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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 117END STAGE RENAL DISEASE FACILITIES
SUBCHAPTER DMINIMUM STANDARDS FOR PATIENT CARE AND TREATMENT
RULE §117.47Clinical Records

(a) A facility shall develop, implement, and enforce policies and procedures for a clinical record system to assure that the care provided to each patient is completely and accurately documented, readily available, and systematically organized to facilitate the compilation and retrieval of information.

  (1) All information shall be centralized in the patient's clinical record and be protected against loss or damage in accordance with state and federal regulations.

  (2) The facility shall provide an area for clinical records storage which is separate from all patient treatment areas, and shall be secured from unauthorized access. The facility shall store the active clinical record of each patient currently treated by the facility on site.

  (3) The facility shall ensure that each patient's personal and clinical records are treated with confidentiality.

  (4) Signature stamps shall not be used to authenticate clinical record entries.

  (5) Clinical records may be preserved electronically. Computerized records shall meet all requirements of paper records, including protection from casual access and retention for the specified period. Systems shall assure that entries regarding the delivery of care may not be altered without evidence and explanation of such alteration.

  (6) Inactive clinical records may be preserved on microfilm, optical disc, or other electronic means, and may be stored off site as long as security is maintained and the record is readily retrievable for review by the department or the department's designee.

  (7) Each patient's clinical record, whether hard copy, electronic, or a combination of both, shall include complete and pertinent information about the condition of the patient, 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 the course of treatment. The record of care shall be readily accessible to every authorized member of the interdisciplinary team so that safe care can be coordinated to best meet the needs of the patient.

  (8) Each clinical record shall include:

    (A) identifying information;

    (B) consents and notifications;

    (C) physician orders;

    (D) progress notes;

    (E) problem list;

    (F) medical history and physical;

    (G) professional assessments by the registered nurse, social worker, and dietitian;

    (H) medication record to include medications given during treatment (which may be listed on the treatment record) and a listing of medications the patient takes at home;

    (I) transfusion record;

    (J) laboratory reports;

    (K) diagnostic studies;

    (L) hospitalization records;

    (M) consultations;

    (N) record of creation and revision of access for dialysis;

    (O) plans of care, including evidence of interdisciplinary team review and adjustment;

    (P) evidence of patient education;

    (Q) daily treatment records; and

    (R) discharge summary, if applicable.

(b) A comprehensive medical history and physical shall be completed within 30 days of a patient's admission to the facility and no less than annually thereafter. For a patient new to dialysis, the physician responsible for the dialysis care shall complete the history and physical. For an established dialysis patient, the history and physical may be completed by an advanced practice registered nurse or physician assistant. Prior to 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 clinical record shall include this data.

(c) The clinical record shall provide an ongoing and accurate picture of the progress of the patient, reflecting changes in patient status, plans for and results of changes in treatment, diagnostic testing, consultations, and unusual events. Each of the interdisciplinary team members shall record the progress of the patient as indicated by any change in the patient's medical, nutritional, or psychosocial condition.

(d) The patient's condition and response to treatment shall be noted on the daily treatment record.

(e) Prior to providing dialysis treatment of a transient patient, a facility shall obtain and include, at a minimum:

  (1) orders for treatment in this facility;

  (2) list of medications and allergies;

  (3) laboratory reports. Such reports shall indicate laboratory work was performed no later than one month prior to treatment at the facility and include screening for hepatitis B status;

  (4) the most current plan of care;

  (5) the most current treatment records from the home facility; and

  (6) records of care and treatment at this facility.

(f) Clinical records shall be completed within 30 days after discharge. The discharge summary shall clearly identify the disposition of the patient 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.

(g) Clinical records are the property of the facility and shall be safeguarded against loss, destruction, or unauthorized use.

(h) Copies of pertinent portions of a patient's record shall be provided when the patient is transferred. The records provided shall include, at a minimum, the most current orders for dialysis treatment, the last three treatment records, the current hepatitis status, and the most current plan of care. If the patient is transferred to another outpatient facility, copies of the most recent history and physical and assessment of each member of the interdisciplinary team shall also be provided.

(i) Records shall be retained by a facility for a minimum of five years after the discharge of the patient and in accordance with state and federal regulations. The facility may not destroy clinical records that relate to any matter that is involved in litigation, if the facility knows the litigation has not been finally resolved.

(j) If a facility ceases operation, there shall be an arrangement for the preservation of records to insure compliance with this section. The facility shall send the department written notification of the location of the clinical records and the name and address of the clinical records custodian.


Source Note: The provisions of this §117.47 adopted to be effective July 6, 2010, 35 TexReg 5835

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