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(5)The client care plan must include written evidence of the client's or client's legal representative's input and participation, unless they refuse to participate. At a minimum, the client care plan must demonstrate that the content was shared with the client or the client's legal representative. (6)For non-stabilized clients, where there is a change in modality, unacceptable laboratory work, uncontrolled weight changes, infections, or a change in family status, the client care plan must be reviewed at least monthly by the interdisciplinary team. Evidence of the review of the client care plan with the client and the interdisciplinary team to evaluate the client's progress or lack of progress toward the goals of the care plan, and interventions taken when progress toward stabilization or the goals are not achieved, must be documented and included in the client record. (7)For a stable client, the client care plan must be reviewed and updated as indicated by any change in the client's medical, nutritional, or psychosocial condition or at least every six months. The long-term program must be revised as needed and reviewed annually. Evidence of the review of the client care plan with the client and the interdisciplinary team to evaluate the client's progress or lack of progress toward the goals of the care plan, and interventions taken when the goals are not achieved, must be documented and included in the client record. (r)Medication administration. Medications must be administered only by licensed personnel. (s)Client records. In addition to the applicable information described in §97.301(a)(9) of this chapter (relating to Client Records), records of home staff assisted dialysis clients must include the following: (1)a medical history and physical; (2)clinical progress notes by the physician, qualified licensed nurse, qualified dietitian, and qualified social worker; (3)dialysis treatment records; (4)laboratory reports; (5)a client care plan; (6)a long-term program; and (7)documentation of supervisory visits. (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 Department of Aging and Disability Services, 701 W. 51st Street, Austin, Texas 78751-2321, and are available for public inspection during regular working hours. (2)Water used for dialysis must be treated as necessary to maintain a continuous water supply that is biologically and chemically compatible with acceptable dialysis techniques. (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 Department of Aging and Disability Services, 701 W. 51st Street, Austin, Texas 78751-2321, and are available for public inspection during regular working hours. (4)Records of test results and equipment maintenance must be maintained at the agency. (u)Equipment testing. An agency must adopt and enforce a policy to describe how the nurse will check the machine for conductivity, temperature, and pH prior to treatment, and describe the equipment required for these tests. The equipment must be available for use prior to each treatment. This policy must reflect current standards. (v)Preventive maintenance for equipment. An agency must develop, and enforce a written preventive maintenance program to ensure client care related equipment receives electrical safety inspections, if appropriate, and maintenance at least annually or more frequently if recommended by the manufacturer. The preventive maintenance may be provided by agency or contract staff qualified by training or experience in the maintenance of dialysis equipment. (1)All equipment used by a client in home dialysis must be maintained free of defects, which could be a potential hazard to clients, the client's family or agency personnel. (A)Agency staff must be able to identify malfunctioning equipment and report such equipment to the appropriate agency staff. Malfunctioning equipment must be immediately removed from use. (B)Written evidence of all preventive maintenance and equipment repairs must be maintained. (C)After repairs or alterations are made to any equipment, the equipment must be thoroughly tested for proper operation before returning to service. (D)An agency must 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 an agency client. (2)In the event that the water used for dialysis purposes or home dialysis equipment is found not to meet safe operating parameters, and corrections cannot be effected to ensure safe care promptly, the client must be transferred to a licensed hospital (if inpatient care is required) or licensed ESRD facility until such time as the water or equipment is found to be operating within safe parameters. (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)An agency's reuse practice must comply with the American National Standard, Reuse of Hemodialyzers, 1993 Edition, published by the AAMI. An agency must adopt and enforce a policy for dialyzer reuse criteria (including any agency-set number of reuses allowed) which is included in client education materials. (2)A transducer protector must be replaced when wetted during a dialysis treatment and must be used for one treatment only. (3)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. (4)An agency must consider and address the health and safety of clients sensitive to disinfectant solution residuals. (5)An agency must provide each client and the client's family or legal representative with information regarding the reuse practices of the agency, the opportunity to tour the reuse facility used by the agency, and the opportunity to have questions answered. (6)An agency practicing reuse of dialyzers must: (A)ensure that dialyzers are reprocessed via automated reprocessing equipment in a licensed ESRD facility or a centralized reprocessing facility; (B)maintain responsibility and accountability for the entire reuse process; (C)adopt and enforce policies to ensure that the transfer and transport of used and reprocessed dialyzers to and from the client's home does not increase contamination of the dialyzers, staff, or the environment; and (D)ensure that DADS staff has access to the reprocessing facility as part of an agency inspection. (x)Laboratory services. Provision of laboratory services must be as follows. (1)All laboratory services ordered for the client by a physician must be performed by a laboratory which meets the Clinical Laboratory Improvement Amendments of 1988, 42 United States Code, §263a, Certification of Laboratories (CLIA 1988) and in accordance with a written arrangement or agreement with the agency. CLIA 1988 applies to all agencies with laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. (2)Copies of all laboratory reports must be maintained in the client's medical record. (3)Hematocrit and blood glucose tests may be performed at the client's home in accordance with §97.284 of this title (relating to Laboratory Services). Results of these tests must be recorded in the client's medical record and signed by the qualified licensed nurse providing the treatment. Maintenance, calibration, and quality control studies must be performed according to the equipment manufacturer's suggestions, and the results must be maintained at the agency. (4)Blood and blood products must only be administered to dialysis clients in their homes by a licensed nurse or physician. (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)In conjunction with the client's attending physician, the agency must ensure that there are sufficient supplies maintained in the client's home to perform the scheduled dialysis treatments and to provide a reasonable number of backup items for replacements, if needed, due to breakage, contamination, or defective products. All dialysis supplies, including medications, must be delivered directly to the client's home by a vendor of such products. However, agency personnel may transport prescription items from a vendor's place of business to the client's home for the client's convenience, so long as the item is properly labeled with the client's name and direction for use. Agency personnel may transport medical devices for reuse. (z)Emergency procedures. The agency must adopt and enforce policies and procedures for medical emergencies and emergencies resulting from a disaster. (1)Procedures must be individualized for each client to include the appropriate evacuation from the home and emergency telephone numbers. Emergency telephone numbers must be posted at each client's home and must include 911 if available, the number of the physician, the ambulance, the qualified registered nurse on call for home dialysis, and any other phone number deemed as an emergency number. (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)The agency must ensure that the client and the client's family know the procedure for disconnecting the dialysis equipment. (4)The agency must ensure that the client and the client's family know emergency call procedures. (5)A working telephone must be available during the dialysis procedure. (6)Depending on the kinds of medications administered, an agency must have available emergency drugs as specified by the medical director. (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)the receiving hospital is given advance notice of the client's arrival; (B)the receiving hospital is given a description of the client's health status; and (C)the selection of personnel, vehicle, and equipment are appropriate to effect a safe transfer.
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 January 28, 2008
TRD-200800446 Kenneth L. Owens
General Counsel
Department of Aging and Disability Services
Effective date: May 1, 2008
Proposal publication date: October 19, 2007
For further information, please call: (512) 438-3734
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