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RULE §139.55Clinical Records

(a) A licensed abortion facility shall maintain a daily patient roster of all patients receiving abortion services. This daily patient roster shall be retained for a period of five years.

(b) A licensed abortion facility shall establish and maintain a clinical record for each patient. A licensed abortion facility shall maintain the record to assure that the care and services provided to each patient is completely and accurately documented, and readily and systematically organized to facilitate the compilation and retrieval of information. Information required for the annual abortion report shall be readily retrievable from the clinical record.

  (1) The facility shall have written procedures which are adopted, implemented, and enforced regarding the removal of records and the release of information. A facility shall not release any portion of a patient record to anyone other than the patient except as allowed by law.

  (2) All information regarding the care and services shall be centralized in the record and be protected against loss or damage and unofficial use.

  (3) The facility shall establish an area for patient record storage. The patient records shall be retrievable within two hours by the facility for patients whose date of the last visit is less than twelve months. For patients whose date of the last visit is greater than twelve months, records shall be retrievable within ten days.

  (4) The facility shall ensure that each record is treated with confidentiality.

  (5) The clinical record shall be an original, a microfilmed copy, an optical disc imaging system or other electronic means, or a certified copy. An original record includes manually signed paper records or electronically signed computer records. Computerized records shall meet all requirements of paper records including protection from unofficial use and retention for the period specified in subsection (d) of this section. Systems shall assure that entries regarding the delivery of care or services are not altered without evidence and explanation of such alteration.

  (6) A facility shall maintain clinical records in their original state. Each entry shall be accurate, dated with the date of entry, and signed by the individual making the entry. Correction fluid or tape shall not be used in the record. Corrections shall be made by striking through the error with a single line, and shall include the date the correction was made and the initials of the person making the correction.

(c) The clinical record shall contain:

  (1) patient identifying information;

  (2) name of physician;

  (3) diagnosis;

  (4) history and physical;

  (5) a preanesthesia evaluation performed by personnel approved by the facility to provide anesthesia services;

  (6) laboratory reports;

  (7) report of gross and/or microscopic examination of tissue obtained during a surgical abortion;

  (8) allergies/drug reactions;

  (9) physician's orders;

  (10) progress notes to include at a minimum notations of vital signs; signs and symptoms; response to medication(s) and treatment(s); and any changes in physical or emotional condition(s). These notations shall be written, dated, and signed by the individual(s) delivering patient care no later than 10 days from the day the patient is discharged from the facility;

  (11) education/information and referral notes;

  (12) signed patient consent form;

  (13) medication administration records. Notations of all pharmaceutical agents shall include the time and date administered, the name of the individual administering the agent, and the signature of the person making the notation if different than the individual administering the agent;

  (14) condition on discharge;

  (15) the medical examination or written referral, if obtained;

  (16) physician documentation of viability or nonviability of fetus(es) at a gestational age greater than 26 weeks; and

  (17) for patients receiving moderate sedation/analgesia or deep sedation/analgesia:

    (A) a minimum of blood pressure, pulse, and respirations shall be obtained and recorded before sedation, during sedation, during the procedure, during the initial recovery period, and before discharge from the facility; and

    (B) the patient's blood oxygenation shall be assessed and recorded, a minimum of at the time of sedation, during the procedure, and after the procedure.

(d) A licensed abortion facility shall retain clinical records for adults for seven years from the time of discharge and clinical records for minors for five years past the age the patient reaches majority.

(e) A licensed abortion facility may not destroy patient records that relate to any matter that is involved in litigation if the facility knows the litigation has not been finally resolved.

(f) If a licensed abortion facility closes, there shall be an arrangement for the preservation of inactive records to ensure compliance with this section. The facility shall send the department written notification of the reason for closure, the location of the patient records, and the name and address of the patient record custodian. If a facility closes with an active patient roster, a copy of the active patient record shall be transferred with the patient to the receiving facility or other health care facility in order to assure continuity of care and services to the patient.

Source Note: The provisions of this §139.55 adopted to be effective June 28, 2009, 34 TexReg 4125

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