(a) - (d)(No change.) (e)Provision of services. An agency that provides home staff-assisted dialysis must, at a minimum, provide nursing services, nutritional counseling, and medical social service. These services must be provided as necessary and as appropriate at the client's home, by telephone, or by a client's visit to a licensed ESRD facility in accordance with this subsection. The use of dialysis technicians in home dialysis is prohibited. (1)Nursing services. (A)(No change.) (B)Dialysis services must be supervised by an RN who meets the qualifications for a supervising nurse as set out in §97.244(c)(2) [§97.244(b)(3)] of this title (relating to Staffing Qualifications). (C)(No change.) (2)Nutritional counseling. A dietitian who meets the qualifications of this paragraph must be employed by or under contract with the agency to provide services. A qualified dietitian must meet the definition of dietitian in §97.2 of this chapter [ title] (relating to Definitions) and have at least one year of experience in clinical nutrition after obtaining eligibility for registration by the American Dietetic Association, Commission on Dietetic Registration. (3)(No change.) (f)Orientation, skills education, and evaluation. (1)All personnel providing dialysis in the home must receive orientation and skills education and demonstrate knowledge of the following: (A) - (Q)(No change.) (R)water treatment to include: (i)standards for treatment of water used for dialysis as described in §3.2.1 (Hemodialysis Systems) and §3.2.2 (Maximum Level of Chemical Contaminants) of the American National Standard, Hemodialysis Systems, March 1992 Edition, published by the Association for the Advancement of Medical Instrumentation (AAMI), 3330 Washington Boulevard, Suite 500, Arlington, Virginia 22201. Copies of the standards are indexed and filed in the [Texas] Department of Aging and Disability [Human] Services, 701 W. 51st Street, Austin, Texas 78751-2321, and are available for public inspection during regular working hours; (ii) - (iv)(No change.) (2)(No change.) (g) - (j)(No change.) (k)Testing for hepatitis B. An agency must conduct routine testing of home dialysis clients and agency employees to ensure detection of hepatitis B in employees and clients. (1)An agency must offer hepatitis B vaccination to previously unvaccinated, susceptible new staff members in accordance with 29 Code of Federal Regulations, §1910.1030(f)(1) - (2) (Bloodborne Pathogens). (A) - (B)(No change.) (C)An agency must establish, implement, and enforce a policy for repeated serologic screening of staff. The repeated serologic screening must be based on each staff member's HBsAg/antibody to HBsAg (anti-HBs), and must be 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 (USDHHS). This document may be obtained by writing the Home and Community Support Services Program, [Texas] Department of Aging and Disability [Human] Services, 701 W. 51st Street, Austin, Texas 78751-2321 or calling 438-3011 or writing the United States Department of Health and Human Services at the Public Health Service, Centers for Disease Control and Prevention, National Center for Infectious Diseases, Hospital Infection Program, Mail Stop C01, Atlanta, Georgia 30333, or calling 404-639-2318. (2)(No change.) (l) - (r)(No change.) (s)Client records. In addition to the applicable information described in §97.301(a)(9) of this chapter [title] (relating to Client Records), records of home staff assisted dialysis clients must include the following: (1) - (7)(No change.) (t)Water treatment. (1)Water used for dialysis purposes must be analyzed for chemical contaminants every six months. Additional chemical analysis must be conducted if test results exceed the maximum levels of chemical contaminants listed in §3.2.2 (Maximum Level of Chemical Contaminants) of the American National Standards for Hemodialysis Systems, March 1992 Edition, published by the AAMI. Copies of the standards are indexed and filed in the [Texas] Department of Aging and Disability [Human] Services, 701 W. 51st Street, Austin, Texas 78751-2321, and are available for public inspection during regular working hours. (2)(No change.) (3)Water used to prepare dialysate must meet the requirements set forth in §3.2.1 (Hemodialysis Systems) and §3.2.2 (Maximum Level of Chemical Contaminants), March 1992 Edition, published by the AAMI. Copies of the standards are indexed and filed in the [Texas ] Department of Aging and Disability [Human] Services, 701 W. 51st Street, Austin, Texas 78751-2321, and are available for public inspection during regular working hours. (4)(No change.) (u) - (v)(No change.) (w)Reuse or reprocessing of medical devices. Reuse or reprocessing of disposable medical devices, including but not limited to, dialyzers, end-caps, and blood lines must be in accordance with this subsection. (1) - (5)(No change.) (6)An agency practicing reuse of dialyzers must: (A) - (C)(No change.) (D)ensure that DADS [DHS] staff has access to the reprocessing facility as part of an agency inspection. (x)(No change.) (y) Home dialysis supplies. Supplies for home dialysis must meet the following requirements. (1) All drugs, biologicals, and legend medical devices must be obtained for each client pursuant to a physician's prescription in accordance with applicable rules of the Texas State Board of Pharmacy. (2)(No change.) (z)Emergency procedures. The agency must adopt and enforce policies and procedures for medical emergencies and emergencies resulting from a disaster [addressing fire, natural disaster, and medical emergencies]. (1)(No change.) (2)The agency must ensure that the client and the client's family know the agency's procedures for medical emergencies and emergencies resulting from a disaster. (3) - (6)(No change.) (7)In the event of a medical emergency or an emergency resulting from a disaster requiring transport to a hospital for care, the agency must assure the following: (A) - (C)(No change.)
This agency hereby certifies that the proposal
has been reviewed by legal counsel and found to be within the agency's
legal authority to adopt.
Filed
with the Office of the Secretary of State on October 8, 2007
TRD-200704750 Kenneth L. Owens
General Counsel
Department of Aging and Disability Services
Earliest possible date of adoption: November 18, 2007
For further information, please call: (512)
438-3734
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