1. A. A licensee operating a freestanding birthing center shall undergo a routine annual survey.
2. B. A licensee shall allow an on-site survey by the Department at any time during the center’s normal hours of operation to evaluate the center’s compliance with the applicable requirements and standards of this chapter.
3. C. Center employees shall make data and records accessible within a reasonable time during the on-site survey.

4. D. Notice of Deficiencies.

   1. (1) If a survey identifies noncompliance with a requirement, the Secretary shall:

      1. (a) Issue a written Statement of Deficiencies that cites each deficiency;
      2. (b) Require the freestanding birthing center to submit an acceptable Plan of Correction within 10 calendar days of receipt of the Statement of Deficiencies;
      3. (c) Notify the freestanding birthing center of any sanctions or that failure to correct the violation may result in sanctions; and
      4. (d) Offer the freestanding birthing center the opportunity for IDR.

5. E. Plan of Correction.

   1. (1) The freestanding birthing center shall submit a written Plan of Correction to the OHCQ that documents steps the licensee will take to come into compliance, including:

      1. (a) How the freestanding birthing center will correct each deficiency;
      2. (b) The date by which each deficient practice will be corrected;
      3. (c) How the freestanding birthing center will prevent the deficient practice from recurring; and
      4. (d) Who will be responsible for ensuring the deficiency will not reoccur.
   2. (2) Failure to return an acceptable Plan of Correction within the allotted time frame may result in a sanction.
   3. (3) A request for an IDR does not change the freestanding birthing center's requirement to submit a Plan of Correction for all deficiencies within 10 calendar days after receipt of the notice of deficiency.

6. F. Immediate Jeopardy.

   1. (1) Declaration of Immediate Jeopardy.

      1. (a) When the OHCQ identifies a situation in which immediate corrective action is necessary because the freestanding birthing center's noncompliance with one or more licensure requirements has already caused, is causing, or is likely to cause, at any time, serious injury or harm, or death, to individuals served by the freestanding birthing center or to the health or safety of the general public, an immediate jeopardy will be declared.
      2. (b) The OHCQ shall provide the freestanding birthing center with a written notice that includes a description of the situation that constitutes an immediate jeopardy.

   2. (2) Removal Plan. The freestanding birthing center shall submit a written removal plan to the OHCQ that includes:

      1. (a) The immediate action a freestanding birthing center will take to prevent serious harm from occurring or recurring;
      2. (b) All actions to remove past, present, and future jeopardy; and
      3. (c) The date by which the freestanding birthing center asserts the likelihood for serious harm to any recipient no longer exists.

   3. (3) OHCQ's Review of the Removal Plan.

      1. (a) The OHCQ shall review the freestanding birthing center's removal plan to determine that the removal plan, if implemented appropriately, will remove the likelihood that serious harm will occur, or recur.
      2. (b) The OHCQ shall verify that the freestanding birthing center has implemented the removal plan.
   4. (4) OHCQ's Approval of the Removal Plan. The OHCQ shall approve the removal plan after verifying that all actions the freestanding birthing center took were effective in removing the likelihood that serious injury, serious harm, serious impairment or death would occur or reoccur.
   5. (5) Plan of Correction. If an immediate jeopardy is identified during a survey, the Plan of Correction must completely correct all noncompliance associated with the immediate jeopardy.

7. G. Informal Dispute Resolution (IDR).

   1. (1) A freestanding birthing center may request an IDR to dispute one or more deficiencies in a Statement of Deficiencies.
   2. (2) The freestanding birthing center shall submit the request for an IDR to the Department within 10 calendar days of receiving the Statement of Deficiencies.
   3. (3) The written request for an IDR shall fully describe the disagreement with the Statement of Deficiencies and be accompanied by all evidence for the Department’s consideration.
   4. (4) At the discretion of the Department, the IDR may be held in person, by telephone, by video conference, or in writing.
   5. (5) IDRs are informal in nature and are not attended by legal counsel representing the freestanding birthing center or the Department.
   6. (6) The IDR process may not delay the effective date of any enforcement action.
   7. (7) In the event a freestanding birthing center requests an IDR of a deficiency written by a designee of the Department, the Department shall request the designee to participate in the IDR process.
   8. (8) There is no appeal of the Department’s decision in an IDR.

Authority: Health-General Article, §19-3B-01 et seq., Annotated Code of Maryland

Effective date: August 23, 1999 (26:17 Md. R. 1322)

Chapter revised effective February 15, 2016 (43:3 Md. R. 272)

Regulation .01B amended effective December 8, 2016 (43:24 Md. R. 1350)

Regulation .06A amended effective December 8, 2016 (43:24 Md. R. 1350)

Chapter revised effective October 13, 2025 (52:20 Md. R. 1000)