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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 137BIRTHING CENTERS
SUBCHAPTER CSURVEY PROCEDURES AND ENFORCEMENT
RULE §137.21On-Site Surveys

(a) Requirement for on-site surveys. A representative of the department may enter the premises of a license applicant or license holder at reasonable times to conduct a survey incidental to the issuance of a license, and at other times as it considers necessary to ensure compliance with the Act and the rules adopted under the Act.

(b) Initial on-site survey.

  (1) The department shall conduct the on-site survey within 90 calendar days of the date of issuance of the initial license to determine if the center meets the requirements of the Act and this chapter.

  (2) The on-site survey shall include a standard-by-standard evaluation.

  (3) At the time of the initial on-site survey, the center shall assure that the administrator or his or her designee(s) is present during the survey.

  (4) If at the time of the initial on-site survey, the center has not admitted its first client for antepartum, intrapartum, or postpartum care, the center must notify the Manager, Health Facility Compliance Group, Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756, when the first such admission and care delivery does occur.

    (A) Within seven calendar days of the first client admission, the center shall submit a copy of the clinical record to the department for review.

    (B) The department shall review the clinical record(s) to evaluate the center's compliance with the care delivery standards of this chapter.

  (5) Upon completion of the on-site survey, a department surveyor shall verify a center's compliance with the provisions of the Act and this chapter and recommend to the department:

    (A) that the center's initial license be continued for the duration of the initial license period; or

    (B) that the department propose an enforcement action.

(c) Subsequent on-site surveys. After the initial on-site survey that is required for an initial license under subsection (b) of this section, an on-site survey shall be performed at least every three years with the following exceptions.

  (1) If the department has written deficiencies for the center under the following provisions of this chapter, that may pose a threat to the health and safety of the center's clients and/or staff, the department shall conduct another on-site survey no later than one year after issuance of the initial or renewal license:

    (A) §137.31 of this title (relating to Operational and Clinical Policies);

    (B) §137.32 of this title (relating to Organizational Structure and Delegation of Authority);

    (C) §137.33(4) and (5) of this title (relating to Personnel Policies);

    (D) §137.34 of this title (relating to Qualifications and Duties of Staff);

    (E) §137.36 of this title (relating to Physical and Environmental Requirements for Centers);

    (F) §137.37 of this title (relating to Infection Control Standards);

    (G) §137.38 of this title (relating to Disposition of Medical Waste);

    (H) §137.39 of this title (relating to General Requirements for the Provision and Coordination of Treatment and Services);

    (I) §137.40 of this title (relating to Risk Assessments);

    (J) §137.41 of this title (relating to Emergency Services);

    (K) §137.48 of this title (relating to Labor and Birth Procedures);

    (L) §137.49 of this title (relating to Care of the Newborn);

    (M) §137.50 of this title (relating to Discharge Procedures); and

    (N) §137.55 of this title (relating to Other State and Federal Compliance Requirements).

  (2) If the department has taken enforcement action against a center and the action allowed the center to remain licensed, the department shall conduct another on-site survey.

  (3) This subsection does not limit complaint surveys by the department.

(d) Survey procedures.

  (1) Prior to the survey, the department may notify the applicant or licensee, in writing by fax or mail to the mailing address of the center, of the date and time of the survey. The department is not required to notify the applicant or licensee prior to a complaint investigation.

  (2) At the start of the survey, the department's surveyor shall notify the person who is in charge of a center of the nature and scope of the survey.

  (3) Except for a complaint investigation or a follow-up visit, a survey will include a standard-by-standard evaluation.

  (4) When the survey is completed, the surveyor shall hold an exit conference and fully inform the person who is in charge of the center of the preliminary findings of the survey and shall give the person a reasonable opportunity to submit additional facts or other information to the surveyor in response to those findings. A written response may be filed and must be received by the department within 14 calendar days of receipt of the preliminary findings of the survey by the center. The surveyor shall identify any records that were duplicated. Any original center records that are removed from a center shall be removed only with the consent of the center.

  (5) After the survey is completed, the department shall provide the administrator of the center specific and timely written notice of the findings of the survey within 14 calendar days of the exit conference.

  (6) If the department determines that the center is in compliance with minimum standards at the time of the on-site inspection, the department will send a license to the center, if applicable.

  (7) If the surveyor determines there are no deficiencies found, a statement shall be provided to the center indicating this fact.

  (8) If the surveyor finds there are deficiencies, the center and the department shall comply with the following procedure.

    (A) The department shall provide the center with a statement of deficiencies within 14 calendar days of the exit conference.

    (B) The center administrator shall sign the written statement of deficiencies and return it to the department with its plan of correction(s) for each deficiency within 14 calendar days of its receipt of the statement of deficiencies. The signature does not indicate the person's agreement with deficiencies stated on the form.

    (C) The department shall determine if the written plan of correction is acceptable. If the plan of correction(s) is not acceptable to the department, the department shall notify the center and request that the plan of correction be modified and resubmitted no later than 14 calendar days from the date notified.

    (D) The center shall come into compliance in accordance with the plan of correction or no later than 60 calendar days prior to the expiration of the license, whichever is sooner.

    (E) Acceptance of a plan of correction by the department does not preclude the department from taking enforcement action as appropriate under §137.22 of this title (relating to License Denial, Suspension, Probation, or Revocation).

  (9) The department may refer issues and complaints relating to the conduct or actions by licensed health care professionals to their appropriate boards.


Source Note: The provisions of this §137.21 adopted to be effective December 2, 2007, 32 TexReg 8507

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