Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 117. END STAGE RENAL DISEASE FACILITIES

The Texas Department of Health (department) adopts amendments to §§117.1-117.3, 117.11-117.17, 117.31-117.34, 117.41-117.46, 117.61-117.65, 117.81-117.86 and new §117.18, concerning the regulation of end stage renal disease facilities. Sections 117.2, 117.31 - 117.34, 117.43, 117.46 and 117.62 are adopted with changes to the proposed text as published in the March 14, 2003, issue of the Texas Register (28 TexReg 2219). Sections 117.1, 117.3, 117.11-117.18, 117.41-117.42, 117.44-117.45, 117.61, 117.63-117.65, and 117.81-117.86 are adopted without changes and will not be republished.

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). Sections 117.1-117.3, 117.11-117.17, 117.31-117.34, 117.41-117.46, 117.61-117.65, 117.81-117.86 have been reviewed and the department has determined that reasons for adopting the sections continue to exist; however, revisions to the sections were necessary as outlined in this preamble.

Specifically, the amendment to §117.1 is editorial. Amendments to §117.2 add definitions for action level, advanced practice nurse, biofilm, charge nurse, dialysate, dialysate supply system, empty bed contact time, governing body, LAL test, technical supervisor, ultrafilter, water distribution systems and water treatment system; delete the definition of chief technician as the term is no longer used in the rules; amend the definitions of change of ownership, interdisciplinary team, medical review board, patient care plan, and presurvey conference to delete obsolete references and for clarification purposes; and renumber definitions as necessary to accommodate the added and deleted definitions. The amendments to §117.3 are editorial and add a fee for a relocation.

The amendment to §117.11 is editorial. The amendments to §117.12 delete ambiguous language and add an additional requirement for licensure. The amendment to §117.13 is editorial. The amendments to §117.14 are editorial and update references. The amendments to §§117.15 -117.16 and 117.17 are editorial. Section 117.18 is new language regarding exceptions to the rules.

The amendments to §117.31 clarify the intent of the section, add new language regarding water systems, and update references. The amendments to §117.32 clarify existing language, update references and add automated external defibrillator to the list of emergency equipment. The amendments to §117.33 add new language relating to water treatment and update references. The amendments to §117.34 delete ambiguous language, update references, and add new language to clarify existing language.

The amendment to §117.41 adds language regarding incidents. The amendments to §117.42 add additional indicators for quality of care and is editorial. The amendments to §117.43 add language regarding disruptive patients or family members, patient care plans, emergency preparedness, medication storage and administration, amend the maximum patient load per full-time equivalent for dietitians, add new language relating to home dialysis, delete ambiguous language, and is editorial. The amendments to §117.44 add language relating to sharing of staff between facilities, add requirements of training curriculum for technical staff, add new language to clarify existing language and is editorial. The amendments to §117.45 add language regarding clinical records and delete ambiguous language. The amendment to §117.46 is editorial and modifies language to include only incidents relating to a death or hepatitis.

The amendment to §117.61 is editorial. The amendments to §117.62 update references and add additional training requirements. The amendment to §117.63 adds additional requirements to a checklist for dialysis technician trainees. The amendment to §117.64 clarifies existing language. The amendments to §117.65 are editorial and add additional acts prohibited for dialysis technicians.

The amendments to §§117.81, 117.82, 117.83, 117.84, 117.85, and 117.86 are all editorial.

The department published a Notice of Intention to Review for §§117.1-117.3, 117.11-117.17, 117.31-117.34, 117.41-117.46, 117.61-117.65, 117.81-117.86 in the Texas Register (25 TexReg 4195) on May 5, 2000. There were no comments received by the department on the sections following publication of the notice.

Due to staff comments, minor editorial changes were made for clarity and to improve the accuracy of the sections.

Change: Concerning §117.32(e), the citation "§§3-4.1" was deleted and the citation "§§3-3.2.1.2(a)(2) was added.

Change: Concerning §117.33(c)(6), the word "know" was deleted and the word "known" was added to correct the spelling.

Comments received during the 30 day comment period included representatives of American Nephrology Nurses' Association, Council of Nephrology Social Workers, Dallas Dietetic Association, DaVita Cy-Fair Dialysis Clinic, Fort Worth Dialysis Associates Inc., Fresenius Medical Care of North America, Gambro Healthcare Southwest, National Kidney Foundation of South & Central Texas, Council on Renal Nutrition in San Antonio and Region 4, National Kidney Foundation, Council on Renal Nutrition, National Nephrology Associates of Texas LP, North Texas Council of Nephrology Social Workers, Renal Care Group, Scott & White Dialysis Clinic, Southeast Texas Council of Nephrology Social Workers, and Unity Medical Equipment & Services Inc. In addition, numerous individual social workers and dieticians commented. All commenters were not against the rules in their entirety, however they expressed concerns, asked questions, and suggested recommendations for change as discussed in the summary of comments. Following the comment is the department's response and any resulting changes.

Comment: Concerning the definition of "advanced practice nurse" in §117.2, the commenter suggested the rules be consistent with Chapter 301, Texas Government Code, Annotated, (Nursing Practice Act), §221.1, and changed to read: "A registered nurse approved by the board to practice as an advanced practice nurse based on completing an advanced educational program acceptable to the board. The term includes a nurse practitioner, nurse-midwife, nurse anesthetist, and a clinical nurse specialist. The advanced practice nurse is prepared to practice in an expanded role to provide health care to individuals, families, and/or groups in a variety of settings including but not limited to homes, hospitals, institutions, offices, industry, schools, community agencies, public and private clinics, and private practice. The advanced practice nurse acts independently and/or in collaboration with other health care professionals in the delivery of health care services."

Response: The department agrees with the commenter and has changed the definition of "advanced practice nurse" to be consistent with Chapter 301, Texas Government Code, Annotated, §221.1, by referencing the Board of Nurse Examiners Statute. (see final-1)

Comment: Concerning §117.2 Definitions, the commenter suggested that a definition be included for "charge nurse" since the term is used in §117.43(e). The commenter suggested the following: "A registered professional nurse practicing nursing in accordance with applicable provisions of law who is responsible for making daily staff assignments based on patient needs, providing immediate supervision of patient care, monitoring patients for changes in condition, and/or communicating with the physician, dietician, and social worker regarding patient needs."

Response: The department agrees with the commenter, and has added a definition for "charge nurse" to §117.2.

Comment: Concerning the definition of "delegation" in §117.2, the commenter suggested the wording of the sentence is awkward, and suggested new wording to read: "The transfer of the authority to perform a selected task or activity in a selected situation to a qualified and properly trained individual."

Response: The department does not agree with the commenter. No change was made as a result of this comment.

Comment: Concerning the definition of "interdisciplinary team" in §117.2, the commenter suggested that end stage renal disease patients were not a professional discipline, and should not be included in the definition of the interdisciplinary team. The commenter stated the language in §117.2(42) in this section and the language at §117.43 referred to the interdisciplinary team working with the patient, which was correct, but was inconsistent with the definition as currently written. The commenter suggested removal of the words "the patient and" from this language.

Response: The department agrees with the commenter's recommendation and has removed the words "the patient and" from the definition in renumbered §117.2(30).

Comment: Concerning the definition of "patient care plan" in §117.2, the commenter suggested adding "family member or guardian" after the word "patient" because it is often a family member or guardian who accompanies or represents the patient in care planning meetings or other dialysis related meetings or events.

Response: The department agrees with the commenter and has changed the definition to include "family member or guardian" in renumbered §117.2(43).

Comment: Concerning the definition of "technical supervisor in §117.2, the commenter disagreed the technical supervisor needed to be facility based. The commenter felt small, rural facilities do not warrant a full-time individual on-site with the experience required of a technical supervisor.

Response: The department agrees with the commenter, and has deleted "facility based" from the definition of technical supervisor in renumbered §117.2(60).

Comment: Concerning §117.18, two commenters stated this language seemed administratively burdensome for a facility in an "emergency situation" and response time of 90 days by the Department was not consistent with or acceptable for dealing with an emergency of any kind, and suggested clarifying language.

Response: The department does not agree with the commenter concerning the 90 day response time, as this section deals with pilot programs or research, not emergency situations. The proposed language was a consensus of the renal community in development of the revised rules. No change was made as a result of this comment.

Comment: One commenter felt the regulations should be revised to exclude existing facilities from the requirement that isolation rooms be outside traffic patterns.

Response: §117.31(a)(1) states the standards in this section shall apply to all facilities that provide outpatient dialysis services. Dialysis facilities in operation on or before September 1, 2003, shall meet the design and space requirements of this section which were in effect at the time the facility was constructed. No change was made as a result of this comment.

Comment: Concerning §117.31, the commenter stated that the language at §117.31(a)(5) contradicted the language at §117.33(b)(8)(C)(iii). The commenter concurred with the language and intent of §117.33(b)(8)(C)(iii), and recommended the language in §117.31(a)(5) be consistent with it.

Response: The department agrees with the commenter. Language at §117.31(a)(5) was changed to read: "Water treatment systems shall include a minimum of two carbon tanks in a series, with the total empty bed contact time (EBCT) of at least ten minutes, and the final tank providing at least five minutes EBCT."

Comment: Concerning §117.32(a), the commenter stated this language is too restrictive, especially as it relates to the RO unit/system. The commenter proposed the language of the regulation be expanded to allow for necessary and adjustable adjustments, and suggested the following, "All equipment used by the facility, including back up equipment, shall be operated within manufacturer specifications, unless the age of the equipment, its components or seasonal/ or day-to-day changes in source water conditions warrant documented adjustments to those specifications, and that such equipment shall be maintained free of any defects which could be a potential hazard to patient, staff or visitors."

Response: The department does not agree with the commenter's suggestion that §117.32(a) is too restrictive. No change was made as a result of this comment.

Comment: Concerning §117.32(g)(1)(F), the commenter referred to the proposed requirement for an automated external defibrillator as emergency equipment for freestanding end stage renal disease facilities. The commenter asked if dialysis facilities within a hospital would be granted a waiver.

Response: The department agrees with the commenter. The rules apply only to freestanding end stage renal disease facilities. No change was made as a result of this comment.

Comment: Concerning §117.33(b)(5), the commenter stated that given the actions required in the event that performance did not fall within acceptable range can be lengthy, the commenter proposed the following language be added: "A description of actions to take in the event that performance is not within an acceptable range shall be clearly posted in the immediate vicinity of the system."

Response: The department does not agree with the commenter. No change was made as a result of this comment.

Comment: Concerning §117.33(b)(8)(C)(iv), for the monitoring of carbon tanks, the commenter recommended this proposed language and requirement be removed. The commenter felt the language was vague, and the requirement had already been addressed under §117.33(b)(8)(C)(v) and (vi).

Response: The department agrees with the commenter and has removed §117.33(b)(8)(C)(iv) from the rules.

Comment: Concerning §117.33(b)(19)(C), a commenter recommended the language concerning quarterly audits in the second sentence be deleted. Two commenters felt that quarterly auditing was excessive and the "repeated results" was vague. One commenter recommended new language to be added which required water testing results be routinely trended and reviewed by the Medical Director in order to determine if results seem questionable or if there was an opportunity for improvement. The commenter also recommended that it should be the responsibility of the Medical Director or the CQI Committee to call for retesting.

Response: The department agrees with the commenter, and has removed the language concerning quality audits in the second sentence and has added the following language: "Water testing results shall be routinely trended and reviewed by the Medical Director in order to determine if results seem questionable or if there is an opportunity for improvement. The Medical Director or the CQI Committee shall determine if there is a need for retesting."

Comment: Concerning §117.33(b)(19)(D), the commenter wanted the department to comment on their reasoning for establishing regulations that are more stringent than the established AAMI Standards, which the department is using to establish regulations regarding water treatment systems within end stage renal disease facilities. The commenter was unable to find the standards in the AAMI Standards and Recommended Practices, Dialysis, 2001 Edition, published by the Association for the Advancement of Medical Instrumentation.

Response: The proposed language for these rules was developed by an Ad Hoc Committee, consisting of renal community representatives. This proposed language was also reviewed and approved by the Network 14 Medical Review Board prior to being published for public comment. The department feels the proposed rules reflect current standards in the renal community. Endotoxin levels in water and dialysate were previously included in American National Standard, Water Treatment Equipment for Hemodialysis Applications, August, 2001 Edition, published by the Association for the Advancement of Medical Instrumentation, 1110 North Glebe Road, Suite 2000, Arlington, Virginia 22201, 703-525-4890. No change was made as a result of this comment.

Comment: Concerning §117.33(b)(23)(A), the commenter recommended the following be added: "New facilities or facilities that add or change the configuration of the water distribution system must draw samples at the most distal point for each water distribution loop on a one time basis."

Response: The department agrees with the commenter and has added the recommended language to §117.33(b)(23)(A).

Comment: Concerning §117.33(c)(4)(B), the commenter felt the rules were unclear and offered clarifying language.

Response: The department disagrees with the commenter and considers the proposed language to accurately reflect the requirement that an end stage renal disease facility must comply with. No change was made as a result of this comment.

Comment: Concerning §117.33(c)(5) , the commenter recommended changing the language to read "Only a licensed nurse may use an additive to increase concentrations of specific electrolytes in the acid concentrate. Mixing procedures shall be followed as specified by the additive manufacturer." The commenter felt that this would add a "label" to start, and would make it clearer that only a licensed nurse is to do this. A second commenter felt the current language was unclear, and wondered if the language referred to changing a bath during a treatment.

Response: The department has changed the language to reflect the commenter's suggestion of clarifying duties of a "licensed nurse". The rule also did not include changing a bath during a treatment.

Comment: Concerning §117.33(c)(11)(F)(iii), the commenter suggests the following language be added: "Testing for residual disinfectant should be done, and documented."

Response: The department agrees with the commenter, and has added the suggested language.

Comment: Concerning §117.34(b)(2)(A), two commenters suggested that the language be changed to clarify at the end of the sentence: "and the disinfectant removed."

Response: The department agrees and has changed the language to read, "Routine disinfections of active and backup dialysis machines shall be performed according to facility defined protocol, accomplishing at least intermediate level infection, and the disinfectant removed."

Comment: Concerning §117.34(d), one commenter suggested that language be added that states that once the staff had two documented positive antibody tests, no further testing would be needed.

Response: The proposed rules refer to 29 Code of Federal Regulations, §1910.1030(f)(1)-(2) (concerning Bloodborne Pathogens). No change was made as a result of this comment.

Comment: Concerning §117.43(a)(13), two commenters recommended the proposed language "in lieu of dismissal from the facility" be changed to "prior to dismissal from the facility." The commenters stated that the rules should recognize that dismissal might be necessary when patients pose an immediate and serious threat to themselves and/or other patients and staff.

Response: The department agrees, and has changed the language to read "prior to dismissal from the facility." The department recognizes some patients may pose an immediate and serious threat to themselves and/or other patients and staff.

Comment: Concerning §117.43(b)(7), two commenters suggested deleting "non-compliant patient" and using the term "patient who does not conform to the treatment plan."

Response: The department agrees with the commenters and has changed the term to "patients who do not conform to the treatment plan" in §117.43(b)(7).

Comment: Concerning §117.43(e)(5) and (7), the commenter stated that although the current staffing requirements are working well, the documented nursing and healthcare workforce shortages and the restrictions imposed by the Board of Nurse Examiners on unlicensed patient care technicians can make it difficult for providers to meet them at all times and overall staffing patterns should be considered when evaluating compliance with this sections. Allowance should be made for a facility that routinely schedules staff consistent with the regulations but finds itself out of compliance at times due to unanticipated changes in patient census and/or unscheduled changes in on-duty personnel. In addition, providers should have the flexibility to manage clinical resources to best meet the needs of its patients.

Response: The department agrees with the commenter. The department has established these licensing rules as minimum requirements for facilities and surveyors are conducting outcome-based surveys. Providers have the flexibility to manage clinical resources while continuing to provide patient centered care which meet state laws. No change was made as a result of this comment.

Comment: Concerning §117.43(h)(5) and (i)(5), the commenter feels there is no data suggesting poor patient outcomes under the current ratios (for dieticians and social workers, respectively), and requests the current requirement and language be retained.

Response: The department disagrees with the commenter. The department has received over 23 letters with over 100 signatures in favor of the lowered ratios for dieticians and over 90 signatures in favor of a ratio for social workers. No change was made as a result of this comment.

Comment: Concerning §117.43(i), the commenter suggested the proposed ratio for social workers to patients was high with the maximum patient load per full-time equivalent of qualified social worker may be 125 patients.

Response: The department disagrees with the commenter since the current rules do not have a ratio and feels that any lower ratio may be too prescriptive. The department also received 90 signatures in favor of the proposed ratio of social workers to patients. No change was made as a result of this comment.

Comment: Concerning §117.44(a)(5), the commenter felt that an annual test should not be required of staff that was dialyzing patients on an ongoing basis in a facility. The commenter felt that knowledge as reflected decision-making and supervisory personnel evaluate technical/ clinical skill competency each day. The commenter stated that evidence of annual performance review in personnel files that specifically indicated acceptable and advancing levels of clinical performance, safety, and adherence to clinical policies and procedures was sufficient.

Response: The department feels that annual testing is congruent with other providers' requirements for staff assessment and evaluation, and will not lower the standards for ESRD facilities. No change was made as a result of this comment.

Comment: Concerning §117.45(b), the commenter stated there should be> of which professional is competent to perform a comprehensive medical history. The commenter felt that in times of decreasing numbers of nephrologists, and increasing numbers of dialysis patients, it seemed unwise to make the requirement that a physician was required to perform this task.

Response: The department feels there is a difference between physicians, and physician assistants and nurse practitioners. New patients need to have evidence they have been seen recently by the physician and that orders reflect the current needs of patients. No change was made as a result of this comment.

Comment: Concerning §117.46, two commenters suggested that a facility should report the only the following occurrence to the department within ten working days of the occurrence: (1) Any conversion of staff or patient to HbsAg positive; or (2) Any unusual death of a patient.

Response: The department agrees and has deleted "or hospitalization" in §117.46(a)(1) and paragraph (3) and (4) of the subsection.

Comment: Concerning §117.62(g)(4), the commenter felt that one-year full time experience is sufficient if the technician has successfully completed the facility's training program (as described in the language), related checklists and competency examination.

Response: The department agrees with the commenter, and has added language to include the following one year experience: "a technician with at least 12 months experience," qualified by training and experience in water treatment, dialysate preparation, reprocessing or other technical aspects of dialysis providing training within their area of expertise.

Comment: Concerning §117.83, the commenter recommended the addition of the following language: "The department will make every effort to appoint a temporary manager who is already familiar with the facility's patient, personnel, policies, procedures and operations to expedite compliance."

Response: The department disagrees with the commenter. The current language in §117.83(b) states the "court shall appoint a temporary manager to manage a facility if the court finds that the appointment of the manager is necessary." No change was made as a result of this comment.

Comment: Concerning the rules in general, five commenters expressed concern that patient care technicians who met certain criteria were not allowed to initiate and terminate dialysis via catheters. The commenters felt that the Ad Hoc Committee had spent many hours developing an alternative to allowing only licensed nurses to perform these duties, only to have the Network 14 Medical Review Board to overturn these recommendations. The commenters felt that the department should reconsider this alternative.

Response: The department respects the expertise of the Network 14 Medical Review Board and will not reconsider the use of technicians to perform catheter care. No changes were made as a result of these comments.

Comment: Concerning §117.44, four commenters stated the original recommendation by the Ad Hoc Committee was to allow a nurse with 12 months experience in nursing to function in the role of a charge nurse after three months of training instead of the current six months. The commenters felt that the Medical Review Board's decision to overturn this recommendation was not acceptable and requested that the department consider this recommendation prior to making the rules final.

Response: The department respects the expertise of the Network 14 Medical Review Board and feels the proposed rules reflect the current needs of the renal community. No changes were made as a result of these comments.

Comment: Concerning §117.43(h), three commenters requested that staffing ratios for dieticians not be lowered. The commenters felt that the current requirements for 110-150 patients were sufficient and worked well.

Response: The department respects the feelings of the commenters but has received 23 letters with over 100 signatures in favor of the lowered ratios for dieticians due to the complexity of working with this population. No changes were made as a result of the comments.

Comment: Concerning the rules in general, one commenter recommended that all state mandated ratios for all healthcare workers including nurses, patient care technicians, dieticians and social workers be eliminated.

Response: The department respects the recommendations of the commenter but feels the proposed language reflects the requirements that facilities must meet to provide safe delivery of service. No change was made as a result of this comment.

Comment: Concerning §117.18, one commenter agreed with the ad hoc committee's recommendation that the rules should allow for mentoring programs in recognition of potential shortages in the resource pool of qualified candidates. The commenter recommended the following language be included: "Any facility employing a mentoring program must document its thorough and ongoing efforts to recruit a qualified candidate, define oversight and require structured supervision for the program."

Response: The department respects the commenter's suggestions, and refers the commenter to the proposed new section, §117.18. No change was made as a result of this comment.

Subchapter A. GENERAL PROVISIONS

25 TAC §§117.1 - 117.3

The amendments are adopted under Health and Safety Code (HSC), Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ESRDs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health. The review of these rules implements Government Code, §2001.039.

§117.2.Definitions.

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

(1) Action level--The point at which steps should be taken to interrupt the trend towards unacceptable levels.

(2) Advanced practice nurse--A registered nurse approved by the Board of Nurse Examiners for the State of Texas to practice as an advanced practice nurse.

(3) Administrator--A person who is delegated the responsibility for the implementation and proper application of policies, programs, and services established for the end stage renal disease facility.

(4) Affiliate--An applicant or owner which is:

(A) a corporation - includes each officer, consultant, stockholder with a direct ownership of at least 5.0%, subsidiary, and parent company;

(B) a limited liability company - includes each officer, member, and parent company;

(C) an individual - includes:

(i) the individual's spouse;

(ii) each partnership and each partner thereof of which the individual or any affiliate of the individual is a partner; and

(iii) each corporation in which the individual is an officer, consultant, or stockholder with a direct ownership of at least 5.0%;

(D) a partnership - includes each partner and any parent company; and

(E) a group of co-owners under any other business arrangement--includes each officer, consultant, or the equivalent under the specific business arrangement and each parent company.

(5) Applicant--The owner of an end stage renal disease facility which is applying for a license under the statute. This is the person in whose name the license is issued.

(6) Biofilm--A coating on surfaces consisting of microcolonies of bacteria embedded in a protective extracellular matrix. The matrix, a slimy material secreted by the cells, protects the bacteria from antibiotics and disinfectants.

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

(8) Change of ownership--A sole proprietor who transfers all or part of the facility's ownership to another person or persons; the removal, addition, or substitution of a person or persons as a partner in a facility owned by a partnership and the tax identification number of the partnership changes; or a corporate sale, transfer, reorganization, or merger of the corporation which owns the facility if sale, transfer, reorganization, or merger causes a change in the facility's ownership to another person or persons and the tax identification number of the corporation changes.

(9) Charge nurse--A registered professional nurse practicing nursing in accordance with applicable provisions of law who is responsible for making daily staff assignments based on patient needs, providing immediate supervision of patient care, monitoring patients for changes in condition, and/or communicating with the physician, dietician, and social worker regarding patient needs.

(10) Commissioner--The commissioner of health.

(11) Competency--The demonstrated ability to carry out specified tasks or activities with reasonable skill and safety that adheres to the prevailing standard of practice.

(12) Core staff members--The facility's medical director, supervising nurse, dietitian, social worker, administrator, and chief technician.

(13) Corrective action plan--A written strategy for correcting a licensing violation. The corrective action plan is developed by the facility and addresses the system(s) operation(s) of the facility as the system(s) operation(s) applies to the deficiency.

(14) Delegation--The transfer to a qualified and properly trained individual of the authority to perform a selected task or activity in a selected situation.

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

(16) Dialysate--An aqueous fluid containing electrolytes and usually dextrose, which is intended to exchange solutes with blood during hemodialysis. The word "dialysate" is used throughout this document to mean the fluid made from water and concentrate which is delivered to the dialyzer by the dialysate supply system. Such phrases as "dialyzing fluid" or "dialysis solution" may be used in place of dialysate. It does not include peritoneal dialysis fluid.

(17) Dialysate supply system--Devices that prepare dialysate on line from water and concentrates or store and distribute premixed dialysate; circulate the dialysate through the dialyzer; monitor the dialysate for temperature, conductivity, pressure, flow and blood leaks; and prevent dialysis during disinfection or cleaning modes. The term includes reservoirs; conduits; proportioning devices for the dialysate; and monitors, associated alarms, and controls assembled as a system for the characteristics listed above. The dialysate supply system is often an integral part of single-patient dialysis machines.

(18) Dialysis--A process by which dissolved substances are removed from a patient's body by diffusion, osmosis and convection (ultrafiltration) from one fluid compartment to another across a semipermeable membrane.

(19) Dialysis technician--An individual who is not a registered nurse or physician and who provides dialysis care under the direct supervision of a registered nurse or physician. If unlicensed, this individual may also be known as a patient care technician.

(20) Dietitian--A person who is currently licensed under the laws of this state to use the title of licensed dietitian, is eligible to be a registered dietitian, and has one year of experience in clinical dietetics after becoming eligible to be a registered dietitian.

(21) Director--The director of the Health Facility Licensing and Compliance Division of the department or his or her designee.

(22) Empty bed contact time (EBCT)--A measure of how much contact occurs between particles, such as activated carbon, and water as the water flows through a bed of the particles.

(23) End stage renal disease--That stage of renal impairment that appears irreversible and permanent and that requires a regular course of dialysis or kidney transplantation to maintain life.

(24) End stage renal disease (ESRD) facility--A facility that provides dialysis treatment or dialysis training to individuals with end stage renal disease.

(25) Full-time--The time period established by a facility as a full working week, as defined and specified in the facility's policies and procedures.

(26) Full-time equivalent--Work time equivalent to 2,080 hours per 12 consecutive months.

(27) Health care facility--Any type of facility or home and community support services agency licensed to provide health care in any state or is certified for Medicare (Title XVIII) or Medicaid (Title XIX) participation in any state.

(28) Governing body--An identified group, which includes the medical director and a representative(s) of the owner of the facility, with full legal authority and responsibility for the governance and operation of the facility.

(29) Hospital--A facility that is licensed under the Texas Hospital Licensing Law, Health and Safety Code, Chapter 241, or if exempt from licensure, certified by the United States Department of Health and Human Services as in compliance with conditions of participation for hospitals in Title XVIII, Social Security Act (42 United States Code, §1395 et seq.).

(30) Interdisciplinary team--A group composed of the primary physician, the registered nurse, the dietitian and the social worker who are responsible for planning care for the patient.

(31) Intermediate level disinfection--A surface treatment using chemical germicides or disinfectants which are capable of inactivating various classes of microorganisms including, but not limited to, viruses (primarily medium to large viruses and lipid-containing viruses), fungi, and actively growing bacteria (including tubercle bacteria) when such chemical germicides or disinfectants are used in accordance with the manufacturer's instructions or per established guidelines. Intermediate level disinfection is generally not effective in inactivating or eliminating bacterial endospores. Examples of intermediate level disinfectants include bleach, 70-90% ethanol or isopropanol, and certain phenolic or iodophor preparations.

(32) Inspection--An investigation or survey conducted by a representative of the department to determine if an applicant or licensee is in compliance with this chapter.

(33) LAL (Limulus Amoebocyte Lysate) test--An assay used to detect endotoxin which exploits the immune response of the horse shoe crab (Limulus polyphemus).

(34) Licensed nurse--A registered nurse or licensed vocational nurse.

(35) Licensed vocational nurse (LVN)--A person who is currently licensed under Texas Civil Statutes, Article 4528c to use the title licensed vocational nurse and who may provide dialysis treatment after meeting the competency requirements specified for dialysis technicians.

(36) Manager--An individual approved or selected by the department who assumes overall management of an end stage renal disease facility to ensure adequate and safe services are provided to patients.

(37) Medical director--A physician who:

(A) is board eligible or board certified in nephrology or pediatric nephrology by a professional board; or

(B) during the five-year period prior to September 1, 1996, has served for at least 12 months as director of a dialysis program.

(38) Medical review board (MRB)--A medical review board that is appointed by a renal disease network organization which includes this state, with the network having a contract with the Centers for Medicare and Medicaid Services of the United States Department of Health and Human Services under 42 United States Code §1395rr.

(39) Monitor--An individual approved or selected by the department who observes, supervises, consults, and educates a facility to correct identified violations of the statute or this chapter.

(40) Notarized copy(ies)--A sworn affidavit stating that attached copy(ies) is a true and correct copy(ies) of the original documents.

(41) Owner--One of the following which holds or will hold a license issued under the statute in the person's name or the person's assumed name:

(A) a corporation;

(B) a limited liability company;

(C) an individual;

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

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

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

(42) Patient--An individual receiving dialysis treatment or training from an end stage renal disease facility.

(43) Patient care plan--Documentation of the interactive process whereby the interdisciplinary team and the patient and/or family member or guardian develop a plan to assist the end stage renal disease patient in managing the disease and its complications.

(44) Pediatric patient--An individual 18 years of age or younger under the care of a facility.

(45) Person--An individual, corporation, or other legal entity.

(46) Physician--An individual who is licensed to practice medicine under the Medical Practice Act, Texas Civil Statutes, Article 4495b.

(47) Physician assistant--A person who is licensed as a physician assistant under the Physician Assistant Licensing Act, Texas Civil Statutes, Article 4495b-1.

(48) Presurvey conference--A conference held with department staff and the applicant or his or her representatives to review licensure standards and survey documents and provide consultation prior to the issuance of the temporary license. The applicant's representatives shall include an individual who will be responsible for the day-to-day supervision of care by the facility.

(49) Product water--The effluent water from the last component of the facility's water treatment system.

(50) Progress note--A dated and signed written notation by a facility staff member summarizing facts about care and a patient's response during a given period of time.

(51) Quality--The degree to which health services for individuals and populations increase the likelihood of desired outcomes that are consistent with current professional knowledge.

(52) Quality assurance--An ongoing, objective, and systematic process of monitoring, evaluating, and improving the quality, appropriateness, and effectiveness of care. The term includes the quality management and quality improvement processes.

(53) Quality management--A management philosophy used to plan and achieve desired processes and outcomes based upon a quality plan, which establishes quality objectives and the means to achieve; quality control, which is a process to evaluate actual performance against expected performance; and quality improvement, which is a process to identify, plan, and implement change for improvement.

(54) Registered nurse (RN)--A person who is currently licensed under the Nursing Practice Act, Texas Civil Statutes, Article 4513 et seq. as a registered nurse.

(55) Social worker--A person who:

(A) is currently licensed as a social worker under the Human Resources Code, Chapter 50, and holds a masters degree from a graduate school of social work accredited by the Council on Social Work Education; or

(B) has worked for at least two years as a social worker, one year of which was in a dialysis facility or transplantation program prior to September 1, 1976, and has established a consultative relationship with a social worker who has a masters degree from a graduate school of social work accredited by the Council on Social Work Education.

(56) Supervising nurse (also may be known as the director of nursing)--An RN who:

(A) has at least 18 months experience as an RN, which includes at least 12 months experience in dialysis which has been obtained within the last 24 months; or

(B) has at least 18 months experience as an RN and holds a current certification from a nationally recognized board in nephrology nursing or hemodialysis.

(57) Supervision--Authoritative procedural guidance by a qualified person for the accomplishment of a function or activity with initial direction and periodic inspection of the actual act of accomplishing the function or activity. Immediate supervision means the supervisor is actually observing the task or activity as it is performed. Direct supervision means the supervisor is on the premises but not necessarily immediately physically present where the task or activity is being performed. Indirect supervision means the supervisor is not on the premises but is accessible by two-way communication and able to respond to an inquiry when made, and is readily available for consultation.

(58) Statute--The Health and Safety Code, Chapter 251.

(59) Training--The learning of tasks through on-the-job experience or instruction by an individual who has the capacity through education or experience to perform the task or activity to be delegated.

(60) Technical supervisor--The supervisor of the facility's mechanical, reuse and water treatment systems.

(61) Ultrafilter--A membrane filter with a pore size in the range 0.001 to 0.05 µm. Performance is usually rated in terms of a nominal molecular weight cut-off (MWCO), which is defined as the smallest molecular weight species for which the filter membrane has more than 90% rejection. Ultrafilters with a nominal MWCO of 20,000 or less are generally adequate for endotoxin removal.

(62) Water distribution systems--Components to include any storage tanks and piping used to distribute the product water from the purification cascade to or from its point of use, including individual hemodialysis machines, dialyzer reprocessing equipment and dialysate concentrate preparation systems.

(63) Water treatment system--A collection of water purification devices and associated piping, pumps, valves, gauges, etc., that together produce purified water for hemodialysis applications and deliver it to the point of use.

(64) Working day--Any day of the calendar week excluding Saturday or Sunday.

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 August 18, 2003.

TRD-200305326

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: September 7, 2003

Proposal publication date: March 14, 2003

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

25 TAC §§117.11 - 117.18

The amendments and new section are adopted under Health and Safety Code (HSC), Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ESRDs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health. The review of these rules implements Government Code, §2001.039.

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

Filed with the Office of the Secretary of State on August 18, 2003.

TRD-200305327

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: September 7, 2003

Proposal publication date: March 14, 2003

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

25 TAC §§117.31 - 117.34

The amendments are adopted under Health and Safety Code (HSC), Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ESRDs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health. The review of these rules implements Government Code, §2001.039.

§117.31.Design and Space Requirements.

(a) General.

(1) The standards in this section shall apply to all facilities that provide outpatient dialysis services. Dialysis facilities in operation on or before September 1, 2003 shall meet the design and space requirements of this section which were in effect at the time the facility was constructed.

(2) A facility must provide a physical environment that protects the health and safety of patients, personnel and the public. The physical premises of the facility and those areas of the facility's surrounding physical structure that are used by the patients (including all stairwells, corridors and passageways) must meet the local building and fire safety codes as they relate to design and space requirements for safe access and patient privacy.

(3) A facility shall comply with Chapter 38 of the National Fire Protection Association 101, Code for Safety to Life from Fire in Buildings and Structures, 2000 Edition (NFPA 101), relating to new business occupancies, published by the National Fire Protection Association. All documents published by the NFPA as referenced in this section may be obtained by writing or calling the NFPA at the following address and telephone number: Post Office Box 9101, Batterymarch Park, Quincy, Massachusetts 02169, 1-800-344-3555.

(4) Water distribution systems shall be configured as a continuous recirculation loop and designed to minimize bacterial proliferation and biofilm. A minimum of three feet per second water flow must be achieved in the distribution loop. This rule shall apply only to new facilities.

(5) Water treatment systems shall include a minimum of two carbon tanks in a series, with the total empty bed contact time (EBCT) of at least ten minutes, and the final tank providing at least five minutes EBCT.

(6) A facility shall provide a reception and information counter or desk and a waiting room separate from the patient treatment area. The waiting room shall provide adequate seating.

(7) The patient treatment area shall be designed and equipped to provide proper and safe treatment as well as privacy and comfort for patients. At a minimum, patient treatment stations shall be 70 square feet, with the smallest dimension at seven feet. The 70 square feet may include aisles or counters.

(8) If hepatitis B positive patients are treated, a separate room with its own designated machine(s), clamp(s), blood pressure cuff(s), sink(s) and other equipment shall be used.

(9) A facility shall provide a call system in patient areas outside the treatment area (e.g., patient restrooms, training rooms, and examination rooms) which is usable by a collapsed patient lying on the floor (e.g., inclusion of a pull cord). Calls shall register at and activate a visible signal in the central nurses station. Call systems which provide two-way communication shall be equipped with an indicating light at each call station which lights and remains lighted as long as the voice circuit is operating.

(10) A facility shall have separate toilet and lavatory facilities for staff and patients.

(11) A facility shall provide a private area for meetings with patients or family members.

(12) A facility shall have a room for medical examinations which includes an examination table, a work counter, and a hand washing sink or lavatory.

(13) Telephone access shall be available in the facility to patients and family members.

(14) A facility located above the ground floor must have an elevator of sufficient size to accommodate a gurney available at all times.

(15) A facility shall provide two exits remote from each other in accordance with NFPA 101, §7-5.1.3. At least one exit door shall be accessible by an ambulance from the outside. This door may also serve as an entry for loading or receiving goods.

(16) A facility shall provide a separate room for peritoneal dialysis patients if the facility provides on-site peritoneal dialysis training. This room shall include a lavatory or sink for hand washing.

(17) Doors to an isolation room or peritoneal dialysis room shall not be lockable from inside the room.

(18) Public corridor widths and all other areas where patients may traverse shall accommodate wheel chair or gurney passage.

(19) Items such as drinking fountains, telephone booths, vending machines and portable equipment (including patient care equipment) shall be located so that they do not project into, restrict, or obstruct exit corridor traffic.

(20) A facility shall utilize a ventilation system which provides adequate comfort to patients during treatment and which minimizes the potential of insect access.

(21) Floors that are subject to traffic while wet shall have nonslip surfaces.

(b) Storage areas.

(1) All storage areas shall be kept clean and orderly at all times.

(2) A facility premises shall be kept free from accumulations of combustible materials not necessary for immediate operation of the facility. Local supplies of combustible liquids shall be stored in cabinets or shelves which are well-ventilated from top to bottom.

(3) A facility shall have a separate space for wheel chair storage.

(4) A facility shall store oxygen in compliance with §4-3 of the National Fire Protection Association 99, Standard for Health Care Facilities, 1999 Edition (NFPA 99) published by the National Fire Protection Association.

(c) Provisions for the handicapped.

(1) If Texas Civil Statutes, Article 9102 applies, a facility shall be designed in accordance with 16 Texas Administrative Code, Chapter 68 (Elimination of Architectural Barriers) administered by the Texas Department of Licensing and Regulation, effective April 1, 1994.

(2) A facility shall meet applicable requirements of 29 United States Code, §794. When federal funds are used for construction, for program requirements, or for client services, the handicapped requirements of §794 will apply.

(3) A facility shall comply with the design and space requirements of the Americans with Disabilities Act, 42 United States Code, §12182(b)(2)(A)(iv) and (v) and §12183, and the regulations and guidelines promulgated under §12186(b) and (c) and §12204, effective July 28, 1991.

(d) Fire protection.

(1) All sprinkler systems, smoke detectors, and other fire-fighting equipment shall be inspected and tested at least once each year to maintain it in serviceable condition. If a facility has a sprinkler system, the sprinkler system shall be installed and maintained in accordance with the National Fire Protection Association 13, Standard for the Installation of Sprinkler Systems, 1999 Edition, published by the National Fire Protection Association.

(2) A facility shall have an emergency lighting system capable of providing sufficient illumination to allow safe evacuation from the building. Battery pack systems shall be maintained and tested quarterly. If a facility maintains a back-up generator, the generator must be installed, tested and maintained in accordance with the National Fire Protection Association 110, Standard for Emergency and Standby Power Systems, 1999 Edition (NFPA 110), published by the National Fire Protection Association.

(3) A facility housed in or adjacent to a building classified as a "high hazard industrial occupancy," as defined in §40-1.4.1 of the NFPA 101, must have a special feature such as a two-hour fire wall between the facility and the other occupancy and written approval by the fire authority having jurisdiction.

(e) Construction. If construction takes place in or near occupied areas, adequate provision shall be made for the safety and comfort of patients during the construction.

(f) Other standards. A facility may impose more stringent design and space standards than the minimum standards in this section.

§117.32.Equipment.

(a) All equipment used by a facility, including backup equipment, shall be operated within manufacturer's specifications, and maintained free of defects which could be a potential hazard to patients, staff, or visitors. Maintenance and repair of all equipment shall be performed by qualified staff or contract personnel.

(1) Staff shall be able to identify malfunctioning equipment and report such equipment to the appropriate staff for immediate repair.

(2) Medical equipment that malfunctions must be clearly labeled and immediately removed from service until the malfunction is identified and corrected.

(3) Written evidence of all maintenance and repairs shall be maintained.

(4) After repairs or alterations are made to any equipment or system, the equipment or system shall be thoroughly tested for proper operation before returning to service. This testing must be documented.

(5) A facility shall comply with the federal Food, Drug, and Cosmetic Act, 21 United States Code (USC), §360i(b), concerning reporting when a medical device as defined in 21 USC §321(h) has or may have caused or contributed to the injury or death of a patient of the facility.

(b) A facility shall develop, implement and enforce a written preventive maintenance program to ensure patient care related equipment used in a facility or provided by a facility for use by the patient in the patient's home receives electrical safety inspections, if appropriate, and maintenance at least annually or more frequently as recommended by the manufacturer. The preventive maintenance may be provided by facility staff or by contract.

(c) At least one complete dialysis machine shall be available on-site as backup for every ten dialysis machines in use. At least one of these backup machines must be completely operational during hours of treatment. Machines not in use during a patient shift may be counted as backup except at the time of an initial or an expansion survey.

(d) If pediatric patients are treated, a facility shall use equipment and supplies, to include blood pressure cuffs, dialyzers, and blood tubing, appropriate for this special population.

(e) All equipment and appliances shall be properly grounded in accordance with the National Fire Protection Association 99, Standard for Health Care Facilities, §§3-3.2.1.2(a)(2) and 7-5.1, 1999 Edition (NFPA 99), published by the National Fire Protection Association. All documents published by the NFPA as referenced in this section may be obtained by writing or calling the NFPA at the following address and telephone number: Post Office Box 9101, Batterymarch Park, Quincy, Massachusetts 02169, 1-800-344-3555.

(f) Extension cords and cables shall not be used for permanent wiring.

(g) A facility shall have emergency equipment and supplies immediately accessible in the treatment area.

(1) At a minimum, the emergency equipment and supplies shall include the following:

(A) oxygen;

(B) ventilatory assistance equipment, to include airways, manual breathing bag, and mask;

(C) suction equipment;

(D) supplies specified by the medical director;

(E) electrocardiograph; and

(F) automated external defibrillator.

(2) If pediatric patients are treated, the facility shall have the appropriate type and size emergency equipment and supplies listed in paragraph (1) of this subsection for this special population.

(3) A facility shall establish, implement, and enforce a policy for the periodic testing and maintenance of the emergency equipment. Staff shall properly maintain and test the emergency equipment and supplies and document the testing and maintenance.

§117.33.Water Treatment, Dialysate Concentrates and Reuse.

(a) Compliance required. A facility shall meet the requirements of this section. A facility may follow more stringent requirements than the minimum standards required by this section.

(1) The facility owner and medical director shall each demonstrate responsibility for the water treatment and dialysate supply systems to protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminates that may be found in improperly prepared dialysate, to ensure that the dialysate is correctly formulated and meets the requirements of all applicable quality standards.

(2) The facility owner and medical director must each assure that policies and procedures related to water treatment, dialysate and reuse are understandable and accessible to the operator(s) and that the training program includes quality testing, risks and hazards of improperly prepared concentrate and bacterial issues.

(3) The facility owner and medical director must be informed prior to any alteration of, or any device being added to, the water system.

(b) Water treatment. These requirements apply to water intended for use in the delivery of hemodialysis, including the preparation of concentrates from powder at a dialysis facility and dialysate, and for reprocessing dialyzers for multiple use.

(1) The design for the water treatment system in a facility shall be based on considerations of the source water for the facility and designed by a water quality professional with education, training, or experience in dialysis system design.

(2) When a public water system supply is not used by a facility, the source water shall be tested by the facility at monthly intervals in the same manner as a public water system as described in 30 Texas Administrative Code, §290.104 (Control Tests), §290.105 (Maximum Contaminant Levels (MCLs) for Microbiological Contaminants), and §290.106 (Bacteriological Monitoring) as adopted by the Texas Commission on Environmental Quality.

(3) The physical space in which the water treatment system is located must be adequate to allow for maintenance, testing, and repair of equipment. If mixing of dialysate is performed in the same area, the physical space must also be adequate to house and allow for the maintenance, testing, and repair of the mixing equipment and for performing the mixing procedure.

(4) The water treatment system components shall be arranged and maintained so that bacterial and chemical contaminant levels in the product water do not exceed the standards for hemodialysis water quality described in §4.2.1 (concerning Water Bacteriology) and §4.2.2 (concerning Maximum Level of Chemical Contaminants) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition, published by the Association for the Advancement of Medical Instrumentation (AAMI). All documents published by the AAMI as referenced in this section may be obtained by writing the following address: 1110 North Glebe Road, Suite 220, Arlington, Virginia 22201.

(5) Written policies and procedures for the operation of the water treatment system must be developed and implemented. Parameters for the operation of each component of the water treatment system must be developed in writing and known to the operator. Each major water system component shall be labeled in a manner that identifies the device; describes its function, how performance is verified and actions to take in the event performance is not within an acceptable range.

(6) The materials of any components of water treatment systems (including piping, storage, filters and distribution systems) that contact the purified water shall not interact chemically or physically so as to affect the purity or quality of the product water adversely. Such components shall be fabricated from unreactive materials (e.g. plastics) or appropriate stainless steel. The use of materials that are known to cause toxicity in hemodialysis, such as copper, brass, galvanized material, or aluminum, is prohibited.

(7) Chemicals infused into the water such as iodine, acid, flocculants, and complexing agents shall be shown to be nondialyzable or shall be adequately removed from product water. Monitors or specific test procedures to verify removal of additives shall be provided and documented.

(8) Each water treatment system shall include reverse osmosis membranes or deionization tanks and a minimum of two carbon tanks in series. If the source water is from a private supply which does not use chlorine/chloramine, the water treatment system shall include reverse osmosis membranes or deionization tanks and a minimum of one carbon tank.

(A) Reverse osmosis membranes, if used, shall meet the standards in §4.3.7 (concerning Reverse Osmosis) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition, published by the AAMI.

(B) Deionization systems.

(i) Deionization systems, if used, shall be monitored continuously to produce water of one megohm-cm or greater specific resistivity (or conductivity of one microsiemen/cm or less) at 25 degrees Celsius. An audible and visual alarm shall be activated when the product water resistivity falls below this level and the product water stream shall be prevented from reaching any point of use.

(ii) Patients shall not be dialyzed on deionized water with a resistivity less than 1.0 megohm-cm measured at the output of the deionizer.

(iii) A minimum of two deionization (DI) tanks in series shall be used with resistivity monitors including audible and visual alarms placed pre and post the final DI tank in the system. The alarms must be audible in the patient care area.

(iv) Feed water for deionization systems shall be pretreated with activated carbon adsorption, or a comparable alternative, to prevent nitrosamine formation.

(v) If a deionization system is the last process in a water treatment system, it shall be followed by an ultrafilter or other bacteria and endotoxin reducing device.

(C) Carbon tanks.

(i) The carbon tanks must contain acid washed carbon, 30-mesh or smaller with a minimum iodine number of 900.

(ii) A minimum of two carbon adsorption beds shall be installed in a series configuration.

(iii) The total empty bed contact time (EBCT) shall be at least ten minutes, with the final tank providing at least five minutes EBCT. Carbon adsorption systems used to prepare water for home dialysis or for portable dialysis systems are exempt from the requirement for the second carbon and a ten minute EBCT if removal of chloramines to below 0.1 mg/1 is verified before each treatment.

(iv) A means shall be provided to sample the product water immediately prior to the final bed(s). Water from this port(s) must be tested for chlorine/chloramine levels immediately prior to each patient shift.

(v) All samples for chlorine/chloramine testing must be drawn when the water treatment system has been operating for at least 15 minutes.

(vi) Tests for total chlorine, which include both free and combined forms of chlorine, may be used as a single analysis with the maximum allowable concentration of 0.1 mg/L. Test results of greater than 0.5 parts per million (ppm) for chlorine or 0.1 ppm for chloramine from the port between the initial tank(s) and final tank(s) shall require testing to be performed at the final exit and replacement of the initial tank(s).

(vii) In a system without a holding tank, if test results at the exit of the final tank(s) are greater than the parameters for chlorine or chloramine described in this subparagraph, dialysis treatment shall be immediately terminated to protect patients from exposure to chlorine/chloramine and the medical director shall be notified. In systems with holding tanks, if the holding tank tests <0.1 mg/L for total chlorine, the reverse osmosis (RO) may be turned off and the product water in the holding tank may be used to finish treatments in process. The medical director shall be notified.

(viii) If means other than granulated carbon are used to remove chlorine/chloramine, the facility's governing body must approve such use in writing after review of the safety of the intended method for use in hemodialysis applications. If such methods include the use of additives, there must be evidence the product water does not contain unsafe levels of these additives.

(9) Water softeners, if used, shall be tested at the end of the treatment day to verify their capacity to treat a sufficient volume of water to supply the facility for the entire treatment day and shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration.

(10) Timers. If used, the face(s) of timer(s) used to control any component of the water treatment or dialysate delivery system shall be visible to the operator at all times. Written evidence that timers are checked for operation and accuracy each day of operation must be maintained.

(11) Filter housings, if used during disinfectant procedures, shall include a means to clear the lower portion of the housing of the disinfecting agents. Filter housings shall be opaque.

(12) Ultrafilters, or other bacterial reducing filters, if used, shall be fitted with pressure gauges on the inlet and outlet water lines to monitor the pressure drop across the membrane. Ultrafilters shall be included in routine disinfection procedures.

(13) Storage tanks. If used, storage tanks shall have a conical or bowl-shaped base and shall drain from the lowest point of the base. Storage tanks shall have a tight fitting lid and be vented through a hydrophobic 0.2 micron air filter. Means shall be provided to effectively disinfect any storage tank installed in a water distribution system.

(14) Ultraviolet (UV) lights, if used, shall be monitored at the frequency recommended by the manufacturer. A log sheet shall be used to record monitoring.

(15) Water treatment system piping shall be labeled to indicate the contents of the pipe and direction of flow.

(16) The water treatment system must be continuously monitored during patient treatment and be guarded by audible and visual alarms which can be seen and heard in the dialysis treatment area should water quality drop below specific parameters. Quality monitor sensing cells shall be located as the last component of the water treatment system and at the beginning of the distribution system. No water treatment components that could affect the quality of the product water as measured by this device shall be located after the sensing cell.

(17) When deionization tanks do not follow a reverse osmosis system, parameters for the rejection rate of the membranes must assure that the lowest rate accepted would provide product water in compliance with §4.2.2 (concerning Maximum Level of Chemical Contaminants) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition published by the AAMI.

(18) A facility shall maintain written logs of the operation of the water treatment system for each treatment day. The log book shall include each component's operating parameter and the action taken when a component is not within the facility's set parameters.

(19) Microbiological testing of product water.

(A) Frequency. Microbiological testing shall be conducted monthly and following any repair or change to the water treatment system. For a newly installed water distribution system, or when a change has been made to an existing system, weekly testing shall be conducted for one month to verify that bacteria and endotoxin levels are consistently within the allowed limits.

(B) Sample sites. At a minimum, sample sites chosen for the testing shall include the beginning of the distribution piping, the product water in the reuse room, at any site of dialysate mixing, and the end of the distribution piping.

(C) Technique. Samples shall be collected immediately before sanitization/disinfection of the water treatment system and dialysis machines. Water testing results shall be routinely trended and reviewed by the Medical Director in order to determine if results seem questionable or if there is an opportunity for improvement. The Medical Director or the CQI Committee shall determine if there is a need for retesting. Repeated results of "no growth" shall be validated via an outside laboratory. A calibrated loop may not be used in microbiological testing of water samples. Colonies shall be counted using a magnifying device.

(D) Expected results. Product water used to prepare dialysate, concentrates from powder, or to reprocess dialyzers for multiple use, shall contain a total viable microbial count less than 200 CFU/ml and an endotoxin concentration less than 2 EU/ml. The action level for the total viable microbial count in the product water shall be 50 CFU/ml and the action level for the endotoxin concentration shall be 1 EU/ml.

(E) Required action for unacceptable results. If the action levels described at paragraph (D) are observed in the product water, corrective measures shall be taken promptly to reduce the levels into an acceptable range.

(F) Records. All bacteria and endotoxin results shall be recorded on a log sheet in order to identify trends that may indicate the need for corrective action.

(20) Ozone generators. If ozone generators are used to disinfect any portion of the water or dialysate delivery system, testing based on the manufacturer's direction shall be used to measure the ozone concentration each time disinfection is performed, to include testing for safe levels of residual ozone at the end of the disinfection cycle. Testing for ozone in the ambient air shall be conducted on a periodic basis as recommended by the manufacturer. Records of all testing must be maintained in a log.

(21) Hot Water Disinfection Systems. If used, hot water disinfection systems shall be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Temperature of the water shall be recorded at a point furthest from the water heater, where the lowest water temperature is likely to occur. The water temperature shall be measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection shall be maintained.

(22) After chemical disinfection, means shall be provided to restore the equipment and the system in which it is installed to a safe condition relative to residual disinfectant prior to the product water being used for dialysis applications.

(23) Water Analysis. Samples of product water must be submitted for chemical analysis every six months and must demonstrate that the quality of the product water used to prepare dialysate, concentrates from powder, or to reprocess dialyzers for multiple use, meets §4.2.2 (concerning Maximum Level of Chemical Contaminants) of the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition, published by the AAMI.

(A) Samples for chemical analysis shall be collected at the end of the water treatment components and at the most distal point in each water distribution loop. All other outlets from the distribution loops shall be inspected to ensure that the outlets are fabricated from compatible materials. Appropriate containers and pH adjustments shall be used to ensure accurate determinations. New facilities or facilities that add or change the configuration of the water distribution system must draw samples at the most distal point for each water distribution loop on a one time basis.

(B) Additional chemical analysis shall be submitted if substantial changes are made to the water treatment system or if the percent rejection of a reverse osmosis system decreased 5.0% or more from the percent rejection measured at the time the water sample for the preceding chemical analysis was taken.

(24) Facility records must include all test results and evidence that the medical director has reviewed the results of the water quality testing and directed corrective action when indicated.

(25) Only persons qualified by the education or experience described in §117.44(f) of this title (relating to Qualifications of Staff) may operate, repair, or replace components of the water treatment system.

(c) Dialysate.

(1) Quality control and quality assurance procedures shall be established to ensure ongoing conformance to policies and procedures regarding dialysate quality.

(2) Each facility shall set all hemodialysis machines to use only one family of concentrates. When new machines are put into service, or the concentrate family or concentrate manufacturer is changed, samples shall be sent to a laboratory for verification.

(3) Prior to each patient treatment, staff shall verify the dialysate conductivity and pH of each machine with an independent device.

(4) Bacteriological testing.

(A) Frequency. Responsible facility staff shall develop a schedule to ensure each hemodialysis machine is tested quarterly for bacterial growth and the presence of endotoxins. Hemodialysis machines of home patients shall be cultured monthly until results not exceeding 200 colony forming units per milliliter are obtained for three consecutive months, then quarterly samples shall be cultured.

(B) Acceptable limits. Dialysate shall contain less than 200 CFU/ml and an endotoxin concentration of less than 2 EU/ml. The action level for total viable microbial count shall be 50 CFU/ml and the action level for endotoxin concentration shall be 1 EU/ml.

(C) Action to be taken. Disinfection and retesting shall be done when bacterial or endotoxin counts exceed the action levels. Additional samples shall be collected when there is a clinical indication of a pyrogenic reaction and/or septicemia.

(5) Only a licensed nurse may use an additive to increase concentrations of specific electrolytes in the acid concentrate. Mixing procedures shall be followed as specified by the additive manufacturer. When additives are prescribed for a specific patient, the container holding the prescribed acid concentrate shall be labeled with the name of the patient, the final concentration of the added electrolyte, the date the prescribed concentrate was made, and the name of the person who mixed the additive.

(6) Materials compatibility. All components used in concentrate preparation systems (including mixing and storage tanks, pumps, valves and piping) shall be fabricated from materials (e.g., plastics or appropriate stainless steel) that do not interact chemically or physically with the concentrate so as to affect its purity, or with the germicides used to disinfect the equipment. The use of materials that are known to cause toxicity in hemodialysis such as copper, brass, galvanized material and aluminum is prohibited.

(7) Storage of acid concentrates. Facility policies shall address means to protect stored acid concentrates from tampering or from degeneration due to exposure to extreme heat or cold.

(8) Bulk storage tanks. Procedures to control the transfer of acid concentrates from the delivery container to the storage tank and prevent the inadvertent mixing of different concentrate formulations shall be developed, implemented and enforced. The storage tanks shall be clearly labeled.

(9) Concentrate mixing systems.

(A) Concentrate mixing systems shall include a purified water source, a suitable drain, and a ground fault protected electrical outlet.

(B) Operators of mixing systems shall use personal protective equipment as specified by the manufacturer during all mixing processes.

(C) The manufacturer's instructions for use of a concentrate mixing system shall be followed, including instructions for mixing the powder with the correct amount of water. The number of bags or weight of powder added shall be determined and recorded.

(D) The mixing tank shall be clearly labeled to indicate the fill and final volumes required to correctly dilute the powder.

(E) Systems for preparing either bicarbonate or acid concentrate from powder shall be monitored according to the manufacturer's instructions.

(F) Concentrates shall not be used, or transferred to holding tanks or distribution systems, until all tests are completed.

(G) If a facility designs its own system for mixing concentrates, procedures shall be developed and validated using an independent laboratory to ensure proper mixing.

(10) Acid concentrate mixing systems.

(A) Acid concentrate mixing tanks shall be designed to allow the inside of the tank to be rinsed when changing concentrate formulas.

(B) Acid mixing systems shall be designed and maintained to prevent rust and corrosion.

(C) Acid concentrate mixing tanks shall be emptied completely and rinsed with product water before mixing another batch of concentrate to prevent cross contamination between different batches.

(D) Acid concentrate mixing equipment shall be disinfected as specified by the equipment manufacturer or in the case where no specifications are given, as defined by facility policy.

(E) Records of disinfection and rinsing of disinfectants to safe residual levels shall be maintained.

(11) Bicarbonate concentrate mixing systems.

(A) Bicarbonate concentrate mixing tanks shall have conical or bowl-shaped bottoms and shall drain from the lowest point of the base. The tank design shall allow all internal surfaces to be disinfected and rinsed.

(B) Bicarbonate concentrate mixing tanks shall not be pre-filled the night before use.

(C) If disinfectant remains in the mixing tank overnight, this solution must be completely drained, the tank rinsed and tested for residual disinfectant prior to preparing the first batch of that day of bicarbonate concentrate.

(D) Unused portions of bicarbonate concentrate shall not be mixed with fresh concentrate.

(E) At a minimum, bicarbonate distribution systems shall be disinfected weekly. More frequent disinfection shall be done if required by the manufacturer, or if dialysate culture results are above the action level.

(F) If jugs are reused to deliver bicarbonate concentrate to individual hemodialysis machines:

(i) jugs shall be emptied of concentrate, rinsed and inverted to drain at the end of each treatment day;

(ii) at a minimum, jugs shall be disinfected weekly, more frequent disinfection shall be considered by the facility quality management committee if dialysate culture results are above the action level; and

(iii) following disinfection, jugs shall be drained, rinsed free of residual disinfectant, and inverted to dry. Testing for residual disinfectant should be done and documented.

(12) Labeling of concentrate containers. All mixing tanks, bulk storage tanks, dispensing tanks and containers for single hemodialysis treatments shall be labeled as to the contents.

(A) Mixing tanks. Prior to batch preparation, a label shall be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling shall remain on the mixing tank until the tank has been emptied.

(B) Bulk storage/dispensing tanks. These tanks shall be permanently labeled to identify the chemical composition or formulation of their contents.

(C) Single-machine containers. At a minimum, single-machine containers shall be labeled with sufficient information to differentiate the contents from other concentrate formulations used in the facility and permit positive identification by users of container contents.

(13) Records of concentrate mixing. Permanent records of batches produced shall be maintained to include the concentrate formula produced, the volume of the batch, lot number(s) of powdered concentrate packages, the manufacturer of the powdered concentrate, date and time of mixing, test results, person performing mixing, test results, and expiration date (if applicable).

(14) Maintenance of dialysate mixing systems. If dialysate concentrates are prepared in the facility, the manufacturers' recommendations shall be followed regarding any preventive maintenance. Records shall be maintained indicating the date, time, person performing the procedure, and the results (if applicable).

(d) Reuse of hemodialyzers and related devices.

(1) Reuse practice in a facility must comply with the American National Standard, Reuse of Hemodialyzers, 1993 Edition published by the AAMI.

(2) Dialyzer manufacturer's labeling shall be reviewed to determine if a specific dialyzer requires special considerations.

(3) A transducer protector shall be replaced when wetted during a dialysis treatment and shall be used for one treatment only.

(4) Arterial lines may be reused only when the arterial lines are labeled to allow for reuse by the manufacturer and the manufacturer-established protocols for the specific line have been approved by the United States Food and Drug Administration.

(5) The water supply in the reuse room shall incorporate a check valve to prevent chemical agents used from inadvertently back flowing into the water distribution system.

(6) Ventilation systems in the reuse room shall be connected to an exhaust system to the outside which is separate from the building exhaust system, have an exhaust fan located at the discharge end of the system, and have an exhaust duct system of noncombustible corrosion-resistant material as needed to meet the planned usage of the system. Exhaust outlets shall be above the roof level and arranged to minimize recirculation of exhaust air into the building.

(7) A facility shall establish, implement, and enforce a policy for dialyzer reuse criteria (including any facility-set number of reuses allowed) which is included in patient education materials and posted in the waiting room and patient treatment areas. A dialyzer may be reused only if that dialyzer's original volume is measured and recorded prior to its first use and the volume of that dialyzer is used as the basis for discard for that dialyzer.

(8) A facility shall consider and address the health and safety of patients sensitive to disinfectant solution residuals.

(9) A facility shall provide each patient with information regarding the reuse practices at the facility, the opportunity to tour the reuse area, and the opportunity to have questions answered.

(10) A facility shall restrict the reprocessing room to authorized personnel.

(11) A facility shall obtain written informed consent of the patient or legal representative.

(e) Centralized dialyzer reprocessing. If a facility participates in centralized reprocessing in which dialyzers from multiple facilities are reprocessed at one site, the facility shall:

(1) appoint a medical director for the centralized reprocessing facility;

(2) require the use of automated reprocessing facility;

(3) maintain responsibility and accountability for the entire reuse process;

(4) adopt, implement, and enforce policies to ensure that the transfer and transport of used and reprocessed dialyzers to and from the off-site location does not increase contamination of the dialyzers, staff, or the environment;

(5) assure that each dialyzer is returned to the appropriate facility or patient home and in the case of home patients who participate in a dialyzer reprocessing program, a system shall be established to verify that the correct dialyzers are being returned to each patient's home; and

(6) provide department staff access to the off-site reprocessing site as part of a facility inspection.

§117.34.Sanitary Conditions and Hygienic Practices.

(a) General infection control measures.

(1) Universal precautions.

(A) Universal precautions shall be followed in the facility for all patient care activities in accordance with 29 Code of Federal Regulations, §1910.1030(d)(1)-(3) (concerning Bloodborne Pathogens) and the Health and Safety Code, Chapter 85, Subchapter I (concerning Prevention of HIV and Hepatitis B Virus by Health Care Workers).

(B) Facility staff shall wash their hands before and after each patient contact in which there is a potential exposure to blood or body fluids. Location and arrangement of hand washing facilities shall permit ease of access and proper use.

(i) Hand washing sinks shall be readily accessible in each patient care area.

(ii) All fixtures and lavatories shall be trimmed with valves which can be operated without the use of hands. There shall be sufficient clearance for the operation of blade-type handles, if they are used.

(iii) Provisions for hand drying shall be included at all hand washing facilities.

(C) Facility staff shall explain the potential risks associated with blood and blood products to patients and family members and provide the indicated personal protective equipment to a patient or family member if the patient or family member assists in procedures which could result in contact with blood or body fluids.

(2) Documentation and coordination of infection control activities.

(A) The facility must designate a person to monitor and coordinate infection control activities.

(B) A facility shall develop and maintain a system to identify and track infections to allow identification of trends or patterns. This activity shall be reviewed as a part of the facility's quality assurance program described in §117.41 of this title (relating to Quality Assurance for Patient Care). The record shall include trends, corrective actions, and improvement actions taken.

(3) Smoking policy. The facility shall establish, implement, and enforce a smoking policy.

(b) Environmental infection control.

(1) General procedures.

(A) A facility shall provide and actively monitor a sanitary environment which minimizes or prevents transmission of infectious diseases.

(i) The facility shall provide a janitor's closet with space for cleaning supplies and equipment.

(ii) Wall bases in patient treatment and other areas which are frequently subject to wet cleaning methods shall be tightly sealed to the floor and the wall, impervious to water and constructed without voids that can harbor insects.

(iii) Floor materials shall be easily cleanable and have wear resistance appropriate for the location involved. In all areas subject to wet cleaning methods, floor materials shall not be physically affected by germicidal and cleaning solutions.

(iv) Wall finishes shall be washable and, in the immediate areas of plumbing fixtures, smooth and moisture resistant.

(v) Floor and wall penetrations by pipes, ducts, and conduits shall be tightly sealed to minimize entry of rodents and insects. Joints of structural elements shall be similarly sealed.

(vi) All exposed ceilings and ceiling structures in areas normally occupied by patients, staff, and visitors shall be finished so as to be cleanable with equipment used in daily housekeeping activities. Ceiling tiles stained with blood shall be cleaned or replaced.

(vii) Ceiling fans shall not be utilized in patient treatment areas.

(B) Blood spills shall be cleaned immediately or as soon as is practical with a disposable cloth and an appropriate chemical disinfectant.

(i) The surface should be subjected to intermediate level disinfection in accordance with the manufacturer's instructions, if a commercial liquid chemical disinfectant is used.

(ii) If a solution of chlorine bleach (sodium hypochlorite) is used, the solution shall be at least 1:100 sodium hypochlorite and the surface to be treated must be compatible with this type of chemical treatment.

(2) Specific procedures for equipment and dialysis machines.

(A) Routine disinfection of active and backup dialysis machines shall be performed according to facility defined protocol, accomplishing at least intermediate level disinfection and the disinfectant removed.

(B) Between patient shifts, facility staff shall clean machine exteriors, treatment chairs, tourniquets, and hemostats. Blood pressure cuffs which become contaminated with blood shall be removed from service, disinfected, and allowed to dry prior to being returned to use.

(c) Medical waste and liquid/sewage waste management.

(1) The facility 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 Commission on Environmental Quality's requirements in Title 30, Texas Administrative Code, §330.1004 (Generators of Medical Waste).

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

(d) Hepatitis B prevention.

(1) Prevention requirements concerning staff. The facility shall offer hepatitis B vaccination to previously unvaccinated, susceptible new staff members in accordance with 29 Code of Federal Regulations, §1910.1030(f)(1)-(2) (concerning Bloodborne Pathogens). Staff vaccination records shall be maintained in each staff member's health record.

(2) Prevention requirements concerning patients.

(A) Hepatitis B vaccination.

(i) With the advice and consent of a patient's attending nephrologist, facility staff shall make the hepatitis B vaccine available to a patient who is susceptible to hepatitis B, provided that the patient has coverage or is willing to pay for vaccination.

(ii) The facility shall make available to patients literature describing the risks and benefits of the hepatitis B vaccination.

(B) Serologic screening of patients.

(i) A patient new to dialysis or returning to a facility after extended hospitalization or absence of 30 calendar days or longer shall have been screened for HBsAg within one month before or at the time of admission to the facility or have a known anti-HBs status of at least 10 milli-international units per milliliter no more than 12 months prior to admission. The facility shall document how this screening requirement is met.

(ii) Repeated serologic screening shall be based on the antigen or antibody status of the patient.

(I) Monthly screening for HBsAg is required for patients whose previous test results are negative for HBsAg.

(II) Screening of HBsAg-positive or anti-HBs-positive patients may be performed on a less frequent basis, provided that the facility's policy on this subject remains congruent with Appendices i and ii of the National Surveillance of Dialysis Associated Disease in the United States, 1993, published by the United States Department of Health and Human Services.

(C) Isolation procedures for the HBsAg-positive patient.

(i) The facility shall treat patients positive for HBsAg in a segregated treatment area which includes a handwashing sink, a work area, patient care supplies and equipment, and sufficient space to prevent cross-contamination to other patients.

(ii) A patient who tests positive for HBsAg shall be dialyzed on equipment reserved and maintained for the HBsAg-positive patient's use only.

(iii) When a caregiver is assigned to both HBsAg-negative and HBsAg-positive patients, the HBsAg-negative patients assigned to this grouping must be Hepatitis B antibody positive. Hepatitis B antibody positive patients are to be seated at the treatment stations nearest the isolation station and be assigned to the same staff member who is caring for the HBsAg+ patient.

(iv) If an HBsAg-positive patient is discharged, the equipment which had been reserved for that patient shall be given intermediate level disinfection prior to use for a patient testing negative for HBsAg.

(v) In the case of patients new to dialysis or a patient returning to a facility after extended hospitalization or absence of 30 calendar days or longer, if these patients are admitted for treatment before results of HBsAg or anti-HBs testing are known, these patients shall undergo treatment as if the HBsAg test results were potentially positive, except that they shall not be treated in the HBsAg isolation room, area, or machine.

(I) The facility shall treat potentially HBsAg-positive patients in a location in the treatment area which is outside of traffic patterns and may not reuse the dialyzer until the HBsAg test results are known.

(II) The dialysis machine used by this patient shall be given intermediate level disinfection prior to its use by another patient.

(III) The facility shall obtain HBsAg status results of the patient no later than three days from admission.

(e) Tuberculosis prevention.

(1) Prevention requirements concerning staff.

(A) Facility staff shall be screened for tuberculosis upon employment or receiving privileges as a member of the medical staff and prior to patient contact.

(B) Subsequent screening of facility staff shall be performed after any potential exposure to laryngeal or pulmonary tuberculosis.

(C) Respiratory isolation procedures and precautions developed by the facility shall be employed by facility staff providing treatment to patients with pulmonary tuberculosis.

(2) Prevention requirements concerning patients.

(A) If the facility treats active pulmonary tuberculosis patients, a separate room with an isolated air handling system shall be utilized for these patients.

(B) The facility shall screen patients for tuberculosis when indicated by the presence of risk factors for, or the signs and symptoms of tuberculosis. Screening shall be performed after potential exposure to active laryngeal or pulmonary tuberculosis.

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 August 18, 2003.

TRD-200305328

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: September 7, 2003

Proposal publication date: March 14, 2003

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

25 TAC §§117.41 - 117.46

The amendments are adopted under Health and Safety Code (HSC), Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ESRDs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health. The review of these rules implements Government Code, §2001.039.

§117.43.Provision and Coordination of Treatment and Services.

(a) Patient rights. Each facility shall adopt, implement, and enforce policies and procedures appropriate to the patient population served which ensure each patient is:

(1) treated with respect, dignity, and full recognition of the patient's individuality and personal needs;

(2) provided privacy and confidentiality, for the patient and the clinical record;

(3) provided a safe and comfortable treatment environment;

(4) provided information in a manner to facilitate understanding by the patient and the patient's legal representative, family or significant other. Written patient information materials shall be available, with materials in languages other than English if the census of the facility includes more than four patients who read that primary language. In lieu of written materials in the patient's primary language, an interpreter may be provided if documentation and patient interview support that information sufficient to allow the patient to participate in the treatment has been communicated;

(5) informed by a physician of the patient's medical status;

(6) informed of all treatment modalities and settings for the treatment of end stage renal disease;

(7) informed about and participates in, if desired, all aspects of care, including the right to refuse treatment, and informed of the medical consequences of such refusal;

(8) aware of all services available in the facility and the charges for services provided;

(9) informed about the facility's reuse of dialysis supplies, including hemodialyzers. If printed materials such as brochures are used to describe a facility and its services, the brochures shall contain a statement with respect to reuse;

(10) assured of a reasonable response by the facility to the patient's requests and needs for treatment or service, within the facility's capacity, the facility's stated mission, and applicable law and regulation;

(11) provided hours of dialysis that are scheduled for patient convenience whenever feasible or possible. Consideration shall be given to a patient's work or school schedule;

(12) transferred or discharged only for medical reasons, for the patient's welfare or that of other patients or staff members, or for nonpayment of fees. A patient shall be given 30 calendar days advance notice to ensure orderly transfer or discharge, except in cases where the patient presents an immediate risk to others;

(13) a facility shall establish, implement and enforce a policy whereby a disruptive patient or family member or non-compliant patient is given an opportunity and assistance to improve the problematic behavior prior to dismissal from the facility. The policy will include requirements at §117.43(b)(7);

(14) provided protection from abuse, neglect, or exploitation as those terms are defined in §1.204 of this title (relating to Abuse, Neglect, and Exploitation Defined);

(15) provided information regarding advance directives and allowed to formulate such directives to the extent permitted by law. This includes documents executed under the Natural Death Act, Health and Safety Code, Chapter 672; Civil Practice and Remedies Code, Chapter 135 concerning durable power of attorney for health care; and Health and Safety Code, Chapter 674 concerning out-of-hospital do-not-resuscitate;

(16) aware of the mechanisms and agencies to express a complaint against the facility without fear of reprisal or denial of services. A facility shall provide to each individual who is admitted to the facility a written statement that informs the individual that a complaint against the facility may be directed to the department. The statement shall be provided at the time of admission and shall advise the patient that registration of complaints may be filed with the director, Health Facility Licensing and Compliance Division, Texas Department of Health, 1100 West 49th Street, Austin, Texas 78756-3199, 1-888-973-0022. Correctional institutions shall not be required to include the 1-888 number in information provided to patients in these facilities; and

(17) fully informed of the rights listed in this subsection, the responsibilities established by the facility, and all rules and regulations governing patient conduct and responsibilities. A written copy of the patient's rights and responsibilities shall be provided to each patient or the patient's legal representative upon admission and a copy shall be posted with the facility license certificate.

(b) Patient care plan.

(1) A facility shall establish, implement, and enforce a policy whereby patient services are coordinated using an interdisciplinary team approach. The interdisciplinary team shall consist of the patient's primary dialysis physician, registered nurse, social worker, and dietitian.

(2) The interdisciplinary team shall engage in an interactive conference in order to develop a written, individualized, comprehensive patient care plan that specifies the services necessary to address the patient's medical, psychological, social, and functional needs, and includes treatment goals.

(3) The patient care plan shall include evidence of coordination with other service providers (e.g. hospitals, long term care facilities, home and community support services agencies, or transportation providers) as needed to assure the provision of safe care.

(4) The patient care plan shall include evidence of the patient's (or patient's legal representative's) input and participation, unless they refuse to participate. At a minimum, the patient care plan shall demonstrate that the content was discussed with the patient or the patient's legal representative by a member of the interdisciplinary team.

(5) The patient care plan shall be developed within 30 days from the patient's admission to the facility and updated as indicated by any change in the patient's medical, nutritional, or psychosocial condition, or at least every six months. Evidence of the review of the patient care plan with the patient and the interdisciplinary team to evaluate the patient's progress or lack of progress toward the goals of the care plan, and interventions taken when the goals are not achieved, shall be documented and included in the patient's clinical record.

(6) A team conference may be conducted via phone conferencing. A phone care plan conference conducted with the interdisciplinary team and the patient (or their legal representative) must be documented as a phone conference.

(7) In the case of disruptive patients or family members or patients who do not conform to the treatment plan, the facility will establish, implement and enforce a process for more intensive team intervention with this patient to include assessment of needs and planned interventions to assist the patient in adjusting to the requirements for safe care.

(c) Emergency preparedness.

(1) A facility shall implement written procedures which describe staff and patient actions to manage potential medical and non-medical emergencies, including but not limited to, fire, equipment failure, power outages, medical emergencies, and natural or other disasters which are likely to threaten the health or safety of facility patients, the staff, or the public.

(2) A facility shall have a functional plan to access the community emergency medical services.

(3) A facility shall have personnel qualified to operate emergency equipment and to provide emergency care to patients on-site and available during all treatment times. A charge nurse qualified to provide basic cardiopulmonary life support (BCLS) shall be on site and available to the treatment area whenever patients are present. All clinical staff members shall maintain current certification and competency in BCLS.

(4) A facility shall have a transfer agreement with one or more hospitals which provide acute dialysis service for the provision of inpatient care and other hospital services to the facility's patients. The facility shall have documentation from the hospital to the effect that patients from the facility will be accepted and treated in emergencies. There shall be reasonable assurances that:

(A) the transfer or referral of patients will be effected between the hospital and the facility whenever such transfer or referral is determined as medically appropriate by the attending physician, with timely acceptance and admission;

(B) the interchange of medical and other information necessary or useful in the care and treatment of the patient transferred will occur within one working day; and

(C) security and accountability will be assured for the transferred patient's personal effects.

(5) A facility shall establish, implement and enforce a written plan for the protection of patients in the event of a fire.

(A) An evacuation plan shall be developed and diagrams posted in conspicuous places.

(B) The facility shall provide approved fire extinguishing equipment adequate for the conditions involved. Every portable fire extinguisher maintained in the facility shall be installed and maintained in accordance with National Fire Protection Association 10, Standard for Portable Fire Extinguishers, 1994 Edition, and the National Fire Protection Association 101, Code for Safety to Life from Fire in Buildings and Structures, 1994 Edition, §26-3.5, published by the National Fire Protection Association, Post Office Box 9101, Batterymarch Park, Quincy, Massachussetts 02169, 1-800-344-3555. Fire extinguishers shall be refilled when necessary, kept in condition for instant use, and tagged or labeled to indicate the name, address, and telephone number of the person recharging the unit and the date of the last inspection. The hose, nozzle, gaskets, and all other parts shall be maintained in good repair at all times.

(C) The facility shall conduct fire drills at least every six months for each patient shift to include the use of alarms and equipment, and discussion with patients, visitors, employees and staff about the evacuation plan. Written reports shall be maintained to include evidence of staff and patient participation.

(D) All staff shall be familiar with the locations of fire-fighting equipment. Fire-fighting equipment shall be located so that a person shall not have to travel more than 75 feet from any point to reach the equipment.

(6) A written disaster preparedness plan for natural and other disasters specific to each facility shall be developed and in place. The plan shall be based on an assessment of the probability and type of disaster in each region and the local resources available to the facility. The plan shall be reviewed by the governing body at least annually. Contact shall be made annually with a local disaster management representative to assess the need to revise the plan and to ensure that local agencies are aware of the dialysis facility, its provision of life-saving treatment, and the patient population served. The plan shall include procedures designed to minimize harm to patients and staff along with ensuring safe facility operations. The plan and in-service programs for patients and staff shall include provisions or procedures for responsibility of direction and control, communications, alerting and warning systems, evacuation, and closure. Each staff member employed by or under contract with the facility shall be able to demonstrate their role or responsibility to implement the facility's disaster preparedness plan.

(7) A facility shall have an emergency lighting system capable of providing sufficient illumination to allow safe discontinuation of treatments and safe evacuation from the building. Battery pack systems shall be maintained and tested quarterly. If a facility maintains a back-up generator, the generator must be installed, tested and maintained in accordance with the National Fire Protection Association 110, Standard for Emergency and Standby Power Systems, 1993 Edition (NFPA 110), published by the National Fire Protection Association.

(8) A facility shall develop and post a telephone number listing specific to the facility equipment and locale to assist staff in contacting mechanical and technical support in the event of an emergency.

(d) Medication storage and administration.

(1) Pharmaceutical services shall be provided in accordance with accepted professional principles and federal and state laws and regulations.

(2) Medications shall be administered only if such medication is ordered by the patient's physician.

(3) All verbal or telephone orders shall be received by a licensed nurse or physician assistant. Orders relating to a specific service (e.g. dietary services), may be received by the licensed professional responsible for providing the service (e.g. dietitian) and countersigned by the physician within 15 calendar days.

(4) Medications maintained in the facility shall be properly stored and safeguarded in enclosures of sufficient size which are not accessible to unauthorized persons. Refrigerators used for storage of medications shall maintain appropriate temperatures for such storage.

(5) A facility shall maintain an emergency stock of medications, as specified by the medical director, to treat the emergency needs of patients.

(6) Medications shall not be prepared for administration in the patient's immediate treatment area. The medication preparation area shall be located in such a manner as to prevent contamination of medicines being prepared for administration and shall include a work counter and a sink.

(7) Multi-dose vials shall not be taken to a patient station. Protocols approved by the Centers for Disease Control must be used in those cases where single-use vials are entered more than once.

(8) Medications not given immediately shall be labeled with the patient's name, the name of the medication, the dosage prepared, and the initials of the person preparing the medication. All medications shall be administered by the individual who prepares them.

(9) All medications shall be administered by licensed nurses, physician assistants, or physicians except that intravenous normal saline, intravenous heparin, subcutaneous lidocaine, and oxygen may be administered as part of a routine hemodialysis treatment by dialysis technicians qualified according to §117.62(b) and (f) of this title (relating to Training Curricula and Instructors) and §117.63(b), (c) and (e) of this title (relating to Competency Evaluation). Such administration by dialysis technicians shall be in compliance with Chapter 157 of the Texas Occupations Code concerning the delegation of medical acts by a licensed physician in the State of Texas.

(e) Nursing services.

(1) Nursing services to prevent or reduce complications and to maximize the patient's functional status shall be provided to a patient and the patient's family or significant other.

(2) A full-time supervising nurse shall be employed to manage the provision of patient care.

(3) A registered nurse shall be responsible for:

(A) conducting admission nursing assessments;

(B) conducting assessments of a patient when indicated by a question relating to a change in the patient's status or at the patient's request;

(C) participating in team review of a patient's progress;

(D) recommending changes in treatment based on the patient's current needs;

(E) facilitating communication between the patient, patient's family or significant other, and other team members to ensure needed care is delivered;

(F) providing oversight and direction to dialysis technicians and licensed vocational nurses; and

(G) participating in continuous quality improvement activities.

(4) A nurse or nurses functioning in the charge role shall be on site and available to the treatment area to provide patient care during all dialysis treatments.

(5) At least one licensed nurse shall be available on-site to provide patient care for every twelve patients or portion thereof. This may include the nurse(s) functioning in the charge role required by paragraph (4) of this subsection.

(6) If pediatric dialysis is provided, a registered nurse with experience or training in pediatric dialysis shall be available to provide care for pediatric dialysis patients smaller than 35 kilograms in weight.

(7) Sufficient direct care staff shall be on-site to meet the needs of the patients.

(A) The staffing level for a facility shall not exceed four patients per licensed nurse or patient care technician per patient shift. During treatment of eight or more patients, one of the licensed nurses qualified to function in the charge role shall not be included in this ratio.

(B) For pediatric dialysis patients, one licensed nurse shall be provided on-site for each patient weighing less than ten kilograms and one licensed nurse provided on- site for every two patients weighing from ten to 20 kilograms.

(8) A facility shall provide a nursing station(s) to allow adequate visual monitoring of patients by nursing staff during treatment.

(9) A licensed nurse or dialysis technician shall collect and document objective and subjective data for each patient before and after treatment according to facility policy and the staff member's level of training. Written protocols may identify parameters which would require a patient be referred to a nurse for evaluation. A registered nurse shall conduct a patient assessment when indicated by a question relating to a change in the patient's status or at the patient's request.

(10) The initial patient evaluation shall be initiated by a licensed nurse qualified to function in the charge role or a registered nurse at the time of the first treatment in the facility and completed by a registered nurse within the first three treatments.

(f) Licensed vocational nurses. This chapter does not preclude a licensed vocational nurse (LVN) from practicing in accordance with the rules adopted by the Texas Board of Vocational Nurse Examiners. If the LVN is acting in the capacity of a dialysis technician, the facility shall determine that the LVN has passed a training and competency evaluation curriculum which meets the requirements in §117.62 of this title (relating to Training Curricula) and §117.63 of this title (relating to Competency Evaluation).

(g) Dialysis technicians. A dialysis technician providing direct patient care shall demonstrate knowledge and competency for the responsibilities specified in §117.62 of this title and §117.63 of this title.

(h) Nutrition services.

(1) Nutrition services shall be provided to a patient and the patient's caregiver(s) in order to maximize the patient's nutritional status.

(2) The dietitian shall be responsible for:

(A) conducting a nutrition assessment of a patient;

(B) participating in a team review of a patient's progress;

(C) recommending therapeutic diets in consideration of cultural preferences and changes in treatment based on the patient's nutritional needs in consultation with the patient's physician;

(D) counseling a patient, a patient's family, and a patient's significant other on prescribed diets and monitoring adherence and response to diet therapy. Correctional institutions shall not be required to provide counseling to family members or significant others;

(E) referring a patient for assistance with nutrition resources such as financial assistance, community resources or in-home assistance;

(F) participating in continuous quality improvement activities; and

(G) providing ongoing monitoring of subjective and objective data to determine the need for timely intervention and follow-up. Measurement criteria include but are not limited to weight changes, blood chemistries, adequacy of dialysis, and medication changes which affect nutrition status and potentially cause adverse nutrient interactions.

(3) The collection of objective and subjective data to assess nutrition status shall occur within two weeks or seven treatments from admission to the facility, whichever occurs later. A comprehensive nutrition assessment with an educational component shall be completed within 30 days or 13 treatments from admission to the facility, whichever occurs later.

(4) A nutrition reassessment shall be conducted annually or more often if indicated.

(5) Each facility shall employ or contract with a dietitian(s) to provide clinical nutrition services for each patient. One full-time equivalent of dietitian time shall be available for up to 100 patients with the maximum patient load per full-time equivalent of dietitian time being 125 patients.

(6) Nutrition services shall be available at the facility during scheduled treatment times. Access to services may require an appointment.

(i) Social services.

(1) Social services shall be provided to patients and their families and shall be directed at supporting and maximizing the adjustment, social functioning, and rehabilitation of the patient.

(2) The social worker shall be responsible for:

(A) conducting psychosocial evaluations;

(B) participating in team review of patient progress;

(C) recommending changes in treatment based on the patient's current psychosocial needs;

(D) providing case work and group work services to patients and their families in dealing with the special problems associated with end stage renal disease;

(E) except in the case of social workers providing service in correctional institutions, identifying community social agencies and other resources and assisting patients and families to utilize them; and

(F) participating in continuous quality improvement activities.

(3) Initial contact between the social worker and the patient shall occur and be documented within two weeks or seven treatments from the patient's admission, whichever occurs later. A comprehensive psychosocial assessment shall be completed within 30 days or 13 treatments from the patient's admission, whichever occurs later.

(4) A psychosocial reassessment shall be conducted annually or more often if indicated.

(5) Each facility shall employ or contract with a social worker(s) to meet the psychosocial needs of the patients. One full-time equivalent of qualified social worker time shall be available for each 100 patients. If the facility provides additional staff who perform supportive services (e.g. assistance with financial services/ transportation), the maximum patient load per full-time equivalent of qualified social worker time may be 125 patients.

(6) Social services shall be available at the facility during the times of patient treatment. Access to social services may require an appointment.

(j) Medical services.

(1) Medical director. The medical director is responsible for:

(A) developing facility treatment goals which are based on review of aggregate data assessed through quality management activities;

(B) assuring adequate training of licensed nurses and dialysis technicians;

(C) adequate monitoring of patients and the dialysis process; and

(D) developing and implementing all policies required by this chapter.

(2) Medical staff.

(A) Each patient shall be under the care of a physician on the medical staff.

(B) The care of a pediatric dialysis patient shall be in accordance with this subparagraph. If a pediatric nephrologist is not available as the primary physician, an adult nephrologist may serve as the primary physician with direct patient evaluation by a pediatric nephrologist according to the following schedule:

(i) for patients two years of age or younger - monthly (two of three evaluations may be by phone);

(ii) for patients three to 12 years of age - quarterly; and

(iii) for patients 13 to 18 years of age--semiannually.

(C) At a minimum, each patient receiving dialysis in the facility shall be seen by a physician on the medical staff once every two weeks during the patient's treatment time. Home patients shall be seen by a physician at least every three months. The record of these contacts shall include evidence of assessment for new and recurrent problems and review of dialysis adequacy, monthly for in-facility patients and quarterly for home patients.

(D) A physician on the medical staff shall be on call and available 24 hours a day (in person or by telecommunication) to patients and staff.

(E) Orders for treatment shall be in writing and signed by the prescribing physician. Routine orders for treatment shall be updated at least annually.

(i) Orders for hemodialysis treatment shall include length of treatment, dialyzer, blood flow rate, dialysate composition, target weight, medications including heparin, and, as needed, specific infection control measures.

(ii) Orders for peritoneal dialysis treatment shall include fill volume(s), number of exchanges, dialysate concentrations, catheter care, medications, and, as needed, specific infection control measures.

(F) If advanced practice nurses or physician assistants are utilized:

(i) there shall be evidence of communication with the treating physician whenever the advanced practice nurse or physician assistant changes treatment orders;

(ii) the advanced practice nurse or physician assistant may not replace the physician in participating in patient care planning or in quality management activities; and

(iii) the treating physician shall be notified and direct the care of patient medical emergencies.

(k) Home dialysis (self dialysis).

(1) If a facility provides self dialysis training, a registered nurse with at least 12 months clinical experience and six months experience in home dialysis shall be responsible for training the patient or family. When other personnel assist in the training, supervision by the registered nurse shall be demonstrated.

(2) For a patient who performs self dialysis at home, the following services shall be provided:

(A) a yearly physical examination;

(B) monthly contact from facility staff by telephone calls or clinic visits;

(C) a clinic visit at least every three months;

(D) communication with the appropriate interdisciplinary team member(s);

(E) routine laboratory work according to facility policy;

(F) a mechanism to contact staff at any time in the event of an emergent need; and

(G) surveillance of the patient's home adaptation, including provisions for visits to the home.

(3) The facility shall provide directly or under arrangement the following services.

(A) For hemodialysis, the required services are:

(i) consultation for the patient with a registered nurse, social worker and a dietitian;

(ii) a record keeping system which assures continuity of care;

(iii) installation and maintenance of equipment;

(iv) testing and appropriate treating of the water used for dialysis; and

(v) ordering of supplies on an ongoing basis.

(B) For continuous ambulatory peritoneal dialysis, the required services are:

(i) consultation for the patient with a registered nurse, a social worker and a dietitian;

(ii) a record keeping system which assures continuity of care; and

(iii) ordering of supplies on an ongoing basis.

(C) For continuous cycling peritoneal dialysis, the required services are:

(i) consultation for the patient with a registered nurse, a social worker and a dietitian;

(ii) a record keeping system which assures continuity of care;

(iii) installation and maintenance of equipment; and

(iv) ordering of supplies on an ongoing basis.

(l) Temporary and transient admissions.

(1) Temporary admissions. If a facility dialyzes a patient who is normally dialyzed in another local facility, the referring and receiving facilities shall meet the requirements in this paragraph.

(A) The individual to be treated by the receiving facility must be a patient of a physician who is a member of the medical staffs of the referring and receiving facilities.

(B) The referring and receiving facilities shall establish, implement, and enforce written policies and procedures for communication of medical information and transfer of clinical records between facilities.

(C) The receiving facility shall continuously evaluate staffing levels and utilize this information in determining whether to accept a temporary admission for treatment.

(D) The receiving facility shall obtain the information described in §117.45(e) of this title (relating to Clinical Records) prior to providing dialysis. However, if the referring facility is closed when the patient's need for dialysis treatment is identified, the receiving facility may provide dialysis with, at a minimum, the following information:

(i) orders for treatment;

(ii) hepatitis B status;

(iii) medical justification by the physician ordering treatment that the patient's need for dialysis outweighs the need for the additional clinical information set out in §117.45(e) of this title.

(E) In the event a temporary patient's hepatitis status is unknown, the patient may undergo treatment as if the HBsAg test results were potentially positive, except that such a patient shall not be treated in the HBsAg isolation room, area, or machine.

(2) Transient admissions. If a facility dialyzes a patient who is normally dialyzed in a distant facility, the facility shall meet the requirements in this paragraph.

(A) The facility shall continuously evaluate staffing levels and utilize this information in determining whether to accept a transient patient for treatment.

(B) The facility shall obtain the information described in §117.45(e) of this title (relating to Clinical Records) prior to providing dialysis. However, if the transient patient arrives unannounced, the facility may provide dialysis with, at a minimum, the following information:

(i) evidence of evaluation of the patient by a physician on the staff of the facility;

(ii) orders for treatment;

(iii) hepatitis B status;

(iv) medical justification by the physician ordering treatment that the patient's need for dialysis outweighs the need for the additional clinical information set out in §117.45(e) of this title.

(C) In the event a transient patient's hepatitis status is unknown, the patient may undergo treatment as if the HBsAg test results were potentially positive, except that such a patient shall not be treated in the HBsAg isolation room, area, or machine.

(m) Laboratory services. A facility that provides laboratory services shall comply with the requirements of Federal Public Law 100-578, Clinical Laboratory Improvement Amendments of 1988 (CLIA 1988). CLIA 1988 applies to all facilities 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.

(n) Illegal remuneration prohibited. A facility shall not violate the Health and Safety Code, §161.191, et seq. concerning the prohibition on illegal remuneration for the purpose of securing or soliciting patients or patronage.

(o) Do-not-resuscitate orders. The facility shall comply with the Health and Safety Code, Chapter 674 concerning out-of-hospital do-not-resuscitate orders.

(p) Audits of billing. A facility shall develop, implement, and enforce a compliance policy for monitoring its receipt and expenditure of state or federal funds.

(q) Student health care professionals. If the facility has a contract or agreement with an accredited school of health care to use their facility for a portion of the students' clinical experience, those students may provide care under the following conditions.

(1) Students may be used in facilities, provided the instructor gives class supervision and assumes responsibility for all student activities occurring within the facility. If the student is licensed (e.g., a licensed vocational nurse attending a registered nurse program for licensure as a registered nurse) the facility shall ensure that the administration of any medication(s) is within the student's licensed scope of practice.

(2) A student may administer medications only if:

(A) on assignment as a student of his or her school of health care; and

(B) the instructor is on the premises and immediately supervises the administration of medication by an unlicensed student and the administration of such medication is within the instructor's licensed scope of practice.

(3) Students shall not be used to fulfill the requirement for administration of medications by licensed personnel.

(4) Students shall not be considered when determining staffing levels required by the facility.

(r) Complaint resolution. A facility shall adopt, implement, and enforce procedures for the resolution of complaints relevant to quality of care or services rendered by licensed health care professionals and other members of the facility staff, including contract services or staff. The facility shall document the receipt and the disposition of the complaint. The investigation and documentation must be completed within 30 calendar days after the facility receives the complaint, unless the facility has and documents reasonable cause for a delay.

§117.46.Reports to the Director.

(a) A facility shall report the following occurrence(s) to the department within ten working days of the occurrence(s):

(1) an accident or incident resulting in the death of a patient; or

(2) conversion of staff or a patient to HbsAg positive.

(b) An occurrence listed in subsection (a) of this section shall be reported to the Director, Health Facility Licensing and Compliance Division, 1100 West 49th Street, Austin, Texas, 78756-3199, telephone number 512-834-6646, fax number 512-834-4514. The report to the director shall be on a form provided by the department and include the information requested on the form. The facility may reproduce the form as needed to maintain an adequate supply.

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 August 18, 2003.

TRD-200305329

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: September 7, 2003

Proposal publication date: March 14, 2003

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

25 TAC §§117.61 - 117.65

The amendments are adopted under Health and Safety Code (HSC), Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ESRDs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health. The review of these rules implements Government Code, §2001.039.

§117.62.Training Curricula and Instructors.

(a) Specific objectives for training curricula. Each training program for dialysis technicians shall develop a written curriculum with objectives specified for each section.

(b) Components of training curricula. The training curricula for dialysis technicians shall include the following minimum components:

(1) introduction to dialytic therapies to include history and major issues as follows:

(A) history of dialysis;

(B) definitions and terminology;

(C) communication skills;

(D) ethics and confidentiality;

(E) multidisciplinary process;

(F) roles of other team members; and

(G) information about renal organizations and resources;

(2) principles of hemodialysis to include:

(A) principles of dialysis;

(B) access to the circulatory system; and

(C) anticoagulation, local anesthetics, and normal saline;

(3) understanding the individual with kidney failure to include:

(A) basic renal anatomy, physiology, and pathophysiology;

(B) the effect of renal failure on other body systems;

(C) symptoms and findings related to the uremic state;

(D) modes of renal replacement therapy, including transplantation;

(E) basic renal nutrition;

(F) basic psychosocial aspects of end stage renal disease (ESRD);

(G) medications commonly administered to patients with ESRD;

(H) confidentiality of patient personal and clinical records;

(I) professional conduct;

(J) patient rights and responsibilities; and

(K) rehabilitation;

(4) dialysis procedures to include:

(A) using aseptic technique;

(B) technical aspects of dialysis, operation and monitoring of equipment, initiation and termination of dialysis;

(C) delivering an adequate dialysis treatment and factors which may result in inadequate treatment;

(D) observing and reporting patient reactions to treatment;

(E) glucose monitoring and hemoglobin/hematocrit monitoring;

(F) emergency procedures and responses such as cardiopulmonary resuscitation, air embolism management, and response to line separation and hemolysis;

(G) external and internal disasters, fire, natural disasters, and emergency preparedness; and

(H) safety, quality control, and continuous quality improvement;

(5) hemodialysis devices to include:

(A) theory and practice of conventional, high efficiency, and high flux dialysis;

(B) dialysate composition, options, indications, complications, and safety;

(C) monitoring and safety; and

(D) disinfection of equipment;

(6) water treatment to include:

(A) standards for water treatment used for dialysis as described in the American National Standard, Water Treatment Equipment for Hemodialysis Applications, August 2001 Edition, published by the American Association for the Advancement of Medical Instrumentation (AAMI), 1110 North Glebe Road, Suite 220, Arlington, Virginia 22201;

(B) systems and devices;

(C) monitoring; and

(D) risks to patients of unsafe water;

(7) reprocessing, if the facility practices reuse, to include:

(A) principles of reuse;

(B) safety, quality control, universal precautions, and water treatment; and

(C) standards for reuse as described in the American National Standard, Reuse of Hemodialyzers, 1993 Edition, published by the AAMI;

(8) patient teaching to include:

(A) the role of the technician in supporting patient education goals; and

(B) adult education principles;

(9) infection control and safety to include:

(A) risks to patients of nosocomial infections, accidents, and errors in treatment;

(B) universal precautions, aseptic technique, sterile technique, and specimen handling;

(C) basic bacteriology and epidemiology;

(D) risks to employees of blood and chemical exposure; and

(E) electrical, fire, disaster, environmental safety, and hazardous substances; and

(10) quality assurance and continuous quality improvement (QA/CQI) to include:

(A) role of the technician in quality assurance activities;

(B) principles of QA/CQI; and

(C) the importance of ongoing quality control activities in assuring safe dialysis treatments are provided to patients.

(c) Additional responsibilities.

(1) If a dialysis technician is to assist with training or treatment of peritoneal dialysis patients, the following content must also be included:

(A) principles of peritoneal dialysis;

(B) sterile technique;

(C) peritoneal dialysis delivery systems;

(D) symptoms of peritonitis; and

(E) other complications of peritoneal dialysis.

(2) If a dialysis technician, other than a licensed vocational nurse (LVN), is to cannulate access or administer normal saline, heparin, or lidocaine, the following content must be included:

(A) access to the circulation to include:

(i) fistula: creation, development, needle placement, and prevention of complications;

(ii) grafts: materials used, creation, needle placement, and prevention of complications; and

(iii) symptoms to report;

(B) safe administration of medications to include:

(i) identifying the right patient;

(ii) assuring the right medication;

(iii) measuring the right dose;

(iv) ascertaining the right route; and

(v) checking the right time for administration;

(C) administration of normal saline to include:

(i) reasons for administration;

(ii) potential complications;

(iii) administration limits; and

(iv) information to report and record;

(D) administration of heparin to include:

(i) reasons for administration;

(ii) methods of administration;

(iii) preparation of ordered dose;

(iv) potential complications; and

(v) information to report and record; and

(E) administration of lidocaine to include:

(i) reasons for administration;

(ii) method of administration;

(iii) preparation of ordered dose;

(iv) potential complications and risks; and

(v) information to report and record.

(F) administration of oxygen to include:

(i) reasons for administration;

(ii) method of administration;

(iii) delivery of the ordered flow rate;

(iv) potential complications and risks; and

(v) information to report and record.

(d) Roster. A roster of attendance for each training class shall be maintained by the instructor.

(e) Trainee evaluation. Each trainee shall be evaluated on a weekly basis during the training program to ascertain the trainee's progress.

(f) Written examination. The dialysis technician trainee shall complete a written examination. The examination shall encompass the content required in subsection (b) of this section. If the dialysis technician trainee will cannulate access and administer medications, the examination shall encompass the content described in subsection (c) of this section. A score of 80% is required on the written examination(s) covering the required content prior to the dialysis technician trainee's release from orientation. Other than the first examination for a specific responsibility in a facility, current certification as a dialysis technician by a nationally recognized testing organization may be substituted for the written examination.

(g) Instructors. An instructor for the course to train an individual as a dialysis technician shall be:

(1) a physician who qualifies as a medical director;

(2) a registered nurse with at least 12 months of experience in hemodialysis obtained within the last 24 months and a current competency skills checklist on file in the facility or a registered nurse instructor of a dialysis technician training course of an accredited college or university;

(3) a qualified dietitian or social worker providing training only within the person's area of expertise; or

(4) a technician with at least 12 months experience, qualified by training and experience in water treatment, dialysate preparation, reprocessing or other technical aspects of dialysis providing training within their area of expertise.

(h) Preceptors. Licensed nurses and patient care technicians who have at least one year of experience in hemodialysis and a current competency skills checklist on file in the facility may assist in didactic sessions and serve as preceptors.

(i) Length of training. For persons with no previous experience in direct patient care, a minimum of 80 clock hours of classroom education and 200 clock hours of directly supervised clinical training shall be required. Training programs for dialysis technician trainees who have previous direct patient care experience may be shortened if competency with the required knowledge and skills is demonstrated, but may not be less than a total of 80 clock hours of combined classroom education and clinical training.

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 August 18, 2003.

TRD-200305330

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: September 7, 2003

Proposal publication date: March 14, 2003

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

25 TAC §§117.81 - 117.86

The amendments are adopted under Health and Safety Code (HSC), Chapter 251, Texas End Stage Renal Disease (ESRD) Facility Licensing Act, which provides the Board of Health (board) with the authority to adopt rules governing the licensing and regulation of ESRDs; and HSC §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and commissioner of health. The review of these rules implements Government Code, §2001.039.

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

Filed with the Office of the Secretary of State on August 18, 2003.

TRD-200305331

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: September 7, 2003

Proposal publication date: March 14, 2003

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

Chapter 411. STATE AUTHORITY RESPONSIBILITIES

Subchapter N. STANDARDS FOR SERVICES TO INDIVIDUALS WITH CO-OCCURRING PSYCHIATRIC AND SUBSTANCE USE DISORDERS (COPSD)

The Texas Department of Mental Health and Mental Retardation (TDMHMR) adopts new §§411.651-411.662 of Chapter 411, Subchapter N, concerning standards for services to individuals with co-occurring psychiatric and substance use disorders (COPSD). Sections §§411.653, 411.654, 411.658, and 411.660, are adopted with changes to the proposed text as published in the May 23, 2003, issue of the Texas Register (28 TexReg 4059-4061). Sections 411.651-411.652, 411.655-411.657, 411.659, and 411.661-411.662 are adopted without changes.

In §411.653, the definition of "access" has been revised to delete the reference to outcomes described in §411.659 because outcomes are not described in §411.659. In the same section, the definition of "co-occurring psychiatric and substance use disorders (COPSD)" has been revised to use the term "psychiatric disorder" rather than "mental illness." The definition of "psychiatric disorder" in §411.653 has been revised on adoption to reference the definition of "mental illness" in the TDMHMR strategic plan. Language is clarified in §411.654 to reflect responsibilities of staff with respect to provision of services to individuals with COPSD. Section 411.658 is revised on adoption to delete subsection (a) and to revise subsection (b) to address the intent of subsection (a). In the same section, subsection (c) is redesignated (b) and language is added that requires entities to ensure that the required competencies described in subsection (a) are demonstrated by staff providing services to individuals with COPSD within 90 days of the effective date of the subchapter. Section 411.660(b)(1) has been revised to add the words "attempt to" with reference to the provider's efforts to involve a family member in treatment planning at request of an individual. Section 411.660(c)(1) has been revised to delete specific timeframes for treatment plan review and to instead indicate that treatment plan review should occur according to TDMHMR-established timeframes.

Public comments on the proposal were received from Sandy Skelton, Executive Director, Texas Council of Community MHMR Centers, Inc., Austin; Arturo Hernandez, Austin-Travis County MHMR, Austin; Pam Gionfriddo, Mental Health Association, Austin; Monica Thyssen, Advocacy, Inc., Austin; and Sam Miller, Lubbock Regional MHMR, Lubbock.

A commenter requested information about arrangements between TDMHMR and the Texas Commission on Alcoholism and Drug Abuse (TCADA) to integrate funding streams to provide for screening, assessments, and treatment services at the local mental health authorities (LMHAs). The department responds that TDMHMR and TCADA have blended funds for specialized services for persons with COPSD since 1996. These funds have been awarded to successful applicants through a request for proposal (RFP) process to purchase specialized adjunct services that address both psychiatric and substance use disorders through intense case management and specific engagement strategies to assist eligible consumers in benefiting from treatment. Non-awarded LMHAs have also served individuals with COPSD (approximately 25% of the TDMHMR adult consumers served in FY02) without the attention to co-occurring disorders that awarded applicants provided. The subchapter seeks to improve outcomes for this population by establishing minimum competencies for staff and standards for assessing and providing services.

A commenter requested information about the funding methodology for services. Another commenter suggested that additional funding would be needed. The department responds that there is not a unique funding methodology for serving members of the TDMHMR priority population who have COPSD. The new subchapter does not impose requirements that are more difficult or more expensive to meet than existing standards. Rather, the subchapter clarifies minimum standards for serving members of the TDMHMR priority population who have COPSD, and it utilizes existing resources and the existing funding methodology.

Commenters asked several questions about training and staff competencies. One commenter requested that the Texas Council of Community MHMR Centers, Inc., through its Quality Management Consortium, Behavioral Health Consortium, and Children's Services Consortium, be provided the opportunity to review and comment on the training curriculum and mode of delivery prior to implementation. The department responds that interested parties are welcome to participate at any time during the development and revision of the curriculum for COPSD. The curriculum is regularly updated to reflect current research and practice. Interested parties may contact Dr. A. J. Ernst at TDMHMR.

A commenter asked if training would be available prior to implementation of the subchapter. The department responds that training opportunities on the competencies identified in the rules will be available prior to and during implementation of the new subchapter.

A commenter asked if LMHAs are expected to budget for staff training to comply with §411.658. The department responds that LMHAs already budget training for staff in areas that are determined by the LMHAs. Although this is an additional training expectation, the LMHAs and other entities identified in the rules will be given train-the-trainer opportunities by the department prior to and during implementation of the new subchapter.

A commenter asked if the interpersonal competencies are measurable. The department responds that interpersonal competencies are measurable and that the curriculum includes a post-test that measures the attendee's mastery of each competency.

A commenter requested that the department distinguish between the competencies needed by persons who screen, assess, and coordinate the development of plans of care, and the competencies needed by substance disorders providers. The department responds that the competencies listed in the new subchapter are minimum competencies for all staff designated to address COPSD with eligible consumers. The competencies do not address substance use disorders for persons with a single diagnosis of a substance use disorder. The required competencies may be met by compliance with the current licensure requirements of the governing or supervisory boards for the respective disciplines involved in serving individuals with COPSD (e.g., LPC, LMSW, LMFT) or by documentation regarding the attainment of the competencies described in the new subchapter.

A commenter noted that there is confusion about the use of the term "COPSD" as it relates to TCADA, Projects for Assistance in Transition from Homelessness (PATH), and TDMHMR. The department responds that "COPSD" is an acronym for "co-occurring psychiatric and substance use disorders." It refers to diagnoses, not specific services. Services to populations with COPSD diagnoses are determined by the funding source. The services currently purchased to serve individuals who have COPSD through TCADA contracts provide individual sessions from cross-trained staff with specific interventions to individuals who are non-responsive to substance abuse or mental health services. PATH purchases specialized outreach services to the homeless, mentally ill population. The new subchapter establishes minimum competencies and standards for assessing and providing services to individuals who have COPSD in a systems approach through mainstream services.

A commenter asked that the department's Office of Medicaid Administration be required to provide documentation assuring local mental health authorities (LMHAs) that Medicaid does not prohibit persons with COPSD from receiving Medicaid rehabilitation services. The department responds that the Office of Medicaid Administration has indicated that Medicaid does not prohibit persons with COPSD from receiving Medicaid rehabilitation services. The Texas Medicaid State Plan stipulates that mental health rehabilitative services are "medically necessary to reduce an individual's disability resulting from mental illness." Therefore, to be reimbursed through Medicaid rehabilitative services, documentation must indicate that the skills training addresses the mental illness. Services that address the substance abuse issues without relating those issues back to the mental illness are not reimbursable under Medicaid rehabilitative services.

A commenter suggested that department staff discuss with members of its Performance Contract Committee whether the department will include substance disorder treatments as part of the performance contract. The department responds that substance disorder treatments are not part of the performance contract. Persons who present for services with a single diagnosis of a substance use disorder do not meet eligibility for services as defined for an "individual" in the new subchapter and must be referred to an appropriate provider for substance abuse services. The services for persons with mental illness that are described in the performance contract, however, do not exclude persons with co-occurring substance use disorders.

With reference to §411.654, a commenter asked if all staff providing services to individuals with COPSD must have the competencies identified in the subchapter. The department responds that individuals with COPSD have access to staff who meet the specialty competencies in order to address COPSD and meet the service requirements that are defined in the subchapter. The new subchapter seeks to improve outcomes for individuals with COPSD by defining minimum staff competencies and identifying minimum standards for assessing and providing services to this population. The subchapter does not restrict services to only those that address COPSD; rather, it requires that COPSD be addressed by appropriate staff.

Concerning §411.657(a), a commenter suggested rewording the subsection to reflect changes in the priority population. The department responds that in response to the commenter's concern, the definition of "psychiatric disorder" for adults has been changed: "In an adult, a diagnosis of mental illness as defined in the TDMHMR strategic plan."

Concerning §411.657, a commenter suggested the addition of the following language: "Entities will work with the criminal justice system to ensure that an individual has access to services while incarcerated." The department responds that it has no authority for provision of services to persons while they are incarcerated. Following release, access to services is addressed in TDMHMR proposed rules governing mental health services admissions, continuity, and discharge.

A commenter suggested that §411.658(a) be deleted and replaced with §411.658(b), because the subsections are redundant. The department concurs and has deleted §411.658(a) and modified §411.658(b) to address age-appropriateness.

With respect to §411.660(a)(1), a commenter noted that the items listed are associated with treatment planning, not screening and assessment. The department responds that the items represent information collected during screening and assessment for purposes that include treatment planning.

Concerning §411.660(b)(1), a commenter asked if the provider will be out of compliance if a family member refuses to participate. The department responds that it has modified §411.660(b)(1) as follows: "If the individual has requested the involvement of a family member, then the provider must attempt to involve the family member in all aspects of planning the individual's treatment."

Regarding §411.660(c), a commenter stated that the treatment plan review should coincide with TDMHMR utilization review guidelines. The department responds that the treatment plan review is a provider activity and may occur at more frequent intervals than utilization review for authorization purposes. The current requirement for provider treatment plan review in Chapter 412, Subchapter G (governing mental health community services standards) states that the treatment plan review should occur as clinically indicated or at least every 90 days. The language in subsection (c) has been revised to reference the timeframes established by the TDMHMR.

1. GENERAL PROVISIONS

25 TAC §§411.651 - 411.656

The new rules are adopted under the Texas Health and Safety Code, §532.015, which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; §533.047 (Managed Care Organizations: Medicaid Program), §534.052 (Rules and Standards), and §534.058 (Standards of Care).

§411.653.Definitions.

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

(1) Access--An individual's ability to obtain the psychiatric and substance use disorder services needed.

(2) Adolescent--A person who is 13 through 17 years of age.

(3) Adult- A person who is 18 years of age or older.

(4) Child--A person who is 0 through 12 years of age.

(5) Contract--A legally enforceable written agreement for the purchase of services.

(6) Co-occurring psychiatric and substance use disorders (COPSD)--The co-occurring diagnoses of psychiatric disorders and substance use disorders.

(7) Diagnostic and Statistical Manual of Mental Disorders (DSM)--The most recent edition of the American Psychiatric Association's official classification of mental disorders.

(8) Entity or entities--The terms used to refer to the following:

(A) local mental health authorities (LMHAs);

(B) Medicaid managed care organizations (MMCOs);

(C) state mental health facilities (SMHF); and

(D) Medicaid providers who are required to comply with Chapter 419, Subchapter L of this title, governing Medicaid Rehabilitative Services, or Chapter 412, Subchapter J of this title, governing Service Coordination.

(9) Family member--Anyone an individual identifies as being involved in the individual's life (e.g., the individual's parent, spouse, child, sibling, significant other, or friend).

(10) Individual--

(A) For an LMHA--An adult with COPSD, adolescent with COPSD, or child with COPSD seeking or receiving services from or through the LMHA or its provider.

(B) For an MMCO--An enrolled adult with COPSD, adolescent with COPSD, or child with COPSD seeking or receiving services from or through the MMCO or its provider.

(C) For an SMHF--An adult with COPSD, adolescent with COPSD, or child with COPSD seeking or receiving services from or through the SMHF or its provider.

(D) For a provider of rehabilitative services or a provider of service coordination reimbursed by Medicaid--An adult with COPSD, adolescent with COPSD, or child with COPSD seeking or receiving rehabilitative services or service coordination reimbursed by Medicaid.

(11) Integrated assessment--An assessment of an individual to gather both substance use and psychiatric information.

(12) Legally authorized representative (LAR)--A person authorized by law to act on behalf of an individual with regard to a matter (e.g., a parent, guardian, or managing conservator of a child or adolescent, a guardian of an adult, or a personal representative of a deceased individual).

(13) Local mental health authority (LMHA)--A governmental entity to which the Texas MHMR Board delegates its authority and responsibility for any, all, or portions of planning, policy development, coordination, resource development and allocation, and oversight of the delivery of mental health services in a local service area.

(14) Medicaid managed care organization (MMCO)--An entity that has a current Texas Department of Insurance certificate of authority to operate as a health maintenance organization (HMO) under Article 20A of the Texas Insurance Code or as an approved nonprofit health corporation under Article 21.52F of the Texas Insurance Code and that provides mental health services to Medicaid recipients.

(15) Psychiatric disorder--A mental illness in a child, adolescent, or adult who is a member of the mental health priority population as defined in the current TDMHMR strategic plan.

(16) Readiness to change--An individual's emotional and cognitive awareness of the need to change, coupled with a commitment to change.

(17) Services--Services provided to treat a psychiatric or substance use disorder.

(18) Staff--Full- or part-time employees, contractors, and students of an entity.

(19) Substance use disorder--The use of one or more drugs, including alcohol, which significantly and negatively impacts one or more major areas of life functioning and which meets criteria described in the current Diagnostic and Statistical Manual of Mental Disorders for substance abuse or substance dependence.

(20) Support services--Services delivered to an individual, legally authorized representative (LAR) or family member(s) to assist the individual in functioning in the living, learning, working, and socializing environments.

(21) Treatment plan--A written document developed by the provider, in consultation with the individual (and LAR on the individual's behalf), that is based on assessments of the individual and which addresses the individual's strengths, needs, goals, and preferences regarding service delivery as referenced in §412.315 (relating to Assessment and Treatment Planning) of Chapter 412, Subchapter G of this title, governing Mental Health Community Services Standards.

§411.654.Services to Individuals.

(a) Staff providing services to an individual with COPSD must ensure that services provided:

(1) address both psychiatric and substance use disorders;

(2) be provided within established practice guidelines for this population; and

(3) facilitate individuals or LARs in accessing available services they need and choose, including self-help groups.

(b) The services provided to an individual with COPSD must be provided:

(1) by staff who are competent in the areas identified in §411.658 of this title (relating to Specialty Competencies of Staff Providing Services to Individuals with COPSD);

(2) in an individual or small group setting;

(3) in an age, gender, and culturally appropriate manner; and

(4) in accordance with the individual's treatment plan.

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 August 18, 2003.

TRD-200305279

Rodolfo Arredondo

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: September 7, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 206-4516

25 TAC §§411.657 - 411.659

The new rules are adopted under the Texas Health and Safety Code, §532.015, which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; §533.047 (Managed Care Organizations: Medicaid Program), §534.052 (Rules and Standards), and §534.058 (Standards of Care).

§411.658.Specialty Competencies of Staff Providing Services to Individuals with COPSD.

(a) Entities must ensure that services to individuals are age-appropriate and are provided by staff within their scope of practice who have the following minimum knowledge, technical, and interpersonal competencies prior to providing services:

(1) Knowledge competencies:

(A) knowledge of the fact that psychiatric and substance use disorders are potentially recurrent relapsing disorders, and that although abstinence is the goal, relapses can be opportunities for learning and growth;

(B) knowledge of the impact of substance use disorders on developmental, social, and physical growth and development of children and adolescents;

(C) knowledge of interpersonal and family dynamics and their impact on individuals;

(D) knowledge of the current Diagnostic and Statistical Manual of Mental Disorders diagnostic criteria for psychiatric disorders and substance use disorders and the relationship between psychiatric disorders and substance use disorders;

(E) knowledge regarding the increased risks of self-harm, suicide, and violence in individuals;

(F) knowledge of the elements of an integrated treatment plan and community support plan for individuals;

(G) basic knowledge of pharmacology as it relates to individuals;

(H) basic understanding of the neurophysiology of addiction;

(I) knowledge of the phases of recovery for individuals;

(J) knowledge of the relationship between COPSD and Axis III disorders; and

(K) basic knowledge of self-help in recovery.

(2) Technical competencies:

(A) ability to perform age-appropriate assessments of individuals; and

(B) ability to formulate an individualized treatment plan and community support plan for individuals.

(3) Interpersonal competencies:

(A) ability to tailor interventions to the process of recovery for individuals;

(B) ability to tailor interventions with readiness to change; and

(C) ability to support individuals who choose to participate in 12-step recovery programs.

(b) Within 90 days of the effective date of this subchapter, entities must ensure that staff who provide services to individuals with COPSD have demonstrated the competencies described in subsection (a) of this section. These competencies may be evidenced by compliance with current licensure requirements of the governing or supervisory boards for the respective disciplines involved in serving individuals with COPSD or by documentation regarding the attainment of the competencies described in subsection (a) of this section. For unlicensed staff delivering these services, these competencies are evidenced by documentation regarding their attainment as required in subsection (a) of this section.

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 August 18, 2003.

TRD-200305280

Rodolfo Arredondo

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: September 7, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 206-4516

25 TAC §411.660

The new rule is adopted under the Texas Health and Safety Code, §532.015, which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; §533.047 (Managed Care Organizations: Medicaid Program), §534.052 (Rules and Standards), and §534.058 (Standards of Care).

§411.660.Screening, Assessment, and Treatment Planning.

(a) Screening and assessment. When a screening determines an assessment is necessary, an integrated assessment must be conducted to consider relevant past and current medical, psychiatric, and substance use information, including:

(1) information from the individual (and LAR on the individual's behalf) regarding the individual's strengths, needs, natural supports, responsiveness to previous treatment, as well as preferences for and objections to specific treatments;

(2) the needs and desire of the individual for family member involvement in treatment and services if the individual is an adult without an LAR; and

(3) recommendations and conclusions regarding treatment needs and eligibility for services for individuals.

(b) Treatment plan development.

(1) The individual (and LAR on the individual's behalf, if applicable) must be involved in all aspects of planning the individual's treatment. If the individual has requested the involvement of a family member, then the provider must attempt to involve the family member in all aspects of planning the individual's treatment.

(2) The treatment plan must identify services to be provided and must include measurable outcomes that address COPSD.

(3) The treatment plan must identify the LAR's or family members' need for education and support services related to the individual's mental illness and substance abuse and a method to facilitate the LAR's or family members' receipt of the needed education and support services.

(4) The individual, LAR, and, if requested, family member, must be given a copy of the treatment plan.

(c) Treatment plan review. Each individual's treatment plan must be reviewed in accordance with TDMHMR-defined timeframes and the review must be documented.

(d) Progress notes. The medical record notes must contain a description of the individual's progress towards goals identified in the treatment plan, as well as other clinically significant activities or events.

(e) Episode of care summary. Upon discharge or transfer of an individual from one entity to another, the individual's medical record must identify the services provided according to this subchapter and the items referenced in §412.315 (relating to Assessment and Treatment Planning) of Chapter 412, Subchapter G of this title, governing Mental Health Community Services Standards.

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 August 18, 2003.

TRD-200305281

Rodolfo Arredondo

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: September 7, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 206-4516

25 TAC §411.661, §411.662

The new rules are adopted under the Texas Health and Safety Code, §532.015, which provides the Texas Mental Health and Mental Retardation Board with broad rulemaking authority; §533.047 (Managed Care Organizations: Medicaid Program), §534.052 (Rules and Standards), and §534.058 (Standards of Care).

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 August 18, 2003.

TRD-200305282

Rodolfo Arredondo

Chairman, Texas MHMR Board

Texas Department of Mental Health and Mental Retardation

Effective date: September 7, 2003

Proposal publication date: May 23, 2003

For further information, please call: (512) 206-4516

Chapter 704. TEXANS CONQUER CANCER PROGRAM

25 TAC §704.7

The Texas Cancer Council adopts amendments to §704.7, concerning the implementation of the Texans Conquer Cancer Program (TCCP) without changes to the proposed text as published in the June 13, 2003, issue of the Texas Register (28 TexReg 4522).

Section 704.7 is being amended to adopt by reference the application form that must be used for the submission of grant proposals and to add guidelines for awarding funds in the Texans Conquer Cancer Account and expense reimbursement. The Council has determined that these guidelines are necessary to assist potential applicants in understanding and correctly submitting their requests for funds from this account. The Guidelines explain how applications will be reviewed, which support services and organizations are eligible for funding, how funding availability will be announced, where applications should be sent, how funding reimbursement will be managed, and reporting requirements for successful applicants. This information is vital to give all applicants every opportunity to effectively present their applications. Adoption of this rule amendment will assure greater consistency and objectivity in proposal review, and a fair, objective process for awarding funds.

No public comments were received.

The amendments are proposed under the Texas Health and Safety Code Annotated, §102.010 which directs the Council to adopt rules governing the submission and approval of grant requests and the cancellation of grants, and §102.017(c) which directs the Council to establish guidelines for spending the money in the Texans Conquer Cancer Account.

These proposed amendments implement Texas Health and Safety Code, §102.017 and §102.018, which create and govern the Texans Conquer Cancer program, account, and advisory committee.

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 August 11, 2003.

TRD-200305014

Mickey L. Jacobs, M.S.H.P.

Executive Director

Texas Cancer Council

Effective date: August 31, 2003

Proposal publication date: June 13, 2003

For further information, please call: (512) 463-3190