Legislative Budget Board for additional funding for producing the reports. The Council will only use available funds to produce any reports by the Council and no exceptional item requests will be made.

Comments by Section

Subchapter Title

One commenter recommended that the phrase "public information" be removed from the subchapter title. The Council agrees with the commenter and has amended the subchapter title.

Preamble

Four commenters questioned the construction of the last sentence of the fiscal impact statement for the persons or hospitals required to comply with the proposed rules. The phrase "additional review time" was inadvertently left off the last sentence. The proposed rules provide seven days for review of technical documentation regarding the report prior to release of the de-identified provider level report for the 60-day review and comment period. The Council believes this is adequate time to review the technical documentation and the report.

§1301.41(1) Committee

Six commenters recommended that the Council include the phrase "group of Council members" in the definition of "Committee". The Council disagrees with the commenters for the following reasons: 1) Chapter 108 of the Health and Safety Code does not require that a Council appointed committee be comprised of Council members; 2) The Council may appoint or elect a group of individuals or an established Technical Advisory Committee to investigate a topic for a report and advise the Council or one of the Council Committees of its findings or recommendations; 3) In the proposed text, an adjective resides in front of the word "committee" when it refers to a specific group of individual on the committee (e.g. - Executive Committee, Initiating Committee, Technical Advisory Committee (TAC)) and these are defined in the proposed text.

§1301.41 (Provider Quality Data)

Five commenters recommended a modified definition of "provider quality data" that was proposed in 25 TAC §1301.11, which appeared in the December 28, 2001, issue of the Texas Register (26 TexReg 10774), be added to these rules. The Council disagrees with adding this definition for the following reasons: 1) The term is not used in the proposed text; and 2) The Council will be looking to modify the definition of "provider quality data" in the near future.

§1301.41(12) PIR--Public Information Report

Five commenters recommended that the definition of "Public Information Report" include aggregate data and not identify providers. The Council disagrees with the commenters for the following reason: The Council is required to identify providers in reports: 1) when the report uses public use data (§108.011(c), Health and Safety Code) and 2) when the Council produces reports using provider quality data and determines that the report provides the intended results, then the Council must report the findings applicable to a provider as prescribed in §108.010(c) of the Health and Safety Code.

§1301.41(13) Qualitative Comparative Measures

Four commenters recommended that the word "qualitative" be replaced by "quality". The Council disagrees with the commenters recommended change for the following reason: The language may create more confusion and inappropriate associations with §108.010 of the Health and Safety Code regarding "Provider Quality Data", therefore the Council has withdrawn this definition and withdrawn the term from the adopted version of the text.

§1301.41(14) Request for Information

Four commenters recommend adding the following phrase "but any Council response to a request for information is available to the public" to the last sentence of the proposed definition of "Request for Information". The Council disagrees with the commenters. The Council believes that making the information available to the public is a matter of interpretation of the "Open Records Act", Chapter 552, Government Code and Chapter 108, Health and Safety Code. The Council lacks authority to determine by rule whether or not information is available to the public.

§1301.42 Procedures for Collaborative Public Information Reports.

The Council received several comments from the commenters on proposed §1301.42 and the Council has chosen to withdraw this section from consideration of adoption.

§1301.43 Procedures for Council Generated Public Information Reports

Four commenters recommended that the title be changed to Procedures for Provider Quality Reports. The Council agrees partially with the commenters' recommended change for the following reasons: 1) The Council believes that the reports created by the Council may come from public use data or may come from provider quality data. 2) The Council believes that eliminating the word "quality" from the commenters' suggested language would be the most effective and understandable for the Council, stakeholders, providers of the data and the public. Retaining this section regarding procedures for provider reports establishes guidelines and deadlines for the Council and providers when the Council produces a report that allows for comparisons of hospitals.

§1301.43(a)

Four commenters recommended that the phrase "provider quality" be inserted between "produce a" and "report". The Council agrees partially and believes that inserting the word "provider" would be the most beneficial to the Council, stakeholders, providers and the public for the same reasons as stated in the response to comments on §1301.43.

§1301.43(b)

Four commenters proposed additional new language to the end of the proposed text that would require Council staff or Council Board members to select the methodology that accurately identifies and measures quality standards and adheres to any federal mandates. The Council disagrees with the commenters for the following reasons: 1) The Council believes that the written charge by the initiating committee chair may request a committee or TAC to locate one or more methodologies to consider, or review two or more methodologies and recommend the best one for the Council's purposes. 2) The commenters copied statutory language, which the Council believes is not necessary to repeat in rule form. 3) The Council believes the commenters' recommended language inappropriately links requirements in §108.010(a), Health and Safety Code that are placed on "provider quality data" onto the "reports" that would be created using provider quality data.

§1301.43(d)

Four commenters recommended language that would require a staff member in conjunction with TAC members to develop a report or reconcile the charge from the initiating committee chair and would require the Council to use hypothetical data and any other means to protect provider and patient confidentiality when the report is reviewed by persons other than Council staff prior to public release of the report. The Council believes that the first sentence needs further clarification and will propose that in future amendments to the rules. The Council disagrees with commenters with regards to putting their recommended language in rule form for the following reasons: 1) The Council believes that the commenters' recommended language may be considered substantive by other stakeholders and would need to be proposed at a later time. 2) Chapter 108, Health and Safety Code does not require that these procedures be put in rule form. 3) The Council believes that a portion (or portions) of the commenters recommended text that refers to the review of a report by persons other than Council staff requires further discussion and may be proposed for a policy and procedure for the Council.

§1301.43 (New subsection following §1301.43(h))

Five commenters recommended language that any provider quality report undergo the review process stated in §1301.45. The recommended language repeats portions of §108.010(c) and (d), Health and Safety Code, which requires the Council to verify the accuracy for the data during this review process and provides the option not to release the report if the intended result is obtained or the provider quality data is inaccurate or inappropriate for dissemination. The Council disagrees with inserting the commenters' recommended language in rule form for the following reasons: 1) The commenters' recommended language restates language that is either stated in Chapter 108, Health and Safety Code or was proposed in the original text. 2) The Council believes the addition of this language would be a substantive change to the proposed rules and would need to be proposed for review and comment.

§1301.44 Technical Documentation regarding Public Information Reports

Four commenters recommended that the title be changed to "Technical Documentation regarding Provider Quality Reports". The Council agrees partially with the commenters' recommended language modification for the same reasons stated in the response to comments for §1301.43 Procedures for Council Generated Public Information Reports.

§1301.44(c)

Four commenters recommended that the phrase "provider quality" replace "public information" in the proposed text. The Council agrees partially and believes that inserting the word "provider" would be the most beneficial to the Council, stakeholders, providers and the public for the same reasons as stated in the response to comments on §1301.43.

§1301.45 Timeline Requirements for Release of Technical documentation and Public Information Reports

Four commenters recommended that the phrase "provider quality" replace "public information" in the proposed text. The Council agrees partially and believes that inserting the word "provider" would be the most beneficial to the Council, stakeholders, providers and public for the same reasons as stated in the response to comments on §1301.43.

§1301.45(a)

Five commenters recommended that the phrase "provider quality" replace "public information" in the proposed text, and the commenters recommended increasing the number of days to 14 days for the release of the technical documentation prior to the release of the masked report. The Council agrees partially and believes that inserting the word "provider" would be the most beneficial to the Council, stakeholders, providers and public for the same reasons as stated in the response to comments on §1301.43. The Council disagrees with commenters' recommendation to increase the review time period to 14 days. The Council believes that a 7 calendar day advance notice and the 60 calendar days to review and comment on the report is a reasonable time allotment.

§1301.45(b)

Three commenters recommended deleting this subsection requiring the Council to release the report within 21 days following the deadline date specified by the Council for the return of comments by the providers. The Council agrees with commenters and has withdrawn this section from the version to be adopted. Withdrawing this section allows the Council more time for releasing the report if the comments raise issues that need to be addressed prior to release of the report to the public.

§1301.46 Provider Level Public Information Reports

Four commenters recommended that §1301.45 and §1301.46 be merged together. The Council agrees with the commenters. In response to other comments on the proposed text, the adopted version of these rules will address specifically provider level reports. The Council believes this would provide the Council, stakeholders, providers and the citizens of Texas the most benefit.

§1301.46(a)

Three commenters recommended renumbering due to the merger of §1301.45 and §1301.46 and replacing the phrase "public information" with the phrase "provider quality" in the proposed text. The commenters also recommended inserting language about protecting the identity and confidentiality of other provider data prior to public release to the end of the sentence. The Council agrees partially and believes that inserting the word "provider" would be the most beneficial to the Council, stakeholders, providers and the public for the same reasons as stated in the response to comments on §1301.43. The Council disagrees with inserting the language at the end of the sentence for the following reasons: 1) The Council believes the language is redundant to the proposed text. 2) Chapter 108, Health and Safety Code does not require this subject to be in rule form. 3) The purpose of masking the providers on the report returned to the providers is a protection mechanism for the Council and the providers. Once the report is released publicly the provider's identity will be revealed as required by Chapter 108, Health and Safety Code.

No specific section addressed

Four commenters recommended that the Council add language to the rules that require the Council to use hypothetical data in the development and revision process to protect confidentiality prior to public release. Secondly, the commenters also recommended that a higher minimum number of cases (30) where statistical tests of significance are applied. The recommended changes would be considered substantive and would need to be proposed for review and comment. The Council will consider the recommendations for future amendments to the rules.

§1301.46(b)(2) and (3)

Three commenters recommended language that would require the Council to accept comments on hospital letterhead, electronically or hardcopy, and then convert those to a portable document format (.pdf). The same commenters recommended language that requires the Council to contact providers and ask them to resubmit their comments if identifying information is discovered. The commenters also recommended that the Council include language that would prohibit the Council from inserting statements into the provider's comments. The commenters recommended the deletion of §1301.46(b)(3). The Council interprets this to be in conjunction with the recommendations on §1301.46(b)(2). The Council disagrees with the commenters recommended language modifications for the following reasons: 1) The process for handling comments submitted on letterhead and converting those to (.pdf) files would require manual intervention, therefore would be labor intensive in dealing with potential comments up to 450 hospitals. 2) The Council already asks providers to resubmit comments if identifying information is found in their comments. The Council believes adding this to the rule is unnecessary and not required by Chapter 108, Health and Safety Code. 3) The Council only inserts statements ("No comments received") into the comments when hospitals indicated they were certifying their data with comments and no comments were received by the Council prior to creation of the public use data file for public release. These statements are factually correct.

§1301.46(b) (New paragraph be added following §1301.46(b)(3))

Three commenters recommended that the Council include language regarding a minimum cell size to protect patient and physician confidentiality similar to the process used by the Council in the release of public use data. The commenters would like to see provider quality data suppressed when the denominator is less than 5 cases per quarter or 20 cases per year. The Council will consider the recommendations for future amendments to the rules. The recommended changes would be considered substantive and would need to be proposed for review and comment.

§1301.46(c)

Four commenters recommended the replacement of the word "qualitative" with "quantitative" and in another section of their comments three of those commenters proposed a complete rewrite of the subsection, which would require that the Council apply each adjustment process specified in §108.010(f) for provider quality reports generated by the Council. The Council disagrees with the commenters' recommended changes to the text for the following reasons: 1) The Council interprets §108.010(f) as a list of adjusting factors that may be applied to "provider quality data" not "reports" based on provider quality data. 2) The Council has reconsidered this subsection and is electing to withdraw it from the adopted version, because it is not required by Chapter 108, Health and Safety Code to be in rule form. 3) Counsel has advised that a complete rewrite of the section is a substantive change requiring publication as a proposed rule in the Texas Register with an opportunity for public comment.

§1301.46(c)(4)

Three commenters recommended that the phrase "and any" be included with the proposed text. The Council disagrees with the commenters for the reasons stated in the response to comments to subsection §1301.46(c).

§1301.47

Three commenters recommended the deletion of §1301.47. The Council has withdrawn this section from the version to be adopted.

The new sections are adopted under the Health and Safety Code, §§108.006, 108.010 and 108.011. The Council interprets §108.006 as authorizing it to adopt rules necessary to carry out Chapter 108, including rules concerning data dissemination requirements. The Council interprets §§108.006, 108.010 and 108.011 as authorizing the Council to produce reports from data collected by the Council from hospitals.

The Health and Safety Code, §§108.002, 108.003 108.006, 108.009, 108.010 and 108.011, are affected by the new sections.

§1301.41.Definitions.

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

(1) Committee--means a body of persons delegated to consider, investigate, take action on, or report on some matter.

(2) Council--means the Texas Health Care Information Council.

(3) Council Board--means the Council's Board members

(4) Chairman--The person appointed by the Governor to chair the Council as specified in §108.003(d) of the Health and Safety Code.

(5) Chairperson--The presiding officer of a meeting or committee.

(6) Executive Committee--means the Council Board Members who serve as officers of the Council Board or Chair one of the Council committees.

(7) Executive Director--means the chief executive officer of the Council

(8) Health care facility--means:

(A) a hospital;

(B) an ambulatory surgical center licensed under Chapter 243;

(D) a renal dialysis facility;

(E) a birthing center;

(F) a rural health clinic; or

(G) a federally qualified health center as defined by 42 U.S.C. §396d(l)(2)(B).

(9) Initiating Committee--means the committee of the Council authoring the charge.

(10) Provider--means a physician or health care facility.

(11) Provider Level--means data or information that identifies specific providers by name or uniform identifier.

(12) PIR--Public Information Report--A report created for providing information related to health care quality or effectiveness or access to health care that will be shared with the public.

(13) Request for information--means a request made by individual or organization for summarized or analyzed responses from publicly available data. The Council does not consider a request for information and responses as a public information report.

(14) TAC--Technical Advisory Committee--as specified in §108.003(g) of the Health and Safety Code.

§1301.42.Procedures for Provider Reports.

(a) One or more committees of the Council shall issue a charge to the Council's staff or to one or more of the technical advisory committees specified in Chapter 108 of the Health and Safety code to produce a provider report.

(b) Council staff shall provide a written description of the charge to the initiating committee chair assigning the charge. Clarification of the charge shall be made at this time, if required.

(d) The person or TAC shall research, investigate, deliberate or reconcile the charge and generate the outcome or draft of the product requested in the charge.

(e) Upon completion of subsection (d) of this section the Council staff or TAC chair shall submit this to any additional TAC for recommendations as required by the charge or Chapter 108, Health and Safety Code.

(f) If additional TAC or Council staff input is required the TAC or Council staff person shall follow the steps in subsections (d) and (e) of this section.

(g) The TAC chair or Council staff shall submit a report or arrange for a presentation to the committee or Council Board, after the TACs and Council staff have made their recommendations or produced the report.

(h) The initiating committee may review, discuss, deliberate or take action on the report or presentation. If the initiating committee approves the report or presentation a recommendation to the Council Board for approval shall be made. If further modifications are required for the report or presentation, the initiating committee shall issue a new charge and subsections (a) - (h) of this section shall be followed until a recommendation for approval or is disapproved.

§1301.43.Technical Documentation regarding Provider Reports.

(a) In conjunction with §1301.42(d) and (e) a draft document containing detailed instructions on the methodology to be used in the reports shall be presented at one of the Quality Methods TAC meetings.

(b) Prior to a final report or presentation being submitted to the initiating committee in §1301.42(h) the document with the methodology shall be finalized and published on the Council's website and presented at one of the TAC meetings.

(c) The provider report shall provide contact and website information to obtain the technical documentation regarding the provider report.

§1301.44.Timeline Requirements for Release of Technical Documentation and Provider Reports.

(a) The Council will make available the Technical Documentation regarding the Provider Report no less than 7 days prior to the masked Provider Report being made available to providers for review and comment.

(b) The Council shall provide access to a paper copy or an electronic copy of the provider report to each hospital named in the report. In providing a copy of the report to each named provider, the Council shall mask the identities of the other providers in the report.

(1) Any comments shall be submitted to and received by the Council, on or prior to the date specified by the Council, which shall not be less than 60 calendar days after notification is sent from the Council.

(2) Comments shall be submitted on a form created by the Council.

(3) Comments shall be returned to the Council in an electronic format specified by the Council.

(4) Comments received by the Council shall be posted on the Council's Internet website with each release of the provider reports.

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 April 1, 2002.

TRD-200202060

Jim Loyd

Executive Director

Texas Health Care Information Council

Effective date: April 21, 2002

Proposal publication date: December 28, 2001

For further information, please call: (512) 482-3320