1. (a) A facility shall develop, implement, and enforce policies and procedures for a clinical record system to ensure complete and accurate documentation of care provided to each patient. The clinical record system shall make documentation readily available and systematically organized to facilitate the compilation and retrieval of information.

   1. (1) The facility shall centralize all information in the patient's clinical record and protect the record against loss or damage in accordance with state and federal regulations.
   2. (2) The facility shall provide an area for clinical records storage that is separate from all patient treatment areas and secured from unauthorized access. The facility shall store the active clinical record of each patient currently treated by the facility on site.
   3. (3) The facility shall maintain the confidentiality of each patient's personal and clinical records.
   4. (4) The facility shall not use signature stamps to authenticate clinical record entries.
   5. (5) The facility may preserve clinical records electronically. Electronic records shall meet all requirements of paper records, including protection from casual access and retention for the specified period. Systems shall ensure that facility staff may not alter entries regarding the delivery of care without evidence and explanation of such alteration.
   6. (6) The facility shall preserve inactive clinical records by electronic means and may store inactive records off site, as long as the facility maintains security, and ensures the record is readily retrievable for review by the Texas Health and Human Services Commission (HHSC) or HHSC designee.
   7. (7) Each patient's clinical record, whether hard copy, electronic, or a combination of both, shall include complete and pertinent information about the patient's condition, assessments by the interdisciplinary team, updated plans of care, all interventions and treatments prescribed and delivered, and details of any events occurring with the patient during treatment. The record of care shall be readily accessible to every authorized interdisciplinary team member so that safe care can be coordinated to best meet the patient's needs.

   8. (8) Each clinical record shall include:

      1. (A) identifying information;
      2. (B) consents and notifications;
      3. (C) if the patient requires an accommodation, details on how staff explained consent forms for treatment, whether staff obtained the patient's consent, and how staff explained to the patient the patient's rights and responsibilities;
      4. (D) documentation that the physician explained the treatment risks, benefits, and complications to the patient before the patient's first treatment;
      5. (E) documentation that a licensed registered nurse witnessed the patient signing the consent forms before the patient's first treatment;
      6. (F) physician orders;
      7. (G) progress notes;
      8. (H) problem list;
      9. (I) medical history and physical examination;
      10. (J) professional assessments by the registered nurse, social worker, and dietitian;
      11. (K) medications given during treatment, which may be listed on the treatment record; and a list of medications the patient takes at home;
      12. (L) transfusion records;
      13. (M) laboratory reports;
      14. (N) diagnostic studies;
      15. (O) hospitalization records;
      16. (P) consultations;
      17. (Q) records of creation and revision of access for dialysis;
      18. (R) plans of care, including evidence of interdisciplinary team review and adjustment;
      19. (S) evidence of patient education;
      20. (T) daily treatment records; and
      21. (U) discharge summary, if applicable.

2. (b) A facility physician shall complete a comprehensive medical history and physical examination no later than 30 calendar days from the patient's admission to the facility and at least annually thereafter.

   1. (1) For a patient new to dialysis, the physician responsible for the dialysis care shall complete the history and examination.
   2. (2) For an established dialysis patient, the history and examination may be completed by an advanced practice registered nurse or physician assistant.
   3. (3) Before the first treatment in the facility, the physician shall inform the registered nurse functioning in the charge role of at least the patient's diagnoses, medications, hepatitis status, allergies, and dialysis prescription. The patient's clinical record shall include this data.
3. (c) The patient's clinical record shall provide an ongoing and accurate report of the patient's progress, reflecting changes in patient status, plans for and results of changes in treatment, diagnostic testing, consultations, and unusual events. Each interdisciplinary team member shall record the patient's progress as indicated by any change in the patient's medical, nutritional, or psychosocial condition.
4. (d) Facility staff shall note the patient's condition and response to treatment on the daily treatment record.

5. (e) A facility shall ensure care for transient patients meets the following requirements.

   1. (1) Except as provided by paragraph (2)(B) of this subsection, before providing dialysis treatment to a transient patient the facility shall obtain and include, at a minimum:

      1. (A) orders for treatment in this facility;
      2. (B) a list of medications and allergies;
      3. (C) laboratory testing results no earlier than one month before treatment, which include screening for Hepatitis B status;
      4. (D) the most current plan of care;
      5. (E) the most current treatment records from the home facility; and
      6. (F) records of care and treatment at this facility.

   2. (2) If a facility dialyzes a patient who is normally dialyzed in another facility, the facility shall meet the following requirements.

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

      2. (B) If a transient patient arrives unannounced, the facility may provide dialysis after obtaining, at a minimum, from the patient records:

         1. (i) orders for treatment;
         2. (ii) Hepatitis B status; and
         3. (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 this subsection.
   3. (3) In the event a transient patient's hepatitis status is unknown, the patient may undergo treatment as if the Hepatitis B surface antigen (HbsAg) test results were potentially positive, except that the facility shall not treat such a patient in the HBsAg isolation room, area, or machine.
6. (f) Facility staff shall complete clinical records within 30 days after discharge. The discharge summary shall clearly identify the patient's disposition and include the diagnosis or cause of death, date of discharge or death, location of death, transplant, or relocation information when appropriate, and reason for discharge if not for transplantation or death.
7. (g) Clinical records are the facility's property, and the facility shall safeguard clinical records against loss, destruction, or unauthorized use.
8. (h) The facility shall provide copies of pertinent portions of a patient's record when the patient is transferred. The records provided shall include, at a minimum, the most current orders for dialysis treatment, last three treatment records, he current hepatitis status, and current plan of care. If the facility transfers the patient to another outpatient facility, the facility shall provide copies of the most recent history and physical and assessment of each interdisciplinary team member.
9. (i) The facility shall retain records for a minimum of five years after the patient's discharge and in accordance with state and federal regulations. The facility shall not destroy clinical records that relate to any matter that is involved in litigation, unless the litigation has been finally resolved.
10. (j) If a facility ceases operation, it shall arrange for the preservation of records to ensure compliance with this section. The facility shall notify HHSC in writing of the location of the clinical records and the clinical records custodian's name and address.

Source Note:The provisions of this §507.55 adopted to be effective December 23, 2025, 50 TexReg 8289.