(a) Patient plan of care.
  (1) A facility shall develop, implement, and enforce policies and procedures on the patient's plan of care process which specifies the services necessary to address the patient's comorbid conditions and other needs based on the patient's interdisciplinary assessment. The patient services are coordinated using an interdisciplinary team approach. The interdisciplinary team shall consist of the patient, 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 plan of care that specifies the services necessary to address the patient's medical, psychological, social, and functional needs, and includes treatment goals.
  (3) The plan of care shall include measurable and expected outcomes and estimated timetables to achieve these outcomes. The plan of care shall include, but not be limited to, the patient's current dose of dialysis, dialysis adequacy, other medical comorbidity issues, nutritional status, mineral metabolism, anemia, vascular access, psychosocial status, modality, transplantation status, rehabilitation status, patient's goals, and patient education and training.
  (4) The patient plan of care 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 continuity of safe care.
  (5) The patient plan of care 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 plan of care shall demonstrate that the content was discussed with the patient or the patient's legal representative by a member of the interdisciplinary team.
  (6) The patient plan of care shall be developed and implemented within 30 calendar days or 13 outpatient dialysis treatments from the patient's admission to the facility. The plan of care shall be revised due to the patient's lack of progress towards the goals of the plan of care, marked deterioration in health status, significant changes in the patient's psychosocial needs, or changes in the patient's nutritional condition, as needed but no less than annually after the date of the patient's last plan of care.
  (7) The facility shall monitor the plan of care at least monthly to recognize and address any deviations from the plan of care as follows:
    (A) implement changes in interventions due to the lack of progress toward the goals of the plan of care;
    (B) document as to the reasons why the patient was unable to achieve the goals; and
    (C) implement changes to address the revised plan of care.
  (8) An interdisciplinary team conference may be conducted via phone conferencing. A phone plan of care conference conducted with the interdisciplinary team and the patient (or their legal representative) shall be documented as a phone conference.
  (9) In the case of disruptive patients or family members or patients who do not conform to the treatment plan, the facility shall develop, implement, and enforce a process for more intensive interdisciplinary 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.
(b) Emergency preparedness.
  (1) In this subsection, unless the context clearly indicates otherwise, "emergency" means an incident likely to threaten the health, welfare, or safety of a facility's patients, facility staff, or the public, including a fire, equipment failure, power outage, flood, interruption in utility service, medical emergency, or natural or other disaster.
  (2) In accordance with Texas Health and Safety Code §251.016, a facility shall implement a written emergency preparedness and contingency operations plan that describes staff and patient actions to manage potential medical and nonmedical emergencies, including fire, equipment failure, power outages, medical emergencies, and natural or other disasters which are likely to threaten the health, welfare, or safety of facility patients, the staff, or the public. The plan shall comply with the following requirements.
    (A) The facility shall update the plan at least annually.
    (B) The facility's leadership shall approve the plan each time the facility updates the plan.
    (C) The plan shall include:
      (i) procedures for notifying each of the following entities, as soon as practicable, regarding the closure or reduction in hours of operation of the facility due to an emergency:
        (I) the Texas Health and Human Services Commission (HHSC);
        (II) each hospital with which the facility has a transfer agreement in accordance with paragraph (10) of this subsection;
        (III) the trauma service area regional advisory council that serves the geographic area in which the facility is located; and
        (IV) each applicable local emergency management agency;
      (ii) a documented patient communications plan that includes procedures for notifying a patient when that patient's scheduled dialysis treatment is interrupted;
      (iii) a continuity of care plan for the provision of dialysis treatment to facility patients during an emergency that meets the requirements under paragraph (4) of this subsection; and
      (iv) a disaster preparedness plan for natural and other disasters that:
        (I) is specific to the facility based on an assessment of the probability and type of disaster in the region and the local resources available to the facility;
        (II) incorporates the use of the HHSC-approved reporting system and participation in the ESRD Network of Texas disaster preparedness activities;
        (III) includes procedures designed to minimize harm to patients and staff along with ensuring safe facility operations;
        (IV) along with in-service programs for patients and staff, includes provisions or procedures for responsibility of direction and control, communications, alerting and warning systems, evacuation, and closure;
        (V) requires each staff member employed by or under contract with the facility to be able to demonstrate their role or responsibility to implement the facility's disaster preparedness plan.
        (VI) designates a person in each facility to monitor and coordinate disaster preparedness activities;
        (VII) maintains in each facility documentation of the monitoring and coordination of disaster preparedness activities; and
        (VIII) addresses the continuity of essential building systems, including emergency power and water, or a contract with another licensed ESRD facility to provide emergency contingency care to patients to meet the requirements of §117.91(h) of this chapter (relating to Fire Prevention, Protection, and Emergency Contingency Plan); and
    (D) except as provided by paragraph (3) of this subsection, requires a facility to execute a contract with another ESRD facility located within a 100-mile radius of the facility stipulating that the other ESRD facility will provide dialysis treatment to facility patients who are unable to receive scheduled dialysis treatment due to the facility's closure or reduction in hours.
  (3) A facility is not required to contract with another ESRD facility under paragraph (2)(D) of this subsection if:
    (A) no other ESRD facility is located within a 100-mile radius of the facility; and
    (B) the facility obtains written approval from HHSC exempting the facility from that requirement.
  (4) A facility shall develop a continuity of care plan for the provision of dialysis treatment to facility patients during an emergency that:
    (A) includes procedures for distributing written materials to facility patients that specifically describe the facility's emergency preparedness and contingency operations plan;
    (B) includes detailed procedures on the facility's continency plans, based on the facility's patient population, including transportation options, for patients to access dialysis treatment at each ESRD facility with which the facility has an agreement or made advance preparations to ensure that the facility's patients have the option to receive dialysis treatment and procedures for notifying a patient when that patient's scheduled dialysis treatment is interrupted;
    (C) is approved by the facility's leadership; and
    (D) is provided by the facility to each patient before providing or scheduling dialysis treatment.
  (5) On request, a facility shall provide the facility's emergency preparedness and contingency operations plan adopted under paragraph (2) of this subsection to:
    (A) HHSC;
Cont'd...
(B) each hospital with which the facility has a transfer agreement in accordance with paragraph (10) of this subsection;
    (C) the trauma service area regional advisory council that serves the geographic area in which the facility is located; and
    (D) each applicable local emergency management agency.
  (6) A facility shall provide annual training to facility staff on the facility's emergency preparedness and contingency operations plan required by paragraph (2) of this subsection.
  (7) A facility shall annually contact a local and state disaster management representative, an emergency operations center, and a trauma service area regional advisory council to:
    (A) request comments on whether the emergency preparedness and contingency plan adopted by the facility under paragraph (2) of this subsection should be modified; and
    (B) ensure that local agencies, regional agencies, state agencies, and hospitals are aware of the facility, the facility's policy on provision of life saving treatment, the facility's patient population and potential transportation needs, and the anticipated number of patients affected.
  (8) A facility shall have a functional plan to access the community emergency medical services.
  (9) 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 direct care staff members shall maintain current certification and competency in BCLS.
  (10) 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 shall 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 shall occur within one working day; and
    (C) security and accountability shall be assured for the transferred patient's personal effects.
  (11) A facility shall 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.
  (12) The facility shall maintain information on the HHSC approved reporting system to be updated online monthly.
(c) Medication storage and administration.
  (1) Pharmaceutical and therapeutic items 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 or an attending physician. Medication shall be administered as ordered.
  (3) All verbal or telephone physician orders shall be documented and authenticated or countersigned by the physician not more than 15 calendar days from the date the order was given.
  (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 be maintained with documentation of the appropriate temperatures for such storage.
  (5) A facility shall maintain emergency 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) Medication vials shall not be taken to a patient station. Intravenous medication vials labeled for single-use shall not be punctured 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, and shall be protected to prevent contamination and casual access of the prepared medications to unauthorized persons. All medications shall be administered by the individual who prepared the medication.
  (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 of this title (relating to Training Curricula and Instructors) and §117.63 of this title (relating to Competency Evaluation). Such administration by dialysis technicians shall be in compliance with Chapter 157 of the Occupations Code concerning the delegation of medical acts by a licensed physician in the State of Texas.
(d) Nursing services.
  (1) Nursing services shall be provided to prevent or reduce complications, to maximize the patient's functional status, and to educate the ESRD patient, the patient's family, patient's caregiver, or significant other.
  (2) A full-time supervising nurse shall be employed to supervise and manage the provision of safe patient care. A contract staff person shall not be considered an employee, and shall not be considered for the full-time supervising nurse.
  (3) A registered nurse shall:
    (A) be in the facility when patients are present in the facility;
    (B) conduct admission nursing assessments;
    (C) conduct assessments of a patient when indicated by a question relating to a change in the patient's status, extended or frequent hospitalizations, or at the patient's request;
    (D) participate in the interdisciplinary team review of a patient's progress;
    (E) recommend changes in treatment based on the patient's current needs;
    (F) facilitate communication between the patient, patient's family or significant other, and other interdisciplinary members to ensure needed care is delivered;
    (G) provide oversight and direction to dialysis technicians and licensed vocational nurses; and
    (H) participate in the facility's QAPI activities.
  (4) A registered nurse functioning in the charge role shall be present during all dialysis treatments.
  (5) 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.
  (6) Sufficient direct care staff, as defined in §117.2(25) of this title (relating to Definitions), shall be on site to meet the needs of the patients, and at least one licensed nurse shall be available on site for every twelve patients or portion thereof.
    (A) During treatment of seven or fewer patients, direct care staff shall consist of one registered nurse and one direct care staff as demonstrated in Table 1 of §117.106 of this title (relating to Tables).
    (B) During treatment of eight but not more than twelve patients, the registered nurse functioning as charge nurse shall not be assigned as direct care staff as demonstrated in Table 1 of §117.106 of this title.
    (C) 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.
  (7) A facility shall ensure that patients are in view of staff during hemodialysis treatments, and shall visualize the patient, their access site, and their bloodline connections during the dialysis treatment.
  (8) 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. There shall be written policies and procedures specific to the facility to guide actions to be taken by the nursing staff in the event a patient's condition deteriorates during treatment, to 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.
Cont'd...
(9) A registered nurse shall conduct the initial patient assessment at the time of the patient's initial dialysis treatment in the facility.
(e) This chapter does not preclude a licensed vocational nurse (LVN) from practicing in accordance with the rules adopted by the Texas Board of Nursing. 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 and §117.63 of this title.
(f) 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.
(g) 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 an interdisciplinary 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 the facility's QAPI 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 initial contact between the dietitian and the patient to assess nutritional status shall occur, and be documented, 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 the patient's admission to the facility, whichever occurs later.
  (4) A nutrition reassessment shall be conducted no less than annually or more often when indicated by a question relating to a change in the patient's status, extended or frequent hospitalizations, a change in the patient's modality, or at the patient's request.
  (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 per facility with the maximum patient load per full-time equivalent of dietitian time being 125 patients for all modalities.
  (6) Nutrition services shall be available at the facility during scheduled treatment times. Access to services may require an appointment.
  (7) There shall be written physician standing orders specific to the facility authorizing delegation of responsibilities for the facility dietitian as determined by the Medical Director and the facility. These standing orders shall be reviewed and approved by the medical director at least annually, and be consistent with the statutes and rules of the Texas Medical Board, the Texas Board of Nursing, and the Texas State Board of Examiners of Dietitians licensure.
  (8) If the facility is using a medication algorithm/protocol for managing renal bone disease the nutritional care for each patient shall be individualized.
(h) 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, which include health-related quality of life surveys;
    (B) participating in the interdisciplinary team review of a patient's progress;
    (C) providing an ongoing assessment and recommend changes in treatment based on the patient's current psychosocial needs;
    (D) providing social work interventions including counseling, 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;
    (F) participating in the facility's QAPI activities; and
    (G) assisting patients to achieve optimum levels of productive activity and making rehabilitation referrals as appropriate.
  (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 no less than annually or more often when indicated by a significant change in the patient's psychosocial needs, extended or frequent hospitalizations, any event that would interfere with the patient's ability to follow aspects of the plan of care, a change in the patient's modality, or at the patient's request.
  (5) Each facility shall employ or contract with a social worker(s) to meet the psychosocial needs of the patients. Personnel shall be assigned to assist a social worker(s) with ancillary tasks (e.g., assistance with financial services, transportation, administrative, clerical, etc.), when the patient load per facility, including all modalities, exceeds 100 patients. The maximum patient load, including all modalities, per full-time equivalent qualified social worker, with assigned personnel assistance, is 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.
(i) Medical services.
  (1) The medical director is responsible for:
    (A) developing facility treatment goals which are based on review of aggregate data assessed through QAPI activities;
    (B) assuring adequate training of licensed nurses and dialysis technicians;
    (C) adequate monitoring of patients and the dialysis process; and
    (D) developing, implementing, and enforcing all policies required by this chapter.
  (2) Medical staff.
    (A) Each patient shall be under the care of a nephrologist 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 dialysis patients shall be seen by a physician, advanced practice registered nurse, or physician's assistant no less than one time a month. If home dialysis patients are seen by an advanced practice registered nurse or a physician's assistant, the physician shall see the patient at least one time every three months. This visit may be conducted in the dialysis facility, at the physician's office, or in the patient's home. The record of these contacts shall include evidence of assessment for new and recurrent problems and review of dialysis adequacy each month.
    (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 physician. Routine orders for treatment shall be updated at least annually. Any changes in patient treatment shall be per physician's order.
Cont'd...
(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.
  (3) Physician Extenders. If advanced practice registered nurses or physician assistants are utilized:
    (A) there shall be evidence of communication with the treating physician whenever the advanced practice registered nurse or physician assistant changes treatment orders;
    (B) the advanced practice registered nurse or physician assistant may not replace the physician in participating in patient care planning or in QAPI activities;
    (C) the advanced practice registered nurse or physician assistant may not replace the physician for the every two week evaluation of the in-center dialysis patient;
    (D) the advanced practice registered nurse or physician assistant shall notify the treating physician of patient medical emergencies;
    (E) if an advanced practice registered nurse or physician assistant is utilized, such individuals shall meet the requirements established by the Texas Board of Nursing (for an advanced practice registered nurse) or the Texas Medical Board (for a physician assistant); and
    (F) if an advanced practice registered nurse or a physician assistant is utilized such individuals shall utilize mechanisms which provide authority for that care. These mechanisms shall include, but are not limited to protocols or other written authorization. The protocols or other written authorization shall be jointly developed by the practitioner and the appropriate physician(s), be signed by both the practitioner and the physician(s), be reviewed and re-signed at least annually, be maintained in the practice setting of the practitioner, and be made available as necessary to the department to verify authority to provide medical aspects of care.
(j) Home dialysis service.
  (1) A dialysis facility that provides home dialysis training and support shall be approved to provide home dialysis services, and ensure through its interdisciplinary team that home dialysis services are at least equivalent to those provided to in-facility patients and meet all applicable licensure rules.
  (2) A facility shall provide a separate room for home dialysis services.
    (A) The room shall include a hand washing sink with hands-free operable controls, warm water, and soap to facilitate hand washing. Provisions for hand drying shall be included at each hand washing sink.
    (B) Clean areas shall be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment. Medications or clean supplies shall not be handled and stored in the same or an immediately adjacent area to that where used supplies, equipment, or blood samples are handled.
    (C) There shall be a designated area in the facility with a separate sink for the disposal of blood or body fluids. Contaminated areas where used supplies, equipment, or blood samples are handled shall be clearly designated.
  (3) On completion of training, each individual home dialysis patient, regardless of modality, shall be assigned one machine for the patient's exclusive use in the home.
  (4) The staffing level for home dialysis patients, including all modalities, shall be one full-time equivalent registered nurse per 20 patients, or portion thereof.
  (5) The training curriculum for the facility that provides home dialysis training and support shall be developed and approved by the medical director of the facility and include, but not be limited to, the following:
    (A) be conducted by a registered nurse with at least 12 months clinical experience and six months experience in the specific modality with the responsibility for training the patient, and the patient's caregiver;
    (B) be conducted for each home dialysis patient and address the specific needs of the patient, in the nature and management of end stage renal disease;
    (C) include the full range of techniques associated with the treatment modality selected, including effective use of dialysis supplies and equipment in achieving and delivering the physician's prescription;
    (D) training of the patient, and/or caregiver regarding the effective, and safe administration of erythropoiesis-stimulating agent(s) (if prescribed) to achieve and maintain a target level hemoglobin, hematocrit, and blood pressure levels, or hematocrit as written in the patient's plan of care;
    (E) training of the patient, and/or caregiver how to detect, report, and manage potential dialysis complications, including water treatment problems;
    (F) training of the patient, and/or caregiver regarding the availability of support resources and how to access and use resources;
    (G) training of the patient, and/or caregiver how to self-monitor health status and record and report health status information;
    (H) training of the patient, and/or caregiver how to handle medical and nonmedical emergencies;
    (I) training of the patient, and/or caregiver regarding infection control precautions;
    (J) training of the patient, and/or caregiver regarding proper waste storage and disposal procedures;
    (K) training of the patient, and/or caregiver how to order supplies on an ongoing basis;
    (L) training of the patient, and/or caregiver that non-medical electrical equipment shall not be used within 6 feet of the home hemodialysis machine; and
    (M) maintain the documentation in the clinical record that the patient, the caregiver, or both received and demonstrated adequate comprehension of the training.
  (6) The interdisciplinary team shall oversee training of the home dialysis patient and the designated caregiver before the initiation of home dialysis, and when the home dialysis caregiver or home dialysis modality changes.
  (7) The dialysis facility shall retrieve and review complete self-monitoring data and other information from the home dialysis self-patient or their designated caregiver(s) at least every two months, and maintain this information in the patient's clinical record in the facility.
  (8) A home dialysis facility shall furnish home dialysis support services, regardless of whether dialysis supplies may be provided by the dialysis facility or a durable medical equipment company.
  (9) Services include, but are not limited to, the following:
    (A) initial monitoring visit of the patient's home adaptation, including visits to the patient's home by facility personnel (including, but not limited to, the registered nurse responsible for training the patient in the chosen modality and technical staff as appropriate) in accordance with the patient's plan of care, and no less than annually thereafter. The initial home visit shall be completed prior to the patient beginning training for the selected home modality.
    (B) The patient shall be seen by the prescribing physician, advanced practice registered nurse, or physician's assistant no less than one time a month. The prescribing physician shall see the patient at least one time every three months, if an advanced practice registered nurse, or physician's assistant sees the patient on a monthly basis. This visit may be conducted in the dialysis facility, at the physician's office, or in the patient's home.
    (C) The development and periodic review of the patient's individualized comprehensive plan of care that specifies the services necessary to address the patient's needs and meets the measurable and expected outcomes, which meet a hemodialysis Kt/V of at least 1.2 (3 times a week), or standard Kt/V of 2.0 (4-6 times a week), or a peritoneal dialysis weekly Kt/V of at least 1.7, or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis.
    (D) The facility shall provide patient consultation with members of the interdisciplinary team, as needed.
  (10) A home dialysis facility shall monitor the quality of water and dialysate used by a home hemodialysis patient including an on-site evaluation and testing of the water and dialysate system initially, and any time repairs or exchanges of the water treatment equipment are made.
    (A) An AAMI analysis of the product water used for dialysate preparation shall be performed annually.
    (B) The water and dialysate system shall be tested in accordance with the manufacturer's direction for use.
Cont'd...
(C) The water and dialysate system shall be tested in accordance with the system's Food and Drug Administration (FDA) approved labeling, for integrated dialysis system designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramines testing) water and dialysate. The facility shall meet testing and other requirements of AAMI RD 52:2004, when using an integrated water and dialysate system, which is designed and validated to meet AAMI quality.
    (D) The bacteriological and endotoxin testing of water used for dialysate preparation and dialysate shall be performed monthly until results do not exceed 200 CFU/ml and an endotoxin concentration less than 2 EU/ml are obtained for three consecutive months and quarterly thereafter, on a more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits.
  (11) The dialysis facility shall correct any water and dialysate quality problem for the home hemodialysis patient, and if necessary, arrange for backup dialysis until the problem is corrected if:
    (A) an analysis of the water and dialysate quality indicates contamination; or
    (B) if the home hemodialysis patient demonstrates clinical symptoms associated with water and dialysate contamination.
  (12) The dialysis facility shall be responsible for the purchase, lease, or rent, and delivery, installation, repair, and shall maintain medically necessary home dialysis supplies and equipment (including supportive equipment) as prescribed by the attending physician. (If the patient purchases, leases or rents dialysis equipment, the facility shall ensure that the equipment is installed, repaired and maintained in accordance with the manufacturer's directions for use.)
  (13) The dialysis facility shall identify a plan and arrange for emergency backup dialysis services when needed.
  (14) The dialysis facility shall maintain a record keeping system that ensures continuity of care and patient privacy.
  (15) Hemodialysis machines of home patients shall be cultured and measured for colony forming units and endotoxins prior to disinfection, if the machine is to be disinfected.
  (16) All dialysis machines and dialysis equipment shall have maintenance logs maintained at the dialysis facility.
  (17) The electrical connection for the home hemodialysis machines shall be connected to a GFCI receptacle in accordance with §117.102(i)(8)(F) of this title (relating to Construction Requirements for a New End Stage Renal Disease Facility).
  (18) Equipment for home hemodialysis includes the conventional (single pass) dialysis machine, the integrated dialysis system, the dialysis system which uses manufactured bagged dialysate, the peritoneal dialysis system which uses manufactured bagged dialysis solution, and the sorbent regeneration system.
    (A) The conventional (single pass) dialysis machine shall comply with the requirements at §117.31 of this title (relating to Equipment), and §117.32 of this title (relating to Water Treatment, Dialysate Concentrates, and Reuse). The facility shall ensure that the water pressure in the patient's home meets the minimum requirement specified by the manufacturer of the water treatment system.
    (B) Integrated dialysis system.
      (i) The facility shall perform an analysis of the source water used for dialysate to ensure the water quality meets the manufacturer's guidelines for source water purity annually or if there is a change in the source water.
      (ii) The chemical quality of the product water shall be obtained every six months prior to a replacement of the water purification disposable component, or when any modifications are made to the integrated dialysis system to ensure that the product water meets the primary standards of AAMI RD 52:2004.
      (iii) A means shall be provided to sample the product water to test for chlorine/chloramines levels immediately prior to using the dialysate. Chlorine/chloramines level shall be less that 0.1 mg/L, and the results shall be documented.
      (iv) The microbiological quality of the dialysate shall be obtained at the end of a prepared dialysate bag, with the requirements at §117.32 of this title.
    (C) The dialysis system, which uses sterile manufactured bagged dialysate, in its existing form, shall be used according to manufacturer's directions for use.
    (D) The peritoneal dialysis system, which uses manufactured bagged dialysis solution, shall be used according to manufacturer's directions for use.
    (E) When sorbent technology is used, the quantity of water used shall not exceed six liters per treatment; and testing for chlorine/chloramines is not required. Prior to each treatment the sorbent regeneration dialysis system (machine) shall be tested through the manufacturer's self-test method, and the evidence of the self-test shall be documented. The facility shall perform an analysis of the source water used for dialysate to ensure the water quality meets the manufacturer's guidelines for source water purity annually or if there is a change in the source water.
  (19) A facility which was licensed prior to the effective date of these rules shall comply with §117.101 of this title (relating to Construction Requirements for an Existing End Stage Renal Disease Facility). A facility which is licensed after the effective date of these rules shall provide a separate training room for home dialysis patients in compliance with §117.102(d)(5) of this title.
(k) If a facility dialyzes a patient who is normally dialyzed in a distant facility, the facility shall meet the requirements in this subsection.
  (1) The facility shall continuously evaluate staffing levels and utilize this information in determining whether to accept a transient patient for treatment.
  (2) The facility shall obtain the information described in §117.47(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:
    (A) evidence of evaluation of the patient by a physician on the staff of the facility;
    (B) orders for treatment;
    (C) hepatitis B status; and
    (D) 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 §117.47(e) of this title.
  (3) 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.
(l) 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.
(m) A facility shall not violate Occupations Code, Chapter 102, concerning the prohibition on soliciting patients or patronage.
(n) The facility shall comply with the Health and Safety Code, Chapter 166, concerning out-of-hospital do-not-resuscitate orders.
(o) A facility or its corporate ownership, shall develop, implement, and enforce a compliance policy for monitoring its receipt and expenditure of state or federal funds.
(p) 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.
(q) 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 shall be completed within 30 calendar days after the facility receives the complaint, unless the facility has and documents reasonable cause for a delay.

Source Note: The provisions of this §117.45 adopted to be effective July 6, 2010, 35 TexReg 5835; amended to be effective February 21, 2023, 48 TexReg 893